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Name of University Maharashtra University of Health Sciences, Nashik Name of Course M.S. (Shalakyatantra) Name of Subject Shalakyatantra Admission Year (Academic) of the student 2018-2019 Submission Year (Academic) of the student 2020-2021 Topic Randomized Comparative Clinical Trial to Study the Efficacy of Agaruwadi Dhoopana and Guggula Dhoopana in Karnasrava w.s.r. to Otomycosis

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Name of University Maharashtra University of Health

Sciences Nashik

Name of Course MS (Shalakyatantra)

Name of Subject Shalakyatantra

Admission Year (Academic) of

the student

2018-2019

Submission Year (Academic) of

the student

2020-2021

Topic Randomized Comparative

Clinical Trial to Study the

Efficacy of Agaruwadi

Dhoopana and Guggula

Dhoopana in Karnasrava wsr

to Otomycosis

Page | 1

INDEX

No Chapter Page No

1 Introduction 2-5

Study Rationale

Epidemiological data

2 Aims and objectives 6

3 Research Question 6

4 Previous work done 7

5 Review of Literature 8-73

i Literary Review

ii Disease Review

iii Drug Review

iv Procedure review

6 Materials and methods 74-91

7 Observations and Results 92-122

8 Discussion 123-136

9 Summary and conclusion 137-142

10 References 143-155

11 Bibliography 156-157

12 Annexures 158-182

i Case Record Form

ii Consents

iii Master Charts

Page | 2

INTRODUCTION

Page | 3

Ayurveda is ancient science of life a system of health and medicine

which aims to assist people in living a healthy life It is a person-centered

medicine which deals with healthy lifestyle systemic diseases prevention

diagnosis and treatment Ayurveda is divided into eight branches[1] It has

a separate branch of clinical and surgical specialization concerning ENT and

ophthalmology known as Shalakyatantra One out of the eight branches of

Ayurveda Shalakyatantra deal with the etiology diagnosis prognosis

prevention treatment and complication of diseases which are located at

Urdhwang Pradesh[2]

Karna is one among the Panchendriya (sense organ) situated at

Urdhwang Pradesha [3] It is originated from Akash Mahabhuta Aachary

Sushruta explains 28 Karnaroga in Uttaratantra Karnaroga Vigyniyam

Aadhaya[4] He mentioned Karnasrava as separate diseases[5] Aacharya

Charaka explain 4 Karnaroga He had not described Karnasrava as

independent diseases but explain Karnasrava as a symptom under four

Karnaroga Acharya Vagbhata mentioned Karnasrava as a symptom in

Karnashoola according to Dosha He included this into Kaphaj Karnashoola

itself[6] Karnasrava means discharge through ear The Samanya Hetu of

Karnaroga are Avashaya or Pratishaya that is common cold Sheeta Vihara

or exposure to cold environment Karnakandu or self-inflicted trauma by

use of ear bud or pine to clean itching in ear Shabda Shashtra Mithyayoga

that is misuse of instrument or listening to high sound frequencies[7] The

other predisposing factors are such as abuse of nonspecific broad-spectrum

antibiotics steroids and immune suppressed disorders

Classical features of Karnasrava can be compared with otomycosis

Otomycosis is acute sub-acute or chronic fungal infection in external ear

which rarely involves the middle ear[8] Otomycosis is characterized by pain

itching discharge conductive deafness of mild to moderate in nature

Fungal spores invade in the epithelial layer of EAC In response to that

inflammatory process starts which will reflect as pain Itching is due to

immune reaction of body during inflammatory process As a result of

Page | 4

inflammatory process exudates were produced which will mix up with

fungal colonies and appear as discharge In initial stage of disease ear

discharge is watery but if there is secondary bacterial infection occur it

becomes mucopurulent Ear blockage and conductive type of hearing loss

are due to accumulation of fungal mass in external auditory canal

Fungal mass appears white or black or brown and is like a wet piece

of filter paper Examination with otoscope Aspergillus Niger appears black

headed filaments growth Aspergillus fumigates as a pale blue or green and

candida as a white or creamy deposit[9]

Otomycosis is a common condition and it mostly occurs in humid

area According to American academy of otolaryngology prevalence of

otomycosis is 52 all over a world and 09 in India 5-25 otitis externa

cases are due to otomycosis Nearly 61 types of fungal species being involve

in otitis externa 90 of fungal infection cases involve Aspergillus species

and the rest candida species[10]

In Ayurveda The common treatment Principle for all is Ghritapana

Rasayana Bhramacharaya Avyayama (Excessive exercise)

Ashirasnana(Head bath) Atibhashashya(Excessive speaking) This can be

used for the prevention and management of Karnaroga[11] Acharya

Sushruta explain specific treatment modality for Karnasrava is

Karnaprakshalana Karnapoorana Karnadhoopana Shirovirechana

Karnadhavana[12]These therapeutic procedure can be updated according to

different stages of these condition

In routine OPD it is observed that patient of otomycosis respond

more frequently to topical therapy than to systemic therapy Among all the

treatment modality Karnadhoopana is an effective and simple procedure

In this regard Karnadhoopana with Agaruwadi Varti or uggula had explain

in Ashtang Samgraha Agaruwadi Varti contain Agaru Yawa Madanphala

All these contains of Agaruwadi Varti and Guggula acts as Ruksha Ushna

Teekshana Laghu Guna acts as effective Shodhaka keeps ear dry reduce

Page | 5

pain discharge foul smell and thus control the infection Dhoopana is also

useful as Adhidaivika Chikitsa to protect the patient from external attack of

visible and invisible organism The principal treatment modality adopted in

Allopathic system of medicine is oral antibiotics and topical antibiotic drop

Long term use of oral antibiotic causes adverse effect like gastric irritation

reduce immunity and resistance to drug Long term use of topical antibiotic

drops cause Ph change in external canal which become prone to fungal

infection

Hence the therapeutic procedure with Guggula or Agaruwadi Varti

Karnadhoopana are cost effective safe and easy procedure and it can be

used more effectively

Page | 6

AIM OF STUDY

To evaluate the effect of Agaruwadi Varti Dhoopana and Guggula Varti

Dhoopana in management of Karnasrava

OBJECTIVE

To compare the efficacy of Agaruwadi Dhoopana and Guggula Dhoopana in

Karnasrava

HYPOTHESIS

NULL HYPOTHESIS -

H0- Agaruwadi Dhoopana is not effective than Guggula Dhoopana in

Karnasrava

ALTERNATE HYPOTHESIS -

H1- Agaruwadi Dhoopana is more or equally effective than Guggula

Dhoopana in Karnasrava

RESEARCH QUESTION

Whether there is significant difference between Agaruwadi Dhoopana and

Guggula Dhoopana in Karnasrava

Page | 7

PREVIOUS WORK DONE -

1 Anupama Patra B Effect Of Arka Taila In The Management Of

Karnasrava With Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching amp Research in Ayurveda

Gujarat Ayurved University Jamnagar 2007

2 Palmer Komalben K Further Study On Role Of Arka Taila In The

Management Of Karnasrava With Special Reference To

Otomycosis Shalakya Tantra Institute for Post Graduate Teaching amp

Research in Ayurveda Gujarat Ayurved University Jamnagar 2010

3 Sathisha Shankar B Management Of Karnasrava With Sthanika

Guggulu Dhoopana And Rasnaadi Guggulu-A Comparitive Study Shalakya

Tantra Government Ayurvedic Medical College Bangalore 2011

4 Shashikala DK Comparative Study On The Efficacy Of Vacha

Lashunaadi Taila Karna Pichu And Nimba Patraadi Dhoopana In The

Management Of Karna Srava Shalakya Tantra Government Ayurvedic

Medical College Bangalore 2014

5 Javale Anant A Clinical Study On The Efficacy Of Arka Taila In The

Management Of Karna-Srava Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching amp Research in Ayurveda

Gujarat Ayurved University Jamnagar 2005

6 Pournima V Koti Management Of Karnasrava With Priyangvadi Taila

Pichu With And Without Saarivadi Vati Shalakya Tantra Sri Jagadguru

Gavisiddeswar Ayurvedic Medical College Koppal 2015

7 Amisha Patel A Clinical Evaluation Of Honey In The Management Of

Karna Shoola With Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching and Research in Ayurveda

Gujarat Ayurved University Jamnagar 2016

Page | 8

REVIEW OF LITRATURE

Page | 9

Ayurvedic literature Ayurveda is a science of life practice since

thousands of years The ancient Indian system of medicine and surgery is

commonly known as Ayurveda This was given the status of Upaveda or

fifth Veda in the next stage of growth Among the available literature three

Samhita that is Charaka Samhita Sushrut Samhita Ashtang Hrudayam and

Ashtang Samgraha are the chief source of knowledge of Ayurveda

Ayurveda consist of eight branches Shalakyatantra is one among them

Shalakyatantra is one of its specialized branch deals with science of

ophthalmology otorhinolaryngology Oro dental surgery and head Acharya

Sushruta himself a practical surgeon was the first to advocate dissection of

dead bodies is indispensable for a successful student of surgery He had

described gross anatomy in the first chapter of Uttartantra Shalakyatantra

define by different Acharys as follows

शालाकय नामोरधवजतरगताना रोगाणा शरणनयनदनघराणाददसशरशरताना वयाशरिनामपशमनारव

स स ११०

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत [13]

चस १७१२

Shalakya Tantra Nirukti and Parichaya

शलाकायााः कमव शालाकय ततपपरिान शलाकयम डलहण [14]

The term Shalakyatantra is derived from Shalakya and Tantra

The word Shalakya means A probe and Tantra denotes teaching and

practices found in scripturesThe compendium in which application of

Shalaka in various surgical procedures is principally described is called as

Shalakya tantra

दनदटिवशारदााः शालाककनाः डलहण ( सउ ११३)[15]

An eye specialist is termed as Shalaki by Dalhana

Page | 10

Synonyms of Shalakya Tantra

Uttamanga Chikitsa Jatrurdhwa Chikitsa Urdhwang Chikitsa Shalakya

Chikitsa

Importance of Shalakyatantra-

Life of living being and all the Indriyas are situated in the head hence it is

known as Uttamanga

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत

चस १७१२

The treatment given to this part of the body is described specially in

Shalakya tantra While describing the importance of Shiras Vagbhata

correlates it to the root of tree (Urdhwa Mula) and body to the trunk of tree

(Adha Shaka)

Sushruta has deal with Mukha Roga in Nidan Shan and its treatment in

Chikitsasthan The description regarding the disease of eye ear nose and

head are found only in UttaraSthan Sushruta specially describes the

disease of Shalakyatantra as told by Videha in the beginning of Uttartantra

itself[16]

Shalakyatantra Itihas-

India Exhibits traditional of more than thousands of years in art literature

language logic and philosophy etc The convention was in its sophisticated

and advanced attire throughout the Vedic period

Vedic period ndash

1 Natush was treated for deafness by Ashwinikumars (Rigveda)

2 Rujaswa and Kanva were treated for blindness by Ashwani Kumaras

(Rigvedas)

Page | 11

3 There are several prayers mentioned for normal functioning of sense

organs (Yajurveda)

4 Structures and functions of Mastishka are described (Atharveda)

5 Mantras having reference to disease of Eye Ear Oral cavity etc are

found (Atharvaveda)

Upanishada Period ndash

1 Samhita Period

a) Sushrut Samhita ndash

bull Explanation regarding Netra Nasa and Shirorogas (Uttartantra 1-

26th chapter)

bull Details regarding Mukha and Karna Roga Nidan and

Chikitsa(Nidansthan 16th and Chikitsasthan 22nd chapter)

bull Description regarding Karna Chedana Sandhana Nasa

Ostasandhana Sutra Sthan 16th chapter

b) Charaka Samhita -

bull Explanation regarding Shirorogas (Sutrasthan 17th chapter)

bull Explanation of Gala rogas like Upajivika Galshundi and Rohini

bull Nasa Shiro Mukha Karna and Netra Chikitsa (Chikitsa sthan 26th

chapter)

bull Description regarding Lakshana and Chikitsa of Shankhaka

Ardhavbhedaka Shirovirechana and Shiro basti (siddhi sthan 9th

chapter)

c)Ashtnga Sangraha ndash

bull Detailed description regarding Shalakyatantara (Uttartantra 11-28

chapter)

bull Description of Kriyakalpa (Sutrasthan 32nd and 33rd)

Page | 12

d)Ashtang Hrudayam

bull Detailed description on Shalakya Tantra (Uttar tantra 8-24 chapters)

bull Kriyakalpas (Sutrasthan 23rd and 24th chapter)

e) Bhela Samhita

bull Chakshushya Vaisheshik and Buddhi Vaisheshik Alochaka pitta

f) Harita Samhita- Branch of Medical science offering elaborating

information about the procedure like Nasya Anjan Gandusha etc

comprehended with their applications in disease of Head Eyes Ears

Eyebrows Throat Temporal region and cervical spine is known as

Shalakyatantara

शशरोरोगा नतररोगा कणवरोगा वशषताः भरकरठशङकमरयास य रोगा समिनदरत दह १३

तषा परततकारकम व नसतयतपयवणजनातन च अभयङगमखगणडषकियााः शालकयसशमतााः १४

इतत शालाकयनाम [17]

Documentation of different ancient literature gives various references

regarding all aspects of Karnasrava in various periods It is very much

important to know the history of Karnasrava from Vedic Pauranic Samhita

and Samgraha period

Vedic period ndash The Vedas being the oldest source of knowledge have no

direct mentioning of Karnasrava

Page | 13

Samhita and Samgraha period ndash

Aacharya Sushruta described about Karnaroga Karnasrava Nidan

Roopa and Chikitsa The detail description is available in Sushrut

Samhita Uttartantra 20 and 21st chapters

Aacharya Charaka did not specify Karnasrava but mentioned 4 types

of Karnarogas that is Vataj Pittaj Kaphaja and Sannipataja and their

treatment in 26th chapter of Chikitsasthan

In Ashtang Hrudaya karnasrava is not explained as a separate disease

but Chikitsa is mentioned in 18th chapter of Astanga Hrudaya

uttartantra

In Ashtang Samgraha Chikitsa is mentioned in 22nd chapter of Astang

Samgraha Uttartantra

The details about Karnasrava are explained in Bhavprakasha

Madhyamakhanda 64th chapter

Madhavakara has explained about Karnasrava in 57th chapter of

Madhymakhanda

Karnasrava is also explained in Sharangadara Samhita Uttarkhand 11th

chapter

The reference for treatment of Karnasrava is available in

Yogaratnakara

In Gadhnigraha Karnasrava and its treatment is mentioned in

Karnarogadhikara Adhaya

Vangasena had mentioned about the disease and treatment in 69th

chapter

Chakradatta explained Karnasrava in 57th chapter

Dalhana has given commentary on Sushrut Samhita Uttartantra 20th

and 21st chapter

Sankhya Samprapti of Karnasrava ndash

Aachary Sushruta explains 28 Karnaroga in Uttaratantra Karnaroga

Vigyniyam Aadhaya Aacharya charaka explain 4 Karnaroga in

Page | 14

Karnarohvigyniyam Adhaya based on doshas Acharya Vagabhata in

Ashtang Hrudaya explain 25 Karnaroga in Adhyaya

कणवशल परणादशरच बाशरियव कषड ए च

कणवसरााः कणवकणडाः कणव चवसतततर च

कशमकणवपरततनाहौ विशरिदवविसततरा

कणवपाकाः पततकणवसततराशवशरचतवविम

कणावबवद सपतवि शोफशरचावप चतवविाः

ऎत कणवगता रोगा अटिावशततरीररतााः

स उ २०- ३ त ५[18]

ातकणवरोग वपततकणवरोग कफकणवरोग

रकतकणवरोग सनदरनपातकणवरोग कणवनाद

बशरिरतप परततनाह कणडाः शोफ पततकणवक

किशमकणवक उियरपविरधयअशो अबवद

कशरचकणवक वपपपली वदाररका पाळीशोष

ततिका पररपोिो उतपपातो उरमरर दाःखिवन

शलहाखयााः परचवशनदरतकणवरोगा उकतााः

इदिीका अ स उ २१ [19]

चतपाराः कणवरोगााः

च स [20]

Page | 15

KARNA

Karna ndash करोतत शबद गरहण [21]

The organ of hearing

Karnasrava- कणवसतय कणवयोाव ससराा [22]

Discharge from the ear is referred as Karnasrava

KARNA SHAREERA

bull Nirukti

कणयवत अकणयवत अनन इती [23]

It means reception and conduction of sound waves

These are the functions of external and middle ear

bull Nirukti of Sravanam

शरयत अनन इती शरणम[24]

It means perception of sound

It can be attributed to the internal ear function

bull Karna Utpatti-

Karna is an organ formed by Akash Mahabhuta[25]

The fundamental characteristic is as follows

Indriya ndash Srotram [26]

Indriya Adhisthan ndash Karna [27]

Indriya Dravy ndash Akasha [28]

Indriya Arth ndashShabdha [29]

Indriya buddhi ndash Srotobyddhi

Page | 16

bull Paryaya of Karna- Shabdapatha Srotrapatha Sravanam shruti

Kuhuram Dwanigraham etc

bull Definition of Karna-

कणवशटकलयनदछिरनमिटिोपगरदहत शरोतरमछयत [30]

मा तन ५७१

The definition of Karna is stated in Madhav Nidanam Indriya which is not

seen with naked eye along with Shashkuli is called Shrotra that is Karna

Indriya is so minute that it is not perceived with any sense organ

In Charak Samhita the word Karna explain as the Indriya Adhisthan of

Shabdha Karna is described as one of the Prathyangas of the body He

emphasizes that all Indriyas manifest during the 3rd month of gestation

period

Acharya Sushruta while describing formation of Purusha from Prakriti or

Avyakta narrated that all Indriyas are developing from the Vikarika and

Taijas Ahankara Both Vagabhata and Sushruta stated that Karna as one of

the Bahirsrotas

शरण नयन दन घराण गदमढराणण न सततरोताशसराणा बदहमवखातन [31]

स शा ५-१०

In Ashtang Hradaya Vagbhata has states that all Indriyas are Atmaja

According to him lower lobule elevated helix projected posterior portion

fleshy and adherent ear are indications of long span of life[32]

ततरखातखातन दह अनदसतमन शरोतर शबद ववकतता [33]

ा शा ३-३

शबदाः शबदनदरिय सवनदछििसमहो ववकतता [34]

स शा १-२६

Page | 17

Ear has the prominence of Akash Mahabhuta The prominent dosha of ear

is Vata It is important seat of Vata The prominent Dhatus are Asthi and

Mamsa Karna is one of the Panchgnanendriyas and it meant for hearing

Sushruta narrated that Karnasthita Asthi and Sandhi

घराणकणवगरीाकषिकोषष तरणातन [35]

सशा ५-२२

शरोतरशरगािकष शखाताव [36]

सशा ५-३२

गडकणवशखटककम [37]

स शा ५-२२

One Sandhi and one Tarunasthi in ear

Sandhi ndash Karna contain two Sandhi one in each ear Type of Sandhi is

Shankhavartha which is present in Shringataka

Mansapeshi ndash 2[38]

Siras ndash 10 [39]

Vataj Sira - 4

Pittaj sira - 2

Kaphaj sira - 2

Raktaj Sira - 2

Avedhya sira-

कणवयोदवश तासा शबदादहनीनामकका पररहरत

सशा ७-२५[40]

Amongst above mentioned ten Siras each Karna lodges one Shabdavaha

Sira It is Avedhya

Page | 18

Dhamani -2

Length of ear is 4 Angula

Karna moola ndash 2 Angula

कणाविरतर चतदवशअगलम

स शा ३५-१४[41]

The distance between two ears through the back of the neck is 14 Angula

bull Marmas of Karna-

1 Vidhuras-

कणवपटठतो अिाःसशरशरत विर ततर बशरियवम

सशा ६-३७[42]

कणतपयादद सतनायममवणी ककनदचचनदरनममनाकर कलयकररणणच

डलहणाचयव[43]

अिसततात कणवयोतनवमन विर शरततहाररणण

ा शा ४-२९[44]

Sankhya-2

Vistara- frac12 Angula

Type- Snayumarma (Susha)

- Dhamanimarma(AH)

- Vaikalykar

Sthana- It is situated in the depressed portion in the back of the ear

Injury to them causes loss of hearing

Page | 19

2 Shringataka marma-

नदजवहाकषिनाशसकाशरोतरखचतटियसरमम

तालरयासतयातन चतपारर सरोतसा तष ममवस

वदि शरगातकाखयष सददसततपयजतत जीवतम

मा तन ५७१ [45]

Sankhya- 4

Type- Siramarma

Sthana- It is in head that is amidst Siras (blood vessels) nursing sense

organ

A palm size area near Talu

Injury to this Marma causes death

In modern anatomy ear divides into Bhayakarna or External ear Mdhyakarn

or Middle ear Antahkarna or Internal ear This is extremely appropriate

Even though the ear is divided into three divisions in the point of modern

anatomy Ayurveda denotes ear organ is one Ayurveda treats disease by

way of assessing Dosha and Dushya Here Dushya is one that is Karnendria

Dosha difference will call for different treatment for different disease Hence

treating the vitiated Dosha will cure the disease irrespective whether it is in

external middle or internal ear The thought is based on different

fundamental principle from Ayurveda

bull Parts of Karna

In Ayurveda classics detailed description about anatomy of ear is not

available But the various parts are mentioned as follows

Bhayakarna- External ear

Mdhyakarna ndash Middle ear

Antahkarna- Internal ear

Page | 20

द कणवशटकशलक दॊ कणवपतरकौ

च शा 7-11[46]

कणवशटकशलक कणवगतातवकौ कणवपतरकौ त बाहयकणा

चिदतत च शा 7-11[47]

शटकली बाहयपालयाशरिटिानम

डलहन- स शरच 25-1 12[48]

Karna Shashkulika ndash It is also called as Karna Shashakuli Charaka has

mentioned this term while describing different Pratyngas of the body

Acharaya Gananatha sen has given the clarification for it as a pinna or

auricle[49]

Karnapali ndash It is popularly known as lobule of the ear Daivakrita Chidra is

present in it

Karnaputrika- Ayurvedic scholars accepted two terms in this cortex They

are Karnaputrika and Karnaputrika The former is considered as Tragus and

antitragus[50]

Karna Prushtha- It can be taken as the cranial surface of mastoid or

auricle[51]

Karnapeetha- Aacharaya Sushruta firstly mention the term Karnapeetha

It is mentioned first by Sushruta while describing the procedure of

Karnavyadana Vagbhata has mentioned that it is Adhobhaga of Karna

Dalhana has clarified that it is the region above the Karnaputrika that is the

region which is at the bottom of the concha

Karnamoola ndash It can be considered as parotid region[52]

Karna lathika ndashAcharaya Dalhana mentioned lobule as a Karna Lathika

Page | 21

Karnaavatu ndashThis term is used by Sushruta while describing the

measurements of different Angapratyangas where he has mentioned that

the distance between the Karnaavatu is 14 Angul Dalhana has comments

that it can be taken as the distance between two ears from behind[53]

Shabdhavahasrotas ndash It also called as Shabdapatha or Srotapatha The

whole passage through which the sound waves pass can be taken as

Shabdavahasrotas[54]

Shrotashringataka ndash It can be taken as the labyrinth of ear[55]

bull Dosha in context to Karna-

Karna is principal location of Vayu

1 Prana Vayu- Prana Vayu circulating in oral cavity is responsible for

Dehadhruka that is keeping all body parts active Indriyadruka that is

keeping all Dnyanendriya healthy by proper nourishment (Purana) helps in

deglutition of food material and convey the stimulation of Indriyabuddhi

and atma

2 Udana Vayu- Bala(strength) Varna speech singing are its function It

is responsible for facial expressions due to pleasure sorrow anger love

frustration etc in general its circulation and actions are just opposite to

Pranavayu

3 Vyana Vayu- Its principal functions are circulation of Rasa and Rakta

through body and various movements Its main location is Hrudaya Five

types of movements for which it is responsible are expansion contraction

upward downward and oblique other activities are opening closure of

eyelid yawning perspiration During circulation if it gets obstructed due

to Srotodushti it generates disease of that Srotas Vyana Vayu gets vitiated

by disease of Rasa Rakta Oja and Chetanadhatu

Page | 22

4 Samana Vayu- It is circulating in the vicinity of stomach and intestine

and helps in keeping the Jatharagni (digestive juices and enzymes) in

equilibrium Disturbance in Jatharagni precipitates disease

5 Tarpaka Kapha- Entire body functions movements are controlled and

executed by various centers in the brain Sensation perceived by sense

organs is conveyed to Mann and Aatma residing in Hrudaya The motor

signals from them are then conveyed to the functioning

organsKarmendriya through Prana Vayu Shira head is therefore a

location of continuous activities motions of Vata All these centers are in

unctuous Majjadhatu in the Shira For stabilizing this ever-active Vata and

to nourish the Majja dhatu very unctuous Tarpaka Kapha situated in Shira

plays an important role

bull Ayurvedic aspect of sound perception [56]

According to Ayurveda Pratyaksha Dnyan or Perception of any sensation

including Shabda occurs due to interaction of the Karnendriya and the

Indriya- Arth -Karma resulting in Sravana

External Environmental acquaintance with living body is executed by five

sense organs namely Netra Karna Nasa Jivha and Twaka All

Dnyanendriya that is sense organ are Panchmahabhautic combination

Despite this fact every Indrya sense organ perceives object Tanmatra of

that Mahabhuta only from which it is originated from Akash Mahabhuta and

hence perceives Shabd only that is audio perception Shrotrendriya is one

of the principal locations of Vata and its function is to perceive Shabda that

is sound waves This sensation is conveyed through Shabdavahi Dhamanis

to Mana and Atma through Pranavayu and the sequence is responsible for

perception of sound in this way external sound is perceived and interpreted

when Atma is linked with Mann Mann is linked with Indriyabuddhi that is

minute virtual Dnyanendriya located in brain Indriyabuddhi is linked with

Adhishthana with prominent Mahabhuta and lastly with Indriya

ArthShabdatanmatra that is sense object Once this sequence is completed

Page | 23

the meaning of a particular sound is interpreted and understood In this

entire process of perception and interpretation of sound waves Pranavayu

and Tarpaka Kapha located in Shira play extremely important role Hence

the healthy status of all the sense organ depends upon the normal

physiologically homeostatic condition of Pranavayu and Tarpaka Kapha

MANAS

ATAMA

BUDDHI

AHANKARA

ARTHA

Page | 24

EAR ANATOMY

bull Embryology of the Ear [57]

1 The sound conducting apparatus develops from the branchial apparatus

whereas the sound perceptive apparatus from the ectodermal otocyst

2 The pinna develops from the six hillocks around the 1st branchial cleft

3 External auditory canal develops from 1st branchial cleft

4 The outpouching of the 1st pharyngeal pouch gives rise to a proximal

narrow part that forms the eustachian tube and distal dilated part that

forms the middle ear cavity

5 Prussakrsquos space is a potential space lateral to the Shrapnellrsquos membrane

and medically by the neck of malleus that can be involved during the

extension of cholesteatoma

6 Development starts in the 3rd week of the intrauterine life and is

completed by 16th week of intrauterine life Membranous and boney

labyrinth develops from the otic capsule

The Ear is divided into

1 External Ear

2 Middle Ear

3 Internal Ear or the labyrinth

Page | 25

Fig 1 Ear Anatomy

EXTERNAL EAR [58]

The outside ear contains pinna and lobule

Pinna is the noticeable piece of outer ear made from single sheet of yellow

flexible ligament covered by subcutaneous tissue and skin It has two

surfaces average and parallel It is intently disciple to perichondrium on its

sidelong surface while it is somewhat free on average surface Pinna

incorporates tragus helix against helix fossa three-sided scaphoid fossa

incisura terminalis

External auditory Canal ndash It extends from the bottom of the conchea to

the tympanic membrane and measures about 24 mm along its posterior

wallit is S shaped

Parts 1 Cartilaginous part

2 Bony part

Page | 26

Cartilaginous part ndash The outer one third is cartilaginous consist of fibro

cartilage is directed first inward backward and upward It has Fissure of

Santorium The skin of this part of the canal contains hair follicles

sebaceous gland and cruminous gland

Bony part ndash The inner two third part is boney It goes forward downward

and medially skin lined in this part is very thin Isthmus is the narrowest

part of the canal lying medial to junction of bony and cartilaginous part

nearly 5 mm lateral to tympanic membrane

The roof and posterior wall of the external auditory canal shorter than floor

and anterior wall The skin lining the tympanic membrane and boney canal

has a self-cleansing property due to migration of keratin layer of epithelium

from drum towards the cartilaginous portion

Relations- Anteriorly- Temporomandibular joint and parotid gland

Superiorly- Middle cranial fossa

Inferiorly- parotid gland

Posterior- Mastoid antrum mastoid air cells and facial nerve

Nerve supply ndashSensory nerve supply of the external ear The auricle

supplied by fibers of the great auricular nerve (C2 and C3) and lesser

occipital nerve (C2) Auriculo temporal branch of the 5th cranial nerve and

auricle branch of the vagus (Arnoldrsquos nerve) supply external canal Facial

nerve has small sensory contribution on posterior-inferior wall

Tympanic Membrane -It is the partition between EAC and middle ear It

is a thin semitranslucent membrane pearly white in colored lying obliquely

in the medial end of EAC with the angle of 55 It is forming major part of

lateral wall of middle ear Annulus tympanicus is attached at its

circumference to the sulcus The TM is oval shape It measures

approximately 10 mm in vertical diameter and 90 mm in horizontal

diameter

Page | 27

Layers ndash Tympanic membrane consist of three layers

1 Outer Epithelium or cuticular layer which is continuous with skin of

external ear

2 Middle fibrous layer has both circular and radial fibers middle layer

missing in upper part

3 Inner layer- Inner mucosal layer which is continuous with middle ear

mucosa

Parts ndash Tympanic membrane consist of two parts

1 Pars tensa -It is largest part below the malleolar folds The inner

surface at the center attached to the handle of malleus Angle of cone

is most illuminated part in the pars tensa at anteroinferior part of pars

tensa

2 Pars flaccida Sharpnells membrane -it is triangular area above the

malleolar folds which are thin and devoid of fibrous tissue and

annulus It fits into notch of Rivinous

Nerve supply 1 Anterior half of lateral surface Auriculotemporal V3

2 Posterior half of lateral surface Auricular branch of vagus cn 10

3 Medial Surface Tympanic branch of CN 9 (Jacobsons nerve)

Fig 2 Tympanic membrane of ear

Page | 28

MIDDLE EAR [59]

The middle ear or tympanic cavity is an irregular laterally compressed

space within the temporal bone It is filled with air that is supplied to you

from the nasal part of the throat through the ear canal It contains a chain

of mobile bones that connect its side with the medial wall and serve to

transmit vibrations transmitted to the eardrum through the cavity to the

inner ear Including the parapet the vertical and anteroposterior diameters

of the cavity are each approximately 15 mm The transverse diameter

measures about 6mm at the top and 4mm at the bottom Compared to the

eardrum it is only about 2mm The eardrum is limited laterally by the

eardrum medially by the lateral wall of the inner ear It communicates

behind with the tympanic antrum and through it with the air cells of the

mastoid and in front with the auditory canal The middle ear together with

the Eustachian tube aditus antral and mastoid air cells is called the

middle ear cleft It is lined by mucus membrane and filled with air

It is divided into 3 parts

1 Mesotympanum (located in front of the pars tensa)

2 Epitympanum or attic (located above the pars tensa but medial to

Sharpnells membrane and the lateral bony wall of the attic)

3 Hypotympanum (located under pars tensa) The middle ear is like a

hexagonal box with a roof

Carotid or Anterior wall- It separates middle ear cavity from internal

carotid artery The various structure passing through anterior wall of

tympanic cavity

bull Canal of chorda tympani nerve

bull Canal of tensor tympani muscle

bull Eustachian tube

bull Anterior malleolar ligament

bull Anterior tympanic artery

Page | 29

Posterior or mastoid wall ndash The upper part of the back wall shows the

opening of the auditorium Below the auditory is a triangular bony

projection known as the pyramidalis processors The stapedial tendon is

transmitted through the apex of the pyramidalis processes The vertical

portion of the facial nerve descends along the posterior wall until it opens

into the stylomastoid foramen

Roof or Tegmental wall (Pars terminalis)- It is formed by a thin bone

plate called the tegman tympanum that separates the skull and tympanic

cavities It is located on the anterior surface of the rocky part of the

temporal bone near the junction with the temporal shell it extends back to

the roof in the tympanic membrane and anteriorly to cover the half canal

of the tensor tympanic muscle The lateral border corresponds to the

remains of the Petro scaly suture

Floor ndash It is formed by a thin plate of bone which separate middle ear from

the bulb of the internal jugular vein lodged in the jugular fossa

Lateral wall ndash It is formed by tympanic membrane and partly by a portion

of squamous part of the temporal bone It separates the middle ear from

external ear

Medial wall- It separates the middle ear from the inner ear

bull The promontory is the most prominent and convex part formed by the

basal rotation of the cochlea

bull The bony lateral semicircular canal is postero-superior to the promontory

above the oval window

bull The oval window is located between the middle ear and the vestibular

slope of the cochlea It is closed by the stirrup footrest and the annular

ligament

Page | 30

bull The round window is located under and behind the cape The round

window recess is directed to the rear It is closed by the secondary eardrum

and separates the middle ear of the Scala tympani from the cochlea

bull The facial nerve passes through the bony fallopian tube above the oval

window

Mastoid Antrum ndash It is a large space with air in the upper part of the

mastoid and communicates with the attic through the aditus The roof is

formed by the antri tegmen which extends and separates the tympani

tegmen from the middle cranial fossa The lateral wall of the antrum is

formed by a bony plate that is on average 15 cm thick in adults It is

marked externally on the surface of the mastoid by the suprameatal triangle

(MacEwen)

Aditus and Antrum- Aditus is a gap through which the attic communicates

with the antrum The boney prominence of the horizontal canal lies on its

medial aspect even as the fossa incudes to thats attaches the quick system

of incus lies laterally Facial nerve publications simply underneath the

aditus

The mastoid and its air cell system-

The mastoid consists of bone cortex with a honeycomb of air cell

underneath Depending on development of air cell three types of mastoids

have been described

1Well-pneumatized or cellular- Mastoid cells are well developed and

intervening septa are thin

2Diploetic- Mastoid consist of marrow spaces and a few air cells

3Sclerotic or acellular ndash There are no cells or marrow spaces

With any type of mastoid pneumatization antrum is always present In

sclerotic mastoids antrum is usually small and the sigmoid sinus is

anteposed

Page | 31

Depending on the location mastoid air cells are divided into

1 Zygomatic cells (In the root of zygoma)

2 Tegman cell (Extending into tegmen tympani)

3 Perisinus cells (overlying the sinus plate)

4 Retrofecial cells (round the facial nerve)

5 Peri labyrinthine cells (located above below and behind the

labyrinthine some of them pass through the arch of superior

semicircular canal These cells may communicate with the petrous

apex)

6 Peritubal (around the Eustachian tube Along with hypotymoanic

cells they also communicate with the petrous apex)

7 Tip cells (which are quite large and lie medial and lateral to the

digastric ridge in the tip of mastoid)

8 Marginal cells (Lying behind the sinus plate and may extend into

the occipital bone)

9 Squamosal cells (Lying in the squamous part of temporal bone)

Development of Mastoid ndash

The mastoid develops from the scaly petrous bone The petrosquamosal

suture may persist in the form of a bone plate - Korners septum which

separates the superficial squamosal cells from the deep rock cells Korners

septum is surgically important because it can cause problems locating the

antrum and deeper cells and thus lead to incomplete removal of the disease

during mastoidectomy The mastoid antrum can only be reached if Korners

septum is removed

Page | 32

Fig 3 Cross section of Mastoid

Contents of the middle ear

Ossicles ndash Three tiny bones which conduct the sound from eardrum to oval

window

Malleus ndash It is the largest and most lateral ossicle measuring 8 mm in

length It has head neck handle anterior and lateral processes The head

is situated in the epitympanum A lateral process project laterally from the

neck while the handle is firmly fixed to the pars tensa of the ear drum

Incus- It has a body short process and long process The body short

process and long process The body articulate with the head of mallelus in

the attic and the short process project into the attic The long process

projects downwards behind the handle of malleus running parallel to it and

articulate with the head of the stapes via the lenticular process

Stapes ndash It is the smallest ossicle measuring about 35 mm and consist of

head neck footplate and anterior and posterior curcura The footplate of

stapes is held to the oval window by the annular ligament

Page | 33

Muscles ndash

1Tensor tympani ndash It is inserted is a branch of the facial nerve which carries

the sense of taste It is first arch muscle supplied by branch of mandibular

nerve V3

2 Stapedious muscles ndash It is inserted to the neck of stapes It is the second

arch muscle supplied by branch of facial nerve that is nerve to stapedius

Fig 4 Contents of the middle ear

Blood supply of Middle Ear

bull Anterior tympanic branch of maxillary artery which supplies tympanic

membrane

bull Stylomastoid branch of posterior auricular artery which supplies middle

ear and mastoid air cells

Page | 34

Four minor vessels are

bull Petrosal branch of middle meningeal artery runs along greater petrosal

nerve

bull Superior tympanic branch of middle meningeal srtery traversing along

the canal for tensor tympanic muscle

bull Branch of artery of pterygoid carotid

bull Tympanic branch of internal carotid

Lymphatic Drainage of Ear

Lymphatics from the middle ear drain into retropharyngeal and parotid

nodes while those of the Surgical Importance ndash Eustachian tube drain into

retropharyngeal group

1 The middle ear is part of contiguous organs including nose nasopharynx

Eustachian tube and mastoid bone lined by respiratory mucosa Any

respiratory infection or allergy is likely to pass to middle is likely to pass to

middle ear

2 Moreover middle ear suppurative disease may spread to adjacent organs

and produce complication eg Labyrinthitis meningitis facial nerve palsy

etc

3 Lenticular process is vulnerable in suppurative ear diseases and causes

ocular disruption

4 Prussac space is the site of primary acquired cholesteatoma

Page | 35

INNER EAR [60]

Inner ear is divided into two parts

1 Bony Labyrinth

2 Membranous labyrinth

Anatomy of bony labyrinth

It is divided into two parts

1 Vestibule

2 Cochlea

3 Semicircular canal

The vestibule is located between the medial wall of the middle ear and the

lateral to internal acoustic meatus anterior to the semicircular canal and

posterior to the cochlea The vestibule is the central part of the inner ear

On its side is the oval window opening which is closed by the bracket foot

plate The bony cochlea is located in front of the vestibule It has 275 turns

wound around a bony axis called a modiolus The cochlea is about 30 mm

long The hollow center of the modiolus is a spiral canal that contains the

fibers and ganglion cells of the cochlear nerve A thin bony sheet the bony

lamina winda around the modiolus This divides the cochlear duct into two

galleries the Scala vestibuli above and the scala tympani below

There are three semicircular canals superior posterior and lateral They

are semicircular in shape and open into the vestibule One end of the

semicircle is enlarged and is known as the sphere

The membranous labyrinth is in the bony labyrinth It is connected to the

bony labyrinth by fibrous trabeculae and is surrounded by perilymph The

endolymph is located in the membranous labyrinth

Page | 36

The utricle is in the upper part of the vestibule while the saccule is found

below Both the utricle and saccule contain a single sensory patch called

the macula Each macula is covered with a neuroepithelium made up of

neuroepithelium made up of sensory hair cells and support cells these cells

are separated by a basement membrane Fibers of the vestibulo-cochlear

nerve enter the macula and pierce the basement membrane to terminate

at the base of the hair cell or cell bodies The utricle and the saccule with

their macula are called otolith organs Membrane semicircular canals are

the membrane canals of the corresponding bony semicircular canals They

open into the utricle through five openings One end of the opening of each

channel is dilated called the sphere in which the sensory organ of each

channel is located The cross section of the Scala standard looks like a right

angle The base is formed by the basilar membrane Sensory cells are

arranged on the surface of the basilar membrane These sensory cells with

their supporting cells form a complex neuroepithelium called the basilar

papilla or the cortical organ named after an Italian microscopist The

organs of the corti have a gelatinous membrane called the tectorial

membrane and they are supported by the pillar of the corti The cortical

pillars enclose a space called the corti tunnel which contains a fluid called

cortical lymph Vestibule is lies between the medial wall of the middle ear

and lateral to internal acoustic meatus anterior to semicircular canal and

posterior to the cochlea Vestibule is the central part of the internal ear On

its lateral surface is the opening of oval window which is closed by the foot

plate of stapes Boney cochlea lies in front of the vestibule It has 275 turns

coiling around boney axis called modiolus Cochlea is approximately 30 mm

in length The hollow center of the modiolus is a spiral canal containing the

fibers and ganglion cells of cochlear nerve A thin boney sheet the osseous

lamina winda around the modiolus This divides the cochlear canal into two

galleries the Scala vestibuli above and the scala tympani below

Page | 37

Semicircular canals are three in number superior posterior and lateral

They are semicircular in shape and opens into the vestibule One of the

ends of the semicircular is enlarged and is known as ampulla

Membranous labyrinth is situated within the boney labyrinth It is connected

to the bony labyrinth by fibrous trabeculae and is surrounded by perilymph

Endolymph is situated within the membranous labyrinth

The utricle lies in the upper part of the vestibule while the saccule lies below

Utricle and saccule both contain single sensory patch called macula Each

macula is covered by neuroepithelium consist of Neuroepithelium consists

of sensory hair cells and supporting cells these cells are separated by

basement membrane Fibers from the vestibulo cochlear nerve enter the

macula and pierce the basement membrane to end either at the base of the

hair cell or cell bodies The utricle and saccule with their macula are referred

to as otolith organs Membranous semicircular ducts are the membranous

ducts in the corresponding bony semicircular canals They open into the

utricle by five openings One end of the opening of each canal is dilated

called ampulla in which the sensory organ of each canal is located The

cross section of Scala media resembles a right angle Its base is formed by

basilar membrane Upon the surface of the basilar membrane the sensory

cells are arranged These sensory cells with their supporting cells form a

complex neuroepithelium called the basilar papilla or Organ of corti named

after an Italian Microscopist Organ of corti has a gelatinous membrane

called tectorial membrane and they are supported by pillar of corti The

pillars of corti enclose a space called tunnel of corti which contains fluid

called corti lymph

Page | 38

Fig 5 Inner Ear

Blood supply of labyrinth

Labyrinthine artery

Common cochlear Anterior vestibular Artery

Vestibulocochlear artery Main cochlear artery

Cochlear branch posterior vestibular artery

Page | 39

PHYSIOLOGY OF HEARING [61]

A sound signal in the environment is collected by the pinna passes through

external auditory canal and strikes the tympanic membrane Vibrations of

the tympanic membrane are transmitted to stapes footplate through a chain

of ossicles coupled to the tympanic membrane Movements of stapes foot

plate cause pressure changes in labyrinthine fluids which move the basilar

membrane This stimulates the hair cells of the Organ of corti It is these

hair cells which act as transducers and convert mechanical energy to

electrical impulses which travel along the auditory nerve

Thus the mechanism of hearing can be broadly divided into

bull Mechanical conduction of sound (conductive apparatus)

bull Transduction of mechanical energy to electrical impulses (sensory

system of cochlea)

bull Conduction of electrical impulses to brain (neural

Fig 6 PHYSIOLOGY OF HEARING

Page | 40

Conduction of sound

Under the surface of water we cannot hear the sound made in air because

9995 of sound energy are reflected away from the surface of water because

of the impedance offered by it A similar situation exists in the ear when

air-conducted sound must travel to cochlear fluids Nature has

compensated for this loss of sound energy by interposing the middle ear

which converts sound of greater amplitude but lesser force to that of lesser

amplitude and greater force This function of middle ear is called impedance

matching mechanism or the transformer action It is accompanied by

a) Lever action of the ossicles

Handle of malleus is 13 times longer than long process of incus providing

a mechanical advantage of 13

b) Hydraulic action of tympanic membrane

The area of tympanic membrane is much larger than the area of stapes foot

plate the average ratio between the two beings 211 As the effective

vibratory area of the tympanic membrane is only two- thirds the effective

areal ratio is reduced to 141 and this is the mechanical advantage

provided by the tympanic membrane

c) curved membrane effect

Movements of tympanic membrane are more at the periphery than at the

center where handle of malleus is attached This too provides some

leverage

Transduction of mechanical energy to electrical impulses

Movements of stapes footplate transmitted to cochlear fluids move the

basilar membrane setting up shearing force between the tectorial

membrane and hair cells The distraction of hair cells gives rise to cochlear

microphonics which triggers the nerve impulse

Page | 41

Neural pathways

Hair cells get innervation from bipolar cells of spiral ganglion Central axons

of these cells collect to form cochlear nerve which goes to ventral and dorsal

cochlear nuclei From there both crossed and uncrossed fibers travel to

superior olivary nucleus lateral lemniscus inferior colliculus and medial

geniculate body and finally reach the auditory cortex of the temporal lobe

Page | 42

DISEASES REVIEW

करणसराव

Nirukti - करणसय कणवयोाव ससराा [62]

Nidana- Acharya Sushruta and Vagbhata describe the common etiological

factors for the Karnaroga

अशयाय जलिीडा कणवकणडयन मरत

शमथययोगन शसततरसतय कवपतो अरय च कोपन ||

सउ २० १२

1 Avashaya or Pratishaya

(Excessive exposure to cold)

2 Jalakrida

(Excessive swimming)

3 Karnakandunyanum

(Excessive scracing due to itching)

4 Mithyayogena Shatrasya

(Improper instrumentation during wax removal or foreign body removal)

5Shabdasya

(Louder sound for long durationperverted contact of sound)

6 Abhighata (Trauma)

7 Vitiation of Tridoshas

Page | 43

Samanya Nidana according to different Samhita

Vishesh Nidan of Karnasrava

Acharya Charaka has not mentioned any kind of Nidana regarding Karnaroga

but has described Utapati of Karnaroga from Siroroga in Karnasirasym

Adhyaya[67]

शशरोअशिघातादरा तनमजजतो जल परपकादरा अवप विि

सरतत पय शरणॊ अतनलात स कणवससरा इतत परककतीत

सउ २० १०

असस ३७२५ [68]

1 Shiroabhighatat - Head Injury-Fracture of middle cranial fossa

2 Jala nimajjana - CSF otorrhoea fracture of middle cranial fossa

3 Karnaprapaka

4 Karna Vidhradhi -Puyasrava

Sr

no

Samanya Nidana SU AH[63] AS[64] YR[65] MN[66]

1 Avashaya + + +

2 Pratishaya + +

3 Shabdha

mithyayoga

+

4 Shashtra

mithyayoga

+ + +

5 Karnakandooyan + + + + +

6 Jalkrida + + + + +

7 Abhighata + + +

Page | 44

Samanya samprapti

परापय शरोतरशसरा कयावत शल शरोतशस गान

त कणवगता रोगा अटिावशततरीता

सउ २० १२

Due to common and specific etiology factors the vitiated Doshas gets

Sthanasamshraya in Karna and causes Karnasrava It is the stages of

Samprapti were Doshas gets lodged in Srotas and start processes of Dosh

Dushya Sammurchsna Due to Shiroabhighata Jalanimmajana Karna Paka

Karna Vidhradi vitiated Vata Dosha and Karna becomes Avruta by Vata and

results in Karnasrava Normal physiology of Dosha Dhatus and Malas entirely

depends on the normality of Srotas Dosh Dushya Sammurchana or

manifestation of diseases will not take place if only vitiation of Doshas take

place without deformity of Srotas Here in Karnasrava vitiation of Srotas are

Atipravritti Sanga and Vimargagamana take place Atipravritti is being excess

production of fungus Sanga is obstruction in external acoustic canal

Vimargagamana is the propagation of discharge through ear

Vishesh Samprapti

Karnasrava occurs due to Nij nidana is Pratishaya while Agantuja nidanas are

Avashya Jalkrida and Karnakanduyan Due to etiological factors which are

Vata-Kapha provocative in nature gradual vitiation of Doshas will occur After

vitiation they get accumulated (Sthan samshraya) in external auditory canal

In other hand when patient does Sevana of Agantuj Nidan like water enter in

external ear scratching of ear unsterile instrumentation leads to Dosh

Prakopa These cause Twak and Mamsa Dhatu Dushti which leads to

discontinuity of epithelium of ear canal which creates suitable atmosphere for

fungal pathogen to grow The vitiated Vata will produce symptoms such as

Page | 45

pain hearing impairment and vitiated Kapha causes symptoms like itching

discharge ear blockage By assessing the symptoms it can be said that Kapha

Avrita Vata Dosha is responsible for the manifestation of clinical features like

pain itching discharge Which are seen in Karnasrava that is otomycosis

Acharya Charaka has mentioned while explaining Samanya Chikitsa of

Karnaroga that it should be treated like Vrana when Paka and Srava is present

as a symptom Fungal spores invade in the epithelial layer of EAC In response

to infection inflammatory process is start This is a Paka Avastha After

removing the fungal mass ulceration in external acoustic canal is commonly

seen As a result of infection process exudates was produced which will mix

up- with fungal colonies and appear as discharge As per Dosha involvement

in Vrana Shoola Srava can be differ According to Acharya Sushruta Ruk is

the Samanya Lakshana of Vrana and Vishesha Lakshana of Vrana includes

pain discharge discoloration itching etc according to Dosha involvement

which are also seen in otomycosis In otomycosis mainly watery and purulent

type of discharge is present which indicates Paka avastha If there is Dosha

involve in Vrana is called Dushta Vrana Acharya Sushruta and Acharya

Vagabhata have mentioned verity of Srava in Twak and Mamsa Vranavastu

which is found in otomycosis Based on this description otomycosis can be

correlated with Karnasrava

Page | 46

Representing the Samprapti of Karnasrava

Vishesh Nidana ndash Shiroabhighatat

Jala nimajjana

Prapaka Vidhradhi

Vitited vata

Avarana by kapha

Vimargagamana of Vata

Karnasrava

Samprapti Ghataka

Dosha ndash Kapha and Vata

Dushya ndash Rasa Rakta and Mansa

Strotodushti ndash Vimargagamana and Sang

Adhishthana ndash Karna (Bhayakarna)

Rogmarga ndash Madhyama

Page | 47

Purvarupa

The Purvarupa of Karnasrava are not mentioned separately in any ayurvedic

classics In routine practice cretin Purvarupa are noted

1 Karnakandu

2 Karnagurutwa

3 Alpa karnashoola

4 Discomfort in ear

Rupa

1 Karnashoola

2 Karnakandu

3 Karnasrava

4 karnabadhirya

5 Cotton wool like or wet newspaper like grayish brown or black colored mass

is seen

6 External auditory canal skin appears edematous and red

Upashaya and Anupashaya

Appropriate application of Aushadhi Ahara and Vihara when produces relief in

the symptom is called as Upashaya and when aggravates the symptoms is

called Anaupashaya There is not any reference available in the classics about

the Upashaya and Anupashaya of karnasrava

Sadhyasadhyata

Sushruta has not mentioned specially the Sadhyasadhyata of Karnarogas But

Vagbhata has mentioned Karnasrava as a Sadhyavyadhi[69]

Sadhysadhyatagives the clear picture of prognosis of the disease It depends

on many factors like nature of disease severity of disease Vaya Prakriti Bala

of the patient etc

Page | 48

Upadrava of Karnasrava

In Samhita there is no reference available regarding the Upadrava of

Karnasrava

Samanya Chikitsa ndash

The common treatment principle for all Karnaroga is Ghritapana Use of

Rasayana Bhrahmacharya Avyayama Shirasnana and Atibhashaya

सामरय कणवरोगष घतपान रसयनम

अवयायमो शशराःसतनान बरमहचयवम कतपरनम

स उ२१३

Ghratapana - Ghrita is a Yogavahi and follow Sanskara in addition to these

acquired properties and capable of retaining its own properties So Ghritapana

is effective in Karnasrava

Rasayana - Rasayana represent the basic approach of Ayurveda which

comprise preventive promotive and curative aspect of health

Brahmacharyaapalana -It is like Sadvrittapalana and is equals to Rasayana

effect

Vyayama - It leads to vitiation if Vatas a Karna is a Sthana of vata and

exercise causes Kshayaj Samprapti hence it is important to avoid exercise in

Karnasrava

Shirasnana- In Shirasnana water enters in external acoustic canal it changes

the PH of meatus skin from acid to alkali which favors the growth of pathogens

Atibhashya - Excessive speaking causes Vata Prakopa and Vatapraokopa is

basic Samprapti for Karnasrava as the preventive aspect avoidance of

excessive speaking is necessary

Page | 49

Ghritapana Rasayana and Brahmacharyapalana should be followed for

preservation of dhatu Samyata and restriction of vitiation of Vata Vayayama

Shirasnana and Atibhashaya should be avoided in Karnasrava to protect the

Siras from the affliction of Vata and Kapha

Vishesha Chikitsa ndash

The general treatment principle of Karnasrava described in classics is closely

related to Dushtavrana Chikitsa

शशरोवरचन च ए िपन परण तरा

परमाजवन िान च ीकषय ीकषय़ाचारत [70]

स उ २१४०

कणवसततरा ोददत कयावत पततकशमकणवयो [71]

ाउ १८३५

उपददि च सततरोत साय परात वपचततवशि परमजय

य अगर मदन सघत गगलना ा िपतयतपा मिना परयत [72]

असउ २२४२४३

In addition to that Shirovirechana Karnadhoopana Karnapurana

karnapramarjana Karnadhavana are also indicated

Page | 50

Treatment is also mentioned for Karnasrava

1 Karnaprakshalana Yoga - with Aargawadadi Gana Kashaya and Surasadi

Gana Kashaya [73]

2 Avachurnana Yoga ndash with Aargawadadi Gana Churna and Surasadi Gana

Churna[74]

3 Karnapoorna Yoga ndash

bull Rasanjana Laksha with Sarjachoorna[75]

bull Panchkashaya with Kapittha swarasa and Madhu[76]

bull Jambu AmrapallavShivalaKshuodra Mahavriksha and Madhuki all are

taken in equal quantity and Kalka is prepared and 4 times Taila is taken

and 16 parts of Kwatha is added and Taila Paka is done[77]

bull Sarjatwak Choorna with Karpashiphalarasa and Madhu[78]

bull Abhaya LodraTindukaSamanga(Manjista) Kwatha of this Dravyas mixed

with Madhu and Kapittha Rasa[79]

bull Yogratnakara mention the following drugs for Karnapoorana-

a Samudraphena Churna[80]

b Jambwambpatra Yoga

4 Karnadhoopana Yoga ndash

bull Dhoopana with Churna of Bilvapatra Haridra Palandu[81]

bull Vartak Dhoopana [82]

5 Internal Medications-

bull Rasnadi Guggula [83]

bull Triphala Guggula [84]

bull Sarivadi Vati [85]

bull Gandhaka Rasayana [86]

Page | 51

According to Vagbhata-

Ear should be cleaned with the Pichu and Varti followed by Guggula Dhoopana

and then Karnapoorana with Madhu Followed by Avachurnanana with

Sukshmachootana of Surasadigana

Pathyaapathya ndash Pathya and Apathy mentioned for Samanya Karnaroga is

recommended in Karnasrava also

पथय[87]

सतदो वरको मन नसतय िमाः शशरावयिाः

गोिमाः शालयो मदगााः याशच परतन हवाः 80

लाो मयरो हररणानदसततततरो नकककिाः

पिोल शशगर ातावक सतनषराण कदठललकम

रसायनातन सवणण बरमहचयवमिाषणाम |

उपयकत यरादोषशमद कणावमय दहतम ||81||

िापर २१

Aharaja Upacharaja

bull Godhuma bull Vamana

bull Shala bull Virechana

bull Mudga bull Nasya

bull Yava bull Dhoomapana

bull Puranagitra bull Kavala

bull Lava Harina Tittiramamsa

Page | 52

अपथय[88]

दरत काटठ शशरसतनान वययाम शलटमल गर

कणडयन तषारशच कणवरोगी पररतपयजत

िापर २१

Viharaja

bull Patola ShigruVartaka bull Bhramacharaya

bull Sunishannaka bull Avyayama

bull Katthlika bull Aakthanam

bull All types of Rasayana bull Upacharaja

bull Vamana

Apathyas

bull Abhishyandakara Aharas

bull Shirasnana

bull Karna kandooyana

bull Tushara sevana

bull Guru Kaphakaraka Aaharas

bull Dantdhavana

Page | 53

OTOMYCOSIS

Definition-

Otomycosis is a superficial acute sub-acute or chronic infection of external

ear canal It is mostly unilateral It is characterized by inflammation purities

and scaling Otomycosis is a common condition encountered in ENT practice

more in chronic and persistent ear infection

The Fungal infections are not communicable in the usual sense but the

humans become an accidental host by their introduction into tissue trauma

The virulence factors favoring colonization of fungus in human host are yet to

be identified Ability of the fungus to grow at 37 C and elaboration of a variety

of enzymes and toxins are speculated to contribute to virulence Only 100 to

150 species are generally recognized as a cause of disease in humans[89]

Prevalence-

Otomycosis is a word wide in distribution and in various record stated that 5

to 20 of all cases of infective otitis externa Otomycosis prevalent is more in

warm and humid climates It is one of the commonest manifestations in India

during rainy season It occurs mostly in humid atmosphere otitis externa due

to fungal infection may resembles the desquamative form of diffuse infective

otitis externa The incidence in temperature climates has increased in

proportion to the use of topical antibiotics which have a medium sterilized of

other organism in which the fungus may flourish

Page | 54

Predisposing factors- [90]

1 Environmental factors such as climate contagious and polluting hygiene

more frequently during rainy season as the humidity increases

2 Individual susceptibility ndashGeneral Immunological status of the Individual

eg HIV infection Radiotherapy chemotherapy Diabetes mellitus

3 Self-inflicted trauma that is use of pins to clean the itching ear or use of ear

bud to clean the wax

4 Wide spread of topical antibiotics steroid preparations which have medium

sterilized of other organism in which the fungus may grow

5 Failure of defense mechanism in External auditory canal

6 During swimming or head bath water enters in External acoustic canal

causes quantitative and qualitative change in ear wax It causes change in pH

7 Long term use of hearing aids

Pathophysiology ndash

The life cycle of the average mold encountered in the ear may be reckoned

as two weeks and flare ups may be anticipated at such intervals Swimming is

held responsible for infection in many cases The sequence sequence of

pathogenic changes produced by molds in the external ear is as follows ndash

1 Implantation of the organism in external ear

2 Growth of organism follows the rate depending on condition of temperature

moisture or preexisting irritation

3 Invasion of epithelium occurs with attendant itching and discomfort which

may be quite severe

Page | 55

4 Exfoliation of epithelium occurs as nature attempts to overcome the

infection by casting off upper most cells

5 Denudation occurs from exfoliation as the top layers of epithelium are cast

off and the canal becomes filled with debris

6 Superficial ulceration and lizematoid dermatitis results if the pathologic

process goes for enough The changes do not always proceed through the

entire sequence sometimes the molds produce changes of the mildest

imaginable character which may be overlooked[91]

Clinical features -

Symptoms-

1 Irritation and itching ndash Irritation is mostly found when the infective

organism is aspergillus niger There is sensation of discomfort which is more

diffuse in the ear canal then localized in the deeper part Candida infection

causes marked itching In external ear it is intense and worse at night

2 Discharge through ear- Intermittent scanty colorless discharge through

ear Mucus being a fungal metabolic product appears as discharge Excessive

discharge is associated with mixed infection

3 Pain and discomfort ndash Mild to severe pain in the ear occasionally Mostly

seen in cases where ear is infected with Aspergillus flavus mixed infection

with gram negative organism or mixed infection with candida and aspergillus

Headache is sometimes associated with pain

4 Deafness- Varying degree of mild to moderate conductive deafness

5 A sensation of fullness in ear

6 Tinnitus 7 Vertigo

Page | 56

Signs ndash

1 The external acoustic meatus may contain a mass formed of epithelial

debris exudates cerumen and fungus

2 Erythematous external canal

Fungal appearance

A Niger - The color of the mass which is usually grey or black is mainly

determined by the type of fungus concerned Its appearance is like wet

newspaper or blotting paper or a cotton wool It has a peculiar musty odor In

this infection fruiting heads may be seen as black specks in the debris

Occasionally as inactive form occurs in which the canal is lined by mold giving

a fluffy appearance due to the presence of tiny mycelia

Candida ndash Candida infections generally show as white deposits on magenta

colored skin when the debris is removed it rapidly recovers in 24 hrs

The underlying canal skin is often inflamed and granular due to invasion by

fungal mycelia and be seen in all cases In rare cases excoriation and

ulceration with marked extensive shedding of the epithelium and deep

ulceration can be seen usually associated with a flavus and with pathogenic

bacteria[92]

Otoscope Appearance

1 Aspergillus Niger ndash Black headed

2 Aspergillus Fumigators ndash pale blue or green

3 Candida Albicans ndash White- or cream-colored deposits

Page | 57

4 Auricle is normal in most cases In severe cases small ulceration with crust

formation may be present on lateral surface

5 Tympanic Membrane

In most cases it is normal with normal mobility and normal hearing In a few

cases the surface of the tympanic membrane is congested and scaly There is

erosion or ulceration of the external epithelial layer and the membrane itself

may be edematous

Diagnosis

1 Above mentioned symptoms and signs

2 In the stage at which patient with otitis externa usually first present

themselves mycelia threads conidiophors not visible to naked eye may

sometimes be identified with the microscope

3 Confirmed by culture

Page | 58

Fig7 Aspergillus Niger Fig8 Candida Albicans

Fig9 Aspergillus Fumigators Fig 10 Wet Paper like appearance

Page | 59

Treatment

1 Antibiotic or steroid drops should be discontinued if they are being instilled

since long time

2 Removal of fungal mass epithelial debris and discharge from the external

canal or mastoid cavity repeatedly and thoroughly by forcepa or suction or

syringing or cautiously blow a stream of air into the canal through a fine

cannula and dry thoroughly by swabbing liquid petroleum on swab used in

cleaning the ear lessens the burning sensation when metacresy acetate is to

be employed in the subsequent treatment

Furuncle is developed as a complication if there is no gentleness in cleaning

Cleansing may have to be delayed until local sensitiveness is lessened which

can usually be accomplished within twenty-four hours If there is excessive

epithelial debris along with otomycosis then metacresyl acetate which is a

keratolytic in introduction into the external auditory canal on cotton wick and

is allowed to remain for twenty-four hours After twenty-four hours the cotton

wick is removed at which time the canal can usually be cleansed with little

discomfort as the medication is also anesthetic The epithelium of the canal

was white from contact with the drug The top layer was detached and this

epithelial debris can be easily wiped away The wick is reinserted and wet with

metacresyl acetate

The treatment is employed for three to four days in succession and then a

bland application is substituted Icthyol iodine is of value at this stage Iodine

ointment 2 in combination with Tannic acid 2 is also an excellent local

application following cresatin treatment

Next one of the fungicides may be applied

Page | 60

1 Nystin Effective for candida infection but less active against aspergillus

group Nystatin in boric powder consisting of 100000units of nystatingm of

powder 3 times week for 3 weeks

2 Clotrimazole Available as 11 cream or drops or lotions Phenyl

(zchlorophenyl) 1 ndash imidazole ndash methane is a chlorinated trityl imidazol 1

effective against candida and dermatophytes and for aspergilli infection

3 Amphotericin B Available as cream and as 3 solution and 015 drops

for topical application Very effective for candida infection can be fungistatic

or fungicidal

4 Econazole Available as solution (Econazole nitrate) and as cream (1)

Broad spectrum ndash more effective for Aspergillus Also active against some

gram-positive bacteria (Staphylococci and Streptococci and Dermatophytes)

5 Miconazole Highly effective against dermatophytes and candida infections

used as a 21 cream applied once or twice a day for 10 days

6 Gentian violet 21 Available as drops (recently some evidence of

carcinogenicity) Discolors the ear canal and this interfere with clinical

examination

Other topical antifungal agents are ketoconazole Natamycin Tolciclat Bifonas

zole Fenticonzole Oxiconazole Tioconazole ciclopiroxolomine Tolnafate

Haloprogin Flucytosine Acetic acid Whit field ointment selenium sulfide

undcyclenic acid triacetin etc

Page | 61

Minimal length of treatment

A month of drug treatment is usually required because the antifungal agents

used are not sporicidal and it is necessary that the period of treatment covers

germination time It may be advisable to give short gaps in the period of

treatment to ensure all spores have germinated before deciding to terminate

therapy

Prevention

Accomplished by strict attention to the predisposing causes

1 Water should be prevented from entering the ear

2 Avoidance of external ear trauma

3 Use of alcohol medicated or plain in the ears after swimming mercuric

cyanide (15000) in ethyl alcohol (70) is a satisfactory liquid to use

Ear stoppers do no good unless their use is followed by some antiseptic in the

canal Divers exposed to water for long periods of time may also use acidic

alcohol

4 During Summer months with their high humidity special efforts are needed

to maintain ear dry 5 Indiscriminate use of topical antibiotics steroid

preparations should be avoided

Page | 62

DRUG REVIEW

1 GUGGULA

Fig11 - Guggula

Historical review of Guggula [93]

bull Atharvaveda one of the well-known Vedas of Hindus The earliest

reference given by Atharvaveda medicinal and therapeutic properties of

Guggula Guggula has long history of use in Ayurveda

bull Acharya Charaka Sushruta and Vagbhata describe detail regarding the

actions uses and indication as well as the variety of Guggula

Page | 63

bull Various Nighantus (Medical lexicons) were written between 12th and 14th

centuries AD was based on the Ayurvedic literature also describes

Guggula

bull The explanation of word Guggula is that Gunjo Vyadhegurdti Rakshati

which means to relief against different diseases

bull Guggula is the best medicine because it develops through the rays of

hot sun on specific circumstances

bull Guggula has an aromatic odor

गगलो कणवदौगवररधय िपन शरटठमछयत[94]

स उ २२११२

Latin name- Commiphora mukul

Family ndash Burseraceae

Rasa- Tikta Katu

Guna ndash Laghu Rukshasukshma vishada sara

Veerya ndash Ushna

Vipaka ndash Katu

Action- Rasayana Lekhana

Doshaghanta - Tridoshhara

Page | 64

Chemical composition [95]

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Oleoresin-Z-Guggulsterone E-Guggulsterone

Gum- guggulignans 1 and 2 guggula Tetrols mukulol allylcembrol c

27

Guggulusterol 1 2 ans 3 Z and E ndash guggulusterol

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Parts Used ndash Gum oleoresin

Guggula purity test

1 Yellowish brown emulsion is obtained when Guggula is triturated with

water

2 An ethereal solution of the drug attains reddish colour when treated

with br2 vapors and purple colour when moistened with nitric acid

Biochemical action ndash Antiseptic Anti-inflammatory Disinfectant Diuretic

Immunostimulant stimulating expectorant Ant suppurative Antipyretic

Enhance phagocytosis

Karma- Rasayana cardiovascular disease

Page | 65

2 AGARU-

Fig 12 Agaru

Historical review of Agaru [96]

bull The word Agaru literally means the one which is the heaviest and no

aromatic wood is heavier than it Since thousands of years Agaru lsquoThe

wood of Godrsquo has been used for multiple purpose like commercial

medicinal spiritual aromatic historical

bull The medicinal use of Agaru have been recorded in many pieces of India

Greek Roman Chinese Middle eastern and European since ancient times

bull Acharya Charaka used Agaru and pest of Rasna to counteract the effect of

cold in Agraya Dravyas

bull Acharya Sushruta used Agaru as a Dhoopana Dravya along with Guggula

Ral and Shoma in the treatment of Karnasweda and Vrana

Page | 66

Types-

bull Dhanwantsri Nighantu describes Kaleyaka as a type of Agaru

bull Sodhala Nighantu describes three types of Agaru ndash Agaru Krishna

Agaru Kakatunda Agaru

bull Raj Nighantu describes five types of Agaru ndash Krishna Agaru Kasht

Agaru Daha Agaru Mangalya Agaru and Agurusaar

bull Arthashasstra describes three Agaru wood product

1 Jongaka ndash Black or variegated black in colour and having variegated

spots

2 Dongaka ndash Black in color

3 Parasamudraka- Black in colour and smells like Navamallika

अगर उटण कि तपछय ततकत ततकषण च वपततलम

लघ कणाविरोगघन शीत ात कफपरणत

िापर २१ [97]

Family- Thymelaccensis

Latin name- Aquilaria agallocha

Guna- Laghu Ruksha Tikshan

Rasa- Katu Tikta

Vipaka ndash Katu

Virya ndash Ushna

Karma- Sheetaprasasmana Vranaorasadan Tvachya Pittavardhaka

Shirovirechana Mangalya Sugandhik and Rochaka in properties [100]

Krishna Agaru karma- Katu Tikta rasa Ushna Sheeta when applied externally

and Pittahara when taken orally

Page | 67

Chemical Constituents -

Agaru hardwood is rich in essential oil resins alkaloids saponins Steroids

terpenoids tannins flavonoids and phenolic compound Agaru wood

predominantly contains 2-[-2-phenylethy]-4H-chromen-4-one derivatives and

sesquiterpenes Agaru oil contains selinene dihydroselinene agarnol b-

agarofuran vetispira-2(11)valerianol dihydrokaranone and tetradecanoic

acids[99]

Part Used ndash

Heartwood- Dark resinous wood which is formed when the plant becomes

infected with a type of fungus (ascomycetous mold) Species of Aspergillus

fusarium and penicillium are reported to be associated with the development

of infection Prior to infection the heartwood is odorless relatively light and

pale colored however as the infection progresses the tree produces a dark

aromatic resin in the heartwood The infected resin in response to the attack

which results in accumulation of a very dense dark resin in the heartwood

The infected resin embedded wood is known as Agarwood Infection is more

common on the trunk roots and the area when branches divide The formation

of Agarwood starts when the tree attains the age of 20 years On an average

approximately 30 ml oil is extracted from 100 kg of infected Agarwood[98]

Qualities of best Agaru-

It should be black in color

It should be extremely heavy and aromatic

It should be oily in appearance and test

It should be sink in water

It should burn easily with bright flame with a bright flame giving off a pleasant

smell

Page | 68

3 MADANA

Fig 13 MADANA

Madana consist of dried fruit of Xeromphis spinosa It is a deciduous thorny

shrub or a small tree reaching a high up to 9 m and girth about a meter

branches numerous thick and horizontal found in sub-Himalayan tracts[101]

मदनो मिरनदसततकतो ीयोटणो लखनो लघ

ानदरतिदवििीहर परततशयायवरणारतक

रि कटठकफ़ानाहशोथगलमवरणापह[102]

िा पर १६० १६1

Page | 69

Latin name-Randia dumetorum

Familly ndash Rubiaceae

Rasa - Madhura Tikta

Guna-Laghu Ruksha

Virya- Ushna

Vipaka ndash Katu

Karma- Vamana and Lekhana

Chemical Composition-

Essential Oil Valerianic acid Saponin tannin resin [103]

Page | 70

YAWA [104]

Fig 14 Yawa

1 In Samhitakala Aacharya Charaka Acharya Sushruta explain detail about

medicinal properties of Yawa

2The use of Yawa in Aaharya Dravya mainly described by Dhanwantari

Nighantu Raj Nighantu Bhavprakash Nighantu[105]

Macroscopic Description-

Fruit a caryopsis elliptical oblong Ovoid and tapering at both ends smooth

about 1cm long and 02- 03cm wide dorsally compressed and flattened on

the sides with a shallow longitudinal furrow 3-5 ridges having shallow

depression between them grains tightly enclosed and adhering the lemma

and palea pale greenish yellow odor not distinct taste sweetish acrid

Page | 71

Latin Name ndash Hordenum vulgare

Family- Poaceae

Rasa- Kashaya Madhura

Virya- Sita

Vipaka- Katu

Karma- Vatakrt Pittahara Kaphahara Medahara Balya Visrya

SthairyakaraLekhana

Page | 72

PROCEDURE REVIEW [105]

In Ayurvedic classics there are many references regarding Dhoopana Dravya

Dhoopana is administering Dhuma with the help of Dhoopana Dravya

In Kashyapa Samhita there are 40 types of Dhoopana advised for children

Anesthesia (Mohajananam Dhoopa) is also mentioned For this Dhoopana the

drug used were herbs hairs of animals legs horns old cloths of Buddhist

monks

From the references available regarding Dhoopana we can understand that

Karna can be protected from maggots (krimi) Bactria (Rakshogna) lice etc

References clearly indicate the analgesic and disinfectant effect of Dhoopana

Karma Dhoopana is mentioned for Dushta Vrana Chikitsa It reduces Vedana

Srava Pootigandha of Dushtavrana It also helps in Vranaropana

Dushtavrana Chikitsa is mentioned in the treatment of Karnasrava[106]

Origin of Dhoopana-

In ancient period children of sages were constantly harassed by the

Rakshasas Hence the sages approached lord Agni for shelter Agni in turn

gave them Dhoopana Dravya and asked sages to use the Dhoopana for

protection against Rakshasas bhutas pishachas

Classification of Dhoopana

1 It is classified into Dhupa Anudhupa Pratidhupa

2 On the basis of Origin it is classified into Jangama and Sthavara

Selection of Guggula for Dhoopana

Page | 73

bull Guggul is a best Vatahara

bull It is Krimighana

bull It contains Oleoresin

bull In Ashtang Hrudaya Guggula Dhoopana mentioned for Karnasrava

Selection of Agaru for Dhoopana

bull Agaru is Laghu Ruksha Katu Tikshna

bull Vranaorasadan Tvachya

bull It should burn easily with bright flame with a bright flame giving off a

pleasant smell

Karna Dhoopana Indication

1 Karnaarava

2 Putikarna

3 Krimikarna

4Vataj Karnashula

Contraindications

Especially for Karnadhoopan contraindication is not mentioned in classic texts

But Dhoopana is contraindicated in Pittaj vaydhi Sharad and Grishma Rutu

Page | 74

MATERIAL AND METHOD

Page | 75

For randomize comparative clinical trial to study the effect of Agaruwadi

Karnadhoopana and Guggula Karnadhoopana in Karnasrava following material

and method were required

Source of data

Patient irrespective of gender occupation religion social economic status

signs and symptoms of classical features of Karnasrava (Otomycosis) selected

from the OPD of Shalakyatantra department

Materials ndash

1Patients

2 Drugs-Agaruwadi Dhoopana

Guggula Dhoopana

3Torch

4Otoscope

5 Tuning fork

6Jobson horn probe

7Cotton

8Case record form

DRUG

Group A Trial Group

1Churana of Agaru Yawa Madan

2Ghrita

3Jala

Group B Control Group

1Googula Churna

Page | 76

Properties of Drug

Table no 1 Properties of Drug

Drug

Family

Rasa Veerya Vipaka Effect

on

Dosha

Guna Karma

Agaru

(Aquilegria

Agallocha)

Thymelaca

ceae

Katu

Tikta

Ushna Katu KV Laghu

Ruksha

Tikshna

Shitaprashamana

Shothahara

Vedanasthapak

Durghandhihara

Madan

(Randia

spinosa)

Rubiaceace

Kashaya

Madhur

Tikat

Katu

Ushna Katu KV Ruksha

Laghu

Vatakaphaghana

Shothahara

Vedanasthapak

Vranashodhak

Yawa

Poaceae

Hordeum

Vulgare

Kashaya

Madhur

Sheeta Madhur KP Ruksha

Laghu

Vataghana

Vernashodhana

Raktshodhaka

Guggula

Commiphora

Mukul

Burseracea

e

Tikta

Kashaya

Anushna Katu VPK Laghu

Ruksha

Shothahara

Vedanasthapaka

Kandughna

Ghrita Madhura Sheet Madhur VK Snigdha Vataghana

Shothahara

Vedanasthapaka

Page | 77

METHODOLOGY

SELECTION CRITERIA

1)INCLUSION CRITERIA

1 Patients having signs and symptoms of Karnasrava (Otomycosis) ie करणशल

( pain ) करणकणड ( Itching ) करणसतराव ( Discharge )बाधिरण ( conductive Loss of

hearing )

2 Patient from age group 19 to 70 years

3 Any Gender

2)EXCLUSION CRITERIA

1 Patients suffering from any systemic disease like DM TB HTN

2 Chronic suppurative otitis media (CSOM)

3 Acute supportive otitis media (ASOM)

3 Perforation of Tympanic membrane

4 Chronic otitis media

3)WITHDRAWAL CRITERIA

1If patient develops any adverse effect such as irritation pain burning

sensation in ear loss of hearing and such patients was withdrawn from trial

and receive prompt appropriate medical attention

2If patient shows aggravation in symptoms

3If patient refuses to continue with the treatment

Page | 78

STUDY SETTING

Types of study - Randomized Clinical comparative Trial

Place of work - OPD of Shalakyatantra

Duration of study - 18 months

Study Population - Patients of Karnasrava in Shalakyatantra OPD

SAMPLE SIZE CALCULATION

Sampling Method ndash Purposive sampling followed by random allocation in two

groups

Sample size calculation-

n = z2 p (1-p)

d2

Were

n = sample size

P = prevalence of disease=10

z = standard normal variable ie 196

d = error ie005

desired Sample Size would be

n = Z2 P(1-P)d2

= (196)2x (0021) x(0979)(005)2

= 34

Visiting ENT OPD (ShalakyaTantra) and IPD (ShalakyaTantra) 21 = 34

n raquo34

So one group includes 34patients

Page | 79

Sampling Method

Total 68 patient of Karnasrava are selected by Purposive sampling followed by

random allocation in two groups Written informed consent is taken prior to

commencement of trial They are divided in 2 groups

Group A (Trial Group) 34 patients treated with Agaruwadi Dhoopana for 7

days

Dose 5 minutes twice in a day

Group B (Control Group) 34 patients treated with Guggula Dhoopana for 7

days

Dose 5 minutes twice in a day

STUDY DESIGN ndash

Open labeled Randomized Comparative Clinical trial

STUDY DESIGN

Screening of patient

Inclusion criteria satisfied Exclusion criteria

Initial assessment Excluded

Counseling of patient Treated accordingly

Patient selection by Simple Random Sampling Method

Page | 80

68 Patients were divided in two groups lsquoArsquo and lsquoBrsquo

Trial group A-34 patients were given

Agaruwadi Dhoopana

Control group B- 34 patients were

given Guggul Dhoopana

Informed written consent

Treatment was given for 7 days

Assessment on 1st 4th and 7th day

Post assessments follow up on 15th day

Observation

Data Collection

Statistical analysis of data

Conclusion

Page | 81

(A) Agaruwadi Varti for group A (Trial group)

Table no 2

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

B) Guggula Varti for group B (Control group)

SOP of it is same as above Agaruwadi Varti

Table no 3

Drug Guggula Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

FOLLOW UP

For both groups follow ups were done on 1st 4th and 7th and post

assessment follow up15th day

EXAMINATIONS

Torch for Local examination of ear

Otoscope examination

Tuning fork Test

Page | 82

OBSERVATION TABLE

Table no 4

Sr no Subjective criteria Day 1 Day 4 Day 7 Day 15

1 करणशल

(pain)

2 करणकणड

(Itching)

3 करणसतराव (Discharge )

4 बाधिरण (Conductive Deafness)

OBSERVATIONS

a) करणशल (Pain) -

0 - Absent

1 ndash Present

b) करणकणड (Itching) -

0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

Page | 83

c) करणसतराव (Discharge)

0- Absent

1- Mild -Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाधिरण (conductive Loss of hearing)

0 - Absent

1- Present

Observations were carried out before and after completion of treatment and

during each follow up After observations the data collected and presented in

the form of graphs charts and table

Page | 84

TRIAL DRUG

Authentication and standardization of raw drug material done After

authentication and standardizing of raw drug material Agaruwadi Varti was

prepared by Varti as explained in Ayurvedic classics

Method of Varti preparations

Panchavidh Kashaya Kalpana that is five method of pharmaceutical

preparation constitutes the fundamental process of Ayurvedic pharmaceutics

which is well explained in Sushrut Samhita Varti Kalpana is one among them

which can be included in Kalka Kalpana

तीररसतरपतपतीनामपरककव तीत [106]

स डलहण शरच 151

Medicines are powered triturated and given the Varti shape that is like wick

of lamp so it is called as Varti Kalpana

Drug content Agaru Madan Yawa

Route of Administration Local

Dose Two times a day

Duration 7 days

Page | 85

Methodology

Standard operating procedure (SOP) of Agaruwadi Varti

Agaruwadi Varti is prepared according to the classical text

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization was done as recommended in pharmacy procedure The

raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 mixed together in

equal quantity to make Agaruwadi churn

Quantity of each churn is 4 grams all are mixed when the Varti get dry total

weight of Varti was 10gram

STEP 4 - Agaruwadi churn triturated with appropriate quantity of water or

Ghrita and prepared Varti in GMP Certified Ayurvedic pharmacy Standard

aseptic precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Varti was packed in sterile air packed container

STEP 6 - Agaruwadi Dhoopana was given with the help of Dhoopana yantra

Authentication and Standardization of raw drug of Agaruwadi Varti was done

Sterilization was done as recommended in pharmacy procedure Sterile

preparation packed in sterile container of suitable size Under all aseptic

precaution Karnadhoopana given to infected ear

Page | 86

Containers for packaging and their sterilization-

Sterilization of the containers for storing Varties was done by Ethylene Oxide

(Eto) method

Ethylene Oxide (Eto) procedure-

It includes exposure of materials to ethylene oxide gas under vacuum in a

sealed chamber It consists of four primary variables

1Gas Concentration

2Humidity

3Temperature

4 Time

EtO gas is an alkylating agent which disturbs the DNA of microorganism

preventing them from reproducing It penetrates the breathable packaging

and sterilizes all the accessible surface of the product to render products

sterility by alkylation of essentials proteins for cell reproduction

Most Eto sterilization methods involves three different stages These can be

separated into three different on the size or number of devices to treat

1Preconditioning stage-

First products are passed through a preconditioning phase to make

microorganism grow The batch load goes through a well time under a

controlled environment of temperature and humidity

2Sterilizer stage-

Performed using process phase specially designed to provide the required level

of EtO exposure to assure sterility for a device or family of devices

3Degasser Aerration stage-

Finally products need to go through a degassing phase to remove any residual

particles of Eto The batch load goes over well time under a temperature-

controlled environment

The sterile containers were then used to store Agaruwadi Varti and handed to

patients included in the study

Page | 87

Packing of Agaruwadi Varti

The ETO sterilize plastic container were used for packing of Agaruwadi Varti

Varti was filled into these sterilize containers (7 in each) In an aseptic

environment plugging and capping was done under aseptic precautions In this

way packing of Agaruwadi Varti done These Varti were given to patient and

advise to take two times a day under all hygienic precautions

History and Examination

bull Proper history and presenting complains was recorded on case record form

bull Ear examination with otoscope was done during initial assessment and each

follow up

bull Otoscopic examination was done during initial assessment and each follow

up

bull Systemic Examination that is Blood Pressure Temperature Respiration

rate Pulse was recorded on case record form

Page | 88

Raw material

Fig14 यव चरण Fig15 मदनफळ चरण

Fig16 अगर चरण Fig17 गगगळ चरण

Page | 89

Preparation of Agaruwadi Varti

Fig18 Preparation of Agaruwadi Varti

Fig19 अगरवादी वरती

Page | 90

Fig20 Instruments used for examination of Karnasrava

Fig19 Karnadhoopana Yantra

Page | 91

Karnadhoopana Procedure

Fig 22 Karnadhoopana Procedure

Page | 92

OBSERVATIONS AND RESULTS

Page | 93

BASED ON DRUGS

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 94

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

AUTHENTICATION CERTIFICATE

Page | 95

BASED ON STASTICIAL ANALYSIS OF DEMOGRAPHIC DATA

68 patients of Karnasrava ndash Otomycosis

Table no 5

No of Patients Total

Group A Group B

Registered 38 37 75

Completed 34 34 68

Discontinue 04 03 07

Total 68 patients were enrolled in study 38 patients registered in group A

amongst them 34 patients completed the treatment and04 patients

discontinued the treatment However in group B 37 patients completed the

treatment and 03 patients discontinued the treatment out of 37 registered

patients

Hence the total number of patients registered in the present study was 75

and out of which 68 patients were discontinued the treatment So they

dropped out from the study While 68 patients were successfully completed

the treatment So observations and result of 68 patients were given below

Here we are going to discuss the statistical analysis of the data obtained in

the form of master chart that was prepared in accordance with the data

collected from the patients that had been included in the study The purpose

of statistical analysis was to analyzed the relation between age gender

occupation diet addiction and education

Page | 96

1 Age wise distribution of patients

Table no 6

In trial group 10 (29412) patients were from age group 18-25 years 14

(41176) patients were from age group 25-35 years 8 (23529) patients

were from age group 35-45 years and 2 (58824) patients were from age

group 45-60 yearsIn control group 6 (17647) patients were from age group

18-25 years 14 (41176) patients were from age group 25-35 years 7

(20588) patients were from age group 35-45 years and 7 (20588)

patients were from age group 45-60 years

Fig 23 Age wise distribution of patients

0

2

4

6

8

10

12

14

15 -25 25-35 35-45 45-60

10

14

8

2

6

14

7 7

Age Distribution

Trial Group N Control Group N

Age Distribution

Trial Group Control Group

N N

18 -25 10 29412 6 17647

25-35 14 41176 14 41176

35-45 8 23529 7 20588

45-60 2 58824 7 20588

Total 34 100 34 100

Page | 97

1 Gender wise distribution of patients

Table no 7

Sex

Trial Group Control Group

N N

Female 23 67647 15 44118

Male 11 32353 19 55882

Total 34 100 34 100

In trial group 23 (67647) patients were female and 11 (32353) patients

were male

In Control group 15 (44118) patients were female and 19 (55882)

patients were male

Fig 24 Gender wise distribution of patients

0

5

10

15

20

25

N N

TRIAL GROUP CONTROL GROUP

23

15

11

19

Gender

Female Male

Page | 98

2 Education wise distribution of patients

Table no 8

Education

Trial Group Control Group

N N

Illiterate 4 11765 3 88235

SSC 4 11765 3 88235

HSC 8 23529 9 26471

Graduation 16 47059 10 29412

Primary 1 29412 3 88235

Post-Graduation 1 29412 6 17647

Total 34 100 34 100

In trial group 4 (11765) patients were illiterate 4 (11765) patients were

SSC educated 8 (23529) patients were HSC educated 16 (47059)

patients were graduated 1 (29412) patients were primary educated and

1(29412) patients were post graduated

In control grou 3 (88235) patients were illiterate 3 (88235) patients

were SSC educated 9 (26471) patients were HSC educated 10 (29412)

patients were graduated 3 (88235) patients were primary educated and

6 (17647) patients were post graduated

Page | 99

Fig 25 Education wise distribution of patients

0

2

4

6

8

10

12

14

16

ILLITERATE SSC HSC GRADUATION PRIMARY POST GRADUATION

4 4

8

16

1 1

3 3

910

3

6

Education

Trial Group N Control Group N

Page | 100

3 Occupation wise distribution of patients

Table no 9

Occupation

Trial Group Control Group

N N

Accountant 1 294 2 588

Housewife 11 3235 8 2353

Engineer 1 294 1 294

Job 1 294 4 1176

Labor 1 294 3 882

Mess 1 294 0 000

Naturotherapyst 1 294 0 000

Pharma 1 294 0 000

Shopkeeper 4 1176 2 588

Singer 1 294 0 000

Student 8 2353 4 1176

Tailor 1 294 1 294

Teacher 1 294 1 294

Worker 1 294 3 882

Farmer 0 000 1 294

Lab Tech 0 000 1 294

Page | 101

Daily Collection 0 000 1 294

Fruit seller 0 000 1 294

Bus Driver 0 000 1 294

Total 34 10000 34 10000

In trial group 11 (3235 ) were housewife 8(2353) were students

4(1176) were shopkeeper 1(294) was accountant 1(294) was

engineer 1(294) was doing job 1(294)was labour 1(294) was

catering 1(294) was Naturotherapyst 1(294) was Pharma 1(294)

was Singer 1(294) was Tailor 1(294) was Teacher and 1(294) was

worker

In Control group 8 (2353)were housewife 4(1176) were students

2(588) were shopkeeper 2(588) was accountant 1(294) was

engineer 4( 1176) was doing job 3(882)was labor 1(294) was

Farmer 1(294) was Lab tech 1(294) was Daily collection 1(294)

was Tailor 1(294) was Teacher and 3(882) was worker 1(294) was

Fruit seller and 1(294) Bus driver

Fig 26 Education wise distribution of patients

0

2

4

6

8

10

12

1

11

1 1 1 1 1 1

4

1

8

1 1 10 0 0 0 0

2

8

1

43

0 0 02

0

4

1 13

1 1 1 1 1

Occupation

Trial Group N Control Group N

Page | 102

4 Religion wise distribution of patients

Table no 10

Religion

Trial Group Control Group

N N

Hindu 31 9118 33 9706

Muslim 3 882 1 294

Total 34 10000 34 10000

In trial group 31 (9118) patients were Hindu and 3 (882) patients were

Muslim

In control group 33 (9706) patients were Hindu and 1 (294) patient

were Muslim

Fig 27 Religion wise distribution of patients

0

5

10

15

20

25

30

35

N N

TRIAL GROUP CONTROL GROUP

3133

31

Religion

Hindu Muslim

Page | 103

5 Diet wise distribution of patients

Table no 11

Diet

Trial Group Control Group

N N

Veg 14 4118 20 5882

Non-Veg 20 5882 14 4118

Total 34 10000 34 10000

In trial group 14 (4118) patients were vegetarian and 20 (5882)

patients were Non vegetarian

In control group 20 (5882) patients were vegetarian and 14 (4118)

patients were Non-Veg

Fig 28 Diet wise distribution of patients

0

5

10

15

20

N N

TRIAL GROUP CONTROL GROUP

14

2020

14

Diet

Veg Non Veg

Page | 104

6 Addiction wise distribution of patients

Table no 12

Addiction

Trial Group Control Group

N N

None 30 8824 27 7941

Alcohol 2 588 0 000

Tobacco 1 294 2 588

Mishri 0 000 1 294

Smoking 1 294 4 1176

Total 34 10000 34 10000

In trial group 30 (8824) patients have no addiction 2 (588) patients

have addiction of alcohol 1 (294) patients have addiction of Tobacco 0

(0) patients have addiction of Mishri and 1 (294) patients have addiction

of smoking

In control group 27 (7941) patients have no addiction 0 (0) patients

have addiction of alcohol 2 (588) patients have addiction of Tobacco 1

(294) patients have addiction of Mishri and 11 (1176) patients have

addiction of smoking

Page | 105

Fig 29 Addiction wise distribution of patients

0

5

10

15

20

25

30

NONE ALCOHOL TOBACCO MISHRI SMOKING

30

21

01

27

0

21

4

Addiction

Trial Group N Control Group N

Page | 106

Statistical Analysis and Results

Effect of study on Karnashoola-

Table no 13

Karnashoola

Group A Group B

BT AT BT AT

N N N N

Grade 2 0 000 0 000 0 000 0 000

Grade 1 30 10000 7 2333 32 10667 5 1667

Grade 0 4 1333 27 9000 2 667 29 9667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 30 Effect of study on Karnashoola

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

30

7

32

54

27

2

29

Karnashoola

Grade 2 Grade 1 Grade 0

Page | 107

Table no 14

Karnashoola Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 088 100 033 006

969 2829E-

08 7667 HS

AT 021 000 041 007

Group

B

BT 094 100 024 004

1037 7103E-

11 8438 HS

AT 015 000 036 007

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 31

000010020030040050060070080090100

BT AT BT AT

GROUP A GROUP B

088

021

094

015

Karnashoola

Mean

Page | 108

Table no 15

Karnashoola

Mean SD Effect

Group

A

Group

B Trial Control Trial Control

Day 1 088 094 033 024 000 000

Day 3 065 071 049 046 2667 2500

Day 5 024 038 043 049 7333 5938

Day 14 021 015 041 036 7667 8438

000

010

020

030

040

050

060

070

080

090

100

Day 1 Day 3 Day 5 Day 14

Karnashoola

Mean Group A Mean Group B

Page | 109

Table no 16

Karnashoola N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3250 110500

510000 275 Control group 34 3650 124100

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 110

Effect of study on Karnakandu

Table no 17

Karnakandu

Group A Group B

BT AT BT AT

N N N N

Grade 3 7 2333 0 000 4 1333 0 000

Grade 2 18 6000 0 000 18 6000 0 000

Grade 1 7 2333 7 2333 10 3333 15 5000

Grade 0 2 667 27 9000 2 667 19 6333

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 32 Effect of study on Karnakandu

0

5

10

15

20

25

30

N N N N

BT AT BT AT

GROUP A GROUP B

7

0

4

0

18

0

18

0

7 7

10

15

2

27

2

19

karnakandu

Grade 3 Grade 2 Grade 1 Grade 0

Page | 111

Table no 18

Karnakandu Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 188 200 081 015

1091 3119E-

10 8906 HS

AT 021 000 041 007

Group

B

BT 171 200 076 014

1032 4746E-

09 7414 HS

AT 044 000 050 009

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Page | 112

Fig 33

Table no 19

Karnakandu

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 188 171 081 076 000 000

Day 3 126 118 057 058 3281 3103

Day 5 071 074 046 051 6250 5690

Day 14 021 044 041 050 8906 7414

000

020

040

060

080

100

120

140

160

180

200

BT AT BT AT

GROUP A GROUP B

188

021

171

044

Karnakandu

Mean

Page | 113

Table no 20

Karnakandu N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 4051 137750

373500 006 Control group 34 2849 96850

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is less than

005 Hence we conclude that there is significant difference between Trial

Group and Control Group

000

020

040

060

080

100

120

140

160

180

200

Day 1 Day 3 Day 5 Day 14

Karnakandu

Mean Group A Mean Group B

Page | 114

Effect of study on Karnasrava

Table no 21

Karnasrava

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 11 3667 0 000 8 2667 0 000

Grade 1 23 7667 3 1000 26 8667 2 667

Grade 0 0 000 31 10333 0 000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 34

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

11

0

8

0

23

3

26

20

31

0

32

Karnasrava

Grade 3 Grade 2 Grade 1 Grade 0

Page | 115

Table no 22

Karnasrava Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 132 100 047 009

1122 4356E-

13 9333 HS

AT 009 000 029 005

Group

B

BT 124 100 043 008

1130 9364E-

14 9524 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 35

000

020

040

060

080

100

120

140

BT AT BT AT

GROUP A GROUP B

132

009

124

006

Karnasrava

Mean

Page | 116

Table no 23

Karnasrava

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 132 124 047 043 000 000

Day 3 100 100 025 025 2444 1905

Day 5 047 038 051 049 6444 6905

Day 14 009 006 029 024 9333 9524

000

020

040

060

080

100

120

140

Day 1 Day 3 Day 5 Day 14

Karnasrava

Mean Group A Mean Group B

Page | 117

Table no 24

Karnasrava N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3535 120200

549000 655 Control

group 34 3365 114400

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 118

Effect of study on Karnabadhirya

Table no 25

Karn

Badhirya

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 0 000 0 000 0 000 0 000

Grade 1 13 4333 0 000 16 5333 2 667

Grade 0 21 7000 34 11333 18 6000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 36

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 00 0 0 0

13

0

16

2

21

34

18

32

Karnabadhirya

Grade 3 Grade 2 Grade 1 Grade 0

Page | 119

Table no 26

Karn

Badhirya Mean Median SD SE

Wilcoxon

W P-Value

Effect Result

Group

A

BT 038 000 049 009

799 7173E-

05 10000 HS

AT 000 000 000 000

Group

B

BT 047 000 051 009

816 0000138 8750 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 38

000

005

010

015

020

025

030

035

040

045

050

BT AT BT AT

GROUP A GROUP B

038

000

047

006

Karnbadhirya

Mean

Page | 120

Table no 27

Karn

Badhirya

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 038 047 049 051 000 000

Day 3 009 006 029 024 7692 8750

Day 5 003 006 017 024 9231 8750

Day 14 000 006 000 024 10000 8750

000

005

010

015

020

025

030

035

040

045

050

Day 1 Day 3 Day 5 Day 14

Karn Badhirya

Mean Group A Mean Group B

Page | 121

Table no 28

Karn

Badhirya N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3400 115600

561000 806 Control

group 34 3500 119000

Total 68

Page | 122

COMPARISION BETWEEN GROUP A AND GROUP B

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Table no 29

Overall Effect

Trial Group Control Group

N N

Marked Improvement 21 6176 16 4706

Moderate Improvement 8 2353 13 3824

Mild Improvement 4 1176 5 1471

No Change 1 2941 0 0

TOTAL 34 100 34 100

Fig 39

0

5

10

15

20

25

MARKED IMPROVEMENT

MODERATE IMPROVEMENT

MILD IMPROVEMENT NO CHANGE

21

8

41

1613

5

0

Overall Effect

Trial Group N Control Group N

Page | 123

DISCUSSION

Page | 124

Discussion is nothing but the logical reasoning of observations In

every research work discussion part is very important because it brings into

light about the logical analysis which are helpful in filling the research gap in

the scientific world

The discussion is categorized into following ways for the ease of

understanding

1 Discussion on selection of topic

2 Discussion on review of literature

3 Discussion on drugs their mode of action on the disease mode of action

of Karnadhoopana

4 Discussion on observation and results

1 Discussion on selection of topic

Otomycosis is commonly encountered in day-to-day practice Majority

of Indian people affected with this pathology This disease commonly

manifests in developing countries low socio-economic standard and lack

of hygiene Now a days due to busy lifestyle people are not able to follow

the proper instruction of care of ear which may be responsible for the

recurrent nature of disease So for the management of this we use

Karnadhoopana with the help of Agaruwadi Varti Dhoopana is simple

easy cost-effective procedure which can be done even at OPD levelso

for the disease Karnasrava we selected Karna Dhoopana as therapeutic

procedure Karnadhoopana was done with Agaruwadi Varti and Guggula

Varti which was very effective for treatment

Page | 125

2 Discussion on review of literature

Karnasrava is one such disease among 28 Karnarogas mentioned by

Acharya Sushruta in the chapter named Karna Roga Vigyana Acharya

Charaka included Karnasrava as symptom under the four types of

Karnarogas due to vitiation of different doshas Acharya Vagbhata has

not described Karnasrava separately It is a fact that systemic

description of Karnarogas is available in all the ancients of pus from a

Vata afflicted ear may results from head injury or immersion in water

Karnasrava is a clinical entity which can be correlated with Otomycosis

Karnasrava is explained as symptom as well as a disease in Ayurveda

Nidana- Karnasrava occur due to Samanya Nidana and Vishesh Nidana

Vishesh Nidana like Shirobhighata Nimmajato jale Mithyayoga of Shashtra

The exact pathology behind Karnasrava is not understood clearly

Purvarupa ndash No specific Purvarupa are found for Karnasrava in classical

literature Acharya Madhukara describe Purvarupa as expression of

Rupa(lakshana) with less intensity that is less intensity itching sound in ear

may considered as Purvarupa of Lakshana

Samprapti- Aacharya Sushruta not explained the Samprapti of Karnasrava

separately and we must consider the general Samprapti of Karnaroga Due to

various aetiologias as cited above ear afflicted by Vata dosha causes Twak

Rakta Mamsa dushti results in Karnasrava According to Acharya Sushruta

Vata-Kapha dose is dominance in Karnasrava

Page | 126

Nidan

Nija Agantuja

Vata ndash kapha prakopak nidana Shirobhighata Nimmajato-jale

Mithya yoga of Shastra

Vata- kapha Prakopaka(Chaya prakopak) Vata-kapha prakopaka

( Achay prakopak)

Twak Rakta Mamsa dushti

Karnasrava

Page | 127

Chikitsa

The curative aspect and this must be done simultaneously giving due

importance to Nidan Parivarjana that is preventive measures So Nidan

Parivarjana that is avoidance of causative factors like Jalkrida Mithyayogen

shashtrasya Karnakandu Shirasnan Pratishaya is the first step in combating

the disease and form the part of line of treatment

Above Samprapti helps us to proceed towards the treatment of Karnasrava

The main protocol of treatment is removal of fungus and wound management

which include various measures to keep area day clean clear of microbes and

providing ideal condition for healing

Samany Chikitsa- Acharya Sushruta described general treatment for

Karnaroga as Snehapana (Drinking ghee) Rasayana (Rejuvenation therapy)

Bhramacharya Avoid excessive speaking Avoidance of physical exercise and

head bath

Vishesha Chikitsa ndash Acharya Sushruta mentioned some procedures in the

treatment of Karnasrava which is Shirovirechana Karnadhoopana

Karnapurana Karanpramarjana Dhavan Avachurnana Karnapurana Above

various procedures described in Ayurveda for management of fungus growth

in ear discharging ear fulfill these requirements of wound management

Page | 128

Discussion on observation and Result

Out of 68 patients 34 patients included for the trial The incidence of

Karnasrava is observed in trial and control groups

The statistical analysis provided the following data

AGE

Trial group- Maximum no of patients that is 14 (41176) patients were from

age group 25-35 years followed by 29412 patients were from age group

18-25 years 23529patients were from age group 35-45 years and

58824 patients were from age group 45-60 years

Control group - Maximum no of patients that is 14 (41176) patients were

from age group 25-35 years followed by 20588 patients were from age

group 35-45 years and 20588 patients were from age group 45-60 years

17647 patients were from age group 15-25 years

The maximum no of cases of Karnasrava found in age group between 25 to

35 years The reason behind this is repeated use of ear bud or emersed water

in ear More use of earphone or working more in cold environment

GENDER

Trial group ndash A higher prevalence seen in females 6764 and 3235 in

males

Control group - A higher prevalence seen in males 5588 and 4411 in

females

Females and males both are prone to disease

Page | 129

EDUCATION

Trial group-It is observed that amongst 34 patients maximum ie16

(47059) patients were graduated 8 (23529) patients were HSC

educated 4 (11765) patients were SSC educated 4 (11765) patients

were illiterate 1 (29412) patient were primary educated and 1(29412)

patient were post graduated

Control group- It is observed that 10 (29412) patients were graduated 9

(26471) patients were HSC educated 6 (17647) patients were post

graduated 3 (88235) patients were SSC educated 3 (88235) patients

were primary educated3 (88235) patients were illiterate

There is no direct relation between education and Otomycosis

RELIGION

Trial group- The incidence of patients of Hindu religion are 9118 and Muslim

religion are 882

Control group- The incidence of patients of Hindu religion are 9706 and

Muslim religion are 294

There is no probable explanation for this maximum number of patients in

Hindu religion it depends upon the patients attend the hospital and

community residing there

Page | 130

DIET

Trial group It was found that maximum ie5882 patients were taking

mixed diet while 4118 were taking vegetarian diet

Control group It was found that maximum ie5882 were taking

vegetarian diet while 4118 patients were taking mixed diet

The dietary habit of person is based on choice availability and religious

customs of the person

ADDICTION-

Trial group- It was found that maximum ie 30 (8824) patients have no

addiction 2 (588) patients have addiction of alcohol 1 (294) patients

have addiction of Tobacco 1 (294) patients have addiction of smoking and

0 (0) patients have addiction of Mishri

Control group - It was found that maximum ie 27 (7941) patients have

no addiction 4(1176) patients have addiction of smoking 2 (588)

patients have addiction of Tobacco 1 (294) patients have addiction of

Mishri and 0 (0) patients have addiction of alcohol

Very few patients were addicted to Alcohol Smoking Tobacco and Mishri

These factors can be taken as provoking factors for Otomycosis

Page | 131

Discussion based on probable Mode of action of Karnadhoopana

In Ayurveda classics Karna Dhoopana is therapeutic procedure explain for

Karnasrava Dhoopana is administration of Dhooma (Fumes) with the help of

Dhoopan Dravya References indicates that analgesic and disinfectant effect

of Dhoopana karma and mention for Dushta Vrana Chikitsa It reduces

Vedana Srava amp also does Vrana Ropana action

Various Dhoopanas and Dhoopan Dravas for different element in various

Samhitas of Ayurveda but there is a lacuna of availability of reference

regarding how to do it and method of procedure Matra Kala Contraindication

etc

Currently simple modified way of Karnadhoopana according to Yukti Praman

and experience but there is lac of standardization

Karnadhoopana is one among the topical Bahiparimajan type of treatment

Karna Parmarjana is procedure of cleaning ear with the help of cotton or gauze

piece soaked in honey

Page | 132

Dhoopan

The fumes coming out on burning Agaruwadi Varti

Administrated directly into external ear canal

Causes vasodilation

Due to this increase blood supply in external ear canal

It helps in absorption of drug

Fumes dries up Srava and bring the analgesic effect

Karnagata Kapha amp Avrut Vata Dosha Shaman

Decrease in signs and symptoms like karnasrava Karnshool Karnabadhirya amp

Karnandu

Page | 133

3 Discussion based on probable mode of action of Agaruwadi

Dhoopana

Agaru ndash

I Agaru is a fragrant tree aroma is a result of fungal pathogenesis when the

wood of tree is contaminated by fungi at wounds it develops scrap filled

with resin and turn out to be aroma Medicinal use of Agaru have been

recorded in ancient medicinal science in in inflammatory disease and some

infective disease

II Acharya Charaka has referred to Agaru as an Ushna dravya despite having

Tikta Rasa Ashtang Samgraha used Agaru as Dhupana Dravya along with

Madan and Yawa in Karnasrava Nighantu recommended is use as a

Dhoopana

III In various Samhitas and Nighantus Agaru described as Tikta Snighdha

Sheetaprashamana Vranaprasadana Tvachya Due to these properties

Agaru is used in the treatment of Karna-Akashi Roga and Dushta Vrana

Shodhaka

IV Agaru is reported to have Antimicrobial Analgesic Antioxidants

Antihistaminic and anxiolytic properties Its Antihistaminic property gives

relief from itching which is cardinal feature of Otomycosis Due to Katu

Ushna Tikta Guna improves blood circulation Bheda stage develop It is

Niram Awastha of Dosha Karnagata kapha and vata get decrease and

symptoms like karnashoolakarnasrava get decrease Agaru also have a

Antioxidant properties

V Chemically Agaru Contain 2-(2-Phenylethyl) Chromones Terpenoids

Flavonoids

VI Natural Agarwood had inhibitive activities towards Staphylococcus Aures

The chloroform extract of Agarwood prolongs the pain threshold[108]

Page | 134

Madan

I Madanphala have therapeutic properties like Anti-inflammatory

Antiallergic Analgesic and Wound healing

II It is Useful in treatment of disease like Shotha (inflammation) Vidradhi

(Abscess) Pratishaya (Common cold) Kushta(Skin disease)

III Extract of Madanphala mainly contain Glcosides Tritorpenct

Glycosides Saponin

IV Saponin glycosides are act as fire extinguisher This property is helpful

for vartiIt also act as a detergent which clean the surface of fungus

V Tritorpenct act as a anti-inflammatory antimicrobial and

immunomodulator compound Interaction of glycosides with sterol

causes disturbance of selective permeability in plasmic membraneso

exudates and discharge get decrease

VI Pharmacological activity [109]

Antibacterial Activity The preliminary antibacterial activity of Methanolic

extract of Randia D lam was done on some standard and wild pathogenic

strains The inhibition of the bacterial growth was more pronounced on E coli

as compared to the other tested organism This shows the antibacterial action

of Randia D secondary infection can prevent

Anti-Allergic Activity In Ayurveda Randia D Extract and its fraction of milk

induced leukocytosis and eosinophilia in mice

Anti-Inflammatory Activity The crude methanol extract of fruit of Randia D

effectively reduced the carrageenin induced oedema in hind paw of the rats

significant reduction in granular tissue formation was recorded This activity

seems to be significant at various acute phases of inflammation and om

formation of granular tissue This proves action of Madanaphala in shopa

(inflammation)

Page | 135

Analgesic Activity Analgesic activity was tested in mice weighing between 20-

250 with six number of animals in each group Methanlic extract of fruit Randia

d give analgesic activity in both models This proves its Shoolanashaka (pain

killer) action

Immunomodulatory Activity Randia D has immunostimulant activity and

chloroform fraction which strongly affected immune system seems to be

bioactive fraction of this plant

The overall effect of Agaru Mandanphala Yawa having Anti-inflammatory

Antiseptic Antimicrobial Property Active ingredient shows these properties

Agaru Yawa Madanphala

Vatakaphaghna

Act as

Vranashodhak

Vedanasthapaka

Sheetaprashamana

Shothara

Avarana of Vata get decrease so helps to Shaman of Vata dosha

Karnakandu Karnashoola Karnasrava

Prashamana

Page | 136

This fact can be taken into consideration and probably acknowledge that

Karnadhoopana with Agaruwadi Varti had not leave any residue in the ear

Removal of fibrin keratinocyte migration and in growth of epithelial tissue

plays a major role in healing It is technique of fumigation of ear with the

smoke of anti-infective drug In Karnadhoopana Sthanik Swedana increase the

blood supply and helps in absorption of the drug reduce Karnakandu amp

Karnshoola associated with infection

Page | 137

SUMMARY AND CONCLUSION

Page | 138

The dissertation entitled randomize comparative clinical trial to study the

effect of Agaruwadi Karnadhoopan and Guggula Karnadhoopan In Karnasrava

wsr to Otomycosis

The dissertation is divided into fallowing parts

Introduction

Review of literature

Ayurvedic review

Modern Review

Drug review

Procedure review

Material and Method

Observation and result

Discussion

Summary and conclusion

bull INTRODUCTION

It includes importance of Shalakyatantra in Sushrut Samhita Charka

Samhita And Ashtang Samgraha

Common and specific causes of Karnasrava

Karnasrava is a clinical entity which can be corelate with Otomycosis

In Ashtang Samgraha stated the procedure like Karnadhoopana with

Agaru Yawa Madanphala in Karnasrava

Page | 139

bull REVIEW OF LITERATURE

1 Ayurvedic review

2 Modern review

3 Drug review

Ayurvedic review-

It includes Rachana-Sharir and Kriya-Sharir of Karna detail description of

Karnaroga and its types Karnaroga Samanya hetu Poorvaroopa Rupa

Samprapti Upadrava Pathya-Apathya of Karnasrava Vishesh Nidan and

Chikitsa of Karnasrava Detail description of Karnadhoopana according to

various Acharays have been mentioned

Modern review-

It includes anatomy and physiology of Ear brief anatomy of ear anatomy of

External middle and Internal ear Detail description of the disease

Otomycosis mechanism of fungal infection in external canal pathophysiology

investigations diagnosis and management

Drug review-

Detail description of Agaru Yawa Madan Guggula and its synonyms

Ayurvedic properties Karma uses Pharmacological action and their

pharmacodynamic properties

Page | 140

MATERIAL AND METHOD

It includes description regarding materials required for the study Preparation

of Agaruwadi Varti its Standardization Sterilization and packaging

Plan of study

1 Total 68 patients completed the treatment Age criteria was kept

between 18-60 years Patient selection was done by done by simple

random sampling method and divided into two groups A (Trial) and

Group B (Control) 34 patients in each group

2 Patients in Group A were treated with Karnadhoopana with Agaruwadi

Varti for 7 days two times in a day while patients in Group B were treated

with Karnadhoopana with Guggula for 7 days two times in a day

3 Clinical examination done during each follow up ie 0th 4rd 7th and

observation were recorded

Page | 141

OBSERVATIONS AND RESULTS

Page | 142

1 It was observed that higher incidence of disease Karnasrava ie

Otomycosis found in age group 25-35 years

2 Disease otomycosis was equal in both male and female

3 The trial group there was significant relief in Karnakandu (8906)

Karnasrava(9333) Karnashoola(7667) and karnabadhirya(100)

4 In control group there was significant relief in Karnakandu (7414)

Karnasrava(9524) Karnashoola(8438) and

karnabadhirya(8750)

Page | 143

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Middle Ear Published by Springer publication Chapter -Middle Ear cavity

Page no 19 to 121

60 DrPLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition Diseases of external ear

Chapter no 7

61 James OPickles An introduction to Physiology of Hearing Published by

Emerald publication 4th edition page no- 1 to 265

62 Raja Radhakantadeva Shabdakalpadruma Naga PublicationsDelhi 3rd

edition -2006 Volume 2 Page no 42

63 VdBramhand Tripathi Ashtanghradaya Uttarsthan Published by

Chaukhamba prakashana 2005 Karnaroga vigyniyam adhaya Shlok

no1713 page no- 998

Page | 151

64 Acharya Trivedi Raguveer Prasad Ashtang sangrah uttartantra

published by Vaidyanath Ayurveda bhavan pvt Shlok no- 212 page no-

730

65 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya Shlok no

1-2 page no- 309

66 Shree Yadunandanopadhyaya Madhavnidan with madhukosh

teekapublished by Chaukhamba Prakashana

67 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sutrasthan published by

Chaukhamba Orientalia Kiyantshirasiya Adhaya Shlok no 1713 page no-

258

68 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya Shlok no-

6 page no- 310

69 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005 Karnarogavigyniym Shlok no- 1725-26 Page no-

1003

70 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2140 page

no 131

71 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005 Adhyay 18 shlok 35

72 Acharya Trivedi Raguveer Prasad Ashtang sangrah uttartantra

published by Vaidyanath Ayurveda bhavan pvt

Karnarogapratishedhoadhya Shlok no-2211 Page no- 735

73 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Page | 152

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2141 page

no 131

74 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2142 page

no 131

75 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2144 page

no 131

76 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 34 page no- 649

77 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2145page

no 131

78 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 37 page no- 649

79 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2146page

no

80 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya page no-

316

81 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Page | 153

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2143page

no

82 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publication Krnarogadhikara adhaya page no-

318

83 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary

Madhyamkhand Vatkalpana shlok no- 782-83 page no- 137

84 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 72-77 page no- 651

85 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya page no-

316

86 Vd Shree Laxmipatishastri Yogratnakara

87 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

Karnarogadhikara Shlok no- 808182 page no- 652

88 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 83 page no- 652

89 (PDF) Otomycosis A Comprehensive Review (researchgatenet)

90 httpswwwncbinlmnihgovpubmed24948980

91 A Simon Carney Scott-Browns Otorhinolaryngology Head and Neck

Surgery CRC press 8th publication Otitis externa and otomycosis

92 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition Diseases of external ear

Chapter no Page no -

93 wwwguggulipidcomtradhtm

Page | 154

94 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

95 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 1 chapter no-28 page no-

43

96 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009Agaru page

no726-728

97 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishra chapter Karpuradi varga Shlok no-31-

43 Page no- 116

98 httpswwwthiemeinimagecatlogsample_chapter_GOMPpdf

99 (PDF) Chemical Constituents and Pharmacological Activity of Agarwood

and Aquilaria Plants (researchgatenet)

100 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 4 chapter no-2 page no-4

101 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 chapter no-152 Madanpage

no376-379

102 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

103 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 1 chapter no-54 page no-

84

104 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 page no697-699

patol-yawa

Page | 155

105 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

106 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

Dhoompanvidhi page no- 252-254

107 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012Chikitasasthan Shlok

no- 151page no-406

108 httpswwwmdpicom1420-3049232342pdf

109 httpswwwijamcoinindexphpijamarticledownload0610201530

0

Page | 156

BIBILOGRAPHY

Page | 157

1 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

2 Scott-Brown WG Diseases of the EarNose and Throat Landon

Botterworth and co(publishers) Ltd1952 Volume 2

3 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012

4 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009

5 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi commantry

Purvakhand and Madhyamkhand

6 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

7 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-Tatva-

Sandipika hindi commentary Published by Chaukhamba Sanskrit

SansthanVaranasi

8 The Ayurvedic Pharmacopeia of India Ministry of Health and family welfare

department of Ayush Part 1 and part 4

9 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005

10 Acharya Trivedi Raguveer Prasad Ashtang sangrah published by

Vaidyanath Ayurveda bhavan pvt

11 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition

12 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary published by Chaukhamba

Orientalia

Page | 158

ANNEXURE

Page | 159

ANNEXURE- 1

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

CASE RECORD FORM

RESEARCH PROFORMA FOR MS (AYU) DESSERTATION

DEPARTMENT OF SHALAKYATANTRA

NAME -

ADDRESS -

GENDER - AGE - OCCUPATION-

RELIGION - EDUCATION - MARITAL STATUS-

OPD IPD NO-

DATE OF ADMISSIONCOMMESEMENT-

DATE OF DISCHARGECOMPLITION-

DATE OF COUNSELLING-

TEL NO-

CHIEF COMPLAINTS-

PAST MEDICAL AND SURGICAL HISTORY-

TREATMENT HISTORY-

FAMILY HISTORY-

Page | 160

PERSONAL HISTORY-

a) Ahar(Diet)

b) Vihar

c) History of addiction

GENERAL EXAMINATION

PULSE - MIN BP - mm of hg

TEMP - 0F RR - MIN

ASHATAVIDHA PARIKSHANA

Nadi- Mutra- Mala-

Jivha- Shabda- Sparsha-

Drik- Aakruti-

SYSTEMIC EXAMINATION

RS ndash

CNS-

CVS ndash

Page | 161

LOCAL EXAMINATION (KARNA PARIKSHAN)

OBSERVATION TABLE FOR SUBJECTIVE CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching )

RIGHT EAR LEFT EAR

KARNASHASHUKULI

KARNAPUTRAK

KARNAPALI

KARNAKUHARA -

SRAVA

GANDH

VARNA

SWARUPA

KARNAPATALA (TM)

Page | 162

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

Hearing Test

1Renne Test ndash

2 Weber Test -

Examination of Ear-

Pathological Investigation-

Other Examination-

Nidan Panchak-

1Hetu-

2Purvarup-

3Rupa-

4Upashayanupashaya-

5Samprapti

Signature of Guide Signature of Doctor(Researcher)

Page | 163

ANNEXURE 12

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Dhoopana Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization were done as recommended in pharmacy procedure

The raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 were mixed together

in equal quantity to make Agaruwadi churn

STEP 4 - Agaruwadi churn were triturated with appropriate quantity of water

and prepared Varti in GMP Certified Ayurvedic pharmacy Standard aseptic

precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Dhoopana Varti was packed in sterile air packed

container

STEP 6 - Agaruwadi Dhoopan was given with the help of Dhoopan yantra

TREATMENT DETAIL-

Purvakarma -

1 The patient is asked to sit comfortably on chair having sufficient light and

less amount of dust

2 The EAC is cleaned thoroughly by Pichu Varti (cotton swab) to remove the

discharge and other debris

Pradhankarma -

1 The patient is asked to relax completely on the chair

Page | 164

2 Fumes are passed to the ear with Dhoopana Yantra

3 Dhoopana yantra is funnel shaped and its one end will keep the ear covered

for the passage of Dhooma into the ear canal and other end where Agaruwadi

Dhoopana Varti were placed which produces fumes

4 This Dhoopana was given for 5 min

Pashchat karma -

1 The patient were advised to avoid cold refrigerated food drinks cold water

bath cold wind fog and prevent water from entering the ear

(A) Agaruwadi Dhoopana Varti

B) Guggula Dhoopana Varti SOP of it is same as above Agaruwadi Dhoopana

Varti

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Page | 165

ANNEXURE 21

INFORMED CONSENT DOCUMENT

Study Title

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

Introduction

- You are invited to take part in a research study RANDOMSIED COMPARATIVE

CLINICAL TRIAL TO STUDY THE EFFECT OF AGARUWADI DHOOPANA AND

GUGGULA DHOOPANA IN KARNASRAVA

- Before you decide it is important for you to understand why the

research is being done and what it will involve

- Please take time to read the following information carefully and discuss

it with friends relatives and your doctor if you wish

- Ask us if there is anything that is not clear or if you would like more

information

Purpose amp Nature of Study

- In this research project by examine you and ldquoKarnasravardquo (Otomycosis)

disease were treated

- In the part of treatment Agaruwadi Dhoopana or Guggula Dhoopan were

given

- Dhoopana means medicated drug fumes were given in ear with the help of

Dhoopan Yantra

Page | 166

- Treatment was given for 7 days

Study Duration

7days

Participation

- Your participation is entirely voluntary

- If you do decide to take part you were given this information sheet to keep

and be asked to sign a informed consent form

- If you decide to take part you are still free to withdraw at any time and

without giving a reason This will not affect the standard of current or future

medical care you may receive

Confidentiality

- All information which is collected about you during the research were

kept strictly confidential

- Any information about you which is collected from the center will have

your identity in the form of a code number so that it will remain confidential

Benefits Of Study

- The results obtained from this study would be helpful for providing better

quality of treatment amp other essential facilities for Karnasrava (Discharge)

patients

- You will get clinical benefit from the study

Page | 167

Risks Of Study

- In this treatment there are few chances of Irritation of Ear Nose and

congestion at EAC if any of these happens then treatment were given

Results Of Study

- If the Results obtained are profitable then they may get published

without disclosing your details

Signature of patient

Date

Time

Phone no of Researcher

Page | 168

रण मादहती पतरक

सशोिनाच शीषवक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE

EFFECT OF AGARUWADI DHOOPANA AND GUGGULA DHOOPANA

IN KARNASRAVA

परसतताना

- आपणास या सशोिनातपमक अभयासात सहिागी होणय़ाच आाहन करणयात यत आह

- सशोिनातील सहिाग तननदशचत करणयापी सशोिनाच उददश समजन घया

- खालील मादहती काळजीपवक ाचा आणण आशयक ािलयास आपलया डॉकिराशी कका

दहतशरचतकाशी चचाव करा

- काही सददिता असलयास कका आणखी मादहती ही असलयास आमछयाशी चचाव करा

सशोिनाच उददीटि सतरप

- सदर सशोिन परकलपामरधय आपलयाला तपासणी करन कणवसरा या वयाशरिची शरचककतपसा दणयात

यणार आह

- सदर वयाशरिची शरचककतपसा महणन आपणास अगरादी िपन कका गगल िपन

दणयात यणार आह

- सदर औषि आपणास 7 ददस घयायाच आह

Page | 169

कालािी

- 7 ददस

सहिाग

- आपला सहिाग हा पणवपण ऎनदछिक आह

- आपला सहिाग तननदशचत असलयास आपणास ही मादहती पतरतरका दणयात यईल आपणास यातील

समती पतरकार सही कराी लागल

- सहिाग तननदशचत असनही आपण कोणतपयाही ळस कोणतही कारण न दता माघार घ शकता

याचा आपलया दयकीय सविर कोणताही पररणाम होणार नाही

गोपनीयता

- सशोिना दरमयान गोळा कलली आपलया वषयाची सव मादहती गोपनीय ठणयात यईल

- आपली यनदकतक मादहती साकततक सतरपात गोपनीय ठणयात यईल

सशोिनाच फ़ायद

- सशोिनाच तनटकषव कणवसरा बाशरित रणाछया दयकीय इतर सविाचा दजाव सिारणयास

फायदशीर ठरतील

सशोिनातील जोणखम

- य़ा शरचककतपसमरधय कान दखण डॊळय़ातन नाकातन पाणी य़ण नाकात जळजळण डोक जड

होण ही लिण ददस शकतात यापकी लिण तनमावण झालयास तपयाची शरचककतपसा कली जाईल

Page | 170

सशोिनाच तनटकषव

सशोिनाच तनटकषव फ़ायदशीर ठरलयास आपली मादहती गोपनीय ठन परकाशशत करणय़ात यईल

रण सतािरी-

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

Page | 171

ANNEXURE 31

INFORMED CONSENT FORM

Patient OPD no __________

Subjectrsquos Identifier

Date of Birth Age Gender

I _____________________________________ age___________ years

exercising my free power of choice hereby give my consent to be included

as a participant in the clinical study entitled

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

1 I confirm that I have read have been read and understood the information

sheet for the above study and can ask questions

2 I understand that my participation in the study is voluntary and that I am

free to withdraw at any time without giving any reason without affecting my

medical care or legal rights

3 I understand that the Ethics Committee members investigators and study

doctors will not need my permission to look at my health records both in

respect of the current study and any further research that may be conducted

in relation to it even if I withdraw from the trial I agree to his access

However I understand that my identity will not be revealed in information

released to third parties or published

4I agree not to restrict the use of any data or results that arisefrom this study

provided such a use only for scientific purpose

5 I agree to take part in the above study

Page | 172

signature with Date-

Left hand thumb impression

Name amp signature of the witness ndash

Name amp signature of the student ndash

Page | 173

ANNEXURE 32

समतीपतरक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

वयकतीच य

ददनाक जरमददनाक

1) मी ह तननदशचत कररत आह ककसदर सशोिन परकलपाबाबतची सपणव मदहती मी ाचली असनमला ती

समजली आहतपयाबददल मला परशन वचारणयाची पणव मिा आह सदर मादहतीन माझ समािान झाल

आह

2) मी सदर सशोिनातन माझया मजीनसार किीही बाहर पड शकतो या माझया अशरिकाराची मला कलपना

आह

3) माझी दयककय मादहती तपासणयाची कागदपतर कळ सशोिनाकररता ापरली जाणार आहत याची

मला मादहती आहसदर सशोिन परकलपातील सबशरित घिकाना माझी दयककय मादहती पाहणयाची मी

समती दत आहतरावप या सदिावतील माझी ओळख दशववणारी मादहती कोणासही ददली जाणार नाहीयाची

मला कलपना दणयात आली आह

4) सदर अभयासातन शमळणारी मादहती अरा तनटकषव कळ शासततरीय हतसाठी ापरल जाणयासाठी माझी

समती आह

5) रील अभयासात सहिागी होणयास माझी समती आह

रण सतािरी-

Page | 174

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

ASSESSMENT CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching)

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

a) कणवशल ( pain )- 0 - Absent

1 ndash Present

Page | 175

b) कणवकणड (Itching)- 0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

c) कणवसततरा ( Discharge )

0- Absent

1-Mild- Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाशरियव ( conductive Loss of hearing )

0 - Present

1 - Absent

Page | 176

Page | 177

Page | 178

Page | 179

Page | 180

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

Page | 181

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 182

AUTHENTIFICATION CERTIFICATE

Page | 1

INDEX

No Chapter Page No

1 Introduction 2-5

Study Rationale

Epidemiological data

2 Aims and objectives 6

3 Research Question 6

4 Previous work done 7

5 Review of Literature 8-73

i Literary Review

ii Disease Review

iii Drug Review

iv Procedure review

6 Materials and methods 74-91

7 Observations and Results 92-122

8 Discussion 123-136

9 Summary and conclusion 137-142

10 References 143-155

11 Bibliography 156-157

12 Annexures 158-182

i Case Record Form

ii Consents

iii Master Charts

Page | 2

INTRODUCTION

Page | 3

Ayurveda is ancient science of life a system of health and medicine

which aims to assist people in living a healthy life It is a person-centered

medicine which deals with healthy lifestyle systemic diseases prevention

diagnosis and treatment Ayurveda is divided into eight branches[1] It has

a separate branch of clinical and surgical specialization concerning ENT and

ophthalmology known as Shalakyatantra One out of the eight branches of

Ayurveda Shalakyatantra deal with the etiology diagnosis prognosis

prevention treatment and complication of diseases which are located at

Urdhwang Pradesh[2]

Karna is one among the Panchendriya (sense organ) situated at

Urdhwang Pradesha [3] It is originated from Akash Mahabhuta Aachary

Sushruta explains 28 Karnaroga in Uttaratantra Karnaroga Vigyniyam

Aadhaya[4] He mentioned Karnasrava as separate diseases[5] Aacharya

Charaka explain 4 Karnaroga He had not described Karnasrava as

independent diseases but explain Karnasrava as a symptom under four

Karnaroga Acharya Vagbhata mentioned Karnasrava as a symptom in

Karnashoola according to Dosha He included this into Kaphaj Karnashoola

itself[6] Karnasrava means discharge through ear The Samanya Hetu of

Karnaroga are Avashaya or Pratishaya that is common cold Sheeta Vihara

or exposure to cold environment Karnakandu or self-inflicted trauma by

use of ear bud or pine to clean itching in ear Shabda Shashtra Mithyayoga

that is misuse of instrument or listening to high sound frequencies[7] The

other predisposing factors are such as abuse of nonspecific broad-spectrum

antibiotics steroids and immune suppressed disorders

Classical features of Karnasrava can be compared with otomycosis

Otomycosis is acute sub-acute or chronic fungal infection in external ear

which rarely involves the middle ear[8] Otomycosis is characterized by pain

itching discharge conductive deafness of mild to moderate in nature

Fungal spores invade in the epithelial layer of EAC In response to that

inflammatory process starts which will reflect as pain Itching is due to

immune reaction of body during inflammatory process As a result of

Page | 4

inflammatory process exudates were produced which will mix up with

fungal colonies and appear as discharge In initial stage of disease ear

discharge is watery but if there is secondary bacterial infection occur it

becomes mucopurulent Ear blockage and conductive type of hearing loss

are due to accumulation of fungal mass in external auditory canal

Fungal mass appears white or black or brown and is like a wet piece

of filter paper Examination with otoscope Aspergillus Niger appears black

headed filaments growth Aspergillus fumigates as a pale blue or green and

candida as a white or creamy deposit[9]

Otomycosis is a common condition and it mostly occurs in humid

area According to American academy of otolaryngology prevalence of

otomycosis is 52 all over a world and 09 in India 5-25 otitis externa

cases are due to otomycosis Nearly 61 types of fungal species being involve

in otitis externa 90 of fungal infection cases involve Aspergillus species

and the rest candida species[10]

In Ayurveda The common treatment Principle for all is Ghritapana

Rasayana Bhramacharaya Avyayama (Excessive exercise)

Ashirasnana(Head bath) Atibhashashya(Excessive speaking) This can be

used for the prevention and management of Karnaroga[11] Acharya

Sushruta explain specific treatment modality for Karnasrava is

Karnaprakshalana Karnapoorana Karnadhoopana Shirovirechana

Karnadhavana[12]These therapeutic procedure can be updated according to

different stages of these condition

In routine OPD it is observed that patient of otomycosis respond

more frequently to topical therapy than to systemic therapy Among all the

treatment modality Karnadhoopana is an effective and simple procedure

In this regard Karnadhoopana with Agaruwadi Varti or uggula had explain

in Ashtang Samgraha Agaruwadi Varti contain Agaru Yawa Madanphala

All these contains of Agaruwadi Varti and Guggula acts as Ruksha Ushna

Teekshana Laghu Guna acts as effective Shodhaka keeps ear dry reduce

Page | 5

pain discharge foul smell and thus control the infection Dhoopana is also

useful as Adhidaivika Chikitsa to protect the patient from external attack of

visible and invisible organism The principal treatment modality adopted in

Allopathic system of medicine is oral antibiotics and topical antibiotic drop

Long term use of oral antibiotic causes adverse effect like gastric irritation

reduce immunity and resistance to drug Long term use of topical antibiotic

drops cause Ph change in external canal which become prone to fungal

infection

Hence the therapeutic procedure with Guggula or Agaruwadi Varti

Karnadhoopana are cost effective safe and easy procedure and it can be

used more effectively

Page | 6

AIM OF STUDY

To evaluate the effect of Agaruwadi Varti Dhoopana and Guggula Varti

Dhoopana in management of Karnasrava

OBJECTIVE

To compare the efficacy of Agaruwadi Dhoopana and Guggula Dhoopana in

Karnasrava

HYPOTHESIS

NULL HYPOTHESIS -

H0- Agaruwadi Dhoopana is not effective than Guggula Dhoopana in

Karnasrava

ALTERNATE HYPOTHESIS -

H1- Agaruwadi Dhoopana is more or equally effective than Guggula

Dhoopana in Karnasrava

RESEARCH QUESTION

Whether there is significant difference between Agaruwadi Dhoopana and

Guggula Dhoopana in Karnasrava

Page | 7

PREVIOUS WORK DONE -

1 Anupama Patra B Effect Of Arka Taila In The Management Of

Karnasrava With Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching amp Research in Ayurveda

Gujarat Ayurved University Jamnagar 2007

2 Palmer Komalben K Further Study On Role Of Arka Taila In The

Management Of Karnasrava With Special Reference To

Otomycosis Shalakya Tantra Institute for Post Graduate Teaching amp

Research in Ayurveda Gujarat Ayurved University Jamnagar 2010

3 Sathisha Shankar B Management Of Karnasrava With Sthanika

Guggulu Dhoopana And Rasnaadi Guggulu-A Comparitive Study Shalakya

Tantra Government Ayurvedic Medical College Bangalore 2011

4 Shashikala DK Comparative Study On The Efficacy Of Vacha

Lashunaadi Taila Karna Pichu And Nimba Patraadi Dhoopana In The

Management Of Karna Srava Shalakya Tantra Government Ayurvedic

Medical College Bangalore 2014

5 Javale Anant A Clinical Study On The Efficacy Of Arka Taila In The

Management Of Karna-Srava Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching amp Research in Ayurveda

Gujarat Ayurved University Jamnagar 2005

6 Pournima V Koti Management Of Karnasrava With Priyangvadi Taila

Pichu With And Without Saarivadi Vati Shalakya Tantra Sri Jagadguru

Gavisiddeswar Ayurvedic Medical College Koppal 2015

7 Amisha Patel A Clinical Evaluation Of Honey In The Management Of

Karna Shoola With Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching and Research in Ayurveda

Gujarat Ayurved University Jamnagar 2016

Page | 8

REVIEW OF LITRATURE

Page | 9

Ayurvedic literature Ayurveda is a science of life practice since

thousands of years The ancient Indian system of medicine and surgery is

commonly known as Ayurveda This was given the status of Upaveda or

fifth Veda in the next stage of growth Among the available literature three

Samhita that is Charaka Samhita Sushrut Samhita Ashtang Hrudayam and

Ashtang Samgraha are the chief source of knowledge of Ayurveda

Ayurveda consist of eight branches Shalakyatantra is one among them

Shalakyatantra is one of its specialized branch deals with science of

ophthalmology otorhinolaryngology Oro dental surgery and head Acharya

Sushruta himself a practical surgeon was the first to advocate dissection of

dead bodies is indispensable for a successful student of surgery He had

described gross anatomy in the first chapter of Uttartantra Shalakyatantra

define by different Acharys as follows

शालाकय नामोरधवजतरगताना रोगाणा शरणनयनदनघराणाददसशरशरताना वयाशरिनामपशमनारव

स स ११०

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत [13]

चस १७१२

Shalakya Tantra Nirukti and Parichaya

शलाकायााः कमव शालाकय ततपपरिान शलाकयम डलहण [14]

The term Shalakyatantra is derived from Shalakya and Tantra

The word Shalakya means A probe and Tantra denotes teaching and

practices found in scripturesThe compendium in which application of

Shalaka in various surgical procedures is principally described is called as

Shalakya tantra

दनदटिवशारदााः शालाककनाः डलहण ( सउ ११३)[15]

An eye specialist is termed as Shalaki by Dalhana

Page | 10

Synonyms of Shalakya Tantra

Uttamanga Chikitsa Jatrurdhwa Chikitsa Urdhwang Chikitsa Shalakya

Chikitsa

Importance of Shalakyatantra-

Life of living being and all the Indriyas are situated in the head hence it is

known as Uttamanga

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत

चस १७१२

The treatment given to this part of the body is described specially in

Shalakya tantra While describing the importance of Shiras Vagbhata

correlates it to the root of tree (Urdhwa Mula) and body to the trunk of tree

(Adha Shaka)

Sushruta has deal with Mukha Roga in Nidan Shan and its treatment in

Chikitsasthan The description regarding the disease of eye ear nose and

head are found only in UttaraSthan Sushruta specially describes the

disease of Shalakyatantra as told by Videha in the beginning of Uttartantra

itself[16]

Shalakyatantra Itihas-

India Exhibits traditional of more than thousands of years in art literature

language logic and philosophy etc The convention was in its sophisticated

and advanced attire throughout the Vedic period

Vedic period ndash

1 Natush was treated for deafness by Ashwinikumars (Rigveda)

2 Rujaswa and Kanva were treated for blindness by Ashwani Kumaras

(Rigvedas)

Page | 11

3 There are several prayers mentioned for normal functioning of sense

organs (Yajurveda)

4 Structures and functions of Mastishka are described (Atharveda)

5 Mantras having reference to disease of Eye Ear Oral cavity etc are

found (Atharvaveda)

Upanishada Period ndash

1 Samhita Period

a) Sushrut Samhita ndash

bull Explanation regarding Netra Nasa and Shirorogas (Uttartantra 1-

26th chapter)

bull Details regarding Mukha and Karna Roga Nidan and

Chikitsa(Nidansthan 16th and Chikitsasthan 22nd chapter)

bull Description regarding Karna Chedana Sandhana Nasa

Ostasandhana Sutra Sthan 16th chapter

b) Charaka Samhita -

bull Explanation regarding Shirorogas (Sutrasthan 17th chapter)

bull Explanation of Gala rogas like Upajivika Galshundi and Rohini

bull Nasa Shiro Mukha Karna and Netra Chikitsa (Chikitsa sthan 26th

chapter)

bull Description regarding Lakshana and Chikitsa of Shankhaka

Ardhavbhedaka Shirovirechana and Shiro basti (siddhi sthan 9th

chapter)

c)Ashtnga Sangraha ndash

bull Detailed description regarding Shalakyatantara (Uttartantra 11-28

chapter)

bull Description of Kriyakalpa (Sutrasthan 32nd and 33rd)

Page | 12

d)Ashtang Hrudayam

bull Detailed description on Shalakya Tantra (Uttar tantra 8-24 chapters)

bull Kriyakalpas (Sutrasthan 23rd and 24th chapter)

e) Bhela Samhita

bull Chakshushya Vaisheshik and Buddhi Vaisheshik Alochaka pitta

f) Harita Samhita- Branch of Medical science offering elaborating

information about the procedure like Nasya Anjan Gandusha etc

comprehended with their applications in disease of Head Eyes Ears

Eyebrows Throat Temporal region and cervical spine is known as

Shalakyatantara

शशरोरोगा नतररोगा कणवरोगा वशषताः भरकरठशङकमरयास य रोगा समिनदरत दह १३

तषा परततकारकम व नसतयतपयवणजनातन च अभयङगमखगणडषकियााः शालकयसशमतााः १४

इतत शालाकयनाम [17]

Documentation of different ancient literature gives various references

regarding all aspects of Karnasrava in various periods It is very much

important to know the history of Karnasrava from Vedic Pauranic Samhita

and Samgraha period

Vedic period ndash The Vedas being the oldest source of knowledge have no

direct mentioning of Karnasrava

Page | 13

Samhita and Samgraha period ndash

Aacharya Sushruta described about Karnaroga Karnasrava Nidan

Roopa and Chikitsa The detail description is available in Sushrut

Samhita Uttartantra 20 and 21st chapters

Aacharya Charaka did not specify Karnasrava but mentioned 4 types

of Karnarogas that is Vataj Pittaj Kaphaja and Sannipataja and their

treatment in 26th chapter of Chikitsasthan

In Ashtang Hrudaya karnasrava is not explained as a separate disease

but Chikitsa is mentioned in 18th chapter of Astanga Hrudaya

uttartantra

In Ashtang Samgraha Chikitsa is mentioned in 22nd chapter of Astang

Samgraha Uttartantra

The details about Karnasrava are explained in Bhavprakasha

Madhyamakhanda 64th chapter

Madhavakara has explained about Karnasrava in 57th chapter of

Madhymakhanda

Karnasrava is also explained in Sharangadara Samhita Uttarkhand 11th

chapter

The reference for treatment of Karnasrava is available in

Yogaratnakara

In Gadhnigraha Karnasrava and its treatment is mentioned in

Karnarogadhikara Adhaya

Vangasena had mentioned about the disease and treatment in 69th

chapter

Chakradatta explained Karnasrava in 57th chapter

Dalhana has given commentary on Sushrut Samhita Uttartantra 20th

and 21st chapter

Sankhya Samprapti of Karnasrava ndash

Aachary Sushruta explains 28 Karnaroga in Uttaratantra Karnaroga

Vigyniyam Aadhaya Aacharya charaka explain 4 Karnaroga in

Page | 14

Karnarohvigyniyam Adhaya based on doshas Acharya Vagabhata in

Ashtang Hrudaya explain 25 Karnaroga in Adhyaya

कणवशल परणादशरच बाशरियव कषड ए च

कणवसरााः कणवकणडाः कणव चवसतततर च

कशमकणवपरततनाहौ विशरिदवविसततरा

कणवपाकाः पततकणवसततराशवशरचतवविम

कणावबवद सपतवि शोफशरचावप चतवविाः

ऎत कणवगता रोगा अटिावशततरीररतााः

स उ २०- ३ त ५[18]

ातकणवरोग वपततकणवरोग कफकणवरोग

रकतकणवरोग सनदरनपातकणवरोग कणवनाद

बशरिरतप परततनाह कणडाः शोफ पततकणवक

किशमकणवक उियरपविरधयअशो अबवद

कशरचकणवक वपपपली वदाररका पाळीशोष

ततिका पररपोिो उतपपातो उरमरर दाःखिवन

शलहाखयााः परचवशनदरतकणवरोगा उकतााः

इदिीका अ स उ २१ [19]

चतपाराः कणवरोगााः

च स [20]

Page | 15

KARNA

Karna ndash करोतत शबद गरहण [21]

The organ of hearing

Karnasrava- कणवसतय कणवयोाव ससराा [22]

Discharge from the ear is referred as Karnasrava

KARNA SHAREERA

bull Nirukti

कणयवत अकणयवत अनन इती [23]

It means reception and conduction of sound waves

These are the functions of external and middle ear

bull Nirukti of Sravanam

शरयत अनन इती शरणम[24]

It means perception of sound

It can be attributed to the internal ear function

bull Karna Utpatti-

Karna is an organ formed by Akash Mahabhuta[25]

The fundamental characteristic is as follows

Indriya ndash Srotram [26]

Indriya Adhisthan ndash Karna [27]

Indriya Dravy ndash Akasha [28]

Indriya Arth ndashShabdha [29]

Indriya buddhi ndash Srotobyddhi

Page | 16

bull Paryaya of Karna- Shabdapatha Srotrapatha Sravanam shruti

Kuhuram Dwanigraham etc

bull Definition of Karna-

कणवशटकलयनदछिरनमिटिोपगरदहत शरोतरमछयत [30]

मा तन ५७१

The definition of Karna is stated in Madhav Nidanam Indriya which is not

seen with naked eye along with Shashkuli is called Shrotra that is Karna

Indriya is so minute that it is not perceived with any sense organ

In Charak Samhita the word Karna explain as the Indriya Adhisthan of

Shabdha Karna is described as one of the Prathyangas of the body He

emphasizes that all Indriyas manifest during the 3rd month of gestation

period

Acharya Sushruta while describing formation of Purusha from Prakriti or

Avyakta narrated that all Indriyas are developing from the Vikarika and

Taijas Ahankara Both Vagabhata and Sushruta stated that Karna as one of

the Bahirsrotas

शरण नयन दन घराण गदमढराणण न सततरोताशसराणा बदहमवखातन [31]

स शा ५-१०

In Ashtang Hradaya Vagbhata has states that all Indriyas are Atmaja

According to him lower lobule elevated helix projected posterior portion

fleshy and adherent ear are indications of long span of life[32]

ततरखातखातन दह अनदसतमन शरोतर शबद ववकतता [33]

ा शा ३-३

शबदाः शबदनदरिय सवनदछििसमहो ववकतता [34]

स शा १-२६

Page | 17

Ear has the prominence of Akash Mahabhuta The prominent dosha of ear

is Vata It is important seat of Vata The prominent Dhatus are Asthi and

Mamsa Karna is one of the Panchgnanendriyas and it meant for hearing

Sushruta narrated that Karnasthita Asthi and Sandhi

घराणकणवगरीाकषिकोषष तरणातन [35]

सशा ५-२२

शरोतरशरगािकष शखाताव [36]

सशा ५-३२

गडकणवशखटककम [37]

स शा ५-२२

One Sandhi and one Tarunasthi in ear

Sandhi ndash Karna contain two Sandhi one in each ear Type of Sandhi is

Shankhavartha which is present in Shringataka

Mansapeshi ndash 2[38]

Siras ndash 10 [39]

Vataj Sira - 4

Pittaj sira - 2

Kaphaj sira - 2

Raktaj Sira - 2

Avedhya sira-

कणवयोदवश तासा शबदादहनीनामकका पररहरत

सशा ७-२५[40]

Amongst above mentioned ten Siras each Karna lodges one Shabdavaha

Sira It is Avedhya

Page | 18

Dhamani -2

Length of ear is 4 Angula

Karna moola ndash 2 Angula

कणाविरतर चतदवशअगलम

स शा ३५-१४[41]

The distance between two ears through the back of the neck is 14 Angula

bull Marmas of Karna-

1 Vidhuras-

कणवपटठतो अिाःसशरशरत विर ततर बशरियवम

सशा ६-३७[42]

कणतपयादद सतनायममवणी ककनदचचनदरनममनाकर कलयकररणणच

डलहणाचयव[43]

अिसततात कणवयोतनवमन विर शरततहाररणण

ा शा ४-२९[44]

Sankhya-2

Vistara- frac12 Angula

Type- Snayumarma (Susha)

- Dhamanimarma(AH)

- Vaikalykar

Sthana- It is situated in the depressed portion in the back of the ear

Injury to them causes loss of hearing

Page | 19

2 Shringataka marma-

नदजवहाकषिनाशसकाशरोतरखचतटियसरमम

तालरयासतयातन चतपारर सरोतसा तष ममवस

वदि शरगातकाखयष सददसततपयजतत जीवतम

मा तन ५७१ [45]

Sankhya- 4

Type- Siramarma

Sthana- It is in head that is amidst Siras (blood vessels) nursing sense

organ

A palm size area near Talu

Injury to this Marma causes death

In modern anatomy ear divides into Bhayakarna or External ear Mdhyakarn

or Middle ear Antahkarna or Internal ear This is extremely appropriate

Even though the ear is divided into three divisions in the point of modern

anatomy Ayurveda denotes ear organ is one Ayurveda treats disease by

way of assessing Dosha and Dushya Here Dushya is one that is Karnendria

Dosha difference will call for different treatment for different disease Hence

treating the vitiated Dosha will cure the disease irrespective whether it is in

external middle or internal ear The thought is based on different

fundamental principle from Ayurveda

bull Parts of Karna

In Ayurveda classics detailed description about anatomy of ear is not

available But the various parts are mentioned as follows

Bhayakarna- External ear

Mdhyakarna ndash Middle ear

Antahkarna- Internal ear

Page | 20

द कणवशटकशलक दॊ कणवपतरकौ

च शा 7-11[46]

कणवशटकशलक कणवगतातवकौ कणवपतरकौ त बाहयकणा

चिदतत च शा 7-11[47]

शटकली बाहयपालयाशरिटिानम

डलहन- स शरच 25-1 12[48]

Karna Shashkulika ndash It is also called as Karna Shashakuli Charaka has

mentioned this term while describing different Pratyngas of the body

Acharaya Gananatha sen has given the clarification for it as a pinna or

auricle[49]

Karnapali ndash It is popularly known as lobule of the ear Daivakrita Chidra is

present in it

Karnaputrika- Ayurvedic scholars accepted two terms in this cortex They

are Karnaputrika and Karnaputrika The former is considered as Tragus and

antitragus[50]

Karna Prushtha- It can be taken as the cranial surface of mastoid or

auricle[51]

Karnapeetha- Aacharaya Sushruta firstly mention the term Karnapeetha

It is mentioned first by Sushruta while describing the procedure of

Karnavyadana Vagbhata has mentioned that it is Adhobhaga of Karna

Dalhana has clarified that it is the region above the Karnaputrika that is the

region which is at the bottom of the concha

Karnamoola ndash It can be considered as parotid region[52]

Karna lathika ndashAcharaya Dalhana mentioned lobule as a Karna Lathika

Page | 21

Karnaavatu ndashThis term is used by Sushruta while describing the

measurements of different Angapratyangas where he has mentioned that

the distance between the Karnaavatu is 14 Angul Dalhana has comments

that it can be taken as the distance between two ears from behind[53]

Shabdhavahasrotas ndash It also called as Shabdapatha or Srotapatha The

whole passage through which the sound waves pass can be taken as

Shabdavahasrotas[54]

Shrotashringataka ndash It can be taken as the labyrinth of ear[55]

bull Dosha in context to Karna-

Karna is principal location of Vayu

1 Prana Vayu- Prana Vayu circulating in oral cavity is responsible for

Dehadhruka that is keeping all body parts active Indriyadruka that is

keeping all Dnyanendriya healthy by proper nourishment (Purana) helps in

deglutition of food material and convey the stimulation of Indriyabuddhi

and atma

2 Udana Vayu- Bala(strength) Varna speech singing are its function It

is responsible for facial expressions due to pleasure sorrow anger love

frustration etc in general its circulation and actions are just opposite to

Pranavayu

3 Vyana Vayu- Its principal functions are circulation of Rasa and Rakta

through body and various movements Its main location is Hrudaya Five

types of movements for which it is responsible are expansion contraction

upward downward and oblique other activities are opening closure of

eyelid yawning perspiration During circulation if it gets obstructed due

to Srotodushti it generates disease of that Srotas Vyana Vayu gets vitiated

by disease of Rasa Rakta Oja and Chetanadhatu

Page | 22

4 Samana Vayu- It is circulating in the vicinity of stomach and intestine

and helps in keeping the Jatharagni (digestive juices and enzymes) in

equilibrium Disturbance in Jatharagni precipitates disease

5 Tarpaka Kapha- Entire body functions movements are controlled and

executed by various centers in the brain Sensation perceived by sense

organs is conveyed to Mann and Aatma residing in Hrudaya The motor

signals from them are then conveyed to the functioning

organsKarmendriya through Prana Vayu Shira head is therefore a

location of continuous activities motions of Vata All these centers are in

unctuous Majjadhatu in the Shira For stabilizing this ever-active Vata and

to nourish the Majja dhatu very unctuous Tarpaka Kapha situated in Shira

plays an important role

bull Ayurvedic aspect of sound perception [56]

According to Ayurveda Pratyaksha Dnyan or Perception of any sensation

including Shabda occurs due to interaction of the Karnendriya and the

Indriya- Arth -Karma resulting in Sravana

External Environmental acquaintance with living body is executed by five

sense organs namely Netra Karna Nasa Jivha and Twaka All

Dnyanendriya that is sense organ are Panchmahabhautic combination

Despite this fact every Indrya sense organ perceives object Tanmatra of

that Mahabhuta only from which it is originated from Akash Mahabhuta and

hence perceives Shabd only that is audio perception Shrotrendriya is one

of the principal locations of Vata and its function is to perceive Shabda that

is sound waves This sensation is conveyed through Shabdavahi Dhamanis

to Mana and Atma through Pranavayu and the sequence is responsible for

perception of sound in this way external sound is perceived and interpreted

when Atma is linked with Mann Mann is linked with Indriyabuddhi that is

minute virtual Dnyanendriya located in brain Indriyabuddhi is linked with

Adhishthana with prominent Mahabhuta and lastly with Indriya

ArthShabdatanmatra that is sense object Once this sequence is completed

Page | 23

the meaning of a particular sound is interpreted and understood In this

entire process of perception and interpretation of sound waves Pranavayu

and Tarpaka Kapha located in Shira play extremely important role Hence

the healthy status of all the sense organ depends upon the normal

physiologically homeostatic condition of Pranavayu and Tarpaka Kapha

MANAS

ATAMA

BUDDHI

AHANKARA

ARTHA

Page | 24

EAR ANATOMY

bull Embryology of the Ear [57]

1 The sound conducting apparatus develops from the branchial apparatus

whereas the sound perceptive apparatus from the ectodermal otocyst

2 The pinna develops from the six hillocks around the 1st branchial cleft

3 External auditory canal develops from 1st branchial cleft

4 The outpouching of the 1st pharyngeal pouch gives rise to a proximal

narrow part that forms the eustachian tube and distal dilated part that

forms the middle ear cavity

5 Prussakrsquos space is a potential space lateral to the Shrapnellrsquos membrane

and medically by the neck of malleus that can be involved during the

extension of cholesteatoma

6 Development starts in the 3rd week of the intrauterine life and is

completed by 16th week of intrauterine life Membranous and boney

labyrinth develops from the otic capsule

The Ear is divided into

1 External Ear

2 Middle Ear

3 Internal Ear or the labyrinth

Page | 25

Fig 1 Ear Anatomy

EXTERNAL EAR [58]

The outside ear contains pinna and lobule

Pinna is the noticeable piece of outer ear made from single sheet of yellow

flexible ligament covered by subcutaneous tissue and skin It has two

surfaces average and parallel It is intently disciple to perichondrium on its

sidelong surface while it is somewhat free on average surface Pinna

incorporates tragus helix against helix fossa three-sided scaphoid fossa

incisura terminalis

External auditory Canal ndash It extends from the bottom of the conchea to

the tympanic membrane and measures about 24 mm along its posterior

wallit is S shaped

Parts 1 Cartilaginous part

2 Bony part

Page | 26

Cartilaginous part ndash The outer one third is cartilaginous consist of fibro

cartilage is directed first inward backward and upward It has Fissure of

Santorium The skin of this part of the canal contains hair follicles

sebaceous gland and cruminous gland

Bony part ndash The inner two third part is boney It goes forward downward

and medially skin lined in this part is very thin Isthmus is the narrowest

part of the canal lying medial to junction of bony and cartilaginous part

nearly 5 mm lateral to tympanic membrane

The roof and posterior wall of the external auditory canal shorter than floor

and anterior wall The skin lining the tympanic membrane and boney canal

has a self-cleansing property due to migration of keratin layer of epithelium

from drum towards the cartilaginous portion

Relations- Anteriorly- Temporomandibular joint and parotid gland

Superiorly- Middle cranial fossa

Inferiorly- parotid gland

Posterior- Mastoid antrum mastoid air cells and facial nerve

Nerve supply ndashSensory nerve supply of the external ear The auricle

supplied by fibers of the great auricular nerve (C2 and C3) and lesser

occipital nerve (C2) Auriculo temporal branch of the 5th cranial nerve and

auricle branch of the vagus (Arnoldrsquos nerve) supply external canal Facial

nerve has small sensory contribution on posterior-inferior wall

Tympanic Membrane -It is the partition between EAC and middle ear It

is a thin semitranslucent membrane pearly white in colored lying obliquely

in the medial end of EAC with the angle of 55 It is forming major part of

lateral wall of middle ear Annulus tympanicus is attached at its

circumference to the sulcus The TM is oval shape It measures

approximately 10 mm in vertical diameter and 90 mm in horizontal

diameter

Page | 27

Layers ndash Tympanic membrane consist of three layers

1 Outer Epithelium or cuticular layer which is continuous with skin of

external ear

2 Middle fibrous layer has both circular and radial fibers middle layer

missing in upper part

3 Inner layer- Inner mucosal layer which is continuous with middle ear

mucosa

Parts ndash Tympanic membrane consist of two parts

1 Pars tensa -It is largest part below the malleolar folds The inner

surface at the center attached to the handle of malleus Angle of cone

is most illuminated part in the pars tensa at anteroinferior part of pars

tensa

2 Pars flaccida Sharpnells membrane -it is triangular area above the

malleolar folds which are thin and devoid of fibrous tissue and

annulus It fits into notch of Rivinous

Nerve supply 1 Anterior half of lateral surface Auriculotemporal V3

2 Posterior half of lateral surface Auricular branch of vagus cn 10

3 Medial Surface Tympanic branch of CN 9 (Jacobsons nerve)

Fig 2 Tympanic membrane of ear

Page | 28

MIDDLE EAR [59]

The middle ear or tympanic cavity is an irregular laterally compressed

space within the temporal bone It is filled with air that is supplied to you

from the nasal part of the throat through the ear canal It contains a chain

of mobile bones that connect its side with the medial wall and serve to

transmit vibrations transmitted to the eardrum through the cavity to the

inner ear Including the parapet the vertical and anteroposterior diameters

of the cavity are each approximately 15 mm The transverse diameter

measures about 6mm at the top and 4mm at the bottom Compared to the

eardrum it is only about 2mm The eardrum is limited laterally by the

eardrum medially by the lateral wall of the inner ear It communicates

behind with the tympanic antrum and through it with the air cells of the

mastoid and in front with the auditory canal The middle ear together with

the Eustachian tube aditus antral and mastoid air cells is called the

middle ear cleft It is lined by mucus membrane and filled with air

It is divided into 3 parts

1 Mesotympanum (located in front of the pars tensa)

2 Epitympanum or attic (located above the pars tensa but medial to

Sharpnells membrane and the lateral bony wall of the attic)

3 Hypotympanum (located under pars tensa) The middle ear is like a

hexagonal box with a roof

Carotid or Anterior wall- It separates middle ear cavity from internal

carotid artery The various structure passing through anterior wall of

tympanic cavity

bull Canal of chorda tympani nerve

bull Canal of tensor tympani muscle

bull Eustachian tube

bull Anterior malleolar ligament

bull Anterior tympanic artery

Page | 29

Posterior or mastoid wall ndash The upper part of the back wall shows the

opening of the auditorium Below the auditory is a triangular bony

projection known as the pyramidalis processors The stapedial tendon is

transmitted through the apex of the pyramidalis processes The vertical

portion of the facial nerve descends along the posterior wall until it opens

into the stylomastoid foramen

Roof or Tegmental wall (Pars terminalis)- It is formed by a thin bone

plate called the tegman tympanum that separates the skull and tympanic

cavities It is located on the anterior surface of the rocky part of the

temporal bone near the junction with the temporal shell it extends back to

the roof in the tympanic membrane and anteriorly to cover the half canal

of the tensor tympanic muscle The lateral border corresponds to the

remains of the Petro scaly suture

Floor ndash It is formed by a thin plate of bone which separate middle ear from

the bulb of the internal jugular vein lodged in the jugular fossa

Lateral wall ndash It is formed by tympanic membrane and partly by a portion

of squamous part of the temporal bone It separates the middle ear from

external ear

Medial wall- It separates the middle ear from the inner ear

bull The promontory is the most prominent and convex part formed by the

basal rotation of the cochlea

bull The bony lateral semicircular canal is postero-superior to the promontory

above the oval window

bull The oval window is located between the middle ear and the vestibular

slope of the cochlea It is closed by the stirrup footrest and the annular

ligament

Page | 30

bull The round window is located under and behind the cape The round

window recess is directed to the rear It is closed by the secondary eardrum

and separates the middle ear of the Scala tympani from the cochlea

bull The facial nerve passes through the bony fallopian tube above the oval

window

Mastoid Antrum ndash It is a large space with air in the upper part of the

mastoid and communicates with the attic through the aditus The roof is

formed by the antri tegmen which extends and separates the tympani

tegmen from the middle cranial fossa The lateral wall of the antrum is

formed by a bony plate that is on average 15 cm thick in adults It is

marked externally on the surface of the mastoid by the suprameatal triangle

(MacEwen)

Aditus and Antrum- Aditus is a gap through which the attic communicates

with the antrum The boney prominence of the horizontal canal lies on its

medial aspect even as the fossa incudes to thats attaches the quick system

of incus lies laterally Facial nerve publications simply underneath the

aditus

The mastoid and its air cell system-

The mastoid consists of bone cortex with a honeycomb of air cell

underneath Depending on development of air cell three types of mastoids

have been described

1Well-pneumatized or cellular- Mastoid cells are well developed and

intervening septa are thin

2Diploetic- Mastoid consist of marrow spaces and a few air cells

3Sclerotic or acellular ndash There are no cells or marrow spaces

With any type of mastoid pneumatization antrum is always present In

sclerotic mastoids antrum is usually small and the sigmoid sinus is

anteposed

Page | 31

Depending on the location mastoid air cells are divided into

1 Zygomatic cells (In the root of zygoma)

2 Tegman cell (Extending into tegmen tympani)

3 Perisinus cells (overlying the sinus plate)

4 Retrofecial cells (round the facial nerve)

5 Peri labyrinthine cells (located above below and behind the

labyrinthine some of them pass through the arch of superior

semicircular canal These cells may communicate with the petrous

apex)

6 Peritubal (around the Eustachian tube Along with hypotymoanic

cells they also communicate with the petrous apex)

7 Tip cells (which are quite large and lie medial and lateral to the

digastric ridge in the tip of mastoid)

8 Marginal cells (Lying behind the sinus plate and may extend into

the occipital bone)

9 Squamosal cells (Lying in the squamous part of temporal bone)

Development of Mastoid ndash

The mastoid develops from the scaly petrous bone The petrosquamosal

suture may persist in the form of a bone plate - Korners septum which

separates the superficial squamosal cells from the deep rock cells Korners

septum is surgically important because it can cause problems locating the

antrum and deeper cells and thus lead to incomplete removal of the disease

during mastoidectomy The mastoid antrum can only be reached if Korners

septum is removed

Page | 32

Fig 3 Cross section of Mastoid

Contents of the middle ear

Ossicles ndash Three tiny bones which conduct the sound from eardrum to oval

window

Malleus ndash It is the largest and most lateral ossicle measuring 8 mm in

length It has head neck handle anterior and lateral processes The head

is situated in the epitympanum A lateral process project laterally from the

neck while the handle is firmly fixed to the pars tensa of the ear drum

Incus- It has a body short process and long process The body short

process and long process The body articulate with the head of mallelus in

the attic and the short process project into the attic The long process

projects downwards behind the handle of malleus running parallel to it and

articulate with the head of the stapes via the lenticular process

Stapes ndash It is the smallest ossicle measuring about 35 mm and consist of

head neck footplate and anterior and posterior curcura The footplate of

stapes is held to the oval window by the annular ligament

Page | 33

Muscles ndash

1Tensor tympani ndash It is inserted is a branch of the facial nerve which carries

the sense of taste It is first arch muscle supplied by branch of mandibular

nerve V3

2 Stapedious muscles ndash It is inserted to the neck of stapes It is the second

arch muscle supplied by branch of facial nerve that is nerve to stapedius

Fig 4 Contents of the middle ear

Blood supply of Middle Ear

bull Anterior tympanic branch of maxillary artery which supplies tympanic

membrane

bull Stylomastoid branch of posterior auricular artery which supplies middle

ear and mastoid air cells

Page | 34

Four minor vessels are

bull Petrosal branch of middle meningeal artery runs along greater petrosal

nerve

bull Superior tympanic branch of middle meningeal srtery traversing along

the canal for tensor tympanic muscle

bull Branch of artery of pterygoid carotid

bull Tympanic branch of internal carotid

Lymphatic Drainage of Ear

Lymphatics from the middle ear drain into retropharyngeal and parotid

nodes while those of the Surgical Importance ndash Eustachian tube drain into

retropharyngeal group

1 The middle ear is part of contiguous organs including nose nasopharynx

Eustachian tube and mastoid bone lined by respiratory mucosa Any

respiratory infection or allergy is likely to pass to middle is likely to pass to

middle ear

2 Moreover middle ear suppurative disease may spread to adjacent organs

and produce complication eg Labyrinthitis meningitis facial nerve palsy

etc

3 Lenticular process is vulnerable in suppurative ear diseases and causes

ocular disruption

4 Prussac space is the site of primary acquired cholesteatoma

Page | 35

INNER EAR [60]

Inner ear is divided into two parts

1 Bony Labyrinth

2 Membranous labyrinth

Anatomy of bony labyrinth

It is divided into two parts

1 Vestibule

2 Cochlea

3 Semicircular canal

The vestibule is located between the medial wall of the middle ear and the

lateral to internal acoustic meatus anterior to the semicircular canal and

posterior to the cochlea The vestibule is the central part of the inner ear

On its side is the oval window opening which is closed by the bracket foot

plate The bony cochlea is located in front of the vestibule It has 275 turns

wound around a bony axis called a modiolus The cochlea is about 30 mm

long The hollow center of the modiolus is a spiral canal that contains the

fibers and ganglion cells of the cochlear nerve A thin bony sheet the bony

lamina winda around the modiolus This divides the cochlear duct into two

galleries the Scala vestibuli above and the scala tympani below

There are three semicircular canals superior posterior and lateral They

are semicircular in shape and open into the vestibule One end of the

semicircle is enlarged and is known as the sphere

The membranous labyrinth is in the bony labyrinth It is connected to the

bony labyrinth by fibrous trabeculae and is surrounded by perilymph The

endolymph is located in the membranous labyrinth

Page | 36

The utricle is in the upper part of the vestibule while the saccule is found

below Both the utricle and saccule contain a single sensory patch called

the macula Each macula is covered with a neuroepithelium made up of

neuroepithelium made up of sensory hair cells and support cells these cells

are separated by a basement membrane Fibers of the vestibulo-cochlear

nerve enter the macula and pierce the basement membrane to terminate

at the base of the hair cell or cell bodies The utricle and the saccule with

their macula are called otolith organs Membrane semicircular canals are

the membrane canals of the corresponding bony semicircular canals They

open into the utricle through five openings One end of the opening of each

channel is dilated called the sphere in which the sensory organ of each

channel is located The cross section of the Scala standard looks like a right

angle The base is formed by the basilar membrane Sensory cells are

arranged on the surface of the basilar membrane These sensory cells with

their supporting cells form a complex neuroepithelium called the basilar

papilla or the cortical organ named after an Italian microscopist The

organs of the corti have a gelatinous membrane called the tectorial

membrane and they are supported by the pillar of the corti The cortical

pillars enclose a space called the corti tunnel which contains a fluid called

cortical lymph Vestibule is lies between the medial wall of the middle ear

and lateral to internal acoustic meatus anterior to semicircular canal and

posterior to the cochlea Vestibule is the central part of the internal ear On

its lateral surface is the opening of oval window which is closed by the foot

plate of stapes Boney cochlea lies in front of the vestibule It has 275 turns

coiling around boney axis called modiolus Cochlea is approximately 30 mm

in length The hollow center of the modiolus is a spiral canal containing the

fibers and ganglion cells of cochlear nerve A thin boney sheet the osseous

lamina winda around the modiolus This divides the cochlear canal into two

galleries the Scala vestibuli above and the scala tympani below

Page | 37

Semicircular canals are three in number superior posterior and lateral

They are semicircular in shape and opens into the vestibule One of the

ends of the semicircular is enlarged and is known as ampulla

Membranous labyrinth is situated within the boney labyrinth It is connected

to the bony labyrinth by fibrous trabeculae and is surrounded by perilymph

Endolymph is situated within the membranous labyrinth

The utricle lies in the upper part of the vestibule while the saccule lies below

Utricle and saccule both contain single sensory patch called macula Each

macula is covered by neuroepithelium consist of Neuroepithelium consists

of sensory hair cells and supporting cells these cells are separated by

basement membrane Fibers from the vestibulo cochlear nerve enter the

macula and pierce the basement membrane to end either at the base of the

hair cell or cell bodies The utricle and saccule with their macula are referred

to as otolith organs Membranous semicircular ducts are the membranous

ducts in the corresponding bony semicircular canals They open into the

utricle by five openings One end of the opening of each canal is dilated

called ampulla in which the sensory organ of each canal is located The

cross section of Scala media resembles a right angle Its base is formed by

basilar membrane Upon the surface of the basilar membrane the sensory

cells are arranged These sensory cells with their supporting cells form a

complex neuroepithelium called the basilar papilla or Organ of corti named

after an Italian Microscopist Organ of corti has a gelatinous membrane

called tectorial membrane and they are supported by pillar of corti The

pillars of corti enclose a space called tunnel of corti which contains fluid

called corti lymph

Page | 38

Fig 5 Inner Ear

Blood supply of labyrinth

Labyrinthine artery

Common cochlear Anterior vestibular Artery

Vestibulocochlear artery Main cochlear artery

Cochlear branch posterior vestibular artery

Page | 39

PHYSIOLOGY OF HEARING [61]

A sound signal in the environment is collected by the pinna passes through

external auditory canal and strikes the tympanic membrane Vibrations of

the tympanic membrane are transmitted to stapes footplate through a chain

of ossicles coupled to the tympanic membrane Movements of stapes foot

plate cause pressure changes in labyrinthine fluids which move the basilar

membrane This stimulates the hair cells of the Organ of corti It is these

hair cells which act as transducers and convert mechanical energy to

electrical impulses which travel along the auditory nerve

Thus the mechanism of hearing can be broadly divided into

bull Mechanical conduction of sound (conductive apparatus)

bull Transduction of mechanical energy to electrical impulses (sensory

system of cochlea)

bull Conduction of electrical impulses to brain (neural

Fig 6 PHYSIOLOGY OF HEARING

Page | 40

Conduction of sound

Under the surface of water we cannot hear the sound made in air because

9995 of sound energy are reflected away from the surface of water because

of the impedance offered by it A similar situation exists in the ear when

air-conducted sound must travel to cochlear fluids Nature has

compensated for this loss of sound energy by interposing the middle ear

which converts sound of greater amplitude but lesser force to that of lesser

amplitude and greater force This function of middle ear is called impedance

matching mechanism or the transformer action It is accompanied by

a) Lever action of the ossicles

Handle of malleus is 13 times longer than long process of incus providing

a mechanical advantage of 13

b) Hydraulic action of tympanic membrane

The area of tympanic membrane is much larger than the area of stapes foot

plate the average ratio between the two beings 211 As the effective

vibratory area of the tympanic membrane is only two- thirds the effective

areal ratio is reduced to 141 and this is the mechanical advantage

provided by the tympanic membrane

c) curved membrane effect

Movements of tympanic membrane are more at the periphery than at the

center where handle of malleus is attached This too provides some

leverage

Transduction of mechanical energy to electrical impulses

Movements of stapes footplate transmitted to cochlear fluids move the

basilar membrane setting up shearing force between the tectorial

membrane and hair cells The distraction of hair cells gives rise to cochlear

microphonics which triggers the nerve impulse

Page | 41

Neural pathways

Hair cells get innervation from bipolar cells of spiral ganglion Central axons

of these cells collect to form cochlear nerve which goes to ventral and dorsal

cochlear nuclei From there both crossed and uncrossed fibers travel to

superior olivary nucleus lateral lemniscus inferior colliculus and medial

geniculate body and finally reach the auditory cortex of the temporal lobe

Page | 42

DISEASES REVIEW

करणसराव

Nirukti - करणसय कणवयोाव ससराा [62]

Nidana- Acharya Sushruta and Vagbhata describe the common etiological

factors for the Karnaroga

अशयाय जलिीडा कणवकणडयन मरत

शमथययोगन शसततरसतय कवपतो अरय च कोपन ||

सउ २० १२

1 Avashaya or Pratishaya

(Excessive exposure to cold)

2 Jalakrida

(Excessive swimming)

3 Karnakandunyanum

(Excessive scracing due to itching)

4 Mithyayogena Shatrasya

(Improper instrumentation during wax removal or foreign body removal)

5Shabdasya

(Louder sound for long durationperverted contact of sound)

6 Abhighata (Trauma)

7 Vitiation of Tridoshas

Page | 43

Samanya Nidana according to different Samhita

Vishesh Nidan of Karnasrava

Acharya Charaka has not mentioned any kind of Nidana regarding Karnaroga

but has described Utapati of Karnaroga from Siroroga in Karnasirasym

Adhyaya[67]

शशरोअशिघातादरा तनमजजतो जल परपकादरा अवप विि

सरतत पय शरणॊ अतनलात स कणवससरा इतत परककतीत

सउ २० १०

असस ३७२५ [68]

1 Shiroabhighatat - Head Injury-Fracture of middle cranial fossa

2 Jala nimajjana - CSF otorrhoea fracture of middle cranial fossa

3 Karnaprapaka

4 Karna Vidhradhi -Puyasrava

Sr

no

Samanya Nidana SU AH[63] AS[64] YR[65] MN[66]

1 Avashaya + + +

2 Pratishaya + +

3 Shabdha

mithyayoga

+

4 Shashtra

mithyayoga

+ + +

5 Karnakandooyan + + + + +

6 Jalkrida + + + + +

7 Abhighata + + +

Page | 44

Samanya samprapti

परापय शरोतरशसरा कयावत शल शरोतशस गान

त कणवगता रोगा अटिावशततरीता

सउ २० १२

Due to common and specific etiology factors the vitiated Doshas gets

Sthanasamshraya in Karna and causes Karnasrava It is the stages of

Samprapti were Doshas gets lodged in Srotas and start processes of Dosh

Dushya Sammurchsna Due to Shiroabhighata Jalanimmajana Karna Paka

Karna Vidhradi vitiated Vata Dosha and Karna becomes Avruta by Vata and

results in Karnasrava Normal physiology of Dosha Dhatus and Malas entirely

depends on the normality of Srotas Dosh Dushya Sammurchana or

manifestation of diseases will not take place if only vitiation of Doshas take

place without deformity of Srotas Here in Karnasrava vitiation of Srotas are

Atipravritti Sanga and Vimargagamana take place Atipravritti is being excess

production of fungus Sanga is obstruction in external acoustic canal

Vimargagamana is the propagation of discharge through ear

Vishesh Samprapti

Karnasrava occurs due to Nij nidana is Pratishaya while Agantuja nidanas are

Avashya Jalkrida and Karnakanduyan Due to etiological factors which are

Vata-Kapha provocative in nature gradual vitiation of Doshas will occur After

vitiation they get accumulated (Sthan samshraya) in external auditory canal

In other hand when patient does Sevana of Agantuj Nidan like water enter in

external ear scratching of ear unsterile instrumentation leads to Dosh

Prakopa These cause Twak and Mamsa Dhatu Dushti which leads to

discontinuity of epithelium of ear canal which creates suitable atmosphere for

fungal pathogen to grow The vitiated Vata will produce symptoms such as

Page | 45

pain hearing impairment and vitiated Kapha causes symptoms like itching

discharge ear blockage By assessing the symptoms it can be said that Kapha

Avrita Vata Dosha is responsible for the manifestation of clinical features like

pain itching discharge Which are seen in Karnasrava that is otomycosis

Acharya Charaka has mentioned while explaining Samanya Chikitsa of

Karnaroga that it should be treated like Vrana when Paka and Srava is present

as a symptom Fungal spores invade in the epithelial layer of EAC In response

to infection inflammatory process is start This is a Paka Avastha After

removing the fungal mass ulceration in external acoustic canal is commonly

seen As a result of infection process exudates was produced which will mix

up- with fungal colonies and appear as discharge As per Dosha involvement

in Vrana Shoola Srava can be differ According to Acharya Sushruta Ruk is

the Samanya Lakshana of Vrana and Vishesha Lakshana of Vrana includes

pain discharge discoloration itching etc according to Dosha involvement

which are also seen in otomycosis In otomycosis mainly watery and purulent

type of discharge is present which indicates Paka avastha If there is Dosha

involve in Vrana is called Dushta Vrana Acharya Sushruta and Acharya

Vagabhata have mentioned verity of Srava in Twak and Mamsa Vranavastu

which is found in otomycosis Based on this description otomycosis can be

correlated with Karnasrava

Page | 46

Representing the Samprapti of Karnasrava

Vishesh Nidana ndash Shiroabhighatat

Jala nimajjana

Prapaka Vidhradhi

Vitited vata

Avarana by kapha

Vimargagamana of Vata

Karnasrava

Samprapti Ghataka

Dosha ndash Kapha and Vata

Dushya ndash Rasa Rakta and Mansa

Strotodushti ndash Vimargagamana and Sang

Adhishthana ndash Karna (Bhayakarna)

Rogmarga ndash Madhyama

Page | 47

Purvarupa

The Purvarupa of Karnasrava are not mentioned separately in any ayurvedic

classics In routine practice cretin Purvarupa are noted

1 Karnakandu

2 Karnagurutwa

3 Alpa karnashoola

4 Discomfort in ear

Rupa

1 Karnashoola

2 Karnakandu

3 Karnasrava

4 karnabadhirya

5 Cotton wool like or wet newspaper like grayish brown or black colored mass

is seen

6 External auditory canal skin appears edematous and red

Upashaya and Anupashaya

Appropriate application of Aushadhi Ahara and Vihara when produces relief in

the symptom is called as Upashaya and when aggravates the symptoms is

called Anaupashaya There is not any reference available in the classics about

the Upashaya and Anupashaya of karnasrava

Sadhyasadhyata

Sushruta has not mentioned specially the Sadhyasadhyata of Karnarogas But

Vagbhata has mentioned Karnasrava as a Sadhyavyadhi[69]

Sadhysadhyatagives the clear picture of prognosis of the disease It depends

on many factors like nature of disease severity of disease Vaya Prakriti Bala

of the patient etc

Page | 48

Upadrava of Karnasrava

In Samhita there is no reference available regarding the Upadrava of

Karnasrava

Samanya Chikitsa ndash

The common treatment principle for all Karnaroga is Ghritapana Use of

Rasayana Bhrahmacharya Avyayama Shirasnana and Atibhashaya

सामरय कणवरोगष घतपान रसयनम

अवयायमो शशराःसतनान बरमहचयवम कतपरनम

स उ२१३

Ghratapana - Ghrita is a Yogavahi and follow Sanskara in addition to these

acquired properties and capable of retaining its own properties So Ghritapana

is effective in Karnasrava

Rasayana - Rasayana represent the basic approach of Ayurveda which

comprise preventive promotive and curative aspect of health

Brahmacharyaapalana -It is like Sadvrittapalana and is equals to Rasayana

effect

Vyayama - It leads to vitiation if Vatas a Karna is a Sthana of vata and

exercise causes Kshayaj Samprapti hence it is important to avoid exercise in

Karnasrava

Shirasnana- In Shirasnana water enters in external acoustic canal it changes

the PH of meatus skin from acid to alkali which favors the growth of pathogens

Atibhashya - Excessive speaking causes Vata Prakopa and Vatapraokopa is

basic Samprapti for Karnasrava as the preventive aspect avoidance of

excessive speaking is necessary

Page | 49

Ghritapana Rasayana and Brahmacharyapalana should be followed for

preservation of dhatu Samyata and restriction of vitiation of Vata Vayayama

Shirasnana and Atibhashaya should be avoided in Karnasrava to protect the

Siras from the affliction of Vata and Kapha

Vishesha Chikitsa ndash

The general treatment principle of Karnasrava described in classics is closely

related to Dushtavrana Chikitsa

शशरोवरचन च ए िपन परण तरा

परमाजवन िान च ीकषय ीकषय़ाचारत [70]

स उ २१४०

कणवसततरा ोददत कयावत पततकशमकणवयो [71]

ाउ १८३५

उपददि च सततरोत साय परात वपचततवशि परमजय

य अगर मदन सघत गगलना ा िपतयतपा मिना परयत [72]

असउ २२४२४३

In addition to that Shirovirechana Karnadhoopana Karnapurana

karnapramarjana Karnadhavana are also indicated

Page | 50

Treatment is also mentioned for Karnasrava

1 Karnaprakshalana Yoga - with Aargawadadi Gana Kashaya and Surasadi

Gana Kashaya [73]

2 Avachurnana Yoga ndash with Aargawadadi Gana Churna and Surasadi Gana

Churna[74]

3 Karnapoorna Yoga ndash

bull Rasanjana Laksha with Sarjachoorna[75]

bull Panchkashaya with Kapittha swarasa and Madhu[76]

bull Jambu AmrapallavShivalaKshuodra Mahavriksha and Madhuki all are

taken in equal quantity and Kalka is prepared and 4 times Taila is taken

and 16 parts of Kwatha is added and Taila Paka is done[77]

bull Sarjatwak Choorna with Karpashiphalarasa and Madhu[78]

bull Abhaya LodraTindukaSamanga(Manjista) Kwatha of this Dravyas mixed

with Madhu and Kapittha Rasa[79]

bull Yogratnakara mention the following drugs for Karnapoorana-

a Samudraphena Churna[80]

b Jambwambpatra Yoga

4 Karnadhoopana Yoga ndash

bull Dhoopana with Churna of Bilvapatra Haridra Palandu[81]

bull Vartak Dhoopana [82]

5 Internal Medications-

bull Rasnadi Guggula [83]

bull Triphala Guggula [84]

bull Sarivadi Vati [85]

bull Gandhaka Rasayana [86]

Page | 51

According to Vagbhata-

Ear should be cleaned with the Pichu and Varti followed by Guggula Dhoopana

and then Karnapoorana with Madhu Followed by Avachurnanana with

Sukshmachootana of Surasadigana

Pathyaapathya ndash Pathya and Apathy mentioned for Samanya Karnaroga is

recommended in Karnasrava also

पथय[87]

सतदो वरको मन नसतय िमाः शशरावयिाः

गोिमाः शालयो मदगााः याशच परतन हवाः 80

लाो मयरो हररणानदसततततरो नकककिाः

पिोल शशगर ातावक सतनषराण कदठललकम

रसायनातन सवणण बरमहचयवमिाषणाम |

उपयकत यरादोषशमद कणावमय दहतम ||81||

िापर २१

Aharaja Upacharaja

bull Godhuma bull Vamana

bull Shala bull Virechana

bull Mudga bull Nasya

bull Yava bull Dhoomapana

bull Puranagitra bull Kavala

bull Lava Harina Tittiramamsa

Page | 52

अपथय[88]

दरत काटठ शशरसतनान वययाम शलटमल गर

कणडयन तषारशच कणवरोगी पररतपयजत

िापर २१

Viharaja

bull Patola ShigruVartaka bull Bhramacharaya

bull Sunishannaka bull Avyayama

bull Katthlika bull Aakthanam

bull All types of Rasayana bull Upacharaja

bull Vamana

Apathyas

bull Abhishyandakara Aharas

bull Shirasnana

bull Karna kandooyana

bull Tushara sevana

bull Guru Kaphakaraka Aaharas

bull Dantdhavana

Page | 53

OTOMYCOSIS

Definition-

Otomycosis is a superficial acute sub-acute or chronic infection of external

ear canal It is mostly unilateral It is characterized by inflammation purities

and scaling Otomycosis is a common condition encountered in ENT practice

more in chronic and persistent ear infection

The Fungal infections are not communicable in the usual sense but the

humans become an accidental host by their introduction into tissue trauma

The virulence factors favoring colonization of fungus in human host are yet to

be identified Ability of the fungus to grow at 37 C and elaboration of a variety

of enzymes and toxins are speculated to contribute to virulence Only 100 to

150 species are generally recognized as a cause of disease in humans[89]

Prevalence-

Otomycosis is a word wide in distribution and in various record stated that 5

to 20 of all cases of infective otitis externa Otomycosis prevalent is more in

warm and humid climates It is one of the commonest manifestations in India

during rainy season It occurs mostly in humid atmosphere otitis externa due

to fungal infection may resembles the desquamative form of diffuse infective

otitis externa The incidence in temperature climates has increased in

proportion to the use of topical antibiotics which have a medium sterilized of

other organism in which the fungus may flourish

Page | 54

Predisposing factors- [90]

1 Environmental factors such as climate contagious and polluting hygiene

more frequently during rainy season as the humidity increases

2 Individual susceptibility ndashGeneral Immunological status of the Individual

eg HIV infection Radiotherapy chemotherapy Diabetes mellitus

3 Self-inflicted trauma that is use of pins to clean the itching ear or use of ear

bud to clean the wax

4 Wide spread of topical antibiotics steroid preparations which have medium

sterilized of other organism in which the fungus may grow

5 Failure of defense mechanism in External auditory canal

6 During swimming or head bath water enters in External acoustic canal

causes quantitative and qualitative change in ear wax It causes change in pH

7 Long term use of hearing aids

Pathophysiology ndash

The life cycle of the average mold encountered in the ear may be reckoned

as two weeks and flare ups may be anticipated at such intervals Swimming is

held responsible for infection in many cases The sequence sequence of

pathogenic changes produced by molds in the external ear is as follows ndash

1 Implantation of the organism in external ear

2 Growth of organism follows the rate depending on condition of temperature

moisture or preexisting irritation

3 Invasion of epithelium occurs with attendant itching and discomfort which

may be quite severe

Page | 55

4 Exfoliation of epithelium occurs as nature attempts to overcome the

infection by casting off upper most cells

5 Denudation occurs from exfoliation as the top layers of epithelium are cast

off and the canal becomes filled with debris

6 Superficial ulceration and lizematoid dermatitis results if the pathologic

process goes for enough The changes do not always proceed through the

entire sequence sometimes the molds produce changes of the mildest

imaginable character which may be overlooked[91]

Clinical features -

Symptoms-

1 Irritation and itching ndash Irritation is mostly found when the infective

organism is aspergillus niger There is sensation of discomfort which is more

diffuse in the ear canal then localized in the deeper part Candida infection

causes marked itching In external ear it is intense and worse at night

2 Discharge through ear- Intermittent scanty colorless discharge through

ear Mucus being a fungal metabolic product appears as discharge Excessive

discharge is associated with mixed infection

3 Pain and discomfort ndash Mild to severe pain in the ear occasionally Mostly

seen in cases where ear is infected with Aspergillus flavus mixed infection

with gram negative organism or mixed infection with candida and aspergillus

Headache is sometimes associated with pain

4 Deafness- Varying degree of mild to moderate conductive deafness

5 A sensation of fullness in ear

6 Tinnitus 7 Vertigo

Page | 56

Signs ndash

1 The external acoustic meatus may contain a mass formed of epithelial

debris exudates cerumen and fungus

2 Erythematous external canal

Fungal appearance

A Niger - The color of the mass which is usually grey or black is mainly

determined by the type of fungus concerned Its appearance is like wet

newspaper or blotting paper or a cotton wool It has a peculiar musty odor In

this infection fruiting heads may be seen as black specks in the debris

Occasionally as inactive form occurs in which the canal is lined by mold giving

a fluffy appearance due to the presence of tiny mycelia

Candida ndash Candida infections generally show as white deposits on magenta

colored skin when the debris is removed it rapidly recovers in 24 hrs

The underlying canal skin is often inflamed and granular due to invasion by

fungal mycelia and be seen in all cases In rare cases excoriation and

ulceration with marked extensive shedding of the epithelium and deep

ulceration can be seen usually associated with a flavus and with pathogenic

bacteria[92]

Otoscope Appearance

1 Aspergillus Niger ndash Black headed

2 Aspergillus Fumigators ndash pale blue or green

3 Candida Albicans ndash White- or cream-colored deposits

Page | 57

4 Auricle is normal in most cases In severe cases small ulceration with crust

formation may be present on lateral surface

5 Tympanic Membrane

In most cases it is normal with normal mobility and normal hearing In a few

cases the surface of the tympanic membrane is congested and scaly There is

erosion or ulceration of the external epithelial layer and the membrane itself

may be edematous

Diagnosis

1 Above mentioned symptoms and signs

2 In the stage at which patient with otitis externa usually first present

themselves mycelia threads conidiophors not visible to naked eye may

sometimes be identified with the microscope

3 Confirmed by culture

Page | 58

Fig7 Aspergillus Niger Fig8 Candida Albicans

Fig9 Aspergillus Fumigators Fig 10 Wet Paper like appearance

Page | 59

Treatment

1 Antibiotic or steroid drops should be discontinued if they are being instilled

since long time

2 Removal of fungal mass epithelial debris and discharge from the external

canal or mastoid cavity repeatedly and thoroughly by forcepa or suction or

syringing or cautiously blow a stream of air into the canal through a fine

cannula and dry thoroughly by swabbing liquid petroleum on swab used in

cleaning the ear lessens the burning sensation when metacresy acetate is to

be employed in the subsequent treatment

Furuncle is developed as a complication if there is no gentleness in cleaning

Cleansing may have to be delayed until local sensitiveness is lessened which

can usually be accomplished within twenty-four hours If there is excessive

epithelial debris along with otomycosis then metacresyl acetate which is a

keratolytic in introduction into the external auditory canal on cotton wick and

is allowed to remain for twenty-four hours After twenty-four hours the cotton

wick is removed at which time the canal can usually be cleansed with little

discomfort as the medication is also anesthetic The epithelium of the canal

was white from contact with the drug The top layer was detached and this

epithelial debris can be easily wiped away The wick is reinserted and wet with

metacresyl acetate

The treatment is employed for three to four days in succession and then a

bland application is substituted Icthyol iodine is of value at this stage Iodine

ointment 2 in combination with Tannic acid 2 is also an excellent local

application following cresatin treatment

Next one of the fungicides may be applied

Page | 60

1 Nystin Effective for candida infection but less active against aspergillus

group Nystatin in boric powder consisting of 100000units of nystatingm of

powder 3 times week for 3 weeks

2 Clotrimazole Available as 11 cream or drops or lotions Phenyl

(zchlorophenyl) 1 ndash imidazole ndash methane is a chlorinated trityl imidazol 1

effective against candida and dermatophytes and for aspergilli infection

3 Amphotericin B Available as cream and as 3 solution and 015 drops

for topical application Very effective for candida infection can be fungistatic

or fungicidal

4 Econazole Available as solution (Econazole nitrate) and as cream (1)

Broad spectrum ndash more effective for Aspergillus Also active against some

gram-positive bacteria (Staphylococci and Streptococci and Dermatophytes)

5 Miconazole Highly effective against dermatophytes and candida infections

used as a 21 cream applied once or twice a day for 10 days

6 Gentian violet 21 Available as drops (recently some evidence of

carcinogenicity) Discolors the ear canal and this interfere with clinical

examination

Other topical antifungal agents are ketoconazole Natamycin Tolciclat Bifonas

zole Fenticonzole Oxiconazole Tioconazole ciclopiroxolomine Tolnafate

Haloprogin Flucytosine Acetic acid Whit field ointment selenium sulfide

undcyclenic acid triacetin etc

Page | 61

Minimal length of treatment

A month of drug treatment is usually required because the antifungal agents

used are not sporicidal and it is necessary that the period of treatment covers

germination time It may be advisable to give short gaps in the period of

treatment to ensure all spores have germinated before deciding to terminate

therapy

Prevention

Accomplished by strict attention to the predisposing causes

1 Water should be prevented from entering the ear

2 Avoidance of external ear trauma

3 Use of alcohol medicated or plain in the ears after swimming mercuric

cyanide (15000) in ethyl alcohol (70) is a satisfactory liquid to use

Ear stoppers do no good unless their use is followed by some antiseptic in the

canal Divers exposed to water for long periods of time may also use acidic

alcohol

4 During Summer months with their high humidity special efforts are needed

to maintain ear dry 5 Indiscriminate use of topical antibiotics steroid

preparations should be avoided

Page | 62

DRUG REVIEW

1 GUGGULA

Fig11 - Guggula

Historical review of Guggula [93]

bull Atharvaveda one of the well-known Vedas of Hindus The earliest

reference given by Atharvaveda medicinal and therapeutic properties of

Guggula Guggula has long history of use in Ayurveda

bull Acharya Charaka Sushruta and Vagbhata describe detail regarding the

actions uses and indication as well as the variety of Guggula

Page | 63

bull Various Nighantus (Medical lexicons) were written between 12th and 14th

centuries AD was based on the Ayurvedic literature also describes

Guggula

bull The explanation of word Guggula is that Gunjo Vyadhegurdti Rakshati

which means to relief against different diseases

bull Guggula is the best medicine because it develops through the rays of

hot sun on specific circumstances

bull Guggula has an aromatic odor

गगलो कणवदौगवररधय िपन शरटठमछयत[94]

स उ २२११२

Latin name- Commiphora mukul

Family ndash Burseraceae

Rasa- Tikta Katu

Guna ndash Laghu Rukshasukshma vishada sara

Veerya ndash Ushna

Vipaka ndash Katu

Action- Rasayana Lekhana

Doshaghanta - Tridoshhara

Page | 64

Chemical composition [95]

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Oleoresin-Z-Guggulsterone E-Guggulsterone

Gum- guggulignans 1 and 2 guggula Tetrols mukulol allylcembrol c

27

Guggulusterol 1 2 ans 3 Z and E ndash guggulusterol

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Parts Used ndash Gum oleoresin

Guggula purity test

1 Yellowish brown emulsion is obtained when Guggula is triturated with

water

2 An ethereal solution of the drug attains reddish colour when treated

with br2 vapors and purple colour when moistened with nitric acid

Biochemical action ndash Antiseptic Anti-inflammatory Disinfectant Diuretic

Immunostimulant stimulating expectorant Ant suppurative Antipyretic

Enhance phagocytosis

Karma- Rasayana cardiovascular disease

Page | 65

2 AGARU-

Fig 12 Agaru

Historical review of Agaru [96]

bull The word Agaru literally means the one which is the heaviest and no

aromatic wood is heavier than it Since thousands of years Agaru lsquoThe

wood of Godrsquo has been used for multiple purpose like commercial

medicinal spiritual aromatic historical

bull The medicinal use of Agaru have been recorded in many pieces of India

Greek Roman Chinese Middle eastern and European since ancient times

bull Acharya Charaka used Agaru and pest of Rasna to counteract the effect of

cold in Agraya Dravyas

bull Acharya Sushruta used Agaru as a Dhoopana Dravya along with Guggula

Ral and Shoma in the treatment of Karnasweda and Vrana

Page | 66

Types-

bull Dhanwantsri Nighantu describes Kaleyaka as a type of Agaru

bull Sodhala Nighantu describes three types of Agaru ndash Agaru Krishna

Agaru Kakatunda Agaru

bull Raj Nighantu describes five types of Agaru ndash Krishna Agaru Kasht

Agaru Daha Agaru Mangalya Agaru and Agurusaar

bull Arthashasstra describes three Agaru wood product

1 Jongaka ndash Black or variegated black in colour and having variegated

spots

2 Dongaka ndash Black in color

3 Parasamudraka- Black in colour and smells like Navamallika

अगर उटण कि तपछय ततकत ततकषण च वपततलम

लघ कणाविरोगघन शीत ात कफपरणत

िापर २१ [97]

Family- Thymelaccensis

Latin name- Aquilaria agallocha

Guna- Laghu Ruksha Tikshan

Rasa- Katu Tikta

Vipaka ndash Katu

Virya ndash Ushna

Karma- Sheetaprasasmana Vranaorasadan Tvachya Pittavardhaka

Shirovirechana Mangalya Sugandhik and Rochaka in properties [100]

Krishna Agaru karma- Katu Tikta rasa Ushna Sheeta when applied externally

and Pittahara when taken orally

Page | 67

Chemical Constituents -

Agaru hardwood is rich in essential oil resins alkaloids saponins Steroids

terpenoids tannins flavonoids and phenolic compound Agaru wood

predominantly contains 2-[-2-phenylethy]-4H-chromen-4-one derivatives and

sesquiterpenes Agaru oil contains selinene dihydroselinene agarnol b-

agarofuran vetispira-2(11)valerianol dihydrokaranone and tetradecanoic

acids[99]

Part Used ndash

Heartwood- Dark resinous wood which is formed when the plant becomes

infected with a type of fungus (ascomycetous mold) Species of Aspergillus

fusarium and penicillium are reported to be associated with the development

of infection Prior to infection the heartwood is odorless relatively light and

pale colored however as the infection progresses the tree produces a dark

aromatic resin in the heartwood The infected resin in response to the attack

which results in accumulation of a very dense dark resin in the heartwood

The infected resin embedded wood is known as Agarwood Infection is more

common on the trunk roots and the area when branches divide The formation

of Agarwood starts when the tree attains the age of 20 years On an average

approximately 30 ml oil is extracted from 100 kg of infected Agarwood[98]

Qualities of best Agaru-

It should be black in color

It should be extremely heavy and aromatic

It should be oily in appearance and test

It should be sink in water

It should burn easily with bright flame with a bright flame giving off a pleasant

smell

Page | 68

3 MADANA

Fig 13 MADANA

Madana consist of dried fruit of Xeromphis spinosa It is a deciduous thorny

shrub or a small tree reaching a high up to 9 m and girth about a meter

branches numerous thick and horizontal found in sub-Himalayan tracts[101]

मदनो मिरनदसततकतो ीयोटणो लखनो लघ

ानदरतिदवििीहर परततशयायवरणारतक

रि कटठकफ़ानाहशोथगलमवरणापह[102]

िा पर १६० १६1

Page | 69

Latin name-Randia dumetorum

Familly ndash Rubiaceae

Rasa - Madhura Tikta

Guna-Laghu Ruksha

Virya- Ushna

Vipaka ndash Katu

Karma- Vamana and Lekhana

Chemical Composition-

Essential Oil Valerianic acid Saponin tannin resin [103]

Page | 70

YAWA [104]

Fig 14 Yawa

1 In Samhitakala Aacharya Charaka Acharya Sushruta explain detail about

medicinal properties of Yawa

2The use of Yawa in Aaharya Dravya mainly described by Dhanwantari

Nighantu Raj Nighantu Bhavprakash Nighantu[105]

Macroscopic Description-

Fruit a caryopsis elliptical oblong Ovoid and tapering at both ends smooth

about 1cm long and 02- 03cm wide dorsally compressed and flattened on

the sides with a shallow longitudinal furrow 3-5 ridges having shallow

depression between them grains tightly enclosed and adhering the lemma

and palea pale greenish yellow odor not distinct taste sweetish acrid

Page | 71

Latin Name ndash Hordenum vulgare

Family- Poaceae

Rasa- Kashaya Madhura

Virya- Sita

Vipaka- Katu

Karma- Vatakrt Pittahara Kaphahara Medahara Balya Visrya

SthairyakaraLekhana

Page | 72

PROCEDURE REVIEW [105]

In Ayurvedic classics there are many references regarding Dhoopana Dravya

Dhoopana is administering Dhuma with the help of Dhoopana Dravya

In Kashyapa Samhita there are 40 types of Dhoopana advised for children

Anesthesia (Mohajananam Dhoopa) is also mentioned For this Dhoopana the

drug used were herbs hairs of animals legs horns old cloths of Buddhist

monks

From the references available regarding Dhoopana we can understand that

Karna can be protected from maggots (krimi) Bactria (Rakshogna) lice etc

References clearly indicate the analgesic and disinfectant effect of Dhoopana

Karma Dhoopana is mentioned for Dushta Vrana Chikitsa It reduces Vedana

Srava Pootigandha of Dushtavrana It also helps in Vranaropana

Dushtavrana Chikitsa is mentioned in the treatment of Karnasrava[106]

Origin of Dhoopana-

In ancient period children of sages were constantly harassed by the

Rakshasas Hence the sages approached lord Agni for shelter Agni in turn

gave them Dhoopana Dravya and asked sages to use the Dhoopana for

protection against Rakshasas bhutas pishachas

Classification of Dhoopana

1 It is classified into Dhupa Anudhupa Pratidhupa

2 On the basis of Origin it is classified into Jangama and Sthavara

Selection of Guggula for Dhoopana

Page | 73

bull Guggul is a best Vatahara

bull It is Krimighana

bull It contains Oleoresin

bull In Ashtang Hrudaya Guggula Dhoopana mentioned for Karnasrava

Selection of Agaru for Dhoopana

bull Agaru is Laghu Ruksha Katu Tikshna

bull Vranaorasadan Tvachya

bull It should burn easily with bright flame with a bright flame giving off a

pleasant smell

Karna Dhoopana Indication

1 Karnaarava

2 Putikarna

3 Krimikarna

4Vataj Karnashula

Contraindications

Especially for Karnadhoopan contraindication is not mentioned in classic texts

But Dhoopana is contraindicated in Pittaj vaydhi Sharad and Grishma Rutu

Page | 74

MATERIAL AND METHOD

Page | 75

For randomize comparative clinical trial to study the effect of Agaruwadi

Karnadhoopana and Guggula Karnadhoopana in Karnasrava following material

and method were required

Source of data

Patient irrespective of gender occupation religion social economic status

signs and symptoms of classical features of Karnasrava (Otomycosis) selected

from the OPD of Shalakyatantra department

Materials ndash

1Patients

2 Drugs-Agaruwadi Dhoopana

Guggula Dhoopana

3Torch

4Otoscope

5 Tuning fork

6Jobson horn probe

7Cotton

8Case record form

DRUG

Group A Trial Group

1Churana of Agaru Yawa Madan

2Ghrita

3Jala

Group B Control Group

1Googula Churna

Page | 76

Properties of Drug

Table no 1 Properties of Drug

Drug

Family

Rasa Veerya Vipaka Effect

on

Dosha

Guna Karma

Agaru

(Aquilegria

Agallocha)

Thymelaca

ceae

Katu

Tikta

Ushna Katu KV Laghu

Ruksha

Tikshna

Shitaprashamana

Shothahara

Vedanasthapak

Durghandhihara

Madan

(Randia

spinosa)

Rubiaceace

Kashaya

Madhur

Tikat

Katu

Ushna Katu KV Ruksha

Laghu

Vatakaphaghana

Shothahara

Vedanasthapak

Vranashodhak

Yawa

Poaceae

Hordeum

Vulgare

Kashaya

Madhur

Sheeta Madhur KP Ruksha

Laghu

Vataghana

Vernashodhana

Raktshodhaka

Guggula

Commiphora

Mukul

Burseracea

e

Tikta

Kashaya

Anushna Katu VPK Laghu

Ruksha

Shothahara

Vedanasthapaka

Kandughna

Ghrita Madhura Sheet Madhur VK Snigdha Vataghana

Shothahara

Vedanasthapaka

Page | 77

METHODOLOGY

SELECTION CRITERIA

1)INCLUSION CRITERIA

1 Patients having signs and symptoms of Karnasrava (Otomycosis) ie करणशल

( pain ) करणकणड ( Itching ) करणसतराव ( Discharge )बाधिरण ( conductive Loss of

hearing )

2 Patient from age group 19 to 70 years

3 Any Gender

2)EXCLUSION CRITERIA

1 Patients suffering from any systemic disease like DM TB HTN

2 Chronic suppurative otitis media (CSOM)

3 Acute supportive otitis media (ASOM)

3 Perforation of Tympanic membrane

4 Chronic otitis media

3)WITHDRAWAL CRITERIA

1If patient develops any adverse effect such as irritation pain burning

sensation in ear loss of hearing and such patients was withdrawn from trial

and receive prompt appropriate medical attention

2If patient shows aggravation in symptoms

3If patient refuses to continue with the treatment

Page | 78

STUDY SETTING

Types of study - Randomized Clinical comparative Trial

Place of work - OPD of Shalakyatantra

Duration of study - 18 months

Study Population - Patients of Karnasrava in Shalakyatantra OPD

SAMPLE SIZE CALCULATION

Sampling Method ndash Purposive sampling followed by random allocation in two

groups

Sample size calculation-

n = z2 p (1-p)

d2

Were

n = sample size

P = prevalence of disease=10

z = standard normal variable ie 196

d = error ie005

desired Sample Size would be

n = Z2 P(1-P)d2

= (196)2x (0021) x(0979)(005)2

= 34

Visiting ENT OPD (ShalakyaTantra) and IPD (ShalakyaTantra) 21 = 34

n raquo34

So one group includes 34patients

Page | 79

Sampling Method

Total 68 patient of Karnasrava are selected by Purposive sampling followed by

random allocation in two groups Written informed consent is taken prior to

commencement of trial They are divided in 2 groups

Group A (Trial Group) 34 patients treated with Agaruwadi Dhoopana for 7

days

Dose 5 minutes twice in a day

Group B (Control Group) 34 patients treated with Guggula Dhoopana for 7

days

Dose 5 minutes twice in a day

STUDY DESIGN ndash

Open labeled Randomized Comparative Clinical trial

STUDY DESIGN

Screening of patient

Inclusion criteria satisfied Exclusion criteria

Initial assessment Excluded

Counseling of patient Treated accordingly

Patient selection by Simple Random Sampling Method

Page | 80

68 Patients were divided in two groups lsquoArsquo and lsquoBrsquo

Trial group A-34 patients were given

Agaruwadi Dhoopana

Control group B- 34 patients were

given Guggul Dhoopana

Informed written consent

Treatment was given for 7 days

Assessment on 1st 4th and 7th day

Post assessments follow up on 15th day

Observation

Data Collection

Statistical analysis of data

Conclusion

Page | 81

(A) Agaruwadi Varti for group A (Trial group)

Table no 2

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

B) Guggula Varti for group B (Control group)

SOP of it is same as above Agaruwadi Varti

Table no 3

Drug Guggula Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

FOLLOW UP

For both groups follow ups were done on 1st 4th and 7th and post

assessment follow up15th day

EXAMINATIONS

Torch for Local examination of ear

Otoscope examination

Tuning fork Test

Page | 82

OBSERVATION TABLE

Table no 4

Sr no Subjective criteria Day 1 Day 4 Day 7 Day 15

1 करणशल

(pain)

2 करणकणड

(Itching)

3 करणसतराव (Discharge )

4 बाधिरण (Conductive Deafness)

OBSERVATIONS

a) करणशल (Pain) -

0 - Absent

1 ndash Present

b) करणकणड (Itching) -

0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

Page | 83

c) करणसतराव (Discharge)

0- Absent

1- Mild -Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाधिरण (conductive Loss of hearing)

0 - Absent

1- Present

Observations were carried out before and after completion of treatment and

during each follow up After observations the data collected and presented in

the form of graphs charts and table

Page | 84

TRIAL DRUG

Authentication and standardization of raw drug material done After

authentication and standardizing of raw drug material Agaruwadi Varti was

prepared by Varti as explained in Ayurvedic classics

Method of Varti preparations

Panchavidh Kashaya Kalpana that is five method of pharmaceutical

preparation constitutes the fundamental process of Ayurvedic pharmaceutics

which is well explained in Sushrut Samhita Varti Kalpana is one among them

which can be included in Kalka Kalpana

तीररसतरपतपतीनामपरककव तीत [106]

स डलहण शरच 151

Medicines are powered triturated and given the Varti shape that is like wick

of lamp so it is called as Varti Kalpana

Drug content Agaru Madan Yawa

Route of Administration Local

Dose Two times a day

Duration 7 days

Page | 85

Methodology

Standard operating procedure (SOP) of Agaruwadi Varti

Agaruwadi Varti is prepared according to the classical text

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization was done as recommended in pharmacy procedure The

raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 mixed together in

equal quantity to make Agaruwadi churn

Quantity of each churn is 4 grams all are mixed when the Varti get dry total

weight of Varti was 10gram

STEP 4 - Agaruwadi churn triturated with appropriate quantity of water or

Ghrita and prepared Varti in GMP Certified Ayurvedic pharmacy Standard

aseptic precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Varti was packed in sterile air packed container

STEP 6 - Agaruwadi Dhoopana was given with the help of Dhoopana yantra

Authentication and Standardization of raw drug of Agaruwadi Varti was done

Sterilization was done as recommended in pharmacy procedure Sterile

preparation packed in sterile container of suitable size Under all aseptic

precaution Karnadhoopana given to infected ear

Page | 86

Containers for packaging and their sterilization-

Sterilization of the containers for storing Varties was done by Ethylene Oxide

(Eto) method

Ethylene Oxide (Eto) procedure-

It includes exposure of materials to ethylene oxide gas under vacuum in a

sealed chamber It consists of four primary variables

1Gas Concentration

2Humidity

3Temperature

4 Time

EtO gas is an alkylating agent which disturbs the DNA of microorganism

preventing them from reproducing It penetrates the breathable packaging

and sterilizes all the accessible surface of the product to render products

sterility by alkylation of essentials proteins for cell reproduction

Most Eto sterilization methods involves three different stages These can be

separated into three different on the size or number of devices to treat

1Preconditioning stage-

First products are passed through a preconditioning phase to make

microorganism grow The batch load goes through a well time under a

controlled environment of temperature and humidity

2Sterilizer stage-

Performed using process phase specially designed to provide the required level

of EtO exposure to assure sterility for a device or family of devices

3Degasser Aerration stage-

Finally products need to go through a degassing phase to remove any residual

particles of Eto The batch load goes over well time under a temperature-

controlled environment

The sterile containers were then used to store Agaruwadi Varti and handed to

patients included in the study

Page | 87

Packing of Agaruwadi Varti

The ETO sterilize plastic container were used for packing of Agaruwadi Varti

Varti was filled into these sterilize containers (7 in each) In an aseptic

environment plugging and capping was done under aseptic precautions In this

way packing of Agaruwadi Varti done These Varti were given to patient and

advise to take two times a day under all hygienic precautions

History and Examination

bull Proper history and presenting complains was recorded on case record form

bull Ear examination with otoscope was done during initial assessment and each

follow up

bull Otoscopic examination was done during initial assessment and each follow

up

bull Systemic Examination that is Blood Pressure Temperature Respiration

rate Pulse was recorded on case record form

Page | 88

Raw material

Fig14 यव चरण Fig15 मदनफळ चरण

Fig16 अगर चरण Fig17 गगगळ चरण

Page | 89

Preparation of Agaruwadi Varti

Fig18 Preparation of Agaruwadi Varti

Fig19 अगरवादी वरती

Page | 90

Fig20 Instruments used for examination of Karnasrava

Fig19 Karnadhoopana Yantra

Page | 91

Karnadhoopana Procedure

Fig 22 Karnadhoopana Procedure

Page | 92

OBSERVATIONS AND RESULTS

Page | 93

BASED ON DRUGS

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 94

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

AUTHENTICATION CERTIFICATE

Page | 95

BASED ON STASTICIAL ANALYSIS OF DEMOGRAPHIC DATA

68 patients of Karnasrava ndash Otomycosis

Table no 5

No of Patients Total

Group A Group B

Registered 38 37 75

Completed 34 34 68

Discontinue 04 03 07

Total 68 patients were enrolled in study 38 patients registered in group A

amongst them 34 patients completed the treatment and04 patients

discontinued the treatment However in group B 37 patients completed the

treatment and 03 patients discontinued the treatment out of 37 registered

patients

Hence the total number of patients registered in the present study was 75

and out of which 68 patients were discontinued the treatment So they

dropped out from the study While 68 patients were successfully completed

the treatment So observations and result of 68 patients were given below

Here we are going to discuss the statistical analysis of the data obtained in

the form of master chart that was prepared in accordance with the data

collected from the patients that had been included in the study The purpose

of statistical analysis was to analyzed the relation between age gender

occupation diet addiction and education

Page | 96

1 Age wise distribution of patients

Table no 6

In trial group 10 (29412) patients were from age group 18-25 years 14

(41176) patients were from age group 25-35 years 8 (23529) patients

were from age group 35-45 years and 2 (58824) patients were from age

group 45-60 yearsIn control group 6 (17647) patients were from age group

18-25 years 14 (41176) patients were from age group 25-35 years 7

(20588) patients were from age group 35-45 years and 7 (20588)

patients were from age group 45-60 years

Fig 23 Age wise distribution of patients

0

2

4

6

8

10

12

14

15 -25 25-35 35-45 45-60

10

14

8

2

6

14

7 7

Age Distribution

Trial Group N Control Group N

Age Distribution

Trial Group Control Group

N N

18 -25 10 29412 6 17647

25-35 14 41176 14 41176

35-45 8 23529 7 20588

45-60 2 58824 7 20588

Total 34 100 34 100

Page | 97

1 Gender wise distribution of patients

Table no 7

Sex

Trial Group Control Group

N N

Female 23 67647 15 44118

Male 11 32353 19 55882

Total 34 100 34 100

In trial group 23 (67647) patients were female and 11 (32353) patients

were male

In Control group 15 (44118) patients were female and 19 (55882)

patients were male

Fig 24 Gender wise distribution of patients

0

5

10

15

20

25

N N

TRIAL GROUP CONTROL GROUP

23

15

11

19

Gender

Female Male

Page | 98

2 Education wise distribution of patients

Table no 8

Education

Trial Group Control Group

N N

Illiterate 4 11765 3 88235

SSC 4 11765 3 88235

HSC 8 23529 9 26471

Graduation 16 47059 10 29412

Primary 1 29412 3 88235

Post-Graduation 1 29412 6 17647

Total 34 100 34 100

In trial group 4 (11765) patients were illiterate 4 (11765) patients were

SSC educated 8 (23529) patients were HSC educated 16 (47059)

patients were graduated 1 (29412) patients were primary educated and

1(29412) patients were post graduated

In control grou 3 (88235) patients were illiterate 3 (88235) patients

were SSC educated 9 (26471) patients were HSC educated 10 (29412)

patients were graduated 3 (88235) patients were primary educated and

6 (17647) patients were post graduated

Page | 99

Fig 25 Education wise distribution of patients

0

2

4

6

8

10

12

14

16

ILLITERATE SSC HSC GRADUATION PRIMARY POST GRADUATION

4 4

8

16

1 1

3 3

910

3

6

Education

Trial Group N Control Group N

Page | 100

3 Occupation wise distribution of patients

Table no 9

Occupation

Trial Group Control Group

N N

Accountant 1 294 2 588

Housewife 11 3235 8 2353

Engineer 1 294 1 294

Job 1 294 4 1176

Labor 1 294 3 882

Mess 1 294 0 000

Naturotherapyst 1 294 0 000

Pharma 1 294 0 000

Shopkeeper 4 1176 2 588

Singer 1 294 0 000

Student 8 2353 4 1176

Tailor 1 294 1 294

Teacher 1 294 1 294

Worker 1 294 3 882

Farmer 0 000 1 294

Lab Tech 0 000 1 294

Page | 101

Daily Collection 0 000 1 294

Fruit seller 0 000 1 294

Bus Driver 0 000 1 294

Total 34 10000 34 10000

In trial group 11 (3235 ) were housewife 8(2353) were students

4(1176) were shopkeeper 1(294) was accountant 1(294) was

engineer 1(294) was doing job 1(294)was labour 1(294) was

catering 1(294) was Naturotherapyst 1(294) was Pharma 1(294)

was Singer 1(294) was Tailor 1(294) was Teacher and 1(294) was

worker

In Control group 8 (2353)were housewife 4(1176) were students

2(588) were shopkeeper 2(588) was accountant 1(294) was

engineer 4( 1176) was doing job 3(882)was labor 1(294) was

Farmer 1(294) was Lab tech 1(294) was Daily collection 1(294)

was Tailor 1(294) was Teacher and 3(882) was worker 1(294) was

Fruit seller and 1(294) Bus driver

Fig 26 Education wise distribution of patients

0

2

4

6

8

10

12

1

11

1 1 1 1 1 1

4

1

8

1 1 10 0 0 0 0

2

8

1

43

0 0 02

0

4

1 13

1 1 1 1 1

Occupation

Trial Group N Control Group N

Page | 102

4 Religion wise distribution of patients

Table no 10

Religion

Trial Group Control Group

N N

Hindu 31 9118 33 9706

Muslim 3 882 1 294

Total 34 10000 34 10000

In trial group 31 (9118) patients were Hindu and 3 (882) patients were

Muslim

In control group 33 (9706) patients were Hindu and 1 (294) patient

were Muslim

Fig 27 Religion wise distribution of patients

0

5

10

15

20

25

30

35

N N

TRIAL GROUP CONTROL GROUP

3133

31

Religion

Hindu Muslim

Page | 103

5 Diet wise distribution of patients

Table no 11

Diet

Trial Group Control Group

N N

Veg 14 4118 20 5882

Non-Veg 20 5882 14 4118

Total 34 10000 34 10000

In trial group 14 (4118) patients were vegetarian and 20 (5882)

patients were Non vegetarian

In control group 20 (5882) patients were vegetarian and 14 (4118)

patients were Non-Veg

Fig 28 Diet wise distribution of patients

0

5

10

15

20

N N

TRIAL GROUP CONTROL GROUP

14

2020

14

Diet

Veg Non Veg

Page | 104

6 Addiction wise distribution of patients

Table no 12

Addiction

Trial Group Control Group

N N

None 30 8824 27 7941

Alcohol 2 588 0 000

Tobacco 1 294 2 588

Mishri 0 000 1 294

Smoking 1 294 4 1176

Total 34 10000 34 10000

In trial group 30 (8824) patients have no addiction 2 (588) patients

have addiction of alcohol 1 (294) patients have addiction of Tobacco 0

(0) patients have addiction of Mishri and 1 (294) patients have addiction

of smoking

In control group 27 (7941) patients have no addiction 0 (0) patients

have addiction of alcohol 2 (588) patients have addiction of Tobacco 1

(294) patients have addiction of Mishri and 11 (1176) patients have

addiction of smoking

Page | 105

Fig 29 Addiction wise distribution of patients

0

5

10

15

20

25

30

NONE ALCOHOL TOBACCO MISHRI SMOKING

30

21

01

27

0

21

4

Addiction

Trial Group N Control Group N

Page | 106

Statistical Analysis and Results

Effect of study on Karnashoola-

Table no 13

Karnashoola

Group A Group B

BT AT BT AT

N N N N

Grade 2 0 000 0 000 0 000 0 000

Grade 1 30 10000 7 2333 32 10667 5 1667

Grade 0 4 1333 27 9000 2 667 29 9667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 30 Effect of study on Karnashoola

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

30

7

32

54

27

2

29

Karnashoola

Grade 2 Grade 1 Grade 0

Page | 107

Table no 14

Karnashoola Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 088 100 033 006

969 2829E-

08 7667 HS

AT 021 000 041 007

Group

B

BT 094 100 024 004

1037 7103E-

11 8438 HS

AT 015 000 036 007

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 31

000010020030040050060070080090100

BT AT BT AT

GROUP A GROUP B

088

021

094

015

Karnashoola

Mean

Page | 108

Table no 15

Karnashoola

Mean SD Effect

Group

A

Group

B Trial Control Trial Control

Day 1 088 094 033 024 000 000

Day 3 065 071 049 046 2667 2500

Day 5 024 038 043 049 7333 5938

Day 14 021 015 041 036 7667 8438

000

010

020

030

040

050

060

070

080

090

100

Day 1 Day 3 Day 5 Day 14

Karnashoola

Mean Group A Mean Group B

Page | 109

Table no 16

Karnashoola N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3250 110500

510000 275 Control group 34 3650 124100

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 110

Effect of study on Karnakandu

Table no 17

Karnakandu

Group A Group B

BT AT BT AT

N N N N

Grade 3 7 2333 0 000 4 1333 0 000

Grade 2 18 6000 0 000 18 6000 0 000

Grade 1 7 2333 7 2333 10 3333 15 5000

Grade 0 2 667 27 9000 2 667 19 6333

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 32 Effect of study on Karnakandu

0

5

10

15

20

25

30

N N N N

BT AT BT AT

GROUP A GROUP B

7

0

4

0

18

0

18

0

7 7

10

15

2

27

2

19

karnakandu

Grade 3 Grade 2 Grade 1 Grade 0

Page | 111

Table no 18

Karnakandu Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 188 200 081 015

1091 3119E-

10 8906 HS

AT 021 000 041 007

Group

B

BT 171 200 076 014

1032 4746E-

09 7414 HS

AT 044 000 050 009

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Page | 112

Fig 33

Table no 19

Karnakandu

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 188 171 081 076 000 000

Day 3 126 118 057 058 3281 3103

Day 5 071 074 046 051 6250 5690

Day 14 021 044 041 050 8906 7414

000

020

040

060

080

100

120

140

160

180

200

BT AT BT AT

GROUP A GROUP B

188

021

171

044

Karnakandu

Mean

Page | 113

Table no 20

Karnakandu N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 4051 137750

373500 006 Control group 34 2849 96850

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is less than

005 Hence we conclude that there is significant difference between Trial

Group and Control Group

000

020

040

060

080

100

120

140

160

180

200

Day 1 Day 3 Day 5 Day 14

Karnakandu

Mean Group A Mean Group B

Page | 114

Effect of study on Karnasrava

Table no 21

Karnasrava

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 11 3667 0 000 8 2667 0 000

Grade 1 23 7667 3 1000 26 8667 2 667

Grade 0 0 000 31 10333 0 000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 34

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

11

0

8

0

23

3

26

20

31

0

32

Karnasrava

Grade 3 Grade 2 Grade 1 Grade 0

Page | 115

Table no 22

Karnasrava Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 132 100 047 009

1122 4356E-

13 9333 HS

AT 009 000 029 005

Group

B

BT 124 100 043 008

1130 9364E-

14 9524 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 35

000

020

040

060

080

100

120

140

BT AT BT AT

GROUP A GROUP B

132

009

124

006

Karnasrava

Mean

Page | 116

Table no 23

Karnasrava

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 132 124 047 043 000 000

Day 3 100 100 025 025 2444 1905

Day 5 047 038 051 049 6444 6905

Day 14 009 006 029 024 9333 9524

000

020

040

060

080

100

120

140

Day 1 Day 3 Day 5 Day 14

Karnasrava

Mean Group A Mean Group B

Page | 117

Table no 24

Karnasrava N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3535 120200

549000 655 Control

group 34 3365 114400

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 118

Effect of study on Karnabadhirya

Table no 25

Karn

Badhirya

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 0 000 0 000 0 000 0 000

Grade 1 13 4333 0 000 16 5333 2 667

Grade 0 21 7000 34 11333 18 6000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 36

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 00 0 0 0

13

0

16

2

21

34

18

32

Karnabadhirya

Grade 3 Grade 2 Grade 1 Grade 0

Page | 119

Table no 26

Karn

Badhirya Mean Median SD SE

Wilcoxon

W P-Value

Effect Result

Group

A

BT 038 000 049 009

799 7173E-

05 10000 HS

AT 000 000 000 000

Group

B

BT 047 000 051 009

816 0000138 8750 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 38

000

005

010

015

020

025

030

035

040

045

050

BT AT BT AT

GROUP A GROUP B

038

000

047

006

Karnbadhirya

Mean

Page | 120

Table no 27

Karn

Badhirya

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 038 047 049 051 000 000

Day 3 009 006 029 024 7692 8750

Day 5 003 006 017 024 9231 8750

Day 14 000 006 000 024 10000 8750

000

005

010

015

020

025

030

035

040

045

050

Day 1 Day 3 Day 5 Day 14

Karn Badhirya

Mean Group A Mean Group B

Page | 121

Table no 28

Karn

Badhirya N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3400 115600

561000 806 Control

group 34 3500 119000

Total 68

Page | 122

COMPARISION BETWEEN GROUP A AND GROUP B

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Table no 29

Overall Effect

Trial Group Control Group

N N

Marked Improvement 21 6176 16 4706

Moderate Improvement 8 2353 13 3824

Mild Improvement 4 1176 5 1471

No Change 1 2941 0 0

TOTAL 34 100 34 100

Fig 39

0

5

10

15

20

25

MARKED IMPROVEMENT

MODERATE IMPROVEMENT

MILD IMPROVEMENT NO CHANGE

21

8

41

1613

5

0

Overall Effect

Trial Group N Control Group N

Page | 123

DISCUSSION

Page | 124

Discussion is nothing but the logical reasoning of observations In

every research work discussion part is very important because it brings into

light about the logical analysis which are helpful in filling the research gap in

the scientific world

The discussion is categorized into following ways for the ease of

understanding

1 Discussion on selection of topic

2 Discussion on review of literature

3 Discussion on drugs their mode of action on the disease mode of action

of Karnadhoopana

4 Discussion on observation and results

1 Discussion on selection of topic

Otomycosis is commonly encountered in day-to-day practice Majority

of Indian people affected with this pathology This disease commonly

manifests in developing countries low socio-economic standard and lack

of hygiene Now a days due to busy lifestyle people are not able to follow

the proper instruction of care of ear which may be responsible for the

recurrent nature of disease So for the management of this we use

Karnadhoopana with the help of Agaruwadi Varti Dhoopana is simple

easy cost-effective procedure which can be done even at OPD levelso

for the disease Karnasrava we selected Karna Dhoopana as therapeutic

procedure Karnadhoopana was done with Agaruwadi Varti and Guggula

Varti which was very effective for treatment

Page | 125

2 Discussion on review of literature

Karnasrava is one such disease among 28 Karnarogas mentioned by

Acharya Sushruta in the chapter named Karna Roga Vigyana Acharya

Charaka included Karnasrava as symptom under the four types of

Karnarogas due to vitiation of different doshas Acharya Vagbhata has

not described Karnasrava separately It is a fact that systemic

description of Karnarogas is available in all the ancients of pus from a

Vata afflicted ear may results from head injury or immersion in water

Karnasrava is a clinical entity which can be correlated with Otomycosis

Karnasrava is explained as symptom as well as a disease in Ayurveda

Nidana- Karnasrava occur due to Samanya Nidana and Vishesh Nidana

Vishesh Nidana like Shirobhighata Nimmajato jale Mithyayoga of Shashtra

The exact pathology behind Karnasrava is not understood clearly

Purvarupa ndash No specific Purvarupa are found for Karnasrava in classical

literature Acharya Madhukara describe Purvarupa as expression of

Rupa(lakshana) with less intensity that is less intensity itching sound in ear

may considered as Purvarupa of Lakshana

Samprapti- Aacharya Sushruta not explained the Samprapti of Karnasrava

separately and we must consider the general Samprapti of Karnaroga Due to

various aetiologias as cited above ear afflicted by Vata dosha causes Twak

Rakta Mamsa dushti results in Karnasrava According to Acharya Sushruta

Vata-Kapha dose is dominance in Karnasrava

Page | 126

Nidan

Nija Agantuja

Vata ndash kapha prakopak nidana Shirobhighata Nimmajato-jale

Mithya yoga of Shastra

Vata- kapha Prakopaka(Chaya prakopak) Vata-kapha prakopaka

( Achay prakopak)

Twak Rakta Mamsa dushti

Karnasrava

Page | 127

Chikitsa

The curative aspect and this must be done simultaneously giving due

importance to Nidan Parivarjana that is preventive measures So Nidan

Parivarjana that is avoidance of causative factors like Jalkrida Mithyayogen

shashtrasya Karnakandu Shirasnan Pratishaya is the first step in combating

the disease and form the part of line of treatment

Above Samprapti helps us to proceed towards the treatment of Karnasrava

The main protocol of treatment is removal of fungus and wound management

which include various measures to keep area day clean clear of microbes and

providing ideal condition for healing

Samany Chikitsa- Acharya Sushruta described general treatment for

Karnaroga as Snehapana (Drinking ghee) Rasayana (Rejuvenation therapy)

Bhramacharya Avoid excessive speaking Avoidance of physical exercise and

head bath

Vishesha Chikitsa ndash Acharya Sushruta mentioned some procedures in the

treatment of Karnasrava which is Shirovirechana Karnadhoopana

Karnapurana Karanpramarjana Dhavan Avachurnana Karnapurana Above

various procedures described in Ayurveda for management of fungus growth

in ear discharging ear fulfill these requirements of wound management

Page | 128

Discussion on observation and Result

Out of 68 patients 34 patients included for the trial The incidence of

Karnasrava is observed in trial and control groups

The statistical analysis provided the following data

AGE

Trial group- Maximum no of patients that is 14 (41176) patients were from

age group 25-35 years followed by 29412 patients were from age group

18-25 years 23529patients were from age group 35-45 years and

58824 patients were from age group 45-60 years

Control group - Maximum no of patients that is 14 (41176) patients were

from age group 25-35 years followed by 20588 patients were from age

group 35-45 years and 20588 patients were from age group 45-60 years

17647 patients were from age group 15-25 years

The maximum no of cases of Karnasrava found in age group between 25 to

35 years The reason behind this is repeated use of ear bud or emersed water

in ear More use of earphone or working more in cold environment

GENDER

Trial group ndash A higher prevalence seen in females 6764 and 3235 in

males

Control group - A higher prevalence seen in males 5588 and 4411 in

females

Females and males both are prone to disease

Page | 129

EDUCATION

Trial group-It is observed that amongst 34 patients maximum ie16

(47059) patients were graduated 8 (23529) patients were HSC

educated 4 (11765) patients were SSC educated 4 (11765) patients

were illiterate 1 (29412) patient were primary educated and 1(29412)

patient were post graduated

Control group- It is observed that 10 (29412) patients were graduated 9

(26471) patients were HSC educated 6 (17647) patients were post

graduated 3 (88235) patients were SSC educated 3 (88235) patients

were primary educated3 (88235) patients were illiterate

There is no direct relation between education and Otomycosis

RELIGION

Trial group- The incidence of patients of Hindu religion are 9118 and Muslim

religion are 882

Control group- The incidence of patients of Hindu religion are 9706 and

Muslim religion are 294

There is no probable explanation for this maximum number of patients in

Hindu religion it depends upon the patients attend the hospital and

community residing there

Page | 130

DIET

Trial group It was found that maximum ie5882 patients were taking

mixed diet while 4118 were taking vegetarian diet

Control group It was found that maximum ie5882 were taking

vegetarian diet while 4118 patients were taking mixed diet

The dietary habit of person is based on choice availability and religious

customs of the person

ADDICTION-

Trial group- It was found that maximum ie 30 (8824) patients have no

addiction 2 (588) patients have addiction of alcohol 1 (294) patients

have addiction of Tobacco 1 (294) patients have addiction of smoking and

0 (0) patients have addiction of Mishri

Control group - It was found that maximum ie 27 (7941) patients have

no addiction 4(1176) patients have addiction of smoking 2 (588)

patients have addiction of Tobacco 1 (294) patients have addiction of

Mishri and 0 (0) patients have addiction of alcohol

Very few patients were addicted to Alcohol Smoking Tobacco and Mishri

These factors can be taken as provoking factors for Otomycosis

Page | 131

Discussion based on probable Mode of action of Karnadhoopana

In Ayurveda classics Karna Dhoopana is therapeutic procedure explain for

Karnasrava Dhoopana is administration of Dhooma (Fumes) with the help of

Dhoopan Dravya References indicates that analgesic and disinfectant effect

of Dhoopana karma and mention for Dushta Vrana Chikitsa It reduces

Vedana Srava amp also does Vrana Ropana action

Various Dhoopanas and Dhoopan Dravas for different element in various

Samhitas of Ayurveda but there is a lacuna of availability of reference

regarding how to do it and method of procedure Matra Kala Contraindication

etc

Currently simple modified way of Karnadhoopana according to Yukti Praman

and experience but there is lac of standardization

Karnadhoopana is one among the topical Bahiparimajan type of treatment

Karna Parmarjana is procedure of cleaning ear with the help of cotton or gauze

piece soaked in honey

Page | 132

Dhoopan

The fumes coming out on burning Agaruwadi Varti

Administrated directly into external ear canal

Causes vasodilation

Due to this increase blood supply in external ear canal

It helps in absorption of drug

Fumes dries up Srava and bring the analgesic effect

Karnagata Kapha amp Avrut Vata Dosha Shaman

Decrease in signs and symptoms like karnasrava Karnshool Karnabadhirya amp

Karnandu

Page | 133

3 Discussion based on probable mode of action of Agaruwadi

Dhoopana

Agaru ndash

I Agaru is a fragrant tree aroma is a result of fungal pathogenesis when the

wood of tree is contaminated by fungi at wounds it develops scrap filled

with resin and turn out to be aroma Medicinal use of Agaru have been

recorded in ancient medicinal science in in inflammatory disease and some

infective disease

II Acharya Charaka has referred to Agaru as an Ushna dravya despite having

Tikta Rasa Ashtang Samgraha used Agaru as Dhupana Dravya along with

Madan and Yawa in Karnasrava Nighantu recommended is use as a

Dhoopana

III In various Samhitas and Nighantus Agaru described as Tikta Snighdha

Sheetaprashamana Vranaprasadana Tvachya Due to these properties

Agaru is used in the treatment of Karna-Akashi Roga and Dushta Vrana

Shodhaka

IV Agaru is reported to have Antimicrobial Analgesic Antioxidants

Antihistaminic and anxiolytic properties Its Antihistaminic property gives

relief from itching which is cardinal feature of Otomycosis Due to Katu

Ushna Tikta Guna improves blood circulation Bheda stage develop It is

Niram Awastha of Dosha Karnagata kapha and vata get decrease and

symptoms like karnashoolakarnasrava get decrease Agaru also have a

Antioxidant properties

V Chemically Agaru Contain 2-(2-Phenylethyl) Chromones Terpenoids

Flavonoids

VI Natural Agarwood had inhibitive activities towards Staphylococcus Aures

The chloroform extract of Agarwood prolongs the pain threshold[108]

Page | 134

Madan

I Madanphala have therapeutic properties like Anti-inflammatory

Antiallergic Analgesic and Wound healing

II It is Useful in treatment of disease like Shotha (inflammation) Vidradhi

(Abscess) Pratishaya (Common cold) Kushta(Skin disease)

III Extract of Madanphala mainly contain Glcosides Tritorpenct

Glycosides Saponin

IV Saponin glycosides are act as fire extinguisher This property is helpful

for vartiIt also act as a detergent which clean the surface of fungus

V Tritorpenct act as a anti-inflammatory antimicrobial and

immunomodulator compound Interaction of glycosides with sterol

causes disturbance of selective permeability in plasmic membraneso

exudates and discharge get decrease

VI Pharmacological activity [109]

Antibacterial Activity The preliminary antibacterial activity of Methanolic

extract of Randia D lam was done on some standard and wild pathogenic

strains The inhibition of the bacterial growth was more pronounced on E coli

as compared to the other tested organism This shows the antibacterial action

of Randia D secondary infection can prevent

Anti-Allergic Activity In Ayurveda Randia D Extract and its fraction of milk

induced leukocytosis and eosinophilia in mice

Anti-Inflammatory Activity The crude methanol extract of fruit of Randia D

effectively reduced the carrageenin induced oedema in hind paw of the rats

significant reduction in granular tissue formation was recorded This activity

seems to be significant at various acute phases of inflammation and om

formation of granular tissue This proves action of Madanaphala in shopa

(inflammation)

Page | 135

Analgesic Activity Analgesic activity was tested in mice weighing between 20-

250 with six number of animals in each group Methanlic extract of fruit Randia

d give analgesic activity in both models This proves its Shoolanashaka (pain

killer) action

Immunomodulatory Activity Randia D has immunostimulant activity and

chloroform fraction which strongly affected immune system seems to be

bioactive fraction of this plant

The overall effect of Agaru Mandanphala Yawa having Anti-inflammatory

Antiseptic Antimicrobial Property Active ingredient shows these properties

Agaru Yawa Madanphala

Vatakaphaghna

Act as

Vranashodhak

Vedanasthapaka

Sheetaprashamana

Shothara

Avarana of Vata get decrease so helps to Shaman of Vata dosha

Karnakandu Karnashoola Karnasrava

Prashamana

Page | 136

This fact can be taken into consideration and probably acknowledge that

Karnadhoopana with Agaruwadi Varti had not leave any residue in the ear

Removal of fibrin keratinocyte migration and in growth of epithelial tissue

plays a major role in healing It is technique of fumigation of ear with the

smoke of anti-infective drug In Karnadhoopana Sthanik Swedana increase the

blood supply and helps in absorption of the drug reduce Karnakandu amp

Karnshoola associated with infection

Page | 137

SUMMARY AND CONCLUSION

Page | 138

The dissertation entitled randomize comparative clinical trial to study the

effect of Agaruwadi Karnadhoopan and Guggula Karnadhoopan In Karnasrava

wsr to Otomycosis

The dissertation is divided into fallowing parts

Introduction

Review of literature

Ayurvedic review

Modern Review

Drug review

Procedure review

Material and Method

Observation and result

Discussion

Summary and conclusion

bull INTRODUCTION

It includes importance of Shalakyatantra in Sushrut Samhita Charka

Samhita And Ashtang Samgraha

Common and specific causes of Karnasrava

Karnasrava is a clinical entity which can be corelate with Otomycosis

In Ashtang Samgraha stated the procedure like Karnadhoopana with

Agaru Yawa Madanphala in Karnasrava

Page | 139

bull REVIEW OF LITERATURE

1 Ayurvedic review

2 Modern review

3 Drug review

Ayurvedic review-

It includes Rachana-Sharir and Kriya-Sharir of Karna detail description of

Karnaroga and its types Karnaroga Samanya hetu Poorvaroopa Rupa

Samprapti Upadrava Pathya-Apathya of Karnasrava Vishesh Nidan and

Chikitsa of Karnasrava Detail description of Karnadhoopana according to

various Acharays have been mentioned

Modern review-

It includes anatomy and physiology of Ear brief anatomy of ear anatomy of

External middle and Internal ear Detail description of the disease

Otomycosis mechanism of fungal infection in external canal pathophysiology

investigations diagnosis and management

Drug review-

Detail description of Agaru Yawa Madan Guggula and its synonyms

Ayurvedic properties Karma uses Pharmacological action and their

pharmacodynamic properties

Page | 140

MATERIAL AND METHOD

It includes description regarding materials required for the study Preparation

of Agaruwadi Varti its Standardization Sterilization and packaging

Plan of study

1 Total 68 patients completed the treatment Age criteria was kept

between 18-60 years Patient selection was done by done by simple

random sampling method and divided into two groups A (Trial) and

Group B (Control) 34 patients in each group

2 Patients in Group A were treated with Karnadhoopana with Agaruwadi

Varti for 7 days two times in a day while patients in Group B were treated

with Karnadhoopana with Guggula for 7 days two times in a day

3 Clinical examination done during each follow up ie 0th 4rd 7th and

observation were recorded

Page | 141

OBSERVATIONS AND RESULTS

Page | 142

1 It was observed that higher incidence of disease Karnasrava ie

Otomycosis found in age group 25-35 years

2 Disease otomycosis was equal in both male and female

3 The trial group there was significant relief in Karnakandu (8906)

Karnasrava(9333) Karnashoola(7667) and karnabadhirya(100)

4 In control group there was significant relief in Karnakandu (7414)

Karnasrava(9524) Karnashoola(8438) and

karnabadhirya(8750)

Page | 143

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Chaukhamba Orientalia Kiyantshirasiya Adhaya Shlok no 1713 page no-

258

68 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya Shlok no-

6 page no- 310

69 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005 Karnarogavigyniym Shlok no- 1725-26 Page no-

1003

70 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2140 page

no 131

71 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005 Adhyay 18 shlok 35

72 Acharya Trivedi Raguveer Prasad Ashtang sangrah uttartantra

published by Vaidyanath Ayurveda bhavan pvt

Karnarogapratishedhoadhya Shlok no-2211 Page no- 735

73 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Page | 152

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2141 page

no 131

74 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2142 page

no 131

75 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2144 page

no 131

76 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 34 page no- 649

77 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2145page

no 131

78 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 37 page no- 649

79 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2146page

no

80 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya page no-

316

81 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Page | 153

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2143page

no

82 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publication Krnarogadhikara adhaya page no-

318

83 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary

Madhyamkhand Vatkalpana shlok no- 782-83 page no- 137

84 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 72-77 page no- 651

85 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya page no-

316

86 Vd Shree Laxmipatishastri Yogratnakara

87 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

Karnarogadhikara Shlok no- 808182 page no- 652

88 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 83 page no- 652

89 (PDF) Otomycosis A Comprehensive Review (researchgatenet)

90 httpswwwncbinlmnihgovpubmed24948980

91 A Simon Carney Scott-Browns Otorhinolaryngology Head and Neck

Surgery CRC press 8th publication Otitis externa and otomycosis

92 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition Diseases of external ear

Chapter no Page no -

93 wwwguggulipidcomtradhtm

Page | 154

94 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

95 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 1 chapter no-28 page no-

43

96 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009Agaru page

no726-728

97 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishra chapter Karpuradi varga Shlok no-31-

43 Page no- 116

98 httpswwwthiemeinimagecatlogsample_chapter_GOMPpdf

99 (PDF) Chemical Constituents and Pharmacological Activity of Agarwood

and Aquilaria Plants (researchgatenet)

100 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 4 chapter no-2 page no-4

101 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 chapter no-152 Madanpage

no376-379

102 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

103 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 1 chapter no-54 page no-

84

104 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 page no697-699

patol-yawa

Page | 155

105 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

106 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

Dhoompanvidhi page no- 252-254

107 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012Chikitasasthan Shlok

no- 151page no-406

108 httpswwwmdpicom1420-3049232342pdf

109 httpswwwijamcoinindexphpijamarticledownload0610201530

0

Page | 156

BIBILOGRAPHY

Page | 157

1 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

2 Scott-Brown WG Diseases of the EarNose and Throat Landon

Botterworth and co(publishers) Ltd1952 Volume 2

3 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012

4 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009

5 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi commantry

Purvakhand and Madhyamkhand

6 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

7 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-Tatva-

Sandipika hindi commentary Published by Chaukhamba Sanskrit

SansthanVaranasi

8 The Ayurvedic Pharmacopeia of India Ministry of Health and family welfare

department of Ayush Part 1 and part 4

9 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005

10 Acharya Trivedi Raguveer Prasad Ashtang sangrah published by

Vaidyanath Ayurveda bhavan pvt

11 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition

12 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary published by Chaukhamba

Orientalia

Page | 158

ANNEXURE

Page | 159

ANNEXURE- 1

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

CASE RECORD FORM

RESEARCH PROFORMA FOR MS (AYU) DESSERTATION

DEPARTMENT OF SHALAKYATANTRA

NAME -

ADDRESS -

GENDER - AGE - OCCUPATION-

RELIGION - EDUCATION - MARITAL STATUS-

OPD IPD NO-

DATE OF ADMISSIONCOMMESEMENT-

DATE OF DISCHARGECOMPLITION-

DATE OF COUNSELLING-

TEL NO-

CHIEF COMPLAINTS-

PAST MEDICAL AND SURGICAL HISTORY-

TREATMENT HISTORY-

FAMILY HISTORY-

Page | 160

PERSONAL HISTORY-

a) Ahar(Diet)

b) Vihar

c) History of addiction

GENERAL EXAMINATION

PULSE - MIN BP - mm of hg

TEMP - 0F RR - MIN

ASHATAVIDHA PARIKSHANA

Nadi- Mutra- Mala-

Jivha- Shabda- Sparsha-

Drik- Aakruti-

SYSTEMIC EXAMINATION

RS ndash

CNS-

CVS ndash

Page | 161

LOCAL EXAMINATION (KARNA PARIKSHAN)

OBSERVATION TABLE FOR SUBJECTIVE CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching )

RIGHT EAR LEFT EAR

KARNASHASHUKULI

KARNAPUTRAK

KARNAPALI

KARNAKUHARA -

SRAVA

GANDH

VARNA

SWARUPA

KARNAPATALA (TM)

Page | 162

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

Hearing Test

1Renne Test ndash

2 Weber Test -

Examination of Ear-

Pathological Investigation-

Other Examination-

Nidan Panchak-

1Hetu-

2Purvarup-

3Rupa-

4Upashayanupashaya-

5Samprapti

Signature of Guide Signature of Doctor(Researcher)

Page | 163

ANNEXURE 12

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Dhoopana Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization were done as recommended in pharmacy procedure

The raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 were mixed together

in equal quantity to make Agaruwadi churn

STEP 4 - Agaruwadi churn were triturated with appropriate quantity of water

and prepared Varti in GMP Certified Ayurvedic pharmacy Standard aseptic

precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Dhoopana Varti was packed in sterile air packed

container

STEP 6 - Agaruwadi Dhoopan was given with the help of Dhoopan yantra

TREATMENT DETAIL-

Purvakarma -

1 The patient is asked to sit comfortably on chair having sufficient light and

less amount of dust

2 The EAC is cleaned thoroughly by Pichu Varti (cotton swab) to remove the

discharge and other debris

Pradhankarma -

1 The patient is asked to relax completely on the chair

Page | 164

2 Fumes are passed to the ear with Dhoopana Yantra

3 Dhoopana yantra is funnel shaped and its one end will keep the ear covered

for the passage of Dhooma into the ear canal and other end where Agaruwadi

Dhoopana Varti were placed which produces fumes

4 This Dhoopana was given for 5 min

Pashchat karma -

1 The patient were advised to avoid cold refrigerated food drinks cold water

bath cold wind fog and prevent water from entering the ear

(A) Agaruwadi Dhoopana Varti

B) Guggula Dhoopana Varti SOP of it is same as above Agaruwadi Dhoopana

Varti

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Page | 165

ANNEXURE 21

INFORMED CONSENT DOCUMENT

Study Title

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

Introduction

- You are invited to take part in a research study RANDOMSIED COMPARATIVE

CLINICAL TRIAL TO STUDY THE EFFECT OF AGARUWADI DHOOPANA AND

GUGGULA DHOOPANA IN KARNASRAVA

- Before you decide it is important for you to understand why the

research is being done and what it will involve

- Please take time to read the following information carefully and discuss

it with friends relatives and your doctor if you wish

- Ask us if there is anything that is not clear or if you would like more

information

Purpose amp Nature of Study

- In this research project by examine you and ldquoKarnasravardquo (Otomycosis)

disease were treated

- In the part of treatment Agaruwadi Dhoopana or Guggula Dhoopan were

given

- Dhoopana means medicated drug fumes were given in ear with the help of

Dhoopan Yantra

Page | 166

- Treatment was given for 7 days

Study Duration

7days

Participation

- Your participation is entirely voluntary

- If you do decide to take part you were given this information sheet to keep

and be asked to sign a informed consent form

- If you decide to take part you are still free to withdraw at any time and

without giving a reason This will not affect the standard of current or future

medical care you may receive

Confidentiality

- All information which is collected about you during the research were

kept strictly confidential

- Any information about you which is collected from the center will have

your identity in the form of a code number so that it will remain confidential

Benefits Of Study

- The results obtained from this study would be helpful for providing better

quality of treatment amp other essential facilities for Karnasrava (Discharge)

patients

- You will get clinical benefit from the study

Page | 167

Risks Of Study

- In this treatment there are few chances of Irritation of Ear Nose and

congestion at EAC if any of these happens then treatment were given

Results Of Study

- If the Results obtained are profitable then they may get published

without disclosing your details

Signature of patient

Date

Time

Phone no of Researcher

Page | 168

रण मादहती पतरक

सशोिनाच शीषवक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE

EFFECT OF AGARUWADI DHOOPANA AND GUGGULA DHOOPANA

IN KARNASRAVA

परसतताना

- आपणास या सशोिनातपमक अभयासात सहिागी होणय़ाच आाहन करणयात यत आह

- सशोिनातील सहिाग तननदशचत करणयापी सशोिनाच उददश समजन घया

- खालील मादहती काळजीपवक ाचा आणण आशयक ािलयास आपलया डॉकिराशी कका

दहतशरचतकाशी चचाव करा

- काही सददिता असलयास कका आणखी मादहती ही असलयास आमछयाशी चचाव करा

सशोिनाच उददीटि सतरप

- सदर सशोिन परकलपामरधय आपलयाला तपासणी करन कणवसरा या वयाशरिची शरचककतपसा दणयात

यणार आह

- सदर वयाशरिची शरचककतपसा महणन आपणास अगरादी िपन कका गगल िपन

दणयात यणार आह

- सदर औषि आपणास 7 ददस घयायाच आह

Page | 169

कालािी

- 7 ददस

सहिाग

- आपला सहिाग हा पणवपण ऎनदछिक आह

- आपला सहिाग तननदशचत असलयास आपणास ही मादहती पतरतरका दणयात यईल आपणास यातील

समती पतरकार सही कराी लागल

- सहिाग तननदशचत असनही आपण कोणतपयाही ळस कोणतही कारण न दता माघार घ शकता

याचा आपलया दयकीय सविर कोणताही पररणाम होणार नाही

गोपनीयता

- सशोिना दरमयान गोळा कलली आपलया वषयाची सव मादहती गोपनीय ठणयात यईल

- आपली यनदकतक मादहती साकततक सतरपात गोपनीय ठणयात यईल

सशोिनाच फ़ायद

- सशोिनाच तनटकषव कणवसरा बाशरित रणाछया दयकीय इतर सविाचा दजाव सिारणयास

फायदशीर ठरतील

सशोिनातील जोणखम

- य़ा शरचककतपसमरधय कान दखण डॊळय़ातन नाकातन पाणी य़ण नाकात जळजळण डोक जड

होण ही लिण ददस शकतात यापकी लिण तनमावण झालयास तपयाची शरचककतपसा कली जाईल

Page | 170

सशोिनाच तनटकषव

सशोिनाच तनटकषव फ़ायदशीर ठरलयास आपली मादहती गोपनीय ठन परकाशशत करणय़ात यईल

रण सतािरी-

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

Page | 171

ANNEXURE 31

INFORMED CONSENT FORM

Patient OPD no __________

Subjectrsquos Identifier

Date of Birth Age Gender

I _____________________________________ age___________ years

exercising my free power of choice hereby give my consent to be included

as a participant in the clinical study entitled

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

1 I confirm that I have read have been read and understood the information

sheet for the above study and can ask questions

2 I understand that my participation in the study is voluntary and that I am

free to withdraw at any time without giving any reason without affecting my

medical care or legal rights

3 I understand that the Ethics Committee members investigators and study

doctors will not need my permission to look at my health records both in

respect of the current study and any further research that may be conducted

in relation to it even if I withdraw from the trial I agree to his access

However I understand that my identity will not be revealed in information

released to third parties or published

4I agree not to restrict the use of any data or results that arisefrom this study

provided such a use only for scientific purpose

5 I agree to take part in the above study

Page | 172

signature with Date-

Left hand thumb impression

Name amp signature of the witness ndash

Name amp signature of the student ndash

Page | 173

ANNEXURE 32

समतीपतरक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

वयकतीच य

ददनाक जरमददनाक

1) मी ह तननदशचत कररत आह ककसदर सशोिन परकलपाबाबतची सपणव मदहती मी ाचली असनमला ती

समजली आहतपयाबददल मला परशन वचारणयाची पणव मिा आह सदर मादहतीन माझ समािान झाल

आह

2) मी सदर सशोिनातन माझया मजीनसार किीही बाहर पड शकतो या माझया अशरिकाराची मला कलपना

आह

3) माझी दयककय मादहती तपासणयाची कागदपतर कळ सशोिनाकररता ापरली जाणार आहत याची

मला मादहती आहसदर सशोिन परकलपातील सबशरित घिकाना माझी दयककय मादहती पाहणयाची मी

समती दत आहतरावप या सदिावतील माझी ओळख दशववणारी मादहती कोणासही ददली जाणार नाहीयाची

मला कलपना दणयात आली आह

4) सदर अभयासातन शमळणारी मादहती अरा तनटकषव कळ शासततरीय हतसाठी ापरल जाणयासाठी माझी

समती आह

5) रील अभयासात सहिागी होणयास माझी समती आह

रण सतािरी-

Page | 174

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

ASSESSMENT CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching)

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

a) कणवशल ( pain )- 0 - Absent

1 ndash Present

Page | 175

b) कणवकणड (Itching)- 0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

c) कणवसततरा ( Discharge )

0- Absent

1-Mild- Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाशरियव ( conductive Loss of hearing )

0 - Present

1 - Absent

Page | 176

Page | 177

Page | 178

Page | 179

Page | 180

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

Page | 181

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 182

AUTHENTIFICATION CERTIFICATE

Page | 2

INTRODUCTION

Page | 3

Ayurveda is ancient science of life a system of health and medicine

which aims to assist people in living a healthy life It is a person-centered

medicine which deals with healthy lifestyle systemic diseases prevention

diagnosis and treatment Ayurveda is divided into eight branches[1] It has

a separate branch of clinical and surgical specialization concerning ENT and

ophthalmology known as Shalakyatantra One out of the eight branches of

Ayurveda Shalakyatantra deal with the etiology diagnosis prognosis

prevention treatment and complication of diseases which are located at

Urdhwang Pradesh[2]

Karna is one among the Panchendriya (sense organ) situated at

Urdhwang Pradesha [3] It is originated from Akash Mahabhuta Aachary

Sushruta explains 28 Karnaroga in Uttaratantra Karnaroga Vigyniyam

Aadhaya[4] He mentioned Karnasrava as separate diseases[5] Aacharya

Charaka explain 4 Karnaroga He had not described Karnasrava as

independent diseases but explain Karnasrava as a symptom under four

Karnaroga Acharya Vagbhata mentioned Karnasrava as a symptom in

Karnashoola according to Dosha He included this into Kaphaj Karnashoola

itself[6] Karnasrava means discharge through ear The Samanya Hetu of

Karnaroga are Avashaya or Pratishaya that is common cold Sheeta Vihara

or exposure to cold environment Karnakandu or self-inflicted trauma by

use of ear bud or pine to clean itching in ear Shabda Shashtra Mithyayoga

that is misuse of instrument or listening to high sound frequencies[7] The

other predisposing factors are such as abuse of nonspecific broad-spectrum

antibiotics steroids and immune suppressed disorders

Classical features of Karnasrava can be compared with otomycosis

Otomycosis is acute sub-acute or chronic fungal infection in external ear

which rarely involves the middle ear[8] Otomycosis is characterized by pain

itching discharge conductive deafness of mild to moderate in nature

Fungal spores invade in the epithelial layer of EAC In response to that

inflammatory process starts which will reflect as pain Itching is due to

immune reaction of body during inflammatory process As a result of

Page | 4

inflammatory process exudates were produced which will mix up with

fungal colonies and appear as discharge In initial stage of disease ear

discharge is watery but if there is secondary bacterial infection occur it

becomes mucopurulent Ear blockage and conductive type of hearing loss

are due to accumulation of fungal mass in external auditory canal

Fungal mass appears white or black or brown and is like a wet piece

of filter paper Examination with otoscope Aspergillus Niger appears black

headed filaments growth Aspergillus fumigates as a pale blue or green and

candida as a white or creamy deposit[9]

Otomycosis is a common condition and it mostly occurs in humid

area According to American academy of otolaryngology prevalence of

otomycosis is 52 all over a world and 09 in India 5-25 otitis externa

cases are due to otomycosis Nearly 61 types of fungal species being involve

in otitis externa 90 of fungal infection cases involve Aspergillus species

and the rest candida species[10]

In Ayurveda The common treatment Principle for all is Ghritapana

Rasayana Bhramacharaya Avyayama (Excessive exercise)

Ashirasnana(Head bath) Atibhashashya(Excessive speaking) This can be

used for the prevention and management of Karnaroga[11] Acharya

Sushruta explain specific treatment modality for Karnasrava is

Karnaprakshalana Karnapoorana Karnadhoopana Shirovirechana

Karnadhavana[12]These therapeutic procedure can be updated according to

different stages of these condition

In routine OPD it is observed that patient of otomycosis respond

more frequently to topical therapy than to systemic therapy Among all the

treatment modality Karnadhoopana is an effective and simple procedure

In this regard Karnadhoopana with Agaruwadi Varti or uggula had explain

in Ashtang Samgraha Agaruwadi Varti contain Agaru Yawa Madanphala

All these contains of Agaruwadi Varti and Guggula acts as Ruksha Ushna

Teekshana Laghu Guna acts as effective Shodhaka keeps ear dry reduce

Page | 5

pain discharge foul smell and thus control the infection Dhoopana is also

useful as Adhidaivika Chikitsa to protect the patient from external attack of

visible and invisible organism The principal treatment modality adopted in

Allopathic system of medicine is oral antibiotics and topical antibiotic drop

Long term use of oral antibiotic causes adverse effect like gastric irritation

reduce immunity and resistance to drug Long term use of topical antibiotic

drops cause Ph change in external canal which become prone to fungal

infection

Hence the therapeutic procedure with Guggula or Agaruwadi Varti

Karnadhoopana are cost effective safe and easy procedure and it can be

used more effectively

Page | 6

AIM OF STUDY

To evaluate the effect of Agaruwadi Varti Dhoopana and Guggula Varti

Dhoopana in management of Karnasrava

OBJECTIVE

To compare the efficacy of Agaruwadi Dhoopana and Guggula Dhoopana in

Karnasrava

HYPOTHESIS

NULL HYPOTHESIS -

H0- Agaruwadi Dhoopana is not effective than Guggula Dhoopana in

Karnasrava

ALTERNATE HYPOTHESIS -

H1- Agaruwadi Dhoopana is more or equally effective than Guggula

Dhoopana in Karnasrava

RESEARCH QUESTION

Whether there is significant difference between Agaruwadi Dhoopana and

Guggula Dhoopana in Karnasrava

Page | 7

PREVIOUS WORK DONE -

1 Anupama Patra B Effect Of Arka Taila In The Management Of

Karnasrava With Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching amp Research in Ayurveda

Gujarat Ayurved University Jamnagar 2007

2 Palmer Komalben K Further Study On Role Of Arka Taila In The

Management Of Karnasrava With Special Reference To

Otomycosis Shalakya Tantra Institute for Post Graduate Teaching amp

Research in Ayurveda Gujarat Ayurved University Jamnagar 2010

3 Sathisha Shankar B Management Of Karnasrava With Sthanika

Guggulu Dhoopana And Rasnaadi Guggulu-A Comparitive Study Shalakya

Tantra Government Ayurvedic Medical College Bangalore 2011

4 Shashikala DK Comparative Study On The Efficacy Of Vacha

Lashunaadi Taila Karna Pichu And Nimba Patraadi Dhoopana In The

Management Of Karna Srava Shalakya Tantra Government Ayurvedic

Medical College Bangalore 2014

5 Javale Anant A Clinical Study On The Efficacy Of Arka Taila In The

Management Of Karna-Srava Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching amp Research in Ayurveda

Gujarat Ayurved University Jamnagar 2005

6 Pournima V Koti Management Of Karnasrava With Priyangvadi Taila

Pichu With And Without Saarivadi Vati Shalakya Tantra Sri Jagadguru

Gavisiddeswar Ayurvedic Medical College Koppal 2015

7 Amisha Patel A Clinical Evaluation Of Honey In The Management Of

Karna Shoola With Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching and Research in Ayurveda

Gujarat Ayurved University Jamnagar 2016

Page | 8

REVIEW OF LITRATURE

Page | 9

Ayurvedic literature Ayurveda is a science of life practice since

thousands of years The ancient Indian system of medicine and surgery is

commonly known as Ayurveda This was given the status of Upaveda or

fifth Veda in the next stage of growth Among the available literature three

Samhita that is Charaka Samhita Sushrut Samhita Ashtang Hrudayam and

Ashtang Samgraha are the chief source of knowledge of Ayurveda

Ayurveda consist of eight branches Shalakyatantra is one among them

Shalakyatantra is one of its specialized branch deals with science of

ophthalmology otorhinolaryngology Oro dental surgery and head Acharya

Sushruta himself a practical surgeon was the first to advocate dissection of

dead bodies is indispensable for a successful student of surgery He had

described gross anatomy in the first chapter of Uttartantra Shalakyatantra

define by different Acharys as follows

शालाकय नामोरधवजतरगताना रोगाणा शरणनयनदनघराणाददसशरशरताना वयाशरिनामपशमनारव

स स ११०

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत [13]

चस १७१२

Shalakya Tantra Nirukti and Parichaya

शलाकायााः कमव शालाकय ततपपरिान शलाकयम डलहण [14]

The term Shalakyatantra is derived from Shalakya and Tantra

The word Shalakya means A probe and Tantra denotes teaching and

practices found in scripturesThe compendium in which application of

Shalaka in various surgical procedures is principally described is called as

Shalakya tantra

दनदटिवशारदााः शालाककनाः डलहण ( सउ ११३)[15]

An eye specialist is termed as Shalaki by Dalhana

Page | 10

Synonyms of Shalakya Tantra

Uttamanga Chikitsa Jatrurdhwa Chikitsa Urdhwang Chikitsa Shalakya

Chikitsa

Importance of Shalakyatantra-

Life of living being and all the Indriyas are situated in the head hence it is

known as Uttamanga

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत

चस १७१२

The treatment given to this part of the body is described specially in

Shalakya tantra While describing the importance of Shiras Vagbhata

correlates it to the root of tree (Urdhwa Mula) and body to the trunk of tree

(Adha Shaka)

Sushruta has deal with Mukha Roga in Nidan Shan and its treatment in

Chikitsasthan The description regarding the disease of eye ear nose and

head are found only in UttaraSthan Sushruta specially describes the

disease of Shalakyatantra as told by Videha in the beginning of Uttartantra

itself[16]

Shalakyatantra Itihas-

India Exhibits traditional of more than thousands of years in art literature

language logic and philosophy etc The convention was in its sophisticated

and advanced attire throughout the Vedic period

Vedic period ndash

1 Natush was treated for deafness by Ashwinikumars (Rigveda)

2 Rujaswa and Kanva were treated for blindness by Ashwani Kumaras

(Rigvedas)

Page | 11

3 There are several prayers mentioned for normal functioning of sense

organs (Yajurveda)

4 Structures and functions of Mastishka are described (Atharveda)

5 Mantras having reference to disease of Eye Ear Oral cavity etc are

found (Atharvaveda)

Upanishada Period ndash

1 Samhita Period

a) Sushrut Samhita ndash

bull Explanation regarding Netra Nasa and Shirorogas (Uttartantra 1-

26th chapter)

bull Details regarding Mukha and Karna Roga Nidan and

Chikitsa(Nidansthan 16th and Chikitsasthan 22nd chapter)

bull Description regarding Karna Chedana Sandhana Nasa

Ostasandhana Sutra Sthan 16th chapter

b) Charaka Samhita -

bull Explanation regarding Shirorogas (Sutrasthan 17th chapter)

bull Explanation of Gala rogas like Upajivika Galshundi and Rohini

bull Nasa Shiro Mukha Karna and Netra Chikitsa (Chikitsa sthan 26th

chapter)

bull Description regarding Lakshana and Chikitsa of Shankhaka

Ardhavbhedaka Shirovirechana and Shiro basti (siddhi sthan 9th

chapter)

c)Ashtnga Sangraha ndash

bull Detailed description regarding Shalakyatantara (Uttartantra 11-28

chapter)

bull Description of Kriyakalpa (Sutrasthan 32nd and 33rd)

Page | 12

d)Ashtang Hrudayam

bull Detailed description on Shalakya Tantra (Uttar tantra 8-24 chapters)

bull Kriyakalpas (Sutrasthan 23rd and 24th chapter)

e) Bhela Samhita

bull Chakshushya Vaisheshik and Buddhi Vaisheshik Alochaka pitta

f) Harita Samhita- Branch of Medical science offering elaborating

information about the procedure like Nasya Anjan Gandusha etc

comprehended with their applications in disease of Head Eyes Ears

Eyebrows Throat Temporal region and cervical spine is known as

Shalakyatantara

शशरोरोगा नतररोगा कणवरोगा वशषताः भरकरठशङकमरयास य रोगा समिनदरत दह १३

तषा परततकारकम व नसतयतपयवणजनातन च अभयङगमखगणडषकियााः शालकयसशमतााः १४

इतत शालाकयनाम [17]

Documentation of different ancient literature gives various references

regarding all aspects of Karnasrava in various periods It is very much

important to know the history of Karnasrava from Vedic Pauranic Samhita

and Samgraha period

Vedic period ndash The Vedas being the oldest source of knowledge have no

direct mentioning of Karnasrava

Page | 13

Samhita and Samgraha period ndash

Aacharya Sushruta described about Karnaroga Karnasrava Nidan

Roopa and Chikitsa The detail description is available in Sushrut

Samhita Uttartantra 20 and 21st chapters

Aacharya Charaka did not specify Karnasrava but mentioned 4 types

of Karnarogas that is Vataj Pittaj Kaphaja and Sannipataja and their

treatment in 26th chapter of Chikitsasthan

In Ashtang Hrudaya karnasrava is not explained as a separate disease

but Chikitsa is mentioned in 18th chapter of Astanga Hrudaya

uttartantra

In Ashtang Samgraha Chikitsa is mentioned in 22nd chapter of Astang

Samgraha Uttartantra

The details about Karnasrava are explained in Bhavprakasha

Madhyamakhanda 64th chapter

Madhavakara has explained about Karnasrava in 57th chapter of

Madhymakhanda

Karnasrava is also explained in Sharangadara Samhita Uttarkhand 11th

chapter

The reference for treatment of Karnasrava is available in

Yogaratnakara

In Gadhnigraha Karnasrava and its treatment is mentioned in

Karnarogadhikara Adhaya

Vangasena had mentioned about the disease and treatment in 69th

chapter

Chakradatta explained Karnasrava in 57th chapter

Dalhana has given commentary on Sushrut Samhita Uttartantra 20th

and 21st chapter

Sankhya Samprapti of Karnasrava ndash

Aachary Sushruta explains 28 Karnaroga in Uttaratantra Karnaroga

Vigyniyam Aadhaya Aacharya charaka explain 4 Karnaroga in

Page | 14

Karnarohvigyniyam Adhaya based on doshas Acharya Vagabhata in

Ashtang Hrudaya explain 25 Karnaroga in Adhyaya

कणवशल परणादशरच बाशरियव कषड ए च

कणवसरााः कणवकणडाः कणव चवसतततर च

कशमकणवपरततनाहौ विशरिदवविसततरा

कणवपाकाः पततकणवसततराशवशरचतवविम

कणावबवद सपतवि शोफशरचावप चतवविाः

ऎत कणवगता रोगा अटिावशततरीररतााः

स उ २०- ३ त ५[18]

ातकणवरोग वपततकणवरोग कफकणवरोग

रकतकणवरोग सनदरनपातकणवरोग कणवनाद

बशरिरतप परततनाह कणडाः शोफ पततकणवक

किशमकणवक उियरपविरधयअशो अबवद

कशरचकणवक वपपपली वदाररका पाळीशोष

ततिका पररपोिो उतपपातो उरमरर दाःखिवन

शलहाखयााः परचवशनदरतकणवरोगा उकतााः

इदिीका अ स उ २१ [19]

चतपाराः कणवरोगााः

च स [20]

Page | 15

KARNA

Karna ndash करोतत शबद गरहण [21]

The organ of hearing

Karnasrava- कणवसतय कणवयोाव ससराा [22]

Discharge from the ear is referred as Karnasrava

KARNA SHAREERA

bull Nirukti

कणयवत अकणयवत अनन इती [23]

It means reception and conduction of sound waves

These are the functions of external and middle ear

bull Nirukti of Sravanam

शरयत अनन इती शरणम[24]

It means perception of sound

It can be attributed to the internal ear function

bull Karna Utpatti-

Karna is an organ formed by Akash Mahabhuta[25]

The fundamental characteristic is as follows

Indriya ndash Srotram [26]

Indriya Adhisthan ndash Karna [27]

Indriya Dravy ndash Akasha [28]

Indriya Arth ndashShabdha [29]

Indriya buddhi ndash Srotobyddhi

Page | 16

bull Paryaya of Karna- Shabdapatha Srotrapatha Sravanam shruti

Kuhuram Dwanigraham etc

bull Definition of Karna-

कणवशटकलयनदछिरनमिटिोपगरदहत शरोतरमछयत [30]

मा तन ५७१

The definition of Karna is stated in Madhav Nidanam Indriya which is not

seen with naked eye along with Shashkuli is called Shrotra that is Karna

Indriya is so minute that it is not perceived with any sense organ

In Charak Samhita the word Karna explain as the Indriya Adhisthan of

Shabdha Karna is described as one of the Prathyangas of the body He

emphasizes that all Indriyas manifest during the 3rd month of gestation

period

Acharya Sushruta while describing formation of Purusha from Prakriti or

Avyakta narrated that all Indriyas are developing from the Vikarika and

Taijas Ahankara Both Vagabhata and Sushruta stated that Karna as one of

the Bahirsrotas

शरण नयन दन घराण गदमढराणण न सततरोताशसराणा बदहमवखातन [31]

स शा ५-१०

In Ashtang Hradaya Vagbhata has states that all Indriyas are Atmaja

According to him lower lobule elevated helix projected posterior portion

fleshy and adherent ear are indications of long span of life[32]

ततरखातखातन दह अनदसतमन शरोतर शबद ववकतता [33]

ा शा ३-३

शबदाः शबदनदरिय सवनदछििसमहो ववकतता [34]

स शा १-२६

Page | 17

Ear has the prominence of Akash Mahabhuta The prominent dosha of ear

is Vata It is important seat of Vata The prominent Dhatus are Asthi and

Mamsa Karna is one of the Panchgnanendriyas and it meant for hearing

Sushruta narrated that Karnasthita Asthi and Sandhi

घराणकणवगरीाकषिकोषष तरणातन [35]

सशा ५-२२

शरोतरशरगािकष शखाताव [36]

सशा ५-३२

गडकणवशखटककम [37]

स शा ५-२२

One Sandhi and one Tarunasthi in ear

Sandhi ndash Karna contain two Sandhi one in each ear Type of Sandhi is

Shankhavartha which is present in Shringataka

Mansapeshi ndash 2[38]

Siras ndash 10 [39]

Vataj Sira - 4

Pittaj sira - 2

Kaphaj sira - 2

Raktaj Sira - 2

Avedhya sira-

कणवयोदवश तासा शबदादहनीनामकका पररहरत

सशा ७-२५[40]

Amongst above mentioned ten Siras each Karna lodges one Shabdavaha

Sira It is Avedhya

Page | 18

Dhamani -2

Length of ear is 4 Angula

Karna moola ndash 2 Angula

कणाविरतर चतदवशअगलम

स शा ३५-१४[41]

The distance between two ears through the back of the neck is 14 Angula

bull Marmas of Karna-

1 Vidhuras-

कणवपटठतो अिाःसशरशरत विर ततर बशरियवम

सशा ६-३७[42]

कणतपयादद सतनायममवणी ककनदचचनदरनममनाकर कलयकररणणच

डलहणाचयव[43]

अिसततात कणवयोतनवमन विर शरततहाररणण

ा शा ४-२९[44]

Sankhya-2

Vistara- frac12 Angula

Type- Snayumarma (Susha)

- Dhamanimarma(AH)

- Vaikalykar

Sthana- It is situated in the depressed portion in the back of the ear

Injury to them causes loss of hearing

Page | 19

2 Shringataka marma-

नदजवहाकषिनाशसकाशरोतरखचतटियसरमम

तालरयासतयातन चतपारर सरोतसा तष ममवस

वदि शरगातकाखयष सददसततपयजतत जीवतम

मा तन ५७१ [45]

Sankhya- 4

Type- Siramarma

Sthana- It is in head that is amidst Siras (blood vessels) nursing sense

organ

A palm size area near Talu

Injury to this Marma causes death

In modern anatomy ear divides into Bhayakarna or External ear Mdhyakarn

or Middle ear Antahkarna or Internal ear This is extremely appropriate

Even though the ear is divided into three divisions in the point of modern

anatomy Ayurveda denotes ear organ is one Ayurveda treats disease by

way of assessing Dosha and Dushya Here Dushya is one that is Karnendria

Dosha difference will call for different treatment for different disease Hence

treating the vitiated Dosha will cure the disease irrespective whether it is in

external middle or internal ear The thought is based on different

fundamental principle from Ayurveda

bull Parts of Karna

In Ayurveda classics detailed description about anatomy of ear is not

available But the various parts are mentioned as follows

Bhayakarna- External ear

Mdhyakarna ndash Middle ear

Antahkarna- Internal ear

Page | 20

द कणवशटकशलक दॊ कणवपतरकौ

च शा 7-11[46]

कणवशटकशलक कणवगतातवकौ कणवपतरकौ त बाहयकणा

चिदतत च शा 7-11[47]

शटकली बाहयपालयाशरिटिानम

डलहन- स शरच 25-1 12[48]

Karna Shashkulika ndash It is also called as Karna Shashakuli Charaka has

mentioned this term while describing different Pratyngas of the body

Acharaya Gananatha sen has given the clarification for it as a pinna or

auricle[49]

Karnapali ndash It is popularly known as lobule of the ear Daivakrita Chidra is

present in it

Karnaputrika- Ayurvedic scholars accepted two terms in this cortex They

are Karnaputrika and Karnaputrika The former is considered as Tragus and

antitragus[50]

Karna Prushtha- It can be taken as the cranial surface of mastoid or

auricle[51]

Karnapeetha- Aacharaya Sushruta firstly mention the term Karnapeetha

It is mentioned first by Sushruta while describing the procedure of

Karnavyadana Vagbhata has mentioned that it is Adhobhaga of Karna

Dalhana has clarified that it is the region above the Karnaputrika that is the

region which is at the bottom of the concha

Karnamoola ndash It can be considered as parotid region[52]

Karna lathika ndashAcharaya Dalhana mentioned lobule as a Karna Lathika

Page | 21

Karnaavatu ndashThis term is used by Sushruta while describing the

measurements of different Angapratyangas where he has mentioned that

the distance between the Karnaavatu is 14 Angul Dalhana has comments

that it can be taken as the distance between two ears from behind[53]

Shabdhavahasrotas ndash It also called as Shabdapatha or Srotapatha The

whole passage through which the sound waves pass can be taken as

Shabdavahasrotas[54]

Shrotashringataka ndash It can be taken as the labyrinth of ear[55]

bull Dosha in context to Karna-

Karna is principal location of Vayu

1 Prana Vayu- Prana Vayu circulating in oral cavity is responsible for

Dehadhruka that is keeping all body parts active Indriyadruka that is

keeping all Dnyanendriya healthy by proper nourishment (Purana) helps in

deglutition of food material and convey the stimulation of Indriyabuddhi

and atma

2 Udana Vayu- Bala(strength) Varna speech singing are its function It

is responsible for facial expressions due to pleasure sorrow anger love

frustration etc in general its circulation and actions are just opposite to

Pranavayu

3 Vyana Vayu- Its principal functions are circulation of Rasa and Rakta

through body and various movements Its main location is Hrudaya Five

types of movements for which it is responsible are expansion contraction

upward downward and oblique other activities are opening closure of

eyelid yawning perspiration During circulation if it gets obstructed due

to Srotodushti it generates disease of that Srotas Vyana Vayu gets vitiated

by disease of Rasa Rakta Oja and Chetanadhatu

Page | 22

4 Samana Vayu- It is circulating in the vicinity of stomach and intestine

and helps in keeping the Jatharagni (digestive juices and enzymes) in

equilibrium Disturbance in Jatharagni precipitates disease

5 Tarpaka Kapha- Entire body functions movements are controlled and

executed by various centers in the brain Sensation perceived by sense

organs is conveyed to Mann and Aatma residing in Hrudaya The motor

signals from them are then conveyed to the functioning

organsKarmendriya through Prana Vayu Shira head is therefore a

location of continuous activities motions of Vata All these centers are in

unctuous Majjadhatu in the Shira For stabilizing this ever-active Vata and

to nourish the Majja dhatu very unctuous Tarpaka Kapha situated in Shira

plays an important role

bull Ayurvedic aspect of sound perception [56]

According to Ayurveda Pratyaksha Dnyan or Perception of any sensation

including Shabda occurs due to interaction of the Karnendriya and the

Indriya- Arth -Karma resulting in Sravana

External Environmental acquaintance with living body is executed by five

sense organs namely Netra Karna Nasa Jivha and Twaka All

Dnyanendriya that is sense organ are Panchmahabhautic combination

Despite this fact every Indrya sense organ perceives object Tanmatra of

that Mahabhuta only from which it is originated from Akash Mahabhuta and

hence perceives Shabd only that is audio perception Shrotrendriya is one

of the principal locations of Vata and its function is to perceive Shabda that

is sound waves This sensation is conveyed through Shabdavahi Dhamanis

to Mana and Atma through Pranavayu and the sequence is responsible for

perception of sound in this way external sound is perceived and interpreted

when Atma is linked with Mann Mann is linked with Indriyabuddhi that is

minute virtual Dnyanendriya located in brain Indriyabuddhi is linked with

Adhishthana with prominent Mahabhuta and lastly with Indriya

ArthShabdatanmatra that is sense object Once this sequence is completed

Page | 23

the meaning of a particular sound is interpreted and understood In this

entire process of perception and interpretation of sound waves Pranavayu

and Tarpaka Kapha located in Shira play extremely important role Hence

the healthy status of all the sense organ depends upon the normal

physiologically homeostatic condition of Pranavayu and Tarpaka Kapha

MANAS

ATAMA

BUDDHI

AHANKARA

ARTHA

Page | 24

EAR ANATOMY

bull Embryology of the Ear [57]

1 The sound conducting apparatus develops from the branchial apparatus

whereas the sound perceptive apparatus from the ectodermal otocyst

2 The pinna develops from the six hillocks around the 1st branchial cleft

3 External auditory canal develops from 1st branchial cleft

4 The outpouching of the 1st pharyngeal pouch gives rise to a proximal

narrow part that forms the eustachian tube and distal dilated part that

forms the middle ear cavity

5 Prussakrsquos space is a potential space lateral to the Shrapnellrsquos membrane

and medically by the neck of malleus that can be involved during the

extension of cholesteatoma

6 Development starts in the 3rd week of the intrauterine life and is

completed by 16th week of intrauterine life Membranous and boney

labyrinth develops from the otic capsule

The Ear is divided into

1 External Ear

2 Middle Ear

3 Internal Ear or the labyrinth

Page | 25

Fig 1 Ear Anatomy

EXTERNAL EAR [58]

The outside ear contains pinna and lobule

Pinna is the noticeable piece of outer ear made from single sheet of yellow

flexible ligament covered by subcutaneous tissue and skin It has two

surfaces average and parallel It is intently disciple to perichondrium on its

sidelong surface while it is somewhat free on average surface Pinna

incorporates tragus helix against helix fossa three-sided scaphoid fossa

incisura terminalis

External auditory Canal ndash It extends from the bottom of the conchea to

the tympanic membrane and measures about 24 mm along its posterior

wallit is S shaped

Parts 1 Cartilaginous part

2 Bony part

Page | 26

Cartilaginous part ndash The outer one third is cartilaginous consist of fibro

cartilage is directed first inward backward and upward It has Fissure of

Santorium The skin of this part of the canal contains hair follicles

sebaceous gland and cruminous gland

Bony part ndash The inner two third part is boney It goes forward downward

and medially skin lined in this part is very thin Isthmus is the narrowest

part of the canal lying medial to junction of bony and cartilaginous part

nearly 5 mm lateral to tympanic membrane

The roof and posterior wall of the external auditory canal shorter than floor

and anterior wall The skin lining the tympanic membrane and boney canal

has a self-cleansing property due to migration of keratin layer of epithelium

from drum towards the cartilaginous portion

Relations- Anteriorly- Temporomandibular joint and parotid gland

Superiorly- Middle cranial fossa

Inferiorly- parotid gland

Posterior- Mastoid antrum mastoid air cells and facial nerve

Nerve supply ndashSensory nerve supply of the external ear The auricle

supplied by fibers of the great auricular nerve (C2 and C3) and lesser

occipital nerve (C2) Auriculo temporal branch of the 5th cranial nerve and

auricle branch of the vagus (Arnoldrsquos nerve) supply external canal Facial

nerve has small sensory contribution on posterior-inferior wall

Tympanic Membrane -It is the partition between EAC and middle ear It

is a thin semitranslucent membrane pearly white in colored lying obliquely

in the medial end of EAC with the angle of 55 It is forming major part of

lateral wall of middle ear Annulus tympanicus is attached at its

circumference to the sulcus The TM is oval shape It measures

approximately 10 mm in vertical diameter and 90 mm in horizontal

diameter

Page | 27

Layers ndash Tympanic membrane consist of three layers

1 Outer Epithelium or cuticular layer which is continuous with skin of

external ear

2 Middle fibrous layer has both circular and radial fibers middle layer

missing in upper part

3 Inner layer- Inner mucosal layer which is continuous with middle ear

mucosa

Parts ndash Tympanic membrane consist of two parts

1 Pars tensa -It is largest part below the malleolar folds The inner

surface at the center attached to the handle of malleus Angle of cone

is most illuminated part in the pars tensa at anteroinferior part of pars

tensa

2 Pars flaccida Sharpnells membrane -it is triangular area above the

malleolar folds which are thin and devoid of fibrous tissue and

annulus It fits into notch of Rivinous

Nerve supply 1 Anterior half of lateral surface Auriculotemporal V3

2 Posterior half of lateral surface Auricular branch of vagus cn 10

3 Medial Surface Tympanic branch of CN 9 (Jacobsons nerve)

Fig 2 Tympanic membrane of ear

Page | 28

MIDDLE EAR [59]

The middle ear or tympanic cavity is an irregular laterally compressed

space within the temporal bone It is filled with air that is supplied to you

from the nasal part of the throat through the ear canal It contains a chain

of mobile bones that connect its side with the medial wall and serve to

transmit vibrations transmitted to the eardrum through the cavity to the

inner ear Including the parapet the vertical and anteroposterior diameters

of the cavity are each approximately 15 mm The transverse diameter

measures about 6mm at the top and 4mm at the bottom Compared to the

eardrum it is only about 2mm The eardrum is limited laterally by the

eardrum medially by the lateral wall of the inner ear It communicates

behind with the tympanic antrum and through it with the air cells of the

mastoid and in front with the auditory canal The middle ear together with

the Eustachian tube aditus antral and mastoid air cells is called the

middle ear cleft It is lined by mucus membrane and filled with air

It is divided into 3 parts

1 Mesotympanum (located in front of the pars tensa)

2 Epitympanum or attic (located above the pars tensa but medial to

Sharpnells membrane and the lateral bony wall of the attic)

3 Hypotympanum (located under pars tensa) The middle ear is like a

hexagonal box with a roof

Carotid or Anterior wall- It separates middle ear cavity from internal

carotid artery The various structure passing through anterior wall of

tympanic cavity

bull Canal of chorda tympani nerve

bull Canal of tensor tympani muscle

bull Eustachian tube

bull Anterior malleolar ligament

bull Anterior tympanic artery

Page | 29

Posterior or mastoid wall ndash The upper part of the back wall shows the

opening of the auditorium Below the auditory is a triangular bony

projection known as the pyramidalis processors The stapedial tendon is

transmitted through the apex of the pyramidalis processes The vertical

portion of the facial nerve descends along the posterior wall until it opens

into the stylomastoid foramen

Roof or Tegmental wall (Pars terminalis)- It is formed by a thin bone

plate called the tegman tympanum that separates the skull and tympanic

cavities It is located on the anterior surface of the rocky part of the

temporal bone near the junction with the temporal shell it extends back to

the roof in the tympanic membrane and anteriorly to cover the half canal

of the tensor tympanic muscle The lateral border corresponds to the

remains of the Petro scaly suture

Floor ndash It is formed by a thin plate of bone which separate middle ear from

the bulb of the internal jugular vein lodged in the jugular fossa

Lateral wall ndash It is formed by tympanic membrane and partly by a portion

of squamous part of the temporal bone It separates the middle ear from

external ear

Medial wall- It separates the middle ear from the inner ear

bull The promontory is the most prominent and convex part formed by the

basal rotation of the cochlea

bull The bony lateral semicircular canal is postero-superior to the promontory

above the oval window

bull The oval window is located between the middle ear and the vestibular

slope of the cochlea It is closed by the stirrup footrest and the annular

ligament

Page | 30

bull The round window is located under and behind the cape The round

window recess is directed to the rear It is closed by the secondary eardrum

and separates the middle ear of the Scala tympani from the cochlea

bull The facial nerve passes through the bony fallopian tube above the oval

window

Mastoid Antrum ndash It is a large space with air in the upper part of the

mastoid and communicates with the attic through the aditus The roof is

formed by the antri tegmen which extends and separates the tympani

tegmen from the middle cranial fossa The lateral wall of the antrum is

formed by a bony plate that is on average 15 cm thick in adults It is

marked externally on the surface of the mastoid by the suprameatal triangle

(MacEwen)

Aditus and Antrum- Aditus is a gap through which the attic communicates

with the antrum The boney prominence of the horizontal canal lies on its

medial aspect even as the fossa incudes to thats attaches the quick system

of incus lies laterally Facial nerve publications simply underneath the

aditus

The mastoid and its air cell system-

The mastoid consists of bone cortex with a honeycomb of air cell

underneath Depending on development of air cell three types of mastoids

have been described

1Well-pneumatized or cellular- Mastoid cells are well developed and

intervening septa are thin

2Diploetic- Mastoid consist of marrow spaces and a few air cells

3Sclerotic or acellular ndash There are no cells or marrow spaces

With any type of mastoid pneumatization antrum is always present In

sclerotic mastoids antrum is usually small and the sigmoid sinus is

anteposed

Page | 31

Depending on the location mastoid air cells are divided into

1 Zygomatic cells (In the root of zygoma)

2 Tegman cell (Extending into tegmen tympani)

3 Perisinus cells (overlying the sinus plate)

4 Retrofecial cells (round the facial nerve)

5 Peri labyrinthine cells (located above below and behind the

labyrinthine some of them pass through the arch of superior

semicircular canal These cells may communicate with the petrous

apex)

6 Peritubal (around the Eustachian tube Along with hypotymoanic

cells they also communicate with the petrous apex)

7 Tip cells (which are quite large and lie medial and lateral to the

digastric ridge in the tip of mastoid)

8 Marginal cells (Lying behind the sinus plate and may extend into

the occipital bone)

9 Squamosal cells (Lying in the squamous part of temporal bone)

Development of Mastoid ndash

The mastoid develops from the scaly petrous bone The petrosquamosal

suture may persist in the form of a bone plate - Korners septum which

separates the superficial squamosal cells from the deep rock cells Korners

septum is surgically important because it can cause problems locating the

antrum and deeper cells and thus lead to incomplete removal of the disease

during mastoidectomy The mastoid antrum can only be reached if Korners

septum is removed

Page | 32

Fig 3 Cross section of Mastoid

Contents of the middle ear

Ossicles ndash Three tiny bones which conduct the sound from eardrum to oval

window

Malleus ndash It is the largest and most lateral ossicle measuring 8 mm in

length It has head neck handle anterior and lateral processes The head

is situated in the epitympanum A lateral process project laterally from the

neck while the handle is firmly fixed to the pars tensa of the ear drum

Incus- It has a body short process and long process The body short

process and long process The body articulate with the head of mallelus in

the attic and the short process project into the attic The long process

projects downwards behind the handle of malleus running parallel to it and

articulate with the head of the stapes via the lenticular process

Stapes ndash It is the smallest ossicle measuring about 35 mm and consist of

head neck footplate and anterior and posterior curcura The footplate of

stapes is held to the oval window by the annular ligament

Page | 33

Muscles ndash

1Tensor tympani ndash It is inserted is a branch of the facial nerve which carries

the sense of taste It is first arch muscle supplied by branch of mandibular

nerve V3

2 Stapedious muscles ndash It is inserted to the neck of stapes It is the second

arch muscle supplied by branch of facial nerve that is nerve to stapedius

Fig 4 Contents of the middle ear

Blood supply of Middle Ear

bull Anterior tympanic branch of maxillary artery which supplies tympanic

membrane

bull Stylomastoid branch of posterior auricular artery which supplies middle

ear and mastoid air cells

Page | 34

Four minor vessels are

bull Petrosal branch of middle meningeal artery runs along greater petrosal

nerve

bull Superior tympanic branch of middle meningeal srtery traversing along

the canal for tensor tympanic muscle

bull Branch of artery of pterygoid carotid

bull Tympanic branch of internal carotid

Lymphatic Drainage of Ear

Lymphatics from the middle ear drain into retropharyngeal and parotid

nodes while those of the Surgical Importance ndash Eustachian tube drain into

retropharyngeal group

1 The middle ear is part of contiguous organs including nose nasopharynx

Eustachian tube and mastoid bone lined by respiratory mucosa Any

respiratory infection or allergy is likely to pass to middle is likely to pass to

middle ear

2 Moreover middle ear suppurative disease may spread to adjacent organs

and produce complication eg Labyrinthitis meningitis facial nerve palsy

etc

3 Lenticular process is vulnerable in suppurative ear diseases and causes

ocular disruption

4 Prussac space is the site of primary acquired cholesteatoma

Page | 35

INNER EAR [60]

Inner ear is divided into two parts

1 Bony Labyrinth

2 Membranous labyrinth

Anatomy of bony labyrinth

It is divided into two parts

1 Vestibule

2 Cochlea

3 Semicircular canal

The vestibule is located between the medial wall of the middle ear and the

lateral to internal acoustic meatus anterior to the semicircular canal and

posterior to the cochlea The vestibule is the central part of the inner ear

On its side is the oval window opening which is closed by the bracket foot

plate The bony cochlea is located in front of the vestibule It has 275 turns

wound around a bony axis called a modiolus The cochlea is about 30 mm

long The hollow center of the modiolus is a spiral canal that contains the

fibers and ganglion cells of the cochlear nerve A thin bony sheet the bony

lamina winda around the modiolus This divides the cochlear duct into two

galleries the Scala vestibuli above and the scala tympani below

There are three semicircular canals superior posterior and lateral They

are semicircular in shape and open into the vestibule One end of the

semicircle is enlarged and is known as the sphere

The membranous labyrinth is in the bony labyrinth It is connected to the

bony labyrinth by fibrous trabeculae and is surrounded by perilymph The

endolymph is located in the membranous labyrinth

Page | 36

The utricle is in the upper part of the vestibule while the saccule is found

below Both the utricle and saccule contain a single sensory patch called

the macula Each macula is covered with a neuroepithelium made up of

neuroepithelium made up of sensory hair cells and support cells these cells

are separated by a basement membrane Fibers of the vestibulo-cochlear

nerve enter the macula and pierce the basement membrane to terminate

at the base of the hair cell or cell bodies The utricle and the saccule with

their macula are called otolith organs Membrane semicircular canals are

the membrane canals of the corresponding bony semicircular canals They

open into the utricle through five openings One end of the opening of each

channel is dilated called the sphere in which the sensory organ of each

channel is located The cross section of the Scala standard looks like a right

angle The base is formed by the basilar membrane Sensory cells are

arranged on the surface of the basilar membrane These sensory cells with

their supporting cells form a complex neuroepithelium called the basilar

papilla or the cortical organ named after an Italian microscopist The

organs of the corti have a gelatinous membrane called the tectorial

membrane and they are supported by the pillar of the corti The cortical

pillars enclose a space called the corti tunnel which contains a fluid called

cortical lymph Vestibule is lies between the medial wall of the middle ear

and lateral to internal acoustic meatus anterior to semicircular canal and

posterior to the cochlea Vestibule is the central part of the internal ear On

its lateral surface is the opening of oval window which is closed by the foot

plate of stapes Boney cochlea lies in front of the vestibule It has 275 turns

coiling around boney axis called modiolus Cochlea is approximately 30 mm

in length The hollow center of the modiolus is a spiral canal containing the

fibers and ganglion cells of cochlear nerve A thin boney sheet the osseous

lamina winda around the modiolus This divides the cochlear canal into two

galleries the Scala vestibuli above and the scala tympani below

Page | 37

Semicircular canals are three in number superior posterior and lateral

They are semicircular in shape and opens into the vestibule One of the

ends of the semicircular is enlarged and is known as ampulla

Membranous labyrinth is situated within the boney labyrinth It is connected

to the bony labyrinth by fibrous trabeculae and is surrounded by perilymph

Endolymph is situated within the membranous labyrinth

The utricle lies in the upper part of the vestibule while the saccule lies below

Utricle and saccule both contain single sensory patch called macula Each

macula is covered by neuroepithelium consist of Neuroepithelium consists

of sensory hair cells and supporting cells these cells are separated by

basement membrane Fibers from the vestibulo cochlear nerve enter the

macula and pierce the basement membrane to end either at the base of the

hair cell or cell bodies The utricle and saccule with their macula are referred

to as otolith organs Membranous semicircular ducts are the membranous

ducts in the corresponding bony semicircular canals They open into the

utricle by five openings One end of the opening of each canal is dilated

called ampulla in which the sensory organ of each canal is located The

cross section of Scala media resembles a right angle Its base is formed by

basilar membrane Upon the surface of the basilar membrane the sensory

cells are arranged These sensory cells with their supporting cells form a

complex neuroepithelium called the basilar papilla or Organ of corti named

after an Italian Microscopist Organ of corti has a gelatinous membrane

called tectorial membrane and they are supported by pillar of corti The

pillars of corti enclose a space called tunnel of corti which contains fluid

called corti lymph

Page | 38

Fig 5 Inner Ear

Blood supply of labyrinth

Labyrinthine artery

Common cochlear Anterior vestibular Artery

Vestibulocochlear artery Main cochlear artery

Cochlear branch posterior vestibular artery

Page | 39

PHYSIOLOGY OF HEARING [61]

A sound signal in the environment is collected by the pinna passes through

external auditory canal and strikes the tympanic membrane Vibrations of

the tympanic membrane are transmitted to stapes footplate through a chain

of ossicles coupled to the tympanic membrane Movements of stapes foot

plate cause pressure changes in labyrinthine fluids which move the basilar

membrane This stimulates the hair cells of the Organ of corti It is these

hair cells which act as transducers and convert mechanical energy to

electrical impulses which travel along the auditory nerve

Thus the mechanism of hearing can be broadly divided into

bull Mechanical conduction of sound (conductive apparatus)

bull Transduction of mechanical energy to electrical impulses (sensory

system of cochlea)

bull Conduction of electrical impulses to brain (neural

Fig 6 PHYSIOLOGY OF HEARING

Page | 40

Conduction of sound

Under the surface of water we cannot hear the sound made in air because

9995 of sound energy are reflected away from the surface of water because

of the impedance offered by it A similar situation exists in the ear when

air-conducted sound must travel to cochlear fluids Nature has

compensated for this loss of sound energy by interposing the middle ear

which converts sound of greater amplitude but lesser force to that of lesser

amplitude and greater force This function of middle ear is called impedance

matching mechanism or the transformer action It is accompanied by

a) Lever action of the ossicles

Handle of malleus is 13 times longer than long process of incus providing

a mechanical advantage of 13

b) Hydraulic action of tympanic membrane

The area of tympanic membrane is much larger than the area of stapes foot

plate the average ratio between the two beings 211 As the effective

vibratory area of the tympanic membrane is only two- thirds the effective

areal ratio is reduced to 141 and this is the mechanical advantage

provided by the tympanic membrane

c) curved membrane effect

Movements of tympanic membrane are more at the periphery than at the

center where handle of malleus is attached This too provides some

leverage

Transduction of mechanical energy to electrical impulses

Movements of stapes footplate transmitted to cochlear fluids move the

basilar membrane setting up shearing force between the tectorial

membrane and hair cells The distraction of hair cells gives rise to cochlear

microphonics which triggers the nerve impulse

Page | 41

Neural pathways

Hair cells get innervation from bipolar cells of spiral ganglion Central axons

of these cells collect to form cochlear nerve which goes to ventral and dorsal

cochlear nuclei From there both crossed and uncrossed fibers travel to

superior olivary nucleus lateral lemniscus inferior colliculus and medial

geniculate body and finally reach the auditory cortex of the temporal lobe

Page | 42

DISEASES REVIEW

करणसराव

Nirukti - करणसय कणवयोाव ससराा [62]

Nidana- Acharya Sushruta and Vagbhata describe the common etiological

factors for the Karnaroga

अशयाय जलिीडा कणवकणडयन मरत

शमथययोगन शसततरसतय कवपतो अरय च कोपन ||

सउ २० १२

1 Avashaya or Pratishaya

(Excessive exposure to cold)

2 Jalakrida

(Excessive swimming)

3 Karnakandunyanum

(Excessive scracing due to itching)

4 Mithyayogena Shatrasya

(Improper instrumentation during wax removal or foreign body removal)

5Shabdasya

(Louder sound for long durationperverted contact of sound)

6 Abhighata (Trauma)

7 Vitiation of Tridoshas

Page | 43

Samanya Nidana according to different Samhita

Vishesh Nidan of Karnasrava

Acharya Charaka has not mentioned any kind of Nidana regarding Karnaroga

but has described Utapati of Karnaroga from Siroroga in Karnasirasym

Adhyaya[67]

शशरोअशिघातादरा तनमजजतो जल परपकादरा अवप विि

सरतत पय शरणॊ अतनलात स कणवससरा इतत परककतीत

सउ २० १०

असस ३७२५ [68]

1 Shiroabhighatat - Head Injury-Fracture of middle cranial fossa

2 Jala nimajjana - CSF otorrhoea fracture of middle cranial fossa

3 Karnaprapaka

4 Karna Vidhradhi -Puyasrava

Sr

no

Samanya Nidana SU AH[63] AS[64] YR[65] MN[66]

1 Avashaya + + +

2 Pratishaya + +

3 Shabdha

mithyayoga

+

4 Shashtra

mithyayoga

+ + +

5 Karnakandooyan + + + + +

6 Jalkrida + + + + +

7 Abhighata + + +

Page | 44

Samanya samprapti

परापय शरोतरशसरा कयावत शल शरोतशस गान

त कणवगता रोगा अटिावशततरीता

सउ २० १२

Due to common and specific etiology factors the vitiated Doshas gets

Sthanasamshraya in Karna and causes Karnasrava It is the stages of

Samprapti were Doshas gets lodged in Srotas and start processes of Dosh

Dushya Sammurchsna Due to Shiroabhighata Jalanimmajana Karna Paka

Karna Vidhradi vitiated Vata Dosha and Karna becomes Avruta by Vata and

results in Karnasrava Normal physiology of Dosha Dhatus and Malas entirely

depends on the normality of Srotas Dosh Dushya Sammurchana or

manifestation of diseases will not take place if only vitiation of Doshas take

place without deformity of Srotas Here in Karnasrava vitiation of Srotas are

Atipravritti Sanga and Vimargagamana take place Atipravritti is being excess

production of fungus Sanga is obstruction in external acoustic canal

Vimargagamana is the propagation of discharge through ear

Vishesh Samprapti

Karnasrava occurs due to Nij nidana is Pratishaya while Agantuja nidanas are

Avashya Jalkrida and Karnakanduyan Due to etiological factors which are

Vata-Kapha provocative in nature gradual vitiation of Doshas will occur After

vitiation they get accumulated (Sthan samshraya) in external auditory canal

In other hand when patient does Sevana of Agantuj Nidan like water enter in

external ear scratching of ear unsterile instrumentation leads to Dosh

Prakopa These cause Twak and Mamsa Dhatu Dushti which leads to

discontinuity of epithelium of ear canal which creates suitable atmosphere for

fungal pathogen to grow The vitiated Vata will produce symptoms such as

Page | 45

pain hearing impairment and vitiated Kapha causes symptoms like itching

discharge ear blockage By assessing the symptoms it can be said that Kapha

Avrita Vata Dosha is responsible for the manifestation of clinical features like

pain itching discharge Which are seen in Karnasrava that is otomycosis

Acharya Charaka has mentioned while explaining Samanya Chikitsa of

Karnaroga that it should be treated like Vrana when Paka and Srava is present

as a symptom Fungal spores invade in the epithelial layer of EAC In response

to infection inflammatory process is start This is a Paka Avastha After

removing the fungal mass ulceration in external acoustic canal is commonly

seen As a result of infection process exudates was produced which will mix

up- with fungal colonies and appear as discharge As per Dosha involvement

in Vrana Shoola Srava can be differ According to Acharya Sushruta Ruk is

the Samanya Lakshana of Vrana and Vishesha Lakshana of Vrana includes

pain discharge discoloration itching etc according to Dosha involvement

which are also seen in otomycosis In otomycosis mainly watery and purulent

type of discharge is present which indicates Paka avastha If there is Dosha

involve in Vrana is called Dushta Vrana Acharya Sushruta and Acharya

Vagabhata have mentioned verity of Srava in Twak and Mamsa Vranavastu

which is found in otomycosis Based on this description otomycosis can be

correlated with Karnasrava

Page | 46

Representing the Samprapti of Karnasrava

Vishesh Nidana ndash Shiroabhighatat

Jala nimajjana

Prapaka Vidhradhi

Vitited vata

Avarana by kapha

Vimargagamana of Vata

Karnasrava

Samprapti Ghataka

Dosha ndash Kapha and Vata

Dushya ndash Rasa Rakta and Mansa

Strotodushti ndash Vimargagamana and Sang

Adhishthana ndash Karna (Bhayakarna)

Rogmarga ndash Madhyama

Page | 47

Purvarupa

The Purvarupa of Karnasrava are not mentioned separately in any ayurvedic

classics In routine practice cretin Purvarupa are noted

1 Karnakandu

2 Karnagurutwa

3 Alpa karnashoola

4 Discomfort in ear

Rupa

1 Karnashoola

2 Karnakandu

3 Karnasrava

4 karnabadhirya

5 Cotton wool like or wet newspaper like grayish brown or black colored mass

is seen

6 External auditory canal skin appears edematous and red

Upashaya and Anupashaya

Appropriate application of Aushadhi Ahara and Vihara when produces relief in

the symptom is called as Upashaya and when aggravates the symptoms is

called Anaupashaya There is not any reference available in the classics about

the Upashaya and Anupashaya of karnasrava

Sadhyasadhyata

Sushruta has not mentioned specially the Sadhyasadhyata of Karnarogas But

Vagbhata has mentioned Karnasrava as a Sadhyavyadhi[69]

Sadhysadhyatagives the clear picture of prognosis of the disease It depends

on many factors like nature of disease severity of disease Vaya Prakriti Bala

of the patient etc

Page | 48

Upadrava of Karnasrava

In Samhita there is no reference available regarding the Upadrava of

Karnasrava

Samanya Chikitsa ndash

The common treatment principle for all Karnaroga is Ghritapana Use of

Rasayana Bhrahmacharya Avyayama Shirasnana and Atibhashaya

सामरय कणवरोगष घतपान रसयनम

अवयायमो शशराःसतनान बरमहचयवम कतपरनम

स उ२१३

Ghratapana - Ghrita is a Yogavahi and follow Sanskara in addition to these

acquired properties and capable of retaining its own properties So Ghritapana

is effective in Karnasrava

Rasayana - Rasayana represent the basic approach of Ayurveda which

comprise preventive promotive and curative aspect of health

Brahmacharyaapalana -It is like Sadvrittapalana and is equals to Rasayana

effect

Vyayama - It leads to vitiation if Vatas a Karna is a Sthana of vata and

exercise causes Kshayaj Samprapti hence it is important to avoid exercise in

Karnasrava

Shirasnana- In Shirasnana water enters in external acoustic canal it changes

the PH of meatus skin from acid to alkali which favors the growth of pathogens

Atibhashya - Excessive speaking causes Vata Prakopa and Vatapraokopa is

basic Samprapti for Karnasrava as the preventive aspect avoidance of

excessive speaking is necessary

Page | 49

Ghritapana Rasayana and Brahmacharyapalana should be followed for

preservation of dhatu Samyata and restriction of vitiation of Vata Vayayama

Shirasnana and Atibhashaya should be avoided in Karnasrava to protect the

Siras from the affliction of Vata and Kapha

Vishesha Chikitsa ndash

The general treatment principle of Karnasrava described in classics is closely

related to Dushtavrana Chikitsa

शशरोवरचन च ए िपन परण तरा

परमाजवन िान च ीकषय ीकषय़ाचारत [70]

स उ २१४०

कणवसततरा ोददत कयावत पततकशमकणवयो [71]

ाउ १८३५

उपददि च सततरोत साय परात वपचततवशि परमजय

य अगर मदन सघत गगलना ा िपतयतपा मिना परयत [72]

असउ २२४२४३

In addition to that Shirovirechana Karnadhoopana Karnapurana

karnapramarjana Karnadhavana are also indicated

Page | 50

Treatment is also mentioned for Karnasrava

1 Karnaprakshalana Yoga - with Aargawadadi Gana Kashaya and Surasadi

Gana Kashaya [73]

2 Avachurnana Yoga ndash with Aargawadadi Gana Churna and Surasadi Gana

Churna[74]

3 Karnapoorna Yoga ndash

bull Rasanjana Laksha with Sarjachoorna[75]

bull Panchkashaya with Kapittha swarasa and Madhu[76]

bull Jambu AmrapallavShivalaKshuodra Mahavriksha and Madhuki all are

taken in equal quantity and Kalka is prepared and 4 times Taila is taken

and 16 parts of Kwatha is added and Taila Paka is done[77]

bull Sarjatwak Choorna with Karpashiphalarasa and Madhu[78]

bull Abhaya LodraTindukaSamanga(Manjista) Kwatha of this Dravyas mixed

with Madhu and Kapittha Rasa[79]

bull Yogratnakara mention the following drugs for Karnapoorana-

a Samudraphena Churna[80]

b Jambwambpatra Yoga

4 Karnadhoopana Yoga ndash

bull Dhoopana with Churna of Bilvapatra Haridra Palandu[81]

bull Vartak Dhoopana [82]

5 Internal Medications-

bull Rasnadi Guggula [83]

bull Triphala Guggula [84]

bull Sarivadi Vati [85]

bull Gandhaka Rasayana [86]

Page | 51

According to Vagbhata-

Ear should be cleaned with the Pichu and Varti followed by Guggula Dhoopana

and then Karnapoorana with Madhu Followed by Avachurnanana with

Sukshmachootana of Surasadigana

Pathyaapathya ndash Pathya and Apathy mentioned for Samanya Karnaroga is

recommended in Karnasrava also

पथय[87]

सतदो वरको मन नसतय िमाः शशरावयिाः

गोिमाः शालयो मदगााः याशच परतन हवाः 80

लाो मयरो हररणानदसततततरो नकककिाः

पिोल शशगर ातावक सतनषराण कदठललकम

रसायनातन सवणण बरमहचयवमिाषणाम |

उपयकत यरादोषशमद कणावमय दहतम ||81||

िापर २१

Aharaja Upacharaja

bull Godhuma bull Vamana

bull Shala bull Virechana

bull Mudga bull Nasya

bull Yava bull Dhoomapana

bull Puranagitra bull Kavala

bull Lava Harina Tittiramamsa

Page | 52

अपथय[88]

दरत काटठ शशरसतनान वययाम शलटमल गर

कणडयन तषारशच कणवरोगी पररतपयजत

िापर २१

Viharaja

bull Patola ShigruVartaka bull Bhramacharaya

bull Sunishannaka bull Avyayama

bull Katthlika bull Aakthanam

bull All types of Rasayana bull Upacharaja

bull Vamana

Apathyas

bull Abhishyandakara Aharas

bull Shirasnana

bull Karna kandooyana

bull Tushara sevana

bull Guru Kaphakaraka Aaharas

bull Dantdhavana

Page | 53

OTOMYCOSIS

Definition-

Otomycosis is a superficial acute sub-acute or chronic infection of external

ear canal It is mostly unilateral It is characterized by inflammation purities

and scaling Otomycosis is a common condition encountered in ENT practice

more in chronic and persistent ear infection

The Fungal infections are not communicable in the usual sense but the

humans become an accidental host by their introduction into tissue trauma

The virulence factors favoring colonization of fungus in human host are yet to

be identified Ability of the fungus to grow at 37 C and elaboration of a variety

of enzymes and toxins are speculated to contribute to virulence Only 100 to

150 species are generally recognized as a cause of disease in humans[89]

Prevalence-

Otomycosis is a word wide in distribution and in various record stated that 5

to 20 of all cases of infective otitis externa Otomycosis prevalent is more in

warm and humid climates It is one of the commonest manifestations in India

during rainy season It occurs mostly in humid atmosphere otitis externa due

to fungal infection may resembles the desquamative form of diffuse infective

otitis externa The incidence in temperature climates has increased in

proportion to the use of topical antibiotics which have a medium sterilized of

other organism in which the fungus may flourish

Page | 54

Predisposing factors- [90]

1 Environmental factors such as climate contagious and polluting hygiene

more frequently during rainy season as the humidity increases

2 Individual susceptibility ndashGeneral Immunological status of the Individual

eg HIV infection Radiotherapy chemotherapy Diabetes mellitus

3 Self-inflicted trauma that is use of pins to clean the itching ear or use of ear

bud to clean the wax

4 Wide spread of topical antibiotics steroid preparations which have medium

sterilized of other organism in which the fungus may grow

5 Failure of defense mechanism in External auditory canal

6 During swimming or head bath water enters in External acoustic canal

causes quantitative and qualitative change in ear wax It causes change in pH

7 Long term use of hearing aids

Pathophysiology ndash

The life cycle of the average mold encountered in the ear may be reckoned

as two weeks and flare ups may be anticipated at such intervals Swimming is

held responsible for infection in many cases The sequence sequence of

pathogenic changes produced by molds in the external ear is as follows ndash

1 Implantation of the organism in external ear

2 Growth of organism follows the rate depending on condition of temperature

moisture or preexisting irritation

3 Invasion of epithelium occurs with attendant itching and discomfort which

may be quite severe

Page | 55

4 Exfoliation of epithelium occurs as nature attempts to overcome the

infection by casting off upper most cells

5 Denudation occurs from exfoliation as the top layers of epithelium are cast

off and the canal becomes filled with debris

6 Superficial ulceration and lizematoid dermatitis results if the pathologic

process goes for enough The changes do not always proceed through the

entire sequence sometimes the molds produce changes of the mildest

imaginable character which may be overlooked[91]

Clinical features -

Symptoms-

1 Irritation and itching ndash Irritation is mostly found when the infective

organism is aspergillus niger There is sensation of discomfort which is more

diffuse in the ear canal then localized in the deeper part Candida infection

causes marked itching In external ear it is intense and worse at night

2 Discharge through ear- Intermittent scanty colorless discharge through

ear Mucus being a fungal metabolic product appears as discharge Excessive

discharge is associated with mixed infection

3 Pain and discomfort ndash Mild to severe pain in the ear occasionally Mostly

seen in cases where ear is infected with Aspergillus flavus mixed infection

with gram negative organism or mixed infection with candida and aspergillus

Headache is sometimes associated with pain

4 Deafness- Varying degree of mild to moderate conductive deafness

5 A sensation of fullness in ear

6 Tinnitus 7 Vertigo

Page | 56

Signs ndash

1 The external acoustic meatus may contain a mass formed of epithelial

debris exudates cerumen and fungus

2 Erythematous external canal

Fungal appearance

A Niger - The color of the mass which is usually grey or black is mainly

determined by the type of fungus concerned Its appearance is like wet

newspaper or blotting paper or a cotton wool It has a peculiar musty odor In

this infection fruiting heads may be seen as black specks in the debris

Occasionally as inactive form occurs in which the canal is lined by mold giving

a fluffy appearance due to the presence of tiny mycelia

Candida ndash Candida infections generally show as white deposits on magenta

colored skin when the debris is removed it rapidly recovers in 24 hrs

The underlying canal skin is often inflamed and granular due to invasion by

fungal mycelia and be seen in all cases In rare cases excoriation and

ulceration with marked extensive shedding of the epithelium and deep

ulceration can be seen usually associated with a flavus and with pathogenic

bacteria[92]

Otoscope Appearance

1 Aspergillus Niger ndash Black headed

2 Aspergillus Fumigators ndash pale blue or green

3 Candida Albicans ndash White- or cream-colored deposits

Page | 57

4 Auricle is normal in most cases In severe cases small ulceration with crust

formation may be present on lateral surface

5 Tympanic Membrane

In most cases it is normal with normal mobility and normal hearing In a few

cases the surface of the tympanic membrane is congested and scaly There is

erosion or ulceration of the external epithelial layer and the membrane itself

may be edematous

Diagnosis

1 Above mentioned symptoms and signs

2 In the stage at which patient with otitis externa usually first present

themselves mycelia threads conidiophors not visible to naked eye may

sometimes be identified with the microscope

3 Confirmed by culture

Page | 58

Fig7 Aspergillus Niger Fig8 Candida Albicans

Fig9 Aspergillus Fumigators Fig 10 Wet Paper like appearance

Page | 59

Treatment

1 Antibiotic or steroid drops should be discontinued if they are being instilled

since long time

2 Removal of fungal mass epithelial debris and discharge from the external

canal or mastoid cavity repeatedly and thoroughly by forcepa or suction or

syringing or cautiously blow a stream of air into the canal through a fine

cannula and dry thoroughly by swabbing liquid petroleum on swab used in

cleaning the ear lessens the burning sensation when metacresy acetate is to

be employed in the subsequent treatment

Furuncle is developed as a complication if there is no gentleness in cleaning

Cleansing may have to be delayed until local sensitiveness is lessened which

can usually be accomplished within twenty-four hours If there is excessive

epithelial debris along with otomycosis then metacresyl acetate which is a

keratolytic in introduction into the external auditory canal on cotton wick and

is allowed to remain for twenty-four hours After twenty-four hours the cotton

wick is removed at which time the canal can usually be cleansed with little

discomfort as the medication is also anesthetic The epithelium of the canal

was white from contact with the drug The top layer was detached and this

epithelial debris can be easily wiped away The wick is reinserted and wet with

metacresyl acetate

The treatment is employed for three to four days in succession and then a

bland application is substituted Icthyol iodine is of value at this stage Iodine

ointment 2 in combination with Tannic acid 2 is also an excellent local

application following cresatin treatment

Next one of the fungicides may be applied

Page | 60

1 Nystin Effective for candida infection but less active against aspergillus

group Nystatin in boric powder consisting of 100000units of nystatingm of

powder 3 times week for 3 weeks

2 Clotrimazole Available as 11 cream or drops or lotions Phenyl

(zchlorophenyl) 1 ndash imidazole ndash methane is a chlorinated trityl imidazol 1

effective against candida and dermatophytes and for aspergilli infection

3 Amphotericin B Available as cream and as 3 solution and 015 drops

for topical application Very effective for candida infection can be fungistatic

or fungicidal

4 Econazole Available as solution (Econazole nitrate) and as cream (1)

Broad spectrum ndash more effective for Aspergillus Also active against some

gram-positive bacteria (Staphylococci and Streptococci and Dermatophytes)

5 Miconazole Highly effective against dermatophytes and candida infections

used as a 21 cream applied once or twice a day for 10 days

6 Gentian violet 21 Available as drops (recently some evidence of

carcinogenicity) Discolors the ear canal and this interfere with clinical

examination

Other topical antifungal agents are ketoconazole Natamycin Tolciclat Bifonas

zole Fenticonzole Oxiconazole Tioconazole ciclopiroxolomine Tolnafate

Haloprogin Flucytosine Acetic acid Whit field ointment selenium sulfide

undcyclenic acid triacetin etc

Page | 61

Minimal length of treatment

A month of drug treatment is usually required because the antifungal agents

used are not sporicidal and it is necessary that the period of treatment covers

germination time It may be advisable to give short gaps in the period of

treatment to ensure all spores have germinated before deciding to terminate

therapy

Prevention

Accomplished by strict attention to the predisposing causes

1 Water should be prevented from entering the ear

2 Avoidance of external ear trauma

3 Use of alcohol medicated or plain in the ears after swimming mercuric

cyanide (15000) in ethyl alcohol (70) is a satisfactory liquid to use

Ear stoppers do no good unless their use is followed by some antiseptic in the

canal Divers exposed to water for long periods of time may also use acidic

alcohol

4 During Summer months with their high humidity special efforts are needed

to maintain ear dry 5 Indiscriminate use of topical antibiotics steroid

preparations should be avoided

Page | 62

DRUG REVIEW

1 GUGGULA

Fig11 - Guggula

Historical review of Guggula [93]

bull Atharvaveda one of the well-known Vedas of Hindus The earliest

reference given by Atharvaveda medicinal and therapeutic properties of

Guggula Guggula has long history of use in Ayurveda

bull Acharya Charaka Sushruta and Vagbhata describe detail regarding the

actions uses and indication as well as the variety of Guggula

Page | 63

bull Various Nighantus (Medical lexicons) were written between 12th and 14th

centuries AD was based on the Ayurvedic literature also describes

Guggula

bull The explanation of word Guggula is that Gunjo Vyadhegurdti Rakshati

which means to relief against different diseases

bull Guggula is the best medicine because it develops through the rays of

hot sun on specific circumstances

bull Guggula has an aromatic odor

गगलो कणवदौगवररधय िपन शरटठमछयत[94]

स उ २२११२

Latin name- Commiphora mukul

Family ndash Burseraceae

Rasa- Tikta Katu

Guna ndash Laghu Rukshasukshma vishada sara

Veerya ndash Ushna

Vipaka ndash Katu

Action- Rasayana Lekhana

Doshaghanta - Tridoshhara

Page | 64

Chemical composition [95]

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Oleoresin-Z-Guggulsterone E-Guggulsterone

Gum- guggulignans 1 and 2 guggula Tetrols mukulol allylcembrol c

27

Guggulusterol 1 2 ans 3 Z and E ndash guggulusterol

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Parts Used ndash Gum oleoresin

Guggula purity test

1 Yellowish brown emulsion is obtained when Guggula is triturated with

water

2 An ethereal solution of the drug attains reddish colour when treated

with br2 vapors and purple colour when moistened with nitric acid

Biochemical action ndash Antiseptic Anti-inflammatory Disinfectant Diuretic

Immunostimulant stimulating expectorant Ant suppurative Antipyretic

Enhance phagocytosis

Karma- Rasayana cardiovascular disease

Page | 65

2 AGARU-

Fig 12 Agaru

Historical review of Agaru [96]

bull The word Agaru literally means the one which is the heaviest and no

aromatic wood is heavier than it Since thousands of years Agaru lsquoThe

wood of Godrsquo has been used for multiple purpose like commercial

medicinal spiritual aromatic historical

bull The medicinal use of Agaru have been recorded in many pieces of India

Greek Roman Chinese Middle eastern and European since ancient times

bull Acharya Charaka used Agaru and pest of Rasna to counteract the effect of

cold in Agraya Dravyas

bull Acharya Sushruta used Agaru as a Dhoopana Dravya along with Guggula

Ral and Shoma in the treatment of Karnasweda and Vrana

Page | 66

Types-

bull Dhanwantsri Nighantu describes Kaleyaka as a type of Agaru

bull Sodhala Nighantu describes three types of Agaru ndash Agaru Krishna

Agaru Kakatunda Agaru

bull Raj Nighantu describes five types of Agaru ndash Krishna Agaru Kasht

Agaru Daha Agaru Mangalya Agaru and Agurusaar

bull Arthashasstra describes three Agaru wood product

1 Jongaka ndash Black or variegated black in colour and having variegated

spots

2 Dongaka ndash Black in color

3 Parasamudraka- Black in colour and smells like Navamallika

अगर उटण कि तपछय ततकत ततकषण च वपततलम

लघ कणाविरोगघन शीत ात कफपरणत

िापर २१ [97]

Family- Thymelaccensis

Latin name- Aquilaria agallocha

Guna- Laghu Ruksha Tikshan

Rasa- Katu Tikta

Vipaka ndash Katu

Virya ndash Ushna

Karma- Sheetaprasasmana Vranaorasadan Tvachya Pittavardhaka

Shirovirechana Mangalya Sugandhik and Rochaka in properties [100]

Krishna Agaru karma- Katu Tikta rasa Ushna Sheeta when applied externally

and Pittahara when taken orally

Page | 67

Chemical Constituents -

Agaru hardwood is rich in essential oil resins alkaloids saponins Steroids

terpenoids tannins flavonoids and phenolic compound Agaru wood

predominantly contains 2-[-2-phenylethy]-4H-chromen-4-one derivatives and

sesquiterpenes Agaru oil contains selinene dihydroselinene agarnol b-

agarofuran vetispira-2(11)valerianol dihydrokaranone and tetradecanoic

acids[99]

Part Used ndash

Heartwood- Dark resinous wood which is formed when the plant becomes

infected with a type of fungus (ascomycetous mold) Species of Aspergillus

fusarium and penicillium are reported to be associated with the development

of infection Prior to infection the heartwood is odorless relatively light and

pale colored however as the infection progresses the tree produces a dark

aromatic resin in the heartwood The infected resin in response to the attack

which results in accumulation of a very dense dark resin in the heartwood

The infected resin embedded wood is known as Agarwood Infection is more

common on the trunk roots and the area when branches divide The formation

of Agarwood starts when the tree attains the age of 20 years On an average

approximately 30 ml oil is extracted from 100 kg of infected Agarwood[98]

Qualities of best Agaru-

It should be black in color

It should be extremely heavy and aromatic

It should be oily in appearance and test

It should be sink in water

It should burn easily with bright flame with a bright flame giving off a pleasant

smell

Page | 68

3 MADANA

Fig 13 MADANA

Madana consist of dried fruit of Xeromphis spinosa It is a deciduous thorny

shrub or a small tree reaching a high up to 9 m and girth about a meter

branches numerous thick and horizontal found in sub-Himalayan tracts[101]

मदनो मिरनदसततकतो ीयोटणो लखनो लघ

ानदरतिदवििीहर परततशयायवरणारतक

रि कटठकफ़ानाहशोथगलमवरणापह[102]

िा पर १६० १६1

Page | 69

Latin name-Randia dumetorum

Familly ndash Rubiaceae

Rasa - Madhura Tikta

Guna-Laghu Ruksha

Virya- Ushna

Vipaka ndash Katu

Karma- Vamana and Lekhana

Chemical Composition-

Essential Oil Valerianic acid Saponin tannin resin [103]

Page | 70

YAWA [104]

Fig 14 Yawa

1 In Samhitakala Aacharya Charaka Acharya Sushruta explain detail about

medicinal properties of Yawa

2The use of Yawa in Aaharya Dravya mainly described by Dhanwantari

Nighantu Raj Nighantu Bhavprakash Nighantu[105]

Macroscopic Description-

Fruit a caryopsis elliptical oblong Ovoid and tapering at both ends smooth

about 1cm long and 02- 03cm wide dorsally compressed and flattened on

the sides with a shallow longitudinal furrow 3-5 ridges having shallow

depression between them grains tightly enclosed and adhering the lemma

and palea pale greenish yellow odor not distinct taste sweetish acrid

Page | 71

Latin Name ndash Hordenum vulgare

Family- Poaceae

Rasa- Kashaya Madhura

Virya- Sita

Vipaka- Katu

Karma- Vatakrt Pittahara Kaphahara Medahara Balya Visrya

SthairyakaraLekhana

Page | 72

PROCEDURE REVIEW [105]

In Ayurvedic classics there are many references regarding Dhoopana Dravya

Dhoopana is administering Dhuma with the help of Dhoopana Dravya

In Kashyapa Samhita there are 40 types of Dhoopana advised for children

Anesthesia (Mohajananam Dhoopa) is also mentioned For this Dhoopana the

drug used were herbs hairs of animals legs horns old cloths of Buddhist

monks

From the references available regarding Dhoopana we can understand that

Karna can be protected from maggots (krimi) Bactria (Rakshogna) lice etc

References clearly indicate the analgesic and disinfectant effect of Dhoopana

Karma Dhoopana is mentioned for Dushta Vrana Chikitsa It reduces Vedana

Srava Pootigandha of Dushtavrana It also helps in Vranaropana

Dushtavrana Chikitsa is mentioned in the treatment of Karnasrava[106]

Origin of Dhoopana-

In ancient period children of sages were constantly harassed by the

Rakshasas Hence the sages approached lord Agni for shelter Agni in turn

gave them Dhoopana Dravya and asked sages to use the Dhoopana for

protection against Rakshasas bhutas pishachas

Classification of Dhoopana

1 It is classified into Dhupa Anudhupa Pratidhupa

2 On the basis of Origin it is classified into Jangama and Sthavara

Selection of Guggula for Dhoopana

Page | 73

bull Guggul is a best Vatahara

bull It is Krimighana

bull It contains Oleoresin

bull In Ashtang Hrudaya Guggula Dhoopana mentioned for Karnasrava

Selection of Agaru for Dhoopana

bull Agaru is Laghu Ruksha Katu Tikshna

bull Vranaorasadan Tvachya

bull It should burn easily with bright flame with a bright flame giving off a

pleasant smell

Karna Dhoopana Indication

1 Karnaarava

2 Putikarna

3 Krimikarna

4Vataj Karnashula

Contraindications

Especially for Karnadhoopan contraindication is not mentioned in classic texts

But Dhoopana is contraindicated in Pittaj vaydhi Sharad and Grishma Rutu

Page | 74

MATERIAL AND METHOD

Page | 75

For randomize comparative clinical trial to study the effect of Agaruwadi

Karnadhoopana and Guggula Karnadhoopana in Karnasrava following material

and method were required

Source of data

Patient irrespective of gender occupation religion social economic status

signs and symptoms of classical features of Karnasrava (Otomycosis) selected

from the OPD of Shalakyatantra department

Materials ndash

1Patients

2 Drugs-Agaruwadi Dhoopana

Guggula Dhoopana

3Torch

4Otoscope

5 Tuning fork

6Jobson horn probe

7Cotton

8Case record form

DRUG

Group A Trial Group

1Churana of Agaru Yawa Madan

2Ghrita

3Jala

Group B Control Group

1Googula Churna

Page | 76

Properties of Drug

Table no 1 Properties of Drug

Drug

Family

Rasa Veerya Vipaka Effect

on

Dosha

Guna Karma

Agaru

(Aquilegria

Agallocha)

Thymelaca

ceae

Katu

Tikta

Ushna Katu KV Laghu

Ruksha

Tikshna

Shitaprashamana

Shothahara

Vedanasthapak

Durghandhihara

Madan

(Randia

spinosa)

Rubiaceace

Kashaya

Madhur

Tikat

Katu

Ushna Katu KV Ruksha

Laghu

Vatakaphaghana

Shothahara

Vedanasthapak

Vranashodhak

Yawa

Poaceae

Hordeum

Vulgare

Kashaya

Madhur

Sheeta Madhur KP Ruksha

Laghu

Vataghana

Vernashodhana

Raktshodhaka

Guggula

Commiphora

Mukul

Burseracea

e

Tikta

Kashaya

Anushna Katu VPK Laghu

Ruksha

Shothahara

Vedanasthapaka

Kandughna

Ghrita Madhura Sheet Madhur VK Snigdha Vataghana

Shothahara

Vedanasthapaka

Page | 77

METHODOLOGY

SELECTION CRITERIA

1)INCLUSION CRITERIA

1 Patients having signs and symptoms of Karnasrava (Otomycosis) ie करणशल

( pain ) करणकणड ( Itching ) करणसतराव ( Discharge )बाधिरण ( conductive Loss of

hearing )

2 Patient from age group 19 to 70 years

3 Any Gender

2)EXCLUSION CRITERIA

1 Patients suffering from any systemic disease like DM TB HTN

2 Chronic suppurative otitis media (CSOM)

3 Acute supportive otitis media (ASOM)

3 Perforation of Tympanic membrane

4 Chronic otitis media

3)WITHDRAWAL CRITERIA

1If patient develops any adverse effect such as irritation pain burning

sensation in ear loss of hearing and such patients was withdrawn from trial

and receive prompt appropriate medical attention

2If patient shows aggravation in symptoms

3If patient refuses to continue with the treatment

Page | 78

STUDY SETTING

Types of study - Randomized Clinical comparative Trial

Place of work - OPD of Shalakyatantra

Duration of study - 18 months

Study Population - Patients of Karnasrava in Shalakyatantra OPD

SAMPLE SIZE CALCULATION

Sampling Method ndash Purposive sampling followed by random allocation in two

groups

Sample size calculation-

n = z2 p (1-p)

d2

Were

n = sample size

P = prevalence of disease=10

z = standard normal variable ie 196

d = error ie005

desired Sample Size would be

n = Z2 P(1-P)d2

= (196)2x (0021) x(0979)(005)2

= 34

Visiting ENT OPD (ShalakyaTantra) and IPD (ShalakyaTantra) 21 = 34

n raquo34

So one group includes 34patients

Page | 79

Sampling Method

Total 68 patient of Karnasrava are selected by Purposive sampling followed by

random allocation in two groups Written informed consent is taken prior to

commencement of trial They are divided in 2 groups

Group A (Trial Group) 34 patients treated with Agaruwadi Dhoopana for 7

days

Dose 5 minutes twice in a day

Group B (Control Group) 34 patients treated with Guggula Dhoopana for 7

days

Dose 5 minutes twice in a day

STUDY DESIGN ndash

Open labeled Randomized Comparative Clinical trial

STUDY DESIGN

Screening of patient

Inclusion criteria satisfied Exclusion criteria

Initial assessment Excluded

Counseling of patient Treated accordingly

Patient selection by Simple Random Sampling Method

Page | 80

68 Patients were divided in two groups lsquoArsquo and lsquoBrsquo

Trial group A-34 patients were given

Agaruwadi Dhoopana

Control group B- 34 patients were

given Guggul Dhoopana

Informed written consent

Treatment was given for 7 days

Assessment on 1st 4th and 7th day

Post assessments follow up on 15th day

Observation

Data Collection

Statistical analysis of data

Conclusion

Page | 81

(A) Agaruwadi Varti for group A (Trial group)

Table no 2

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

B) Guggula Varti for group B (Control group)

SOP of it is same as above Agaruwadi Varti

Table no 3

Drug Guggula Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

FOLLOW UP

For both groups follow ups were done on 1st 4th and 7th and post

assessment follow up15th day

EXAMINATIONS

Torch for Local examination of ear

Otoscope examination

Tuning fork Test

Page | 82

OBSERVATION TABLE

Table no 4

Sr no Subjective criteria Day 1 Day 4 Day 7 Day 15

1 करणशल

(pain)

2 करणकणड

(Itching)

3 करणसतराव (Discharge )

4 बाधिरण (Conductive Deafness)

OBSERVATIONS

a) करणशल (Pain) -

0 - Absent

1 ndash Present

b) करणकणड (Itching) -

0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

Page | 83

c) करणसतराव (Discharge)

0- Absent

1- Mild -Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाधिरण (conductive Loss of hearing)

0 - Absent

1- Present

Observations were carried out before and after completion of treatment and

during each follow up After observations the data collected and presented in

the form of graphs charts and table

Page | 84

TRIAL DRUG

Authentication and standardization of raw drug material done After

authentication and standardizing of raw drug material Agaruwadi Varti was

prepared by Varti as explained in Ayurvedic classics

Method of Varti preparations

Panchavidh Kashaya Kalpana that is five method of pharmaceutical

preparation constitutes the fundamental process of Ayurvedic pharmaceutics

which is well explained in Sushrut Samhita Varti Kalpana is one among them

which can be included in Kalka Kalpana

तीररसतरपतपतीनामपरककव तीत [106]

स डलहण शरच 151

Medicines are powered triturated and given the Varti shape that is like wick

of lamp so it is called as Varti Kalpana

Drug content Agaru Madan Yawa

Route of Administration Local

Dose Two times a day

Duration 7 days

Page | 85

Methodology

Standard operating procedure (SOP) of Agaruwadi Varti

Agaruwadi Varti is prepared according to the classical text

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization was done as recommended in pharmacy procedure The

raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 mixed together in

equal quantity to make Agaruwadi churn

Quantity of each churn is 4 grams all are mixed when the Varti get dry total

weight of Varti was 10gram

STEP 4 - Agaruwadi churn triturated with appropriate quantity of water or

Ghrita and prepared Varti in GMP Certified Ayurvedic pharmacy Standard

aseptic precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Varti was packed in sterile air packed container

STEP 6 - Agaruwadi Dhoopana was given with the help of Dhoopana yantra

Authentication and Standardization of raw drug of Agaruwadi Varti was done

Sterilization was done as recommended in pharmacy procedure Sterile

preparation packed in sterile container of suitable size Under all aseptic

precaution Karnadhoopana given to infected ear

Page | 86

Containers for packaging and their sterilization-

Sterilization of the containers for storing Varties was done by Ethylene Oxide

(Eto) method

Ethylene Oxide (Eto) procedure-

It includes exposure of materials to ethylene oxide gas under vacuum in a

sealed chamber It consists of four primary variables

1Gas Concentration

2Humidity

3Temperature

4 Time

EtO gas is an alkylating agent which disturbs the DNA of microorganism

preventing them from reproducing It penetrates the breathable packaging

and sterilizes all the accessible surface of the product to render products

sterility by alkylation of essentials proteins for cell reproduction

Most Eto sterilization methods involves three different stages These can be

separated into three different on the size or number of devices to treat

1Preconditioning stage-

First products are passed through a preconditioning phase to make

microorganism grow The batch load goes through a well time under a

controlled environment of temperature and humidity

2Sterilizer stage-

Performed using process phase specially designed to provide the required level

of EtO exposure to assure sterility for a device or family of devices

3Degasser Aerration stage-

Finally products need to go through a degassing phase to remove any residual

particles of Eto The batch load goes over well time under a temperature-

controlled environment

The sterile containers were then used to store Agaruwadi Varti and handed to

patients included in the study

Page | 87

Packing of Agaruwadi Varti

The ETO sterilize plastic container were used for packing of Agaruwadi Varti

Varti was filled into these sterilize containers (7 in each) In an aseptic

environment plugging and capping was done under aseptic precautions In this

way packing of Agaruwadi Varti done These Varti were given to patient and

advise to take two times a day under all hygienic precautions

History and Examination

bull Proper history and presenting complains was recorded on case record form

bull Ear examination with otoscope was done during initial assessment and each

follow up

bull Otoscopic examination was done during initial assessment and each follow

up

bull Systemic Examination that is Blood Pressure Temperature Respiration

rate Pulse was recorded on case record form

Page | 88

Raw material

Fig14 यव चरण Fig15 मदनफळ चरण

Fig16 अगर चरण Fig17 गगगळ चरण

Page | 89

Preparation of Agaruwadi Varti

Fig18 Preparation of Agaruwadi Varti

Fig19 अगरवादी वरती

Page | 90

Fig20 Instruments used for examination of Karnasrava

Fig19 Karnadhoopana Yantra

Page | 91

Karnadhoopana Procedure

Fig 22 Karnadhoopana Procedure

Page | 92

OBSERVATIONS AND RESULTS

Page | 93

BASED ON DRUGS

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 94

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

AUTHENTICATION CERTIFICATE

Page | 95

BASED ON STASTICIAL ANALYSIS OF DEMOGRAPHIC DATA

68 patients of Karnasrava ndash Otomycosis

Table no 5

No of Patients Total

Group A Group B

Registered 38 37 75

Completed 34 34 68

Discontinue 04 03 07

Total 68 patients were enrolled in study 38 patients registered in group A

amongst them 34 patients completed the treatment and04 patients

discontinued the treatment However in group B 37 patients completed the

treatment and 03 patients discontinued the treatment out of 37 registered

patients

Hence the total number of patients registered in the present study was 75

and out of which 68 patients were discontinued the treatment So they

dropped out from the study While 68 patients were successfully completed

the treatment So observations and result of 68 patients were given below

Here we are going to discuss the statistical analysis of the data obtained in

the form of master chart that was prepared in accordance with the data

collected from the patients that had been included in the study The purpose

of statistical analysis was to analyzed the relation between age gender

occupation diet addiction and education

Page | 96

1 Age wise distribution of patients

Table no 6

In trial group 10 (29412) patients were from age group 18-25 years 14

(41176) patients were from age group 25-35 years 8 (23529) patients

were from age group 35-45 years and 2 (58824) patients were from age

group 45-60 yearsIn control group 6 (17647) patients were from age group

18-25 years 14 (41176) patients were from age group 25-35 years 7

(20588) patients were from age group 35-45 years and 7 (20588)

patients were from age group 45-60 years

Fig 23 Age wise distribution of patients

0

2

4

6

8

10

12

14

15 -25 25-35 35-45 45-60

10

14

8

2

6

14

7 7

Age Distribution

Trial Group N Control Group N

Age Distribution

Trial Group Control Group

N N

18 -25 10 29412 6 17647

25-35 14 41176 14 41176

35-45 8 23529 7 20588

45-60 2 58824 7 20588

Total 34 100 34 100

Page | 97

1 Gender wise distribution of patients

Table no 7

Sex

Trial Group Control Group

N N

Female 23 67647 15 44118

Male 11 32353 19 55882

Total 34 100 34 100

In trial group 23 (67647) patients were female and 11 (32353) patients

were male

In Control group 15 (44118) patients were female and 19 (55882)

patients were male

Fig 24 Gender wise distribution of patients

0

5

10

15

20

25

N N

TRIAL GROUP CONTROL GROUP

23

15

11

19

Gender

Female Male

Page | 98

2 Education wise distribution of patients

Table no 8

Education

Trial Group Control Group

N N

Illiterate 4 11765 3 88235

SSC 4 11765 3 88235

HSC 8 23529 9 26471

Graduation 16 47059 10 29412

Primary 1 29412 3 88235

Post-Graduation 1 29412 6 17647

Total 34 100 34 100

In trial group 4 (11765) patients were illiterate 4 (11765) patients were

SSC educated 8 (23529) patients were HSC educated 16 (47059)

patients were graduated 1 (29412) patients were primary educated and

1(29412) patients were post graduated

In control grou 3 (88235) patients were illiterate 3 (88235) patients

were SSC educated 9 (26471) patients were HSC educated 10 (29412)

patients were graduated 3 (88235) patients were primary educated and

6 (17647) patients were post graduated

Page | 99

Fig 25 Education wise distribution of patients

0

2

4

6

8

10

12

14

16

ILLITERATE SSC HSC GRADUATION PRIMARY POST GRADUATION

4 4

8

16

1 1

3 3

910

3

6

Education

Trial Group N Control Group N

Page | 100

3 Occupation wise distribution of patients

Table no 9

Occupation

Trial Group Control Group

N N

Accountant 1 294 2 588

Housewife 11 3235 8 2353

Engineer 1 294 1 294

Job 1 294 4 1176

Labor 1 294 3 882

Mess 1 294 0 000

Naturotherapyst 1 294 0 000

Pharma 1 294 0 000

Shopkeeper 4 1176 2 588

Singer 1 294 0 000

Student 8 2353 4 1176

Tailor 1 294 1 294

Teacher 1 294 1 294

Worker 1 294 3 882

Farmer 0 000 1 294

Lab Tech 0 000 1 294

Page | 101

Daily Collection 0 000 1 294

Fruit seller 0 000 1 294

Bus Driver 0 000 1 294

Total 34 10000 34 10000

In trial group 11 (3235 ) were housewife 8(2353) were students

4(1176) were shopkeeper 1(294) was accountant 1(294) was

engineer 1(294) was doing job 1(294)was labour 1(294) was

catering 1(294) was Naturotherapyst 1(294) was Pharma 1(294)

was Singer 1(294) was Tailor 1(294) was Teacher and 1(294) was

worker

In Control group 8 (2353)were housewife 4(1176) were students

2(588) were shopkeeper 2(588) was accountant 1(294) was

engineer 4( 1176) was doing job 3(882)was labor 1(294) was

Farmer 1(294) was Lab tech 1(294) was Daily collection 1(294)

was Tailor 1(294) was Teacher and 3(882) was worker 1(294) was

Fruit seller and 1(294) Bus driver

Fig 26 Education wise distribution of patients

0

2

4

6

8

10

12

1

11

1 1 1 1 1 1

4

1

8

1 1 10 0 0 0 0

2

8

1

43

0 0 02

0

4

1 13

1 1 1 1 1

Occupation

Trial Group N Control Group N

Page | 102

4 Religion wise distribution of patients

Table no 10

Religion

Trial Group Control Group

N N

Hindu 31 9118 33 9706

Muslim 3 882 1 294

Total 34 10000 34 10000

In trial group 31 (9118) patients were Hindu and 3 (882) patients were

Muslim

In control group 33 (9706) patients were Hindu and 1 (294) patient

were Muslim

Fig 27 Religion wise distribution of patients

0

5

10

15

20

25

30

35

N N

TRIAL GROUP CONTROL GROUP

3133

31

Religion

Hindu Muslim

Page | 103

5 Diet wise distribution of patients

Table no 11

Diet

Trial Group Control Group

N N

Veg 14 4118 20 5882

Non-Veg 20 5882 14 4118

Total 34 10000 34 10000

In trial group 14 (4118) patients were vegetarian and 20 (5882)

patients were Non vegetarian

In control group 20 (5882) patients were vegetarian and 14 (4118)

patients were Non-Veg

Fig 28 Diet wise distribution of patients

0

5

10

15

20

N N

TRIAL GROUP CONTROL GROUP

14

2020

14

Diet

Veg Non Veg

Page | 104

6 Addiction wise distribution of patients

Table no 12

Addiction

Trial Group Control Group

N N

None 30 8824 27 7941

Alcohol 2 588 0 000

Tobacco 1 294 2 588

Mishri 0 000 1 294

Smoking 1 294 4 1176

Total 34 10000 34 10000

In trial group 30 (8824) patients have no addiction 2 (588) patients

have addiction of alcohol 1 (294) patients have addiction of Tobacco 0

(0) patients have addiction of Mishri and 1 (294) patients have addiction

of smoking

In control group 27 (7941) patients have no addiction 0 (0) patients

have addiction of alcohol 2 (588) patients have addiction of Tobacco 1

(294) patients have addiction of Mishri and 11 (1176) patients have

addiction of smoking

Page | 105

Fig 29 Addiction wise distribution of patients

0

5

10

15

20

25

30

NONE ALCOHOL TOBACCO MISHRI SMOKING

30

21

01

27

0

21

4

Addiction

Trial Group N Control Group N

Page | 106

Statistical Analysis and Results

Effect of study on Karnashoola-

Table no 13

Karnashoola

Group A Group B

BT AT BT AT

N N N N

Grade 2 0 000 0 000 0 000 0 000

Grade 1 30 10000 7 2333 32 10667 5 1667

Grade 0 4 1333 27 9000 2 667 29 9667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 30 Effect of study on Karnashoola

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

30

7

32

54

27

2

29

Karnashoola

Grade 2 Grade 1 Grade 0

Page | 107

Table no 14

Karnashoola Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 088 100 033 006

969 2829E-

08 7667 HS

AT 021 000 041 007

Group

B

BT 094 100 024 004

1037 7103E-

11 8438 HS

AT 015 000 036 007

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 31

000010020030040050060070080090100

BT AT BT AT

GROUP A GROUP B

088

021

094

015

Karnashoola

Mean

Page | 108

Table no 15

Karnashoola

Mean SD Effect

Group

A

Group

B Trial Control Trial Control

Day 1 088 094 033 024 000 000

Day 3 065 071 049 046 2667 2500

Day 5 024 038 043 049 7333 5938

Day 14 021 015 041 036 7667 8438

000

010

020

030

040

050

060

070

080

090

100

Day 1 Day 3 Day 5 Day 14

Karnashoola

Mean Group A Mean Group B

Page | 109

Table no 16

Karnashoola N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3250 110500

510000 275 Control group 34 3650 124100

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 110

Effect of study on Karnakandu

Table no 17

Karnakandu

Group A Group B

BT AT BT AT

N N N N

Grade 3 7 2333 0 000 4 1333 0 000

Grade 2 18 6000 0 000 18 6000 0 000

Grade 1 7 2333 7 2333 10 3333 15 5000

Grade 0 2 667 27 9000 2 667 19 6333

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 32 Effect of study on Karnakandu

0

5

10

15

20

25

30

N N N N

BT AT BT AT

GROUP A GROUP B

7

0

4

0

18

0

18

0

7 7

10

15

2

27

2

19

karnakandu

Grade 3 Grade 2 Grade 1 Grade 0

Page | 111

Table no 18

Karnakandu Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 188 200 081 015

1091 3119E-

10 8906 HS

AT 021 000 041 007

Group

B

BT 171 200 076 014

1032 4746E-

09 7414 HS

AT 044 000 050 009

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Page | 112

Fig 33

Table no 19

Karnakandu

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 188 171 081 076 000 000

Day 3 126 118 057 058 3281 3103

Day 5 071 074 046 051 6250 5690

Day 14 021 044 041 050 8906 7414

000

020

040

060

080

100

120

140

160

180

200

BT AT BT AT

GROUP A GROUP B

188

021

171

044

Karnakandu

Mean

Page | 113

Table no 20

Karnakandu N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 4051 137750

373500 006 Control group 34 2849 96850

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is less than

005 Hence we conclude that there is significant difference between Trial

Group and Control Group

000

020

040

060

080

100

120

140

160

180

200

Day 1 Day 3 Day 5 Day 14

Karnakandu

Mean Group A Mean Group B

Page | 114

Effect of study on Karnasrava

Table no 21

Karnasrava

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 11 3667 0 000 8 2667 0 000

Grade 1 23 7667 3 1000 26 8667 2 667

Grade 0 0 000 31 10333 0 000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 34

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

11

0

8

0

23

3

26

20

31

0

32

Karnasrava

Grade 3 Grade 2 Grade 1 Grade 0

Page | 115

Table no 22

Karnasrava Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 132 100 047 009

1122 4356E-

13 9333 HS

AT 009 000 029 005

Group

B

BT 124 100 043 008

1130 9364E-

14 9524 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 35

000

020

040

060

080

100

120

140

BT AT BT AT

GROUP A GROUP B

132

009

124

006

Karnasrava

Mean

Page | 116

Table no 23

Karnasrava

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 132 124 047 043 000 000

Day 3 100 100 025 025 2444 1905

Day 5 047 038 051 049 6444 6905

Day 14 009 006 029 024 9333 9524

000

020

040

060

080

100

120

140

Day 1 Day 3 Day 5 Day 14

Karnasrava

Mean Group A Mean Group B

Page | 117

Table no 24

Karnasrava N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3535 120200

549000 655 Control

group 34 3365 114400

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 118

Effect of study on Karnabadhirya

Table no 25

Karn

Badhirya

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 0 000 0 000 0 000 0 000

Grade 1 13 4333 0 000 16 5333 2 667

Grade 0 21 7000 34 11333 18 6000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 36

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 00 0 0 0

13

0

16

2

21

34

18

32

Karnabadhirya

Grade 3 Grade 2 Grade 1 Grade 0

Page | 119

Table no 26

Karn

Badhirya Mean Median SD SE

Wilcoxon

W P-Value

Effect Result

Group

A

BT 038 000 049 009

799 7173E-

05 10000 HS

AT 000 000 000 000

Group

B

BT 047 000 051 009

816 0000138 8750 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 38

000

005

010

015

020

025

030

035

040

045

050

BT AT BT AT

GROUP A GROUP B

038

000

047

006

Karnbadhirya

Mean

Page | 120

Table no 27

Karn

Badhirya

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 038 047 049 051 000 000

Day 3 009 006 029 024 7692 8750

Day 5 003 006 017 024 9231 8750

Day 14 000 006 000 024 10000 8750

000

005

010

015

020

025

030

035

040

045

050

Day 1 Day 3 Day 5 Day 14

Karn Badhirya

Mean Group A Mean Group B

Page | 121

Table no 28

Karn

Badhirya N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3400 115600

561000 806 Control

group 34 3500 119000

Total 68

Page | 122

COMPARISION BETWEEN GROUP A AND GROUP B

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Table no 29

Overall Effect

Trial Group Control Group

N N

Marked Improvement 21 6176 16 4706

Moderate Improvement 8 2353 13 3824

Mild Improvement 4 1176 5 1471

No Change 1 2941 0 0

TOTAL 34 100 34 100

Fig 39

0

5

10

15

20

25

MARKED IMPROVEMENT

MODERATE IMPROVEMENT

MILD IMPROVEMENT NO CHANGE

21

8

41

1613

5

0

Overall Effect

Trial Group N Control Group N

Page | 123

DISCUSSION

Page | 124

Discussion is nothing but the logical reasoning of observations In

every research work discussion part is very important because it brings into

light about the logical analysis which are helpful in filling the research gap in

the scientific world

The discussion is categorized into following ways for the ease of

understanding

1 Discussion on selection of topic

2 Discussion on review of literature

3 Discussion on drugs their mode of action on the disease mode of action

of Karnadhoopana

4 Discussion on observation and results

1 Discussion on selection of topic

Otomycosis is commonly encountered in day-to-day practice Majority

of Indian people affected with this pathology This disease commonly

manifests in developing countries low socio-economic standard and lack

of hygiene Now a days due to busy lifestyle people are not able to follow

the proper instruction of care of ear which may be responsible for the

recurrent nature of disease So for the management of this we use

Karnadhoopana with the help of Agaruwadi Varti Dhoopana is simple

easy cost-effective procedure which can be done even at OPD levelso

for the disease Karnasrava we selected Karna Dhoopana as therapeutic

procedure Karnadhoopana was done with Agaruwadi Varti and Guggula

Varti which was very effective for treatment

Page | 125

2 Discussion on review of literature

Karnasrava is one such disease among 28 Karnarogas mentioned by

Acharya Sushruta in the chapter named Karna Roga Vigyana Acharya

Charaka included Karnasrava as symptom under the four types of

Karnarogas due to vitiation of different doshas Acharya Vagbhata has

not described Karnasrava separately It is a fact that systemic

description of Karnarogas is available in all the ancients of pus from a

Vata afflicted ear may results from head injury or immersion in water

Karnasrava is a clinical entity which can be correlated with Otomycosis

Karnasrava is explained as symptom as well as a disease in Ayurveda

Nidana- Karnasrava occur due to Samanya Nidana and Vishesh Nidana

Vishesh Nidana like Shirobhighata Nimmajato jale Mithyayoga of Shashtra

The exact pathology behind Karnasrava is not understood clearly

Purvarupa ndash No specific Purvarupa are found for Karnasrava in classical

literature Acharya Madhukara describe Purvarupa as expression of

Rupa(lakshana) with less intensity that is less intensity itching sound in ear

may considered as Purvarupa of Lakshana

Samprapti- Aacharya Sushruta not explained the Samprapti of Karnasrava

separately and we must consider the general Samprapti of Karnaroga Due to

various aetiologias as cited above ear afflicted by Vata dosha causes Twak

Rakta Mamsa dushti results in Karnasrava According to Acharya Sushruta

Vata-Kapha dose is dominance in Karnasrava

Page | 126

Nidan

Nija Agantuja

Vata ndash kapha prakopak nidana Shirobhighata Nimmajato-jale

Mithya yoga of Shastra

Vata- kapha Prakopaka(Chaya prakopak) Vata-kapha prakopaka

( Achay prakopak)

Twak Rakta Mamsa dushti

Karnasrava

Page | 127

Chikitsa

The curative aspect and this must be done simultaneously giving due

importance to Nidan Parivarjana that is preventive measures So Nidan

Parivarjana that is avoidance of causative factors like Jalkrida Mithyayogen

shashtrasya Karnakandu Shirasnan Pratishaya is the first step in combating

the disease and form the part of line of treatment

Above Samprapti helps us to proceed towards the treatment of Karnasrava

The main protocol of treatment is removal of fungus and wound management

which include various measures to keep area day clean clear of microbes and

providing ideal condition for healing

Samany Chikitsa- Acharya Sushruta described general treatment for

Karnaroga as Snehapana (Drinking ghee) Rasayana (Rejuvenation therapy)

Bhramacharya Avoid excessive speaking Avoidance of physical exercise and

head bath

Vishesha Chikitsa ndash Acharya Sushruta mentioned some procedures in the

treatment of Karnasrava which is Shirovirechana Karnadhoopana

Karnapurana Karanpramarjana Dhavan Avachurnana Karnapurana Above

various procedures described in Ayurveda for management of fungus growth

in ear discharging ear fulfill these requirements of wound management

Page | 128

Discussion on observation and Result

Out of 68 patients 34 patients included for the trial The incidence of

Karnasrava is observed in trial and control groups

The statistical analysis provided the following data

AGE

Trial group- Maximum no of patients that is 14 (41176) patients were from

age group 25-35 years followed by 29412 patients were from age group

18-25 years 23529patients were from age group 35-45 years and

58824 patients were from age group 45-60 years

Control group - Maximum no of patients that is 14 (41176) patients were

from age group 25-35 years followed by 20588 patients were from age

group 35-45 years and 20588 patients were from age group 45-60 years

17647 patients were from age group 15-25 years

The maximum no of cases of Karnasrava found in age group between 25 to

35 years The reason behind this is repeated use of ear bud or emersed water

in ear More use of earphone or working more in cold environment

GENDER

Trial group ndash A higher prevalence seen in females 6764 and 3235 in

males

Control group - A higher prevalence seen in males 5588 and 4411 in

females

Females and males both are prone to disease

Page | 129

EDUCATION

Trial group-It is observed that amongst 34 patients maximum ie16

(47059) patients were graduated 8 (23529) patients were HSC

educated 4 (11765) patients were SSC educated 4 (11765) patients

were illiterate 1 (29412) patient were primary educated and 1(29412)

patient were post graduated

Control group- It is observed that 10 (29412) patients were graduated 9

(26471) patients were HSC educated 6 (17647) patients were post

graduated 3 (88235) patients were SSC educated 3 (88235) patients

were primary educated3 (88235) patients were illiterate

There is no direct relation between education and Otomycosis

RELIGION

Trial group- The incidence of patients of Hindu religion are 9118 and Muslim

religion are 882

Control group- The incidence of patients of Hindu religion are 9706 and

Muslim religion are 294

There is no probable explanation for this maximum number of patients in

Hindu religion it depends upon the patients attend the hospital and

community residing there

Page | 130

DIET

Trial group It was found that maximum ie5882 patients were taking

mixed diet while 4118 were taking vegetarian diet

Control group It was found that maximum ie5882 were taking

vegetarian diet while 4118 patients were taking mixed diet

The dietary habit of person is based on choice availability and religious

customs of the person

ADDICTION-

Trial group- It was found that maximum ie 30 (8824) patients have no

addiction 2 (588) patients have addiction of alcohol 1 (294) patients

have addiction of Tobacco 1 (294) patients have addiction of smoking and

0 (0) patients have addiction of Mishri

Control group - It was found that maximum ie 27 (7941) patients have

no addiction 4(1176) patients have addiction of smoking 2 (588)

patients have addiction of Tobacco 1 (294) patients have addiction of

Mishri and 0 (0) patients have addiction of alcohol

Very few patients were addicted to Alcohol Smoking Tobacco and Mishri

These factors can be taken as provoking factors for Otomycosis

Page | 131

Discussion based on probable Mode of action of Karnadhoopana

In Ayurveda classics Karna Dhoopana is therapeutic procedure explain for

Karnasrava Dhoopana is administration of Dhooma (Fumes) with the help of

Dhoopan Dravya References indicates that analgesic and disinfectant effect

of Dhoopana karma and mention for Dushta Vrana Chikitsa It reduces

Vedana Srava amp also does Vrana Ropana action

Various Dhoopanas and Dhoopan Dravas for different element in various

Samhitas of Ayurveda but there is a lacuna of availability of reference

regarding how to do it and method of procedure Matra Kala Contraindication

etc

Currently simple modified way of Karnadhoopana according to Yukti Praman

and experience but there is lac of standardization

Karnadhoopana is one among the topical Bahiparimajan type of treatment

Karna Parmarjana is procedure of cleaning ear with the help of cotton or gauze

piece soaked in honey

Page | 132

Dhoopan

The fumes coming out on burning Agaruwadi Varti

Administrated directly into external ear canal

Causes vasodilation

Due to this increase blood supply in external ear canal

It helps in absorption of drug

Fumes dries up Srava and bring the analgesic effect

Karnagata Kapha amp Avrut Vata Dosha Shaman

Decrease in signs and symptoms like karnasrava Karnshool Karnabadhirya amp

Karnandu

Page | 133

3 Discussion based on probable mode of action of Agaruwadi

Dhoopana

Agaru ndash

I Agaru is a fragrant tree aroma is a result of fungal pathogenesis when the

wood of tree is contaminated by fungi at wounds it develops scrap filled

with resin and turn out to be aroma Medicinal use of Agaru have been

recorded in ancient medicinal science in in inflammatory disease and some

infective disease

II Acharya Charaka has referred to Agaru as an Ushna dravya despite having

Tikta Rasa Ashtang Samgraha used Agaru as Dhupana Dravya along with

Madan and Yawa in Karnasrava Nighantu recommended is use as a

Dhoopana

III In various Samhitas and Nighantus Agaru described as Tikta Snighdha

Sheetaprashamana Vranaprasadana Tvachya Due to these properties

Agaru is used in the treatment of Karna-Akashi Roga and Dushta Vrana

Shodhaka

IV Agaru is reported to have Antimicrobial Analgesic Antioxidants

Antihistaminic and anxiolytic properties Its Antihistaminic property gives

relief from itching which is cardinal feature of Otomycosis Due to Katu

Ushna Tikta Guna improves blood circulation Bheda stage develop It is

Niram Awastha of Dosha Karnagata kapha and vata get decrease and

symptoms like karnashoolakarnasrava get decrease Agaru also have a

Antioxidant properties

V Chemically Agaru Contain 2-(2-Phenylethyl) Chromones Terpenoids

Flavonoids

VI Natural Agarwood had inhibitive activities towards Staphylococcus Aures

The chloroform extract of Agarwood prolongs the pain threshold[108]

Page | 134

Madan

I Madanphala have therapeutic properties like Anti-inflammatory

Antiallergic Analgesic and Wound healing

II It is Useful in treatment of disease like Shotha (inflammation) Vidradhi

(Abscess) Pratishaya (Common cold) Kushta(Skin disease)

III Extract of Madanphala mainly contain Glcosides Tritorpenct

Glycosides Saponin

IV Saponin glycosides are act as fire extinguisher This property is helpful

for vartiIt also act as a detergent which clean the surface of fungus

V Tritorpenct act as a anti-inflammatory antimicrobial and

immunomodulator compound Interaction of glycosides with sterol

causes disturbance of selective permeability in plasmic membraneso

exudates and discharge get decrease

VI Pharmacological activity [109]

Antibacterial Activity The preliminary antibacterial activity of Methanolic

extract of Randia D lam was done on some standard and wild pathogenic

strains The inhibition of the bacterial growth was more pronounced on E coli

as compared to the other tested organism This shows the antibacterial action

of Randia D secondary infection can prevent

Anti-Allergic Activity In Ayurveda Randia D Extract and its fraction of milk

induced leukocytosis and eosinophilia in mice

Anti-Inflammatory Activity The crude methanol extract of fruit of Randia D

effectively reduced the carrageenin induced oedema in hind paw of the rats

significant reduction in granular tissue formation was recorded This activity

seems to be significant at various acute phases of inflammation and om

formation of granular tissue This proves action of Madanaphala in shopa

(inflammation)

Page | 135

Analgesic Activity Analgesic activity was tested in mice weighing between 20-

250 with six number of animals in each group Methanlic extract of fruit Randia

d give analgesic activity in both models This proves its Shoolanashaka (pain

killer) action

Immunomodulatory Activity Randia D has immunostimulant activity and

chloroform fraction which strongly affected immune system seems to be

bioactive fraction of this plant

The overall effect of Agaru Mandanphala Yawa having Anti-inflammatory

Antiseptic Antimicrobial Property Active ingredient shows these properties

Agaru Yawa Madanphala

Vatakaphaghna

Act as

Vranashodhak

Vedanasthapaka

Sheetaprashamana

Shothara

Avarana of Vata get decrease so helps to Shaman of Vata dosha

Karnakandu Karnashoola Karnasrava

Prashamana

Page | 136

This fact can be taken into consideration and probably acknowledge that

Karnadhoopana with Agaruwadi Varti had not leave any residue in the ear

Removal of fibrin keratinocyte migration and in growth of epithelial tissue

plays a major role in healing It is technique of fumigation of ear with the

smoke of anti-infective drug In Karnadhoopana Sthanik Swedana increase the

blood supply and helps in absorption of the drug reduce Karnakandu amp

Karnshoola associated with infection

Page | 137

SUMMARY AND CONCLUSION

Page | 138

The dissertation entitled randomize comparative clinical trial to study the

effect of Agaruwadi Karnadhoopan and Guggula Karnadhoopan In Karnasrava

wsr to Otomycosis

The dissertation is divided into fallowing parts

Introduction

Review of literature

Ayurvedic review

Modern Review

Drug review

Procedure review

Material and Method

Observation and result

Discussion

Summary and conclusion

bull INTRODUCTION

It includes importance of Shalakyatantra in Sushrut Samhita Charka

Samhita And Ashtang Samgraha

Common and specific causes of Karnasrava

Karnasrava is a clinical entity which can be corelate with Otomycosis

In Ashtang Samgraha stated the procedure like Karnadhoopana with

Agaru Yawa Madanphala in Karnasrava

Page | 139

bull REVIEW OF LITERATURE

1 Ayurvedic review

2 Modern review

3 Drug review

Ayurvedic review-

It includes Rachana-Sharir and Kriya-Sharir of Karna detail description of

Karnaroga and its types Karnaroga Samanya hetu Poorvaroopa Rupa

Samprapti Upadrava Pathya-Apathya of Karnasrava Vishesh Nidan and

Chikitsa of Karnasrava Detail description of Karnadhoopana according to

various Acharays have been mentioned

Modern review-

It includes anatomy and physiology of Ear brief anatomy of ear anatomy of

External middle and Internal ear Detail description of the disease

Otomycosis mechanism of fungal infection in external canal pathophysiology

investigations diagnosis and management

Drug review-

Detail description of Agaru Yawa Madan Guggula and its synonyms

Ayurvedic properties Karma uses Pharmacological action and their

pharmacodynamic properties

Page | 140

MATERIAL AND METHOD

It includes description regarding materials required for the study Preparation

of Agaruwadi Varti its Standardization Sterilization and packaging

Plan of study

1 Total 68 patients completed the treatment Age criteria was kept

between 18-60 years Patient selection was done by done by simple

random sampling method and divided into two groups A (Trial) and

Group B (Control) 34 patients in each group

2 Patients in Group A were treated with Karnadhoopana with Agaruwadi

Varti for 7 days two times in a day while patients in Group B were treated

with Karnadhoopana with Guggula for 7 days two times in a day

3 Clinical examination done during each follow up ie 0th 4rd 7th and

observation were recorded

Page | 141

OBSERVATIONS AND RESULTS

Page | 142

1 It was observed that higher incidence of disease Karnasrava ie

Otomycosis found in age group 25-35 years

2 Disease otomycosis was equal in both male and female

3 The trial group there was significant relief in Karnakandu (8906)

Karnasrava(9333) Karnashoola(7667) and karnabadhirya(100)

4 In control group there was significant relief in Karnakandu (7414)

Karnasrava(9524) Karnashoola(8438) and

karnabadhirya(8750)

Page | 143

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75 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2144 page

no 131

76 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 34 page no- 649

77 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2145page

no 131

78 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 37 page no- 649

79 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2146page

no

80 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya page no-

316

81 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Page | 153

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2143page

no

82 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publication Krnarogadhikara adhaya page no-

318

83 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary

Madhyamkhand Vatkalpana shlok no- 782-83 page no- 137

84 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 72-77 page no- 651

85 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya page no-

316

86 Vd Shree Laxmipatishastri Yogratnakara

87 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

Karnarogadhikara Shlok no- 808182 page no- 652

88 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 83 page no- 652

89 (PDF) Otomycosis A Comprehensive Review (researchgatenet)

90 httpswwwncbinlmnihgovpubmed24948980

91 A Simon Carney Scott-Browns Otorhinolaryngology Head and Neck

Surgery CRC press 8th publication Otitis externa and otomycosis

92 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition Diseases of external ear

Chapter no Page no -

93 wwwguggulipidcomtradhtm

Page | 154

94 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

95 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 1 chapter no-28 page no-

43

96 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009Agaru page

no726-728

97 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishra chapter Karpuradi varga Shlok no-31-

43 Page no- 116

98 httpswwwthiemeinimagecatlogsample_chapter_GOMPpdf

99 (PDF) Chemical Constituents and Pharmacological Activity of Agarwood

and Aquilaria Plants (researchgatenet)

100 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 4 chapter no-2 page no-4

101 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 chapter no-152 Madanpage

no376-379

102 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

103 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 1 chapter no-54 page no-

84

104 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 page no697-699

patol-yawa

Page | 155

105 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

106 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

Dhoompanvidhi page no- 252-254

107 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012Chikitasasthan Shlok

no- 151page no-406

108 httpswwwmdpicom1420-3049232342pdf

109 httpswwwijamcoinindexphpijamarticledownload0610201530

0

Page | 156

BIBILOGRAPHY

Page | 157

1 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

2 Scott-Brown WG Diseases of the EarNose and Throat Landon

Botterworth and co(publishers) Ltd1952 Volume 2

3 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012

4 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009

5 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi commantry

Purvakhand and Madhyamkhand

6 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

7 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-Tatva-

Sandipika hindi commentary Published by Chaukhamba Sanskrit

SansthanVaranasi

8 The Ayurvedic Pharmacopeia of India Ministry of Health and family welfare

department of Ayush Part 1 and part 4

9 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005

10 Acharya Trivedi Raguveer Prasad Ashtang sangrah published by

Vaidyanath Ayurveda bhavan pvt

11 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition

12 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary published by Chaukhamba

Orientalia

Page | 158

ANNEXURE

Page | 159

ANNEXURE- 1

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

CASE RECORD FORM

RESEARCH PROFORMA FOR MS (AYU) DESSERTATION

DEPARTMENT OF SHALAKYATANTRA

NAME -

ADDRESS -

GENDER - AGE - OCCUPATION-

RELIGION - EDUCATION - MARITAL STATUS-

OPD IPD NO-

DATE OF ADMISSIONCOMMESEMENT-

DATE OF DISCHARGECOMPLITION-

DATE OF COUNSELLING-

TEL NO-

CHIEF COMPLAINTS-

PAST MEDICAL AND SURGICAL HISTORY-

TREATMENT HISTORY-

FAMILY HISTORY-

Page | 160

PERSONAL HISTORY-

a) Ahar(Diet)

b) Vihar

c) History of addiction

GENERAL EXAMINATION

PULSE - MIN BP - mm of hg

TEMP - 0F RR - MIN

ASHATAVIDHA PARIKSHANA

Nadi- Mutra- Mala-

Jivha- Shabda- Sparsha-

Drik- Aakruti-

SYSTEMIC EXAMINATION

RS ndash

CNS-

CVS ndash

Page | 161

LOCAL EXAMINATION (KARNA PARIKSHAN)

OBSERVATION TABLE FOR SUBJECTIVE CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching )

RIGHT EAR LEFT EAR

KARNASHASHUKULI

KARNAPUTRAK

KARNAPALI

KARNAKUHARA -

SRAVA

GANDH

VARNA

SWARUPA

KARNAPATALA (TM)

Page | 162

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

Hearing Test

1Renne Test ndash

2 Weber Test -

Examination of Ear-

Pathological Investigation-

Other Examination-

Nidan Panchak-

1Hetu-

2Purvarup-

3Rupa-

4Upashayanupashaya-

5Samprapti

Signature of Guide Signature of Doctor(Researcher)

Page | 163

ANNEXURE 12

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Dhoopana Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization were done as recommended in pharmacy procedure

The raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 were mixed together

in equal quantity to make Agaruwadi churn

STEP 4 - Agaruwadi churn were triturated with appropriate quantity of water

and prepared Varti in GMP Certified Ayurvedic pharmacy Standard aseptic

precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Dhoopana Varti was packed in sterile air packed

container

STEP 6 - Agaruwadi Dhoopan was given with the help of Dhoopan yantra

TREATMENT DETAIL-

Purvakarma -

1 The patient is asked to sit comfortably on chair having sufficient light and

less amount of dust

2 The EAC is cleaned thoroughly by Pichu Varti (cotton swab) to remove the

discharge and other debris

Pradhankarma -

1 The patient is asked to relax completely on the chair

Page | 164

2 Fumes are passed to the ear with Dhoopana Yantra

3 Dhoopana yantra is funnel shaped and its one end will keep the ear covered

for the passage of Dhooma into the ear canal and other end where Agaruwadi

Dhoopana Varti were placed which produces fumes

4 This Dhoopana was given for 5 min

Pashchat karma -

1 The patient were advised to avoid cold refrigerated food drinks cold water

bath cold wind fog and prevent water from entering the ear

(A) Agaruwadi Dhoopana Varti

B) Guggula Dhoopana Varti SOP of it is same as above Agaruwadi Dhoopana

Varti

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Page | 165

ANNEXURE 21

INFORMED CONSENT DOCUMENT

Study Title

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

Introduction

- You are invited to take part in a research study RANDOMSIED COMPARATIVE

CLINICAL TRIAL TO STUDY THE EFFECT OF AGARUWADI DHOOPANA AND

GUGGULA DHOOPANA IN KARNASRAVA

- Before you decide it is important for you to understand why the

research is being done and what it will involve

- Please take time to read the following information carefully and discuss

it with friends relatives and your doctor if you wish

- Ask us if there is anything that is not clear or if you would like more

information

Purpose amp Nature of Study

- In this research project by examine you and ldquoKarnasravardquo (Otomycosis)

disease were treated

- In the part of treatment Agaruwadi Dhoopana or Guggula Dhoopan were

given

- Dhoopana means medicated drug fumes were given in ear with the help of

Dhoopan Yantra

Page | 166

- Treatment was given for 7 days

Study Duration

7days

Participation

- Your participation is entirely voluntary

- If you do decide to take part you were given this information sheet to keep

and be asked to sign a informed consent form

- If you decide to take part you are still free to withdraw at any time and

without giving a reason This will not affect the standard of current or future

medical care you may receive

Confidentiality

- All information which is collected about you during the research were

kept strictly confidential

- Any information about you which is collected from the center will have

your identity in the form of a code number so that it will remain confidential

Benefits Of Study

- The results obtained from this study would be helpful for providing better

quality of treatment amp other essential facilities for Karnasrava (Discharge)

patients

- You will get clinical benefit from the study

Page | 167

Risks Of Study

- In this treatment there are few chances of Irritation of Ear Nose and

congestion at EAC if any of these happens then treatment were given

Results Of Study

- If the Results obtained are profitable then they may get published

without disclosing your details

Signature of patient

Date

Time

Phone no of Researcher

Page | 168

रण मादहती पतरक

सशोिनाच शीषवक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE

EFFECT OF AGARUWADI DHOOPANA AND GUGGULA DHOOPANA

IN KARNASRAVA

परसतताना

- आपणास या सशोिनातपमक अभयासात सहिागी होणय़ाच आाहन करणयात यत आह

- सशोिनातील सहिाग तननदशचत करणयापी सशोिनाच उददश समजन घया

- खालील मादहती काळजीपवक ाचा आणण आशयक ािलयास आपलया डॉकिराशी कका

दहतशरचतकाशी चचाव करा

- काही सददिता असलयास कका आणखी मादहती ही असलयास आमछयाशी चचाव करा

सशोिनाच उददीटि सतरप

- सदर सशोिन परकलपामरधय आपलयाला तपासणी करन कणवसरा या वयाशरिची शरचककतपसा दणयात

यणार आह

- सदर वयाशरिची शरचककतपसा महणन आपणास अगरादी िपन कका गगल िपन

दणयात यणार आह

- सदर औषि आपणास 7 ददस घयायाच आह

Page | 169

कालािी

- 7 ददस

सहिाग

- आपला सहिाग हा पणवपण ऎनदछिक आह

- आपला सहिाग तननदशचत असलयास आपणास ही मादहती पतरतरका दणयात यईल आपणास यातील

समती पतरकार सही कराी लागल

- सहिाग तननदशचत असनही आपण कोणतपयाही ळस कोणतही कारण न दता माघार घ शकता

याचा आपलया दयकीय सविर कोणताही पररणाम होणार नाही

गोपनीयता

- सशोिना दरमयान गोळा कलली आपलया वषयाची सव मादहती गोपनीय ठणयात यईल

- आपली यनदकतक मादहती साकततक सतरपात गोपनीय ठणयात यईल

सशोिनाच फ़ायद

- सशोिनाच तनटकषव कणवसरा बाशरित रणाछया दयकीय इतर सविाचा दजाव सिारणयास

फायदशीर ठरतील

सशोिनातील जोणखम

- य़ा शरचककतपसमरधय कान दखण डॊळय़ातन नाकातन पाणी य़ण नाकात जळजळण डोक जड

होण ही लिण ददस शकतात यापकी लिण तनमावण झालयास तपयाची शरचककतपसा कली जाईल

Page | 170

सशोिनाच तनटकषव

सशोिनाच तनटकषव फ़ायदशीर ठरलयास आपली मादहती गोपनीय ठन परकाशशत करणय़ात यईल

रण सतािरी-

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

Page | 171

ANNEXURE 31

INFORMED CONSENT FORM

Patient OPD no __________

Subjectrsquos Identifier

Date of Birth Age Gender

I _____________________________________ age___________ years

exercising my free power of choice hereby give my consent to be included

as a participant in the clinical study entitled

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

1 I confirm that I have read have been read and understood the information

sheet for the above study and can ask questions

2 I understand that my participation in the study is voluntary and that I am

free to withdraw at any time without giving any reason without affecting my

medical care or legal rights

3 I understand that the Ethics Committee members investigators and study

doctors will not need my permission to look at my health records both in

respect of the current study and any further research that may be conducted

in relation to it even if I withdraw from the trial I agree to his access

However I understand that my identity will not be revealed in information

released to third parties or published

4I agree not to restrict the use of any data or results that arisefrom this study

provided such a use only for scientific purpose

5 I agree to take part in the above study

Page | 172

signature with Date-

Left hand thumb impression

Name amp signature of the witness ndash

Name amp signature of the student ndash

Page | 173

ANNEXURE 32

समतीपतरक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

वयकतीच य

ददनाक जरमददनाक

1) मी ह तननदशचत कररत आह ककसदर सशोिन परकलपाबाबतची सपणव मदहती मी ाचली असनमला ती

समजली आहतपयाबददल मला परशन वचारणयाची पणव मिा आह सदर मादहतीन माझ समािान झाल

आह

2) मी सदर सशोिनातन माझया मजीनसार किीही बाहर पड शकतो या माझया अशरिकाराची मला कलपना

आह

3) माझी दयककय मादहती तपासणयाची कागदपतर कळ सशोिनाकररता ापरली जाणार आहत याची

मला मादहती आहसदर सशोिन परकलपातील सबशरित घिकाना माझी दयककय मादहती पाहणयाची मी

समती दत आहतरावप या सदिावतील माझी ओळख दशववणारी मादहती कोणासही ददली जाणार नाहीयाची

मला कलपना दणयात आली आह

4) सदर अभयासातन शमळणारी मादहती अरा तनटकषव कळ शासततरीय हतसाठी ापरल जाणयासाठी माझी

समती आह

5) रील अभयासात सहिागी होणयास माझी समती आह

रण सतािरी-

Page | 174

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

ASSESSMENT CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching)

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

a) कणवशल ( pain )- 0 - Absent

1 ndash Present

Page | 175

b) कणवकणड (Itching)- 0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

c) कणवसततरा ( Discharge )

0- Absent

1-Mild- Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाशरियव ( conductive Loss of hearing )

0 - Present

1 - Absent

Page | 176

Page | 177

Page | 178

Page | 179

Page | 180

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

Page | 181

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 182

AUTHENTIFICATION CERTIFICATE

Page | 3

Ayurveda is ancient science of life a system of health and medicine

which aims to assist people in living a healthy life It is a person-centered

medicine which deals with healthy lifestyle systemic diseases prevention

diagnosis and treatment Ayurveda is divided into eight branches[1] It has

a separate branch of clinical and surgical specialization concerning ENT and

ophthalmology known as Shalakyatantra One out of the eight branches of

Ayurveda Shalakyatantra deal with the etiology diagnosis prognosis

prevention treatment and complication of diseases which are located at

Urdhwang Pradesh[2]

Karna is one among the Panchendriya (sense organ) situated at

Urdhwang Pradesha [3] It is originated from Akash Mahabhuta Aachary

Sushruta explains 28 Karnaroga in Uttaratantra Karnaroga Vigyniyam

Aadhaya[4] He mentioned Karnasrava as separate diseases[5] Aacharya

Charaka explain 4 Karnaroga He had not described Karnasrava as

independent diseases but explain Karnasrava as a symptom under four

Karnaroga Acharya Vagbhata mentioned Karnasrava as a symptom in

Karnashoola according to Dosha He included this into Kaphaj Karnashoola

itself[6] Karnasrava means discharge through ear The Samanya Hetu of

Karnaroga are Avashaya or Pratishaya that is common cold Sheeta Vihara

or exposure to cold environment Karnakandu or self-inflicted trauma by

use of ear bud or pine to clean itching in ear Shabda Shashtra Mithyayoga

that is misuse of instrument or listening to high sound frequencies[7] The

other predisposing factors are such as abuse of nonspecific broad-spectrum

antibiotics steroids and immune suppressed disorders

Classical features of Karnasrava can be compared with otomycosis

Otomycosis is acute sub-acute or chronic fungal infection in external ear

which rarely involves the middle ear[8] Otomycosis is characterized by pain

itching discharge conductive deafness of mild to moderate in nature

Fungal spores invade in the epithelial layer of EAC In response to that

inflammatory process starts which will reflect as pain Itching is due to

immune reaction of body during inflammatory process As a result of

Page | 4

inflammatory process exudates were produced which will mix up with

fungal colonies and appear as discharge In initial stage of disease ear

discharge is watery but if there is secondary bacterial infection occur it

becomes mucopurulent Ear blockage and conductive type of hearing loss

are due to accumulation of fungal mass in external auditory canal

Fungal mass appears white or black or brown and is like a wet piece

of filter paper Examination with otoscope Aspergillus Niger appears black

headed filaments growth Aspergillus fumigates as a pale blue or green and

candida as a white or creamy deposit[9]

Otomycosis is a common condition and it mostly occurs in humid

area According to American academy of otolaryngology prevalence of

otomycosis is 52 all over a world and 09 in India 5-25 otitis externa

cases are due to otomycosis Nearly 61 types of fungal species being involve

in otitis externa 90 of fungal infection cases involve Aspergillus species

and the rest candida species[10]

In Ayurveda The common treatment Principle for all is Ghritapana

Rasayana Bhramacharaya Avyayama (Excessive exercise)

Ashirasnana(Head bath) Atibhashashya(Excessive speaking) This can be

used for the prevention and management of Karnaroga[11] Acharya

Sushruta explain specific treatment modality for Karnasrava is

Karnaprakshalana Karnapoorana Karnadhoopana Shirovirechana

Karnadhavana[12]These therapeutic procedure can be updated according to

different stages of these condition

In routine OPD it is observed that patient of otomycosis respond

more frequently to topical therapy than to systemic therapy Among all the

treatment modality Karnadhoopana is an effective and simple procedure

In this regard Karnadhoopana with Agaruwadi Varti or uggula had explain

in Ashtang Samgraha Agaruwadi Varti contain Agaru Yawa Madanphala

All these contains of Agaruwadi Varti and Guggula acts as Ruksha Ushna

Teekshana Laghu Guna acts as effective Shodhaka keeps ear dry reduce

Page | 5

pain discharge foul smell and thus control the infection Dhoopana is also

useful as Adhidaivika Chikitsa to protect the patient from external attack of

visible and invisible organism The principal treatment modality adopted in

Allopathic system of medicine is oral antibiotics and topical antibiotic drop

Long term use of oral antibiotic causes adverse effect like gastric irritation

reduce immunity and resistance to drug Long term use of topical antibiotic

drops cause Ph change in external canal which become prone to fungal

infection

Hence the therapeutic procedure with Guggula or Agaruwadi Varti

Karnadhoopana are cost effective safe and easy procedure and it can be

used more effectively

Page | 6

AIM OF STUDY

To evaluate the effect of Agaruwadi Varti Dhoopana and Guggula Varti

Dhoopana in management of Karnasrava

OBJECTIVE

To compare the efficacy of Agaruwadi Dhoopana and Guggula Dhoopana in

Karnasrava

HYPOTHESIS

NULL HYPOTHESIS -

H0- Agaruwadi Dhoopana is not effective than Guggula Dhoopana in

Karnasrava

ALTERNATE HYPOTHESIS -

H1- Agaruwadi Dhoopana is more or equally effective than Guggula

Dhoopana in Karnasrava

RESEARCH QUESTION

Whether there is significant difference between Agaruwadi Dhoopana and

Guggula Dhoopana in Karnasrava

Page | 7

PREVIOUS WORK DONE -

1 Anupama Patra B Effect Of Arka Taila In The Management Of

Karnasrava With Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching amp Research in Ayurveda

Gujarat Ayurved University Jamnagar 2007

2 Palmer Komalben K Further Study On Role Of Arka Taila In The

Management Of Karnasrava With Special Reference To

Otomycosis Shalakya Tantra Institute for Post Graduate Teaching amp

Research in Ayurveda Gujarat Ayurved University Jamnagar 2010

3 Sathisha Shankar B Management Of Karnasrava With Sthanika

Guggulu Dhoopana And Rasnaadi Guggulu-A Comparitive Study Shalakya

Tantra Government Ayurvedic Medical College Bangalore 2011

4 Shashikala DK Comparative Study On The Efficacy Of Vacha

Lashunaadi Taila Karna Pichu And Nimba Patraadi Dhoopana In The

Management Of Karna Srava Shalakya Tantra Government Ayurvedic

Medical College Bangalore 2014

5 Javale Anant A Clinical Study On The Efficacy Of Arka Taila In The

Management Of Karna-Srava Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching amp Research in Ayurveda

Gujarat Ayurved University Jamnagar 2005

6 Pournima V Koti Management Of Karnasrava With Priyangvadi Taila

Pichu With And Without Saarivadi Vati Shalakya Tantra Sri Jagadguru

Gavisiddeswar Ayurvedic Medical College Koppal 2015

7 Amisha Patel A Clinical Evaluation Of Honey In The Management Of

Karna Shoola With Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching and Research in Ayurveda

Gujarat Ayurved University Jamnagar 2016

Page | 8

REVIEW OF LITRATURE

Page | 9

Ayurvedic literature Ayurveda is a science of life practice since

thousands of years The ancient Indian system of medicine and surgery is

commonly known as Ayurveda This was given the status of Upaveda or

fifth Veda in the next stage of growth Among the available literature three

Samhita that is Charaka Samhita Sushrut Samhita Ashtang Hrudayam and

Ashtang Samgraha are the chief source of knowledge of Ayurveda

Ayurveda consist of eight branches Shalakyatantra is one among them

Shalakyatantra is one of its specialized branch deals with science of

ophthalmology otorhinolaryngology Oro dental surgery and head Acharya

Sushruta himself a practical surgeon was the first to advocate dissection of

dead bodies is indispensable for a successful student of surgery He had

described gross anatomy in the first chapter of Uttartantra Shalakyatantra

define by different Acharys as follows

शालाकय नामोरधवजतरगताना रोगाणा शरणनयनदनघराणाददसशरशरताना वयाशरिनामपशमनारव

स स ११०

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत [13]

चस १७१२

Shalakya Tantra Nirukti and Parichaya

शलाकायााः कमव शालाकय ततपपरिान शलाकयम डलहण [14]

The term Shalakyatantra is derived from Shalakya and Tantra

The word Shalakya means A probe and Tantra denotes teaching and

practices found in scripturesThe compendium in which application of

Shalaka in various surgical procedures is principally described is called as

Shalakya tantra

दनदटिवशारदााः शालाककनाः डलहण ( सउ ११३)[15]

An eye specialist is termed as Shalaki by Dalhana

Page | 10

Synonyms of Shalakya Tantra

Uttamanga Chikitsa Jatrurdhwa Chikitsa Urdhwang Chikitsa Shalakya

Chikitsa

Importance of Shalakyatantra-

Life of living being and all the Indriyas are situated in the head hence it is

known as Uttamanga

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत

चस १७१२

The treatment given to this part of the body is described specially in

Shalakya tantra While describing the importance of Shiras Vagbhata

correlates it to the root of tree (Urdhwa Mula) and body to the trunk of tree

(Adha Shaka)

Sushruta has deal with Mukha Roga in Nidan Shan and its treatment in

Chikitsasthan The description regarding the disease of eye ear nose and

head are found only in UttaraSthan Sushruta specially describes the

disease of Shalakyatantra as told by Videha in the beginning of Uttartantra

itself[16]

Shalakyatantra Itihas-

India Exhibits traditional of more than thousands of years in art literature

language logic and philosophy etc The convention was in its sophisticated

and advanced attire throughout the Vedic period

Vedic period ndash

1 Natush was treated for deafness by Ashwinikumars (Rigveda)

2 Rujaswa and Kanva were treated for blindness by Ashwani Kumaras

(Rigvedas)

Page | 11

3 There are several prayers mentioned for normal functioning of sense

organs (Yajurveda)

4 Structures and functions of Mastishka are described (Atharveda)

5 Mantras having reference to disease of Eye Ear Oral cavity etc are

found (Atharvaveda)

Upanishada Period ndash

1 Samhita Period

a) Sushrut Samhita ndash

bull Explanation regarding Netra Nasa and Shirorogas (Uttartantra 1-

26th chapter)

bull Details regarding Mukha and Karna Roga Nidan and

Chikitsa(Nidansthan 16th and Chikitsasthan 22nd chapter)

bull Description regarding Karna Chedana Sandhana Nasa

Ostasandhana Sutra Sthan 16th chapter

b) Charaka Samhita -

bull Explanation regarding Shirorogas (Sutrasthan 17th chapter)

bull Explanation of Gala rogas like Upajivika Galshundi and Rohini

bull Nasa Shiro Mukha Karna and Netra Chikitsa (Chikitsa sthan 26th

chapter)

bull Description regarding Lakshana and Chikitsa of Shankhaka

Ardhavbhedaka Shirovirechana and Shiro basti (siddhi sthan 9th

chapter)

c)Ashtnga Sangraha ndash

bull Detailed description regarding Shalakyatantara (Uttartantra 11-28

chapter)

bull Description of Kriyakalpa (Sutrasthan 32nd and 33rd)

Page | 12

d)Ashtang Hrudayam

bull Detailed description on Shalakya Tantra (Uttar tantra 8-24 chapters)

bull Kriyakalpas (Sutrasthan 23rd and 24th chapter)

e) Bhela Samhita

bull Chakshushya Vaisheshik and Buddhi Vaisheshik Alochaka pitta

f) Harita Samhita- Branch of Medical science offering elaborating

information about the procedure like Nasya Anjan Gandusha etc

comprehended with their applications in disease of Head Eyes Ears

Eyebrows Throat Temporal region and cervical spine is known as

Shalakyatantara

शशरोरोगा नतररोगा कणवरोगा वशषताः भरकरठशङकमरयास य रोगा समिनदरत दह १३

तषा परततकारकम व नसतयतपयवणजनातन च अभयङगमखगणडषकियााः शालकयसशमतााः १४

इतत शालाकयनाम [17]

Documentation of different ancient literature gives various references

regarding all aspects of Karnasrava in various periods It is very much

important to know the history of Karnasrava from Vedic Pauranic Samhita

and Samgraha period

Vedic period ndash The Vedas being the oldest source of knowledge have no

direct mentioning of Karnasrava

Page | 13

Samhita and Samgraha period ndash

Aacharya Sushruta described about Karnaroga Karnasrava Nidan

Roopa and Chikitsa The detail description is available in Sushrut

Samhita Uttartantra 20 and 21st chapters

Aacharya Charaka did not specify Karnasrava but mentioned 4 types

of Karnarogas that is Vataj Pittaj Kaphaja and Sannipataja and their

treatment in 26th chapter of Chikitsasthan

In Ashtang Hrudaya karnasrava is not explained as a separate disease

but Chikitsa is mentioned in 18th chapter of Astanga Hrudaya

uttartantra

In Ashtang Samgraha Chikitsa is mentioned in 22nd chapter of Astang

Samgraha Uttartantra

The details about Karnasrava are explained in Bhavprakasha

Madhyamakhanda 64th chapter

Madhavakara has explained about Karnasrava in 57th chapter of

Madhymakhanda

Karnasrava is also explained in Sharangadara Samhita Uttarkhand 11th

chapter

The reference for treatment of Karnasrava is available in

Yogaratnakara

In Gadhnigraha Karnasrava and its treatment is mentioned in

Karnarogadhikara Adhaya

Vangasena had mentioned about the disease and treatment in 69th

chapter

Chakradatta explained Karnasrava in 57th chapter

Dalhana has given commentary on Sushrut Samhita Uttartantra 20th

and 21st chapter

Sankhya Samprapti of Karnasrava ndash

Aachary Sushruta explains 28 Karnaroga in Uttaratantra Karnaroga

Vigyniyam Aadhaya Aacharya charaka explain 4 Karnaroga in

Page | 14

Karnarohvigyniyam Adhaya based on doshas Acharya Vagabhata in

Ashtang Hrudaya explain 25 Karnaroga in Adhyaya

कणवशल परणादशरच बाशरियव कषड ए च

कणवसरााः कणवकणडाः कणव चवसतततर च

कशमकणवपरततनाहौ विशरिदवविसततरा

कणवपाकाः पततकणवसततराशवशरचतवविम

कणावबवद सपतवि शोफशरचावप चतवविाः

ऎत कणवगता रोगा अटिावशततरीररतााः

स उ २०- ३ त ५[18]

ातकणवरोग वपततकणवरोग कफकणवरोग

रकतकणवरोग सनदरनपातकणवरोग कणवनाद

बशरिरतप परततनाह कणडाः शोफ पततकणवक

किशमकणवक उियरपविरधयअशो अबवद

कशरचकणवक वपपपली वदाररका पाळीशोष

ततिका पररपोिो उतपपातो उरमरर दाःखिवन

शलहाखयााः परचवशनदरतकणवरोगा उकतााः

इदिीका अ स उ २१ [19]

चतपाराः कणवरोगााः

च स [20]

Page | 15

KARNA

Karna ndash करोतत शबद गरहण [21]

The organ of hearing

Karnasrava- कणवसतय कणवयोाव ससराा [22]

Discharge from the ear is referred as Karnasrava

KARNA SHAREERA

bull Nirukti

कणयवत अकणयवत अनन इती [23]

It means reception and conduction of sound waves

These are the functions of external and middle ear

bull Nirukti of Sravanam

शरयत अनन इती शरणम[24]

It means perception of sound

It can be attributed to the internal ear function

bull Karna Utpatti-

Karna is an organ formed by Akash Mahabhuta[25]

The fundamental characteristic is as follows

Indriya ndash Srotram [26]

Indriya Adhisthan ndash Karna [27]

Indriya Dravy ndash Akasha [28]

Indriya Arth ndashShabdha [29]

Indriya buddhi ndash Srotobyddhi

Page | 16

bull Paryaya of Karna- Shabdapatha Srotrapatha Sravanam shruti

Kuhuram Dwanigraham etc

bull Definition of Karna-

कणवशटकलयनदछिरनमिटिोपगरदहत शरोतरमछयत [30]

मा तन ५७१

The definition of Karna is stated in Madhav Nidanam Indriya which is not

seen with naked eye along with Shashkuli is called Shrotra that is Karna

Indriya is so minute that it is not perceived with any sense organ

In Charak Samhita the word Karna explain as the Indriya Adhisthan of

Shabdha Karna is described as one of the Prathyangas of the body He

emphasizes that all Indriyas manifest during the 3rd month of gestation

period

Acharya Sushruta while describing formation of Purusha from Prakriti or

Avyakta narrated that all Indriyas are developing from the Vikarika and

Taijas Ahankara Both Vagabhata and Sushruta stated that Karna as one of

the Bahirsrotas

शरण नयन दन घराण गदमढराणण न सततरोताशसराणा बदहमवखातन [31]

स शा ५-१०

In Ashtang Hradaya Vagbhata has states that all Indriyas are Atmaja

According to him lower lobule elevated helix projected posterior portion

fleshy and adherent ear are indications of long span of life[32]

ततरखातखातन दह अनदसतमन शरोतर शबद ववकतता [33]

ा शा ३-३

शबदाः शबदनदरिय सवनदछििसमहो ववकतता [34]

स शा १-२६

Page | 17

Ear has the prominence of Akash Mahabhuta The prominent dosha of ear

is Vata It is important seat of Vata The prominent Dhatus are Asthi and

Mamsa Karna is one of the Panchgnanendriyas and it meant for hearing

Sushruta narrated that Karnasthita Asthi and Sandhi

घराणकणवगरीाकषिकोषष तरणातन [35]

सशा ५-२२

शरोतरशरगािकष शखाताव [36]

सशा ५-३२

गडकणवशखटककम [37]

स शा ५-२२

One Sandhi and one Tarunasthi in ear

Sandhi ndash Karna contain two Sandhi one in each ear Type of Sandhi is

Shankhavartha which is present in Shringataka

Mansapeshi ndash 2[38]

Siras ndash 10 [39]

Vataj Sira - 4

Pittaj sira - 2

Kaphaj sira - 2

Raktaj Sira - 2

Avedhya sira-

कणवयोदवश तासा शबदादहनीनामकका पररहरत

सशा ७-२५[40]

Amongst above mentioned ten Siras each Karna lodges one Shabdavaha

Sira It is Avedhya

Page | 18

Dhamani -2

Length of ear is 4 Angula

Karna moola ndash 2 Angula

कणाविरतर चतदवशअगलम

स शा ३५-१४[41]

The distance between two ears through the back of the neck is 14 Angula

bull Marmas of Karna-

1 Vidhuras-

कणवपटठतो अिाःसशरशरत विर ततर बशरियवम

सशा ६-३७[42]

कणतपयादद सतनायममवणी ककनदचचनदरनममनाकर कलयकररणणच

डलहणाचयव[43]

अिसततात कणवयोतनवमन विर शरततहाररणण

ा शा ४-२९[44]

Sankhya-2

Vistara- frac12 Angula

Type- Snayumarma (Susha)

- Dhamanimarma(AH)

- Vaikalykar

Sthana- It is situated in the depressed portion in the back of the ear

Injury to them causes loss of hearing

Page | 19

2 Shringataka marma-

नदजवहाकषिनाशसकाशरोतरखचतटियसरमम

तालरयासतयातन चतपारर सरोतसा तष ममवस

वदि शरगातकाखयष सददसततपयजतत जीवतम

मा तन ५७१ [45]

Sankhya- 4

Type- Siramarma

Sthana- It is in head that is amidst Siras (blood vessels) nursing sense

organ

A palm size area near Talu

Injury to this Marma causes death

In modern anatomy ear divides into Bhayakarna or External ear Mdhyakarn

or Middle ear Antahkarna or Internal ear This is extremely appropriate

Even though the ear is divided into three divisions in the point of modern

anatomy Ayurveda denotes ear organ is one Ayurveda treats disease by

way of assessing Dosha and Dushya Here Dushya is one that is Karnendria

Dosha difference will call for different treatment for different disease Hence

treating the vitiated Dosha will cure the disease irrespective whether it is in

external middle or internal ear The thought is based on different

fundamental principle from Ayurveda

bull Parts of Karna

In Ayurveda classics detailed description about anatomy of ear is not

available But the various parts are mentioned as follows

Bhayakarna- External ear

Mdhyakarna ndash Middle ear

Antahkarna- Internal ear

Page | 20

द कणवशटकशलक दॊ कणवपतरकौ

च शा 7-11[46]

कणवशटकशलक कणवगतातवकौ कणवपतरकौ त बाहयकणा

चिदतत च शा 7-11[47]

शटकली बाहयपालयाशरिटिानम

डलहन- स शरच 25-1 12[48]

Karna Shashkulika ndash It is also called as Karna Shashakuli Charaka has

mentioned this term while describing different Pratyngas of the body

Acharaya Gananatha sen has given the clarification for it as a pinna or

auricle[49]

Karnapali ndash It is popularly known as lobule of the ear Daivakrita Chidra is

present in it

Karnaputrika- Ayurvedic scholars accepted two terms in this cortex They

are Karnaputrika and Karnaputrika The former is considered as Tragus and

antitragus[50]

Karna Prushtha- It can be taken as the cranial surface of mastoid or

auricle[51]

Karnapeetha- Aacharaya Sushruta firstly mention the term Karnapeetha

It is mentioned first by Sushruta while describing the procedure of

Karnavyadana Vagbhata has mentioned that it is Adhobhaga of Karna

Dalhana has clarified that it is the region above the Karnaputrika that is the

region which is at the bottom of the concha

Karnamoola ndash It can be considered as parotid region[52]

Karna lathika ndashAcharaya Dalhana mentioned lobule as a Karna Lathika

Page | 21

Karnaavatu ndashThis term is used by Sushruta while describing the

measurements of different Angapratyangas where he has mentioned that

the distance between the Karnaavatu is 14 Angul Dalhana has comments

that it can be taken as the distance between two ears from behind[53]

Shabdhavahasrotas ndash It also called as Shabdapatha or Srotapatha The

whole passage through which the sound waves pass can be taken as

Shabdavahasrotas[54]

Shrotashringataka ndash It can be taken as the labyrinth of ear[55]

bull Dosha in context to Karna-

Karna is principal location of Vayu

1 Prana Vayu- Prana Vayu circulating in oral cavity is responsible for

Dehadhruka that is keeping all body parts active Indriyadruka that is

keeping all Dnyanendriya healthy by proper nourishment (Purana) helps in

deglutition of food material and convey the stimulation of Indriyabuddhi

and atma

2 Udana Vayu- Bala(strength) Varna speech singing are its function It

is responsible for facial expressions due to pleasure sorrow anger love

frustration etc in general its circulation and actions are just opposite to

Pranavayu

3 Vyana Vayu- Its principal functions are circulation of Rasa and Rakta

through body and various movements Its main location is Hrudaya Five

types of movements for which it is responsible are expansion contraction

upward downward and oblique other activities are opening closure of

eyelid yawning perspiration During circulation if it gets obstructed due

to Srotodushti it generates disease of that Srotas Vyana Vayu gets vitiated

by disease of Rasa Rakta Oja and Chetanadhatu

Page | 22

4 Samana Vayu- It is circulating in the vicinity of stomach and intestine

and helps in keeping the Jatharagni (digestive juices and enzymes) in

equilibrium Disturbance in Jatharagni precipitates disease

5 Tarpaka Kapha- Entire body functions movements are controlled and

executed by various centers in the brain Sensation perceived by sense

organs is conveyed to Mann and Aatma residing in Hrudaya The motor

signals from them are then conveyed to the functioning

organsKarmendriya through Prana Vayu Shira head is therefore a

location of continuous activities motions of Vata All these centers are in

unctuous Majjadhatu in the Shira For stabilizing this ever-active Vata and

to nourish the Majja dhatu very unctuous Tarpaka Kapha situated in Shira

plays an important role

bull Ayurvedic aspect of sound perception [56]

According to Ayurveda Pratyaksha Dnyan or Perception of any sensation

including Shabda occurs due to interaction of the Karnendriya and the

Indriya- Arth -Karma resulting in Sravana

External Environmental acquaintance with living body is executed by five

sense organs namely Netra Karna Nasa Jivha and Twaka All

Dnyanendriya that is sense organ are Panchmahabhautic combination

Despite this fact every Indrya sense organ perceives object Tanmatra of

that Mahabhuta only from which it is originated from Akash Mahabhuta and

hence perceives Shabd only that is audio perception Shrotrendriya is one

of the principal locations of Vata and its function is to perceive Shabda that

is sound waves This sensation is conveyed through Shabdavahi Dhamanis

to Mana and Atma through Pranavayu and the sequence is responsible for

perception of sound in this way external sound is perceived and interpreted

when Atma is linked with Mann Mann is linked with Indriyabuddhi that is

minute virtual Dnyanendriya located in brain Indriyabuddhi is linked with

Adhishthana with prominent Mahabhuta and lastly with Indriya

ArthShabdatanmatra that is sense object Once this sequence is completed

Page | 23

the meaning of a particular sound is interpreted and understood In this

entire process of perception and interpretation of sound waves Pranavayu

and Tarpaka Kapha located in Shira play extremely important role Hence

the healthy status of all the sense organ depends upon the normal

physiologically homeostatic condition of Pranavayu and Tarpaka Kapha

MANAS

ATAMA

BUDDHI

AHANKARA

ARTHA

Page | 24

EAR ANATOMY

bull Embryology of the Ear [57]

1 The sound conducting apparatus develops from the branchial apparatus

whereas the sound perceptive apparatus from the ectodermal otocyst

2 The pinna develops from the six hillocks around the 1st branchial cleft

3 External auditory canal develops from 1st branchial cleft

4 The outpouching of the 1st pharyngeal pouch gives rise to a proximal

narrow part that forms the eustachian tube and distal dilated part that

forms the middle ear cavity

5 Prussakrsquos space is a potential space lateral to the Shrapnellrsquos membrane

and medically by the neck of malleus that can be involved during the

extension of cholesteatoma

6 Development starts in the 3rd week of the intrauterine life and is

completed by 16th week of intrauterine life Membranous and boney

labyrinth develops from the otic capsule

The Ear is divided into

1 External Ear

2 Middle Ear

3 Internal Ear or the labyrinth

Page | 25

Fig 1 Ear Anatomy

EXTERNAL EAR [58]

The outside ear contains pinna and lobule

Pinna is the noticeable piece of outer ear made from single sheet of yellow

flexible ligament covered by subcutaneous tissue and skin It has two

surfaces average and parallel It is intently disciple to perichondrium on its

sidelong surface while it is somewhat free on average surface Pinna

incorporates tragus helix against helix fossa three-sided scaphoid fossa

incisura terminalis

External auditory Canal ndash It extends from the bottom of the conchea to

the tympanic membrane and measures about 24 mm along its posterior

wallit is S shaped

Parts 1 Cartilaginous part

2 Bony part

Page | 26

Cartilaginous part ndash The outer one third is cartilaginous consist of fibro

cartilage is directed first inward backward and upward It has Fissure of

Santorium The skin of this part of the canal contains hair follicles

sebaceous gland and cruminous gland

Bony part ndash The inner two third part is boney It goes forward downward

and medially skin lined in this part is very thin Isthmus is the narrowest

part of the canal lying medial to junction of bony and cartilaginous part

nearly 5 mm lateral to tympanic membrane

The roof and posterior wall of the external auditory canal shorter than floor

and anterior wall The skin lining the tympanic membrane and boney canal

has a self-cleansing property due to migration of keratin layer of epithelium

from drum towards the cartilaginous portion

Relations- Anteriorly- Temporomandibular joint and parotid gland

Superiorly- Middle cranial fossa

Inferiorly- parotid gland

Posterior- Mastoid antrum mastoid air cells and facial nerve

Nerve supply ndashSensory nerve supply of the external ear The auricle

supplied by fibers of the great auricular nerve (C2 and C3) and lesser

occipital nerve (C2) Auriculo temporal branch of the 5th cranial nerve and

auricle branch of the vagus (Arnoldrsquos nerve) supply external canal Facial

nerve has small sensory contribution on posterior-inferior wall

Tympanic Membrane -It is the partition between EAC and middle ear It

is a thin semitranslucent membrane pearly white in colored lying obliquely

in the medial end of EAC with the angle of 55 It is forming major part of

lateral wall of middle ear Annulus tympanicus is attached at its

circumference to the sulcus The TM is oval shape It measures

approximately 10 mm in vertical diameter and 90 mm in horizontal

diameter

Page | 27

Layers ndash Tympanic membrane consist of three layers

1 Outer Epithelium or cuticular layer which is continuous with skin of

external ear

2 Middle fibrous layer has both circular and radial fibers middle layer

missing in upper part

3 Inner layer- Inner mucosal layer which is continuous with middle ear

mucosa

Parts ndash Tympanic membrane consist of two parts

1 Pars tensa -It is largest part below the malleolar folds The inner

surface at the center attached to the handle of malleus Angle of cone

is most illuminated part in the pars tensa at anteroinferior part of pars

tensa

2 Pars flaccida Sharpnells membrane -it is triangular area above the

malleolar folds which are thin and devoid of fibrous tissue and

annulus It fits into notch of Rivinous

Nerve supply 1 Anterior half of lateral surface Auriculotemporal V3

2 Posterior half of lateral surface Auricular branch of vagus cn 10

3 Medial Surface Tympanic branch of CN 9 (Jacobsons nerve)

Fig 2 Tympanic membrane of ear

Page | 28

MIDDLE EAR [59]

The middle ear or tympanic cavity is an irregular laterally compressed

space within the temporal bone It is filled with air that is supplied to you

from the nasal part of the throat through the ear canal It contains a chain

of mobile bones that connect its side with the medial wall and serve to

transmit vibrations transmitted to the eardrum through the cavity to the

inner ear Including the parapet the vertical and anteroposterior diameters

of the cavity are each approximately 15 mm The transverse diameter

measures about 6mm at the top and 4mm at the bottom Compared to the

eardrum it is only about 2mm The eardrum is limited laterally by the

eardrum medially by the lateral wall of the inner ear It communicates

behind with the tympanic antrum and through it with the air cells of the

mastoid and in front with the auditory canal The middle ear together with

the Eustachian tube aditus antral and mastoid air cells is called the

middle ear cleft It is lined by mucus membrane and filled with air

It is divided into 3 parts

1 Mesotympanum (located in front of the pars tensa)

2 Epitympanum or attic (located above the pars tensa but medial to

Sharpnells membrane and the lateral bony wall of the attic)

3 Hypotympanum (located under pars tensa) The middle ear is like a

hexagonal box with a roof

Carotid or Anterior wall- It separates middle ear cavity from internal

carotid artery The various structure passing through anterior wall of

tympanic cavity

bull Canal of chorda tympani nerve

bull Canal of tensor tympani muscle

bull Eustachian tube

bull Anterior malleolar ligament

bull Anterior tympanic artery

Page | 29

Posterior or mastoid wall ndash The upper part of the back wall shows the

opening of the auditorium Below the auditory is a triangular bony

projection known as the pyramidalis processors The stapedial tendon is

transmitted through the apex of the pyramidalis processes The vertical

portion of the facial nerve descends along the posterior wall until it opens

into the stylomastoid foramen

Roof or Tegmental wall (Pars terminalis)- It is formed by a thin bone

plate called the tegman tympanum that separates the skull and tympanic

cavities It is located on the anterior surface of the rocky part of the

temporal bone near the junction with the temporal shell it extends back to

the roof in the tympanic membrane and anteriorly to cover the half canal

of the tensor tympanic muscle The lateral border corresponds to the

remains of the Petro scaly suture

Floor ndash It is formed by a thin plate of bone which separate middle ear from

the bulb of the internal jugular vein lodged in the jugular fossa

Lateral wall ndash It is formed by tympanic membrane and partly by a portion

of squamous part of the temporal bone It separates the middle ear from

external ear

Medial wall- It separates the middle ear from the inner ear

bull The promontory is the most prominent and convex part formed by the

basal rotation of the cochlea

bull The bony lateral semicircular canal is postero-superior to the promontory

above the oval window

bull The oval window is located between the middle ear and the vestibular

slope of the cochlea It is closed by the stirrup footrest and the annular

ligament

Page | 30

bull The round window is located under and behind the cape The round

window recess is directed to the rear It is closed by the secondary eardrum

and separates the middle ear of the Scala tympani from the cochlea

bull The facial nerve passes through the bony fallopian tube above the oval

window

Mastoid Antrum ndash It is a large space with air in the upper part of the

mastoid and communicates with the attic through the aditus The roof is

formed by the antri tegmen which extends and separates the tympani

tegmen from the middle cranial fossa The lateral wall of the antrum is

formed by a bony plate that is on average 15 cm thick in adults It is

marked externally on the surface of the mastoid by the suprameatal triangle

(MacEwen)

Aditus and Antrum- Aditus is a gap through which the attic communicates

with the antrum The boney prominence of the horizontal canal lies on its

medial aspect even as the fossa incudes to thats attaches the quick system

of incus lies laterally Facial nerve publications simply underneath the

aditus

The mastoid and its air cell system-

The mastoid consists of bone cortex with a honeycomb of air cell

underneath Depending on development of air cell three types of mastoids

have been described

1Well-pneumatized or cellular- Mastoid cells are well developed and

intervening septa are thin

2Diploetic- Mastoid consist of marrow spaces and a few air cells

3Sclerotic or acellular ndash There are no cells or marrow spaces

With any type of mastoid pneumatization antrum is always present In

sclerotic mastoids antrum is usually small and the sigmoid sinus is

anteposed

Page | 31

Depending on the location mastoid air cells are divided into

1 Zygomatic cells (In the root of zygoma)

2 Tegman cell (Extending into tegmen tympani)

3 Perisinus cells (overlying the sinus plate)

4 Retrofecial cells (round the facial nerve)

5 Peri labyrinthine cells (located above below and behind the

labyrinthine some of them pass through the arch of superior

semicircular canal These cells may communicate with the petrous

apex)

6 Peritubal (around the Eustachian tube Along with hypotymoanic

cells they also communicate with the petrous apex)

7 Tip cells (which are quite large and lie medial and lateral to the

digastric ridge in the tip of mastoid)

8 Marginal cells (Lying behind the sinus plate and may extend into

the occipital bone)

9 Squamosal cells (Lying in the squamous part of temporal bone)

Development of Mastoid ndash

The mastoid develops from the scaly petrous bone The petrosquamosal

suture may persist in the form of a bone plate - Korners septum which

separates the superficial squamosal cells from the deep rock cells Korners

septum is surgically important because it can cause problems locating the

antrum and deeper cells and thus lead to incomplete removal of the disease

during mastoidectomy The mastoid antrum can only be reached if Korners

septum is removed

Page | 32

Fig 3 Cross section of Mastoid

Contents of the middle ear

Ossicles ndash Three tiny bones which conduct the sound from eardrum to oval

window

Malleus ndash It is the largest and most lateral ossicle measuring 8 mm in

length It has head neck handle anterior and lateral processes The head

is situated in the epitympanum A lateral process project laterally from the

neck while the handle is firmly fixed to the pars tensa of the ear drum

Incus- It has a body short process and long process The body short

process and long process The body articulate with the head of mallelus in

the attic and the short process project into the attic The long process

projects downwards behind the handle of malleus running parallel to it and

articulate with the head of the stapes via the lenticular process

Stapes ndash It is the smallest ossicle measuring about 35 mm and consist of

head neck footplate and anterior and posterior curcura The footplate of

stapes is held to the oval window by the annular ligament

Page | 33

Muscles ndash

1Tensor tympani ndash It is inserted is a branch of the facial nerve which carries

the sense of taste It is first arch muscle supplied by branch of mandibular

nerve V3

2 Stapedious muscles ndash It is inserted to the neck of stapes It is the second

arch muscle supplied by branch of facial nerve that is nerve to stapedius

Fig 4 Contents of the middle ear

Blood supply of Middle Ear

bull Anterior tympanic branch of maxillary artery which supplies tympanic

membrane

bull Stylomastoid branch of posterior auricular artery which supplies middle

ear and mastoid air cells

Page | 34

Four minor vessels are

bull Petrosal branch of middle meningeal artery runs along greater petrosal

nerve

bull Superior tympanic branch of middle meningeal srtery traversing along

the canal for tensor tympanic muscle

bull Branch of artery of pterygoid carotid

bull Tympanic branch of internal carotid

Lymphatic Drainage of Ear

Lymphatics from the middle ear drain into retropharyngeal and parotid

nodes while those of the Surgical Importance ndash Eustachian tube drain into

retropharyngeal group

1 The middle ear is part of contiguous organs including nose nasopharynx

Eustachian tube and mastoid bone lined by respiratory mucosa Any

respiratory infection or allergy is likely to pass to middle is likely to pass to

middle ear

2 Moreover middle ear suppurative disease may spread to adjacent organs

and produce complication eg Labyrinthitis meningitis facial nerve palsy

etc

3 Lenticular process is vulnerable in suppurative ear diseases and causes

ocular disruption

4 Prussac space is the site of primary acquired cholesteatoma

Page | 35

INNER EAR [60]

Inner ear is divided into two parts

1 Bony Labyrinth

2 Membranous labyrinth

Anatomy of bony labyrinth

It is divided into two parts

1 Vestibule

2 Cochlea

3 Semicircular canal

The vestibule is located between the medial wall of the middle ear and the

lateral to internal acoustic meatus anterior to the semicircular canal and

posterior to the cochlea The vestibule is the central part of the inner ear

On its side is the oval window opening which is closed by the bracket foot

plate The bony cochlea is located in front of the vestibule It has 275 turns

wound around a bony axis called a modiolus The cochlea is about 30 mm

long The hollow center of the modiolus is a spiral canal that contains the

fibers and ganglion cells of the cochlear nerve A thin bony sheet the bony

lamina winda around the modiolus This divides the cochlear duct into two

galleries the Scala vestibuli above and the scala tympani below

There are three semicircular canals superior posterior and lateral They

are semicircular in shape and open into the vestibule One end of the

semicircle is enlarged and is known as the sphere

The membranous labyrinth is in the bony labyrinth It is connected to the

bony labyrinth by fibrous trabeculae and is surrounded by perilymph The

endolymph is located in the membranous labyrinth

Page | 36

The utricle is in the upper part of the vestibule while the saccule is found

below Both the utricle and saccule contain a single sensory patch called

the macula Each macula is covered with a neuroepithelium made up of

neuroepithelium made up of sensory hair cells and support cells these cells

are separated by a basement membrane Fibers of the vestibulo-cochlear

nerve enter the macula and pierce the basement membrane to terminate

at the base of the hair cell or cell bodies The utricle and the saccule with

their macula are called otolith organs Membrane semicircular canals are

the membrane canals of the corresponding bony semicircular canals They

open into the utricle through five openings One end of the opening of each

channel is dilated called the sphere in which the sensory organ of each

channel is located The cross section of the Scala standard looks like a right

angle The base is formed by the basilar membrane Sensory cells are

arranged on the surface of the basilar membrane These sensory cells with

their supporting cells form a complex neuroepithelium called the basilar

papilla or the cortical organ named after an Italian microscopist The

organs of the corti have a gelatinous membrane called the tectorial

membrane and they are supported by the pillar of the corti The cortical

pillars enclose a space called the corti tunnel which contains a fluid called

cortical lymph Vestibule is lies between the medial wall of the middle ear

and lateral to internal acoustic meatus anterior to semicircular canal and

posterior to the cochlea Vestibule is the central part of the internal ear On

its lateral surface is the opening of oval window which is closed by the foot

plate of stapes Boney cochlea lies in front of the vestibule It has 275 turns

coiling around boney axis called modiolus Cochlea is approximately 30 mm

in length The hollow center of the modiolus is a spiral canal containing the

fibers and ganglion cells of cochlear nerve A thin boney sheet the osseous

lamina winda around the modiolus This divides the cochlear canal into two

galleries the Scala vestibuli above and the scala tympani below

Page | 37

Semicircular canals are three in number superior posterior and lateral

They are semicircular in shape and opens into the vestibule One of the

ends of the semicircular is enlarged and is known as ampulla

Membranous labyrinth is situated within the boney labyrinth It is connected

to the bony labyrinth by fibrous trabeculae and is surrounded by perilymph

Endolymph is situated within the membranous labyrinth

The utricle lies in the upper part of the vestibule while the saccule lies below

Utricle and saccule both contain single sensory patch called macula Each

macula is covered by neuroepithelium consist of Neuroepithelium consists

of sensory hair cells and supporting cells these cells are separated by

basement membrane Fibers from the vestibulo cochlear nerve enter the

macula and pierce the basement membrane to end either at the base of the

hair cell or cell bodies The utricle and saccule with their macula are referred

to as otolith organs Membranous semicircular ducts are the membranous

ducts in the corresponding bony semicircular canals They open into the

utricle by five openings One end of the opening of each canal is dilated

called ampulla in which the sensory organ of each canal is located The

cross section of Scala media resembles a right angle Its base is formed by

basilar membrane Upon the surface of the basilar membrane the sensory

cells are arranged These sensory cells with their supporting cells form a

complex neuroepithelium called the basilar papilla or Organ of corti named

after an Italian Microscopist Organ of corti has a gelatinous membrane

called tectorial membrane and they are supported by pillar of corti The

pillars of corti enclose a space called tunnel of corti which contains fluid

called corti lymph

Page | 38

Fig 5 Inner Ear

Blood supply of labyrinth

Labyrinthine artery

Common cochlear Anterior vestibular Artery

Vestibulocochlear artery Main cochlear artery

Cochlear branch posterior vestibular artery

Page | 39

PHYSIOLOGY OF HEARING [61]

A sound signal in the environment is collected by the pinna passes through

external auditory canal and strikes the tympanic membrane Vibrations of

the tympanic membrane are transmitted to stapes footplate through a chain

of ossicles coupled to the tympanic membrane Movements of stapes foot

plate cause pressure changes in labyrinthine fluids which move the basilar

membrane This stimulates the hair cells of the Organ of corti It is these

hair cells which act as transducers and convert mechanical energy to

electrical impulses which travel along the auditory nerve

Thus the mechanism of hearing can be broadly divided into

bull Mechanical conduction of sound (conductive apparatus)

bull Transduction of mechanical energy to electrical impulses (sensory

system of cochlea)

bull Conduction of electrical impulses to brain (neural

Fig 6 PHYSIOLOGY OF HEARING

Page | 40

Conduction of sound

Under the surface of water we cannot hear the sound made in air because

9995 of sound energy are reflected away from the surface of water because

of the impedance offered by it A similar situation exists in the ear when

air-conducted sound must travel to cochlear fluids Nature has

compensated for this loss of sound energy by interposing the middle ear

which converts sound of greater amplitude but lesser force to that of lesser

amplitude and greater force This function of middle ear is called impedance

matching mechanism or the transformer action It is accompanied by

a) Lever action of the ossicles

Handle of malleus is 13 times longer than long process of incus providing

a mechanical advantage of 13

b) Hydraulic action of tympanic membrane

The area of tympanic membrane is much larger than the area of stapes foot

plate the average ratio between the two beings 211 As the effective

vibratory area of the tympanic membrane is only two- thirds the effective

areal ratio is reduced to 141 and this is the mechanical advantage

provided by the tympanic membrane

c) curved membrane effect

Movements of tympanic membrane are more at the periphery than at the

center where handle of malleus is attached This too provides some

leverage

Transduction of mechanical energy to electrical impulses

Movements of stapes footplate transmitted to cochlear fluids move the

basilar membrane setting up shearing force between the tectorial

membrane and hair cells The distraction of hair cells gives rise to cochlear

microphonics which triggers the nerve impulse

Page | 41

Neural pathways

Hair cells get innervation from bipolar cells of spiral ganglion Central axons

of these cells collect to form cochlear nerve which goes to ventral and dorsal

cochlear nuclei From there both crossed and uncrossed fibers travel to

superior olivary nucleus lateral lemniscus inferior colliculus and medial

geniculate body and finally reach the auditory cortex of the temporal lobe

Page | 42

DISEASES REVIEW

करणसराव

Nirukti - करणसय कणवयोाव ससराा [62]

Nidana- Acharya Sushruta and Vagbhata describe the common etiological

factors for the Karnaroga

अशयाय जलिीडा कणवकणडयन मरत

शमथययोगन शसततरसतय कवपतो अरय च कोपन ||

सउ २० १२

1 Avashaya or Pratishaya

(Excessive exposure to cold)

2 Jalakrida

(Excessive swimming)

3 Karnakandunyanum

(Excessive scracing due to itching)

4 Mithyayogena Shatrasya

(Improper instrumentation during wax removal or foreign body removal)

5Shabdasya

(Louder sound for long durationperverted contact of sound)

6 Abhighata (Trauma)

7 Vitiation of Tridoshas

Page | 43

Samanya Nidana according to different Samhita

Vishesh Nidan of Karnasrava

Acharya Charaka has not mentioned any kind of Nidana regarding Karnaroga

but has described Utapati of Karnaroga from Siroroga in Karnasirasym

Adhyaya[67]

शशरोअशिघातादरा तनमजजतो जल परपकादरा अवप विि

सरतत पय शरणॊ अतनलात स कणवससरा इतत परककतीत

सउ २० १०

असस ३७२५ [68]

1 Shiroabhighatat - Head Injury-Fracture of middle cranial fossa

2 Jala nimajjana - CSF otorrhoea fracture of middle cranial fossa

3 Karnaprapaka

4 Karna Vidhradhi -Puyasrava

Sr

no

Samanya Nidana SU AH[63] AS[64] YR[65] MN[66]

1 Avashaya + + +

2 Pratishaya + +

3 Shabdha

mithyayoga

+

4 Shashtra

mithyayoga

+ + +

5 Karnakandooyan + + + + +

6 Jalkrida + + + + +

7 Abhighata + + +

Page | 44

Samanya samprapti

परापय शरोतरशसरा कयावत शल शरोतशस गान

त कणवगता रोगा अटिावशततरीता

सउ २० १२

Due to common and specific etiology factors the vitiated Doshas gets

Sthanasamshraya in Karna and causes Karnasrava It is the stages of

Samprapti were Doshas gets lodged in Srotas and start processes of Dosh

Dushya Sammurchsna Due to Shiroabhighata Jalanimmajana Karna Paka

Karna Vidhradi vitiated Vata Dosha and Karna becomes Avruta by Vata and

results in Karnasrava Normal physiology of Dosha Dhatus and Malas entirely

depends on the normality of Srotas Dosh Dushya Sammurchana or

manifestation of diseases will not take place if only vitiation of Doshas take

place without deformity of Srotas Here in Karnasrava vitiation of Srotas are

Atipravritti Sanga and Vimargagamana take place Atipravritti is being excess

production of fungus Sanga is obstruction in external acoustic canal

Vimargagamana is the propagation of discharge through ear

Vishesh Samprapti

Karnasrava occurs due to Nij nidana is Pratishaya while Agantuja nidanas are

Avashya Jalkrida and Karnakanduyan Due to etiological factors which are

Vata-Kapha provocative in nature gradual vitiation of Doshas will occur After

vitiation they get accumulated (Sthan samshraya) in external auditory canal

In other hand when patient does Sevana of Agantuj Nidan like water enter in

external ear scratching of ear unsterile instrumentation leads to Dosh

Prakopa These cause Twak and Mamsa Dhatu Dushti which leads to

discontinuity of epithelium of ear canal which creates suitable atmosphere for

fungal pathogen to grow The vitiated Vata will produce symptoms such as

Page | 45

pain hearing impairment and vitiated Kapha causes symptoms like itching

discharge ear blockage By assessing the symptoms it can be said that Kapha

Avrita Vata Dosha is responsible for the manifestation of clinical features like

pain itching discharge Which are seen in Karnasrava that is otomycosis

Acharya Charaka has mentioned while explaining Samanya Chikitsa of

Karnaroga that it should be treated like Vrana when Paka and Srava is present

as a symptom Fungal spores invade in the epithelial layer of EAC In response

to infection inflammatory process is start This is a Paka Avastha After

removing the fungal mass ulceration in external acoustic canal is commonly

seen As a result of infection process exudates was produced which will mix

up- with fungal colonies and appear as discharge As per Dosha involvement

in Vrana Shoola Srava can be differ According to Acharya Sushruta Ruk is

the Samanya Lakshana of Vrana and Vishesha Lakshana of Vrana includes

pain discharge discoloration itching etc according to Dosha involvement

which are also seen in otomycosis In otomycosis mainly watery and purulent

type of discharge is present which indicates Paka avastha If there is Dosha

involve in Vrana is called Dushta Vrana Acharya Sushruta and Acharya

Vagabhata have mentioned verity of Srava in Twak and Mamsa Vranavastu

which is found in otomycosis Based on this description otomycosis can be

correlated with Karnasrava

Page | 46

Representing the Samprapti of Karnasrava

Vishesh Nidana ndash Shiroabhighatat

Jala nimajjana

Prapaka Vidhradhi

Vitited vata

Avarana by kapha

Vimargagamana of Vata

Karnasrava

Samprapti Ghataka

Dosha ndash Kapha and Vata

Dushya ndash Rasa Rakta and Mansa

Strotodushti ndash Vimargagamana and Sang

Adhishthana ndash Karna (Bhayakarna)

Rogmarga ndash Madhyama

Page | 47

Purvarupa

The Purvarupa of Karnasrava are not mentioned separately in any ayurvedic

classics In routine practice cretin Purvarupa are noted

1 Karnakandu

2 Karnagurutwa

3 Alpa karnashoola

4 Discomfort in ear

Rupa

1 Karnashoola

2 Karnakandu

3 Karnasrava

4 karnabadhirya

5 Cotton wool like or wet newspaper like grayish brown or black colored mass

is seen

6 External auditory canal skin appears edematous and red

Upashaya and Anupashaya

Appropriate application of Aushadhi Ahara and Vihara when produces relief in

the symptom is called as Upashaya and when aggravates the symptoms is

called Anaupashaya There is not any reference available in the classics about

the Upashaya and Anupashaya of karnasrava

Sadhyasadhyata

Sushruta has not mentioned specially the Sadhyasadhyata of Karnarogas But

Vagbhata has mentioned Karnasrava as a Sadhyavyadhi[69]

Sadhysadhyatagives the clear picture of prognosis of the disease It depends

on many factors like nature of disease severity of disease Vaya Prakriti Bala

of the patient etc

Page | 48

Upadrava of Karnasrava

In Samhita there is no reference available regarding the Upadrava of

Karnasrava

Samanya Chikitsa ndash

The common treatment principle for all Karnaroga is Ghritapana Use of

Rasayana Bhrahmacharya Avyayama Shirasnana and Atibhashaya

सामरय कणवरोगष घतपान रसयनम

अवयायमो शशराःसतनान बरमहचयवम कतपरनम

स उ२१३

Ghratapana - Ghrita is a Yogavahi and follow Sanskara in addition to these

acquired properties and capable of retaining its own properties So Ghritapana

is effective in Karnasrava

Rasayana - Rasayana represent the basic approach of Ayurveda which

comprise preventive promotive and curative aspect of health

Brahmacharyaapalana -It is like Sadvrittapalana and is equals to Rasayana

effect

Vyayama - It leads to vitiation if Vatas a Karna is a Sthana of vata and

exercise causes Kshayaj Samprapti hence it is important to avoid exercise in

Karnasrava

Shirasnana- In Shirasnana water enters in external acoustic canal it changes

the PH of meatus skin from acid to alkali which favors the growth of pathogens

Atibhashya - Excessive speaking causes Vata Prakopa and Vatapraokopa is

basic Samprapti for Karnasrava as the preventive aspect avoidance of

excessive speaking is necessary

Page | 49

Ghritapana Rasayana and Brahmacharyapalana should be followed for

preservation of dhatu Samyata and restriction of vitiation of Vata Vayayama

Shirasnana and Atibhashaya should be avoided in Karnasrava to protect the

Siras from the affliction of Vata and Kapha

Vishesha Chikitsa ndash

The general treatment principle of Karnasrava described in classics is closely

related to Dushtavrana Chikitsa

शशरोवरचन च ए िपन परण तरा

परमाजवन िान च ीकषय ीकषय़ाचारत [70]

स उ २१४०

कणवसततरा ोददत कयावत पततकशमकणवयो [71]

ाउ १८३५

उपददि च सततरोत साय परात वपचततवशि परमजय

य अगर मदन सघत गगलना ा िपतयतपा मिना परयत [72]

असउ २२४२४३

In addition to that Shirovirechana Karnadhoopana Karnapurana

karnapramarjana Karnadhavana are also indicated

Page | 50

Treatment is also mentioned for Karnasrava

1 Karnaprakshalana Yoga - with Aargawadadi Gana Kashaya and Surasadi

Gana Kashaya [73]

2 Avachurnana Yoga ndash with Aargawadadi Gana Churna and Surasadi Gana

Churna[74]

3 Karnapoorna Yoga ndash

bull Rasanjana Laksha with Sarjachoorna[75]

bull Panchkashaya with Kapittha swarasa and Madhu[76]

bull Jambu AmrapallavShivalaKshuodra Mahavriksha and Madhuki all are

taken in equal quantity and Kalka is prepared and 4 times Taila is taken

and 16 parts of Kwatha is added and Taila Paka is done[77]

bull Sarjatwak Choorna with Karpashiphalarasa and Madhu[78]

bull Abhaya LodraTindukaSamanga(Manjista) Kwatha of this Dravyas mixed

with Madhu and Kapittha Rasa[79]

bull Yogratnakara mention the following drugs for Karnapoorana-

a Samudraphena Churna[80]

b Jambwambpatra Yoga

4 Karnadhoopana Yoga ndash

bull Dhoopana with Churna of Bilvapatra Haridra Palandu[81]

bull Vartak Dhoopana [82]

5 Internal Medications-

bull Rasnadi Guggula [83]

bull Triphala Guggula [84]

bull Sarivadi Vati [85]

bull Gandhaka Rasayana [86]

Page | 51

According to Vagbhata-

Ear should be cleaned with the Pichu and Varti followed by Guggula Dhoopana

and then Karnapoorana with Madhu Followed by Avachurnanana with

Sukshmachootana of Surasadigana

Pathyaapathya ndash Pathya and Apathy mentioned for Samanya Karnaroga is

recommended in Karnasrava also

पथय[87]

सतदो वरको मन नसतय िमाः शशरावयिाः

गोिमाः शालयो मदगााः याशच परतन हवाः 80

लाो मयरो हररणानदसततततरो नकककिाः

पिोल शशगर ातावक सतनषराण कदठललकम

रसायनातन सवणण बरमहचयवमिाषणाम |

उपयकत यरादोषशमद कणावमय दहतम ||81||

िापर २१

Aharaja Upacharaja

bull Godhuma bull Vamana

bull Shala bull Virechana

bull Mudga bull Nasya

bull Yava bull Dhoomapana

bull Puranagitra bull Kavala

bull Lava Harina Tittiramamsa

Page | 52

अपथय[88]

दरत काटठ शशरसतनान वययाम शलटमल गर

कणडयन तषारशच कणवरोगी पररतपयजत

िापर २१

Viharaja

bull Patola ShigruVartaka bull Bhramacharaya

bull Sunishannaka bull Avyayama

bull Katthlika bull Aakthanam

bull All types of Rasayana bull Upacharaja

bull Vamana

Apathyas

bull Abhishyandakara Aharas

bull Shirasnana

bull Karna kandooyana

bull Tushara sevana

bull Guru Kaphakaraka Aaharas

bull Dantdhavana

Page | 53

OTOMYCOSIS

Definition-

Otomycosis is a superficial acute sub-acute or chronic infection of external

ear canal It is mostly unilateral It is characterized by inflammation purities

and scaling Otomycosis is a common condition encountered in ENT practice

more in chronic and persistent ear infection

The Fungal infections are not communicable in the usual sense but the

humans become an accidental host by their introduction into tissue trauma

The virulence factors favoring colonization of fungus in human host are yet to

be identified Ability of the fungus to grow at 37 C and elaboration of a variety

of enzymes and toxins are speculated to contribute to virulence Only 100 to

150 species are generally recognized as a cause of disease in humans[89]

Prevalence-

Otomycosis is a word wide in distribution and in various record stated that 5

to 20 of all cases of infective otitis externa Otomycosis prevalent is more in

warm and humid climates It is one of the commonest manifestations in India

during rainy season It occurs mostly in humid atmosphere otitis externa due

to fungal infection may resembles the desquamative form of diffuse infective

otitis externa The incidence in temperature climates has increased in

proportion to the use of topical antibiotics which have a medium sterilized of

other organism in which the fungus may flourish

Page | 54

Predisposing factors- [90]

1 Environmental factors such as climate contagious and polluting hygiene

more frequently during rainy season as the humidity increases

2 Individual susceptibility ndashGeneral Immunological status of the Individual

eg HIV infection Radiotherapy chemotherapy Diabetes mellitus

3 Self-inflicted trauma that is use of pins to clean the itching ear or use of ear

bud to clean the wax

4 Wide spread of topical antibiotics steroid preparations which have medium

sterilized of other organism in which the fungus may grow

5 Failure of defense mechanism in External auditory canal

6 During swimming or head bath water enters in External acoustic canal

causes quantitative and qualitative change in ear wax It causes change in pH

7 Long term use of hearing aids

Pathophysiology ndash

The life cycle of the average mold encountered in the ear may be reckoned

as two weeks and flare ups may be anticipated at such intervals Swimming is

held responsible for infection in many cases The sequence sequence of

pathogenic changes produced by molds in the external ear is as follows ndash

1 Implantation of the organism in external ear

2 Growth of organism follows the rate depending on condition of temperature

moisture or preexisting irritation

3 Invasion of epithelium occurs with attendant itching and discomfort which

may be quite severe

Page | 55

4 Exfoliation of epithelium occurs as nature attempts to overcome the

infection by casting off upper most cells

5 Denudation occurs from exfoliation as the top layers of epithelium are cast

off and the canal becomes filled with debris

6 Superficial ulceration and lizematoid dermatitis results if the pathologic

process goes for enough The changes do not always proceed through the

entire sequence sometimes the molds produce changes of the mildest

imaginable character which may be overlooked[91]

Clinical features -

Symptoms-

1 Irritation and itching ndash Irritation is mostly found when the infective

organism is aspergillus niger There is sensation of discomfort which is more

diffuse in the ear canal then localized in the deeper part Candida infection

causes marked itching In external ear it is intense and worse at night

2 Discharge through ear- Intermittent scanty colorless discharge through

ear Mucus being a fungal metabolic product appears as discharge Excessive

discharge is associated with mixed infection

3 Pain and discomfort ndash Mild to severe pain in the ear occasionally Mostly

seen in cases where ear is infected with Aspergillus flavus mixed infection

with gram negative organism or mixed infection with candida and aspergillus

Headache is sometimes associated with pain

4 Deafness- Varying degree of mild to moderate conductive deafness

5 A sensation of fullness in ear

6 Tinnitus 7 Vertigo

Page | 56

Signs ndash

1 The external acoustic meatus may contain a mass formed of epithelial

debris exudates cerumen and fungus

2 Erythematous external canal

Fungal appearance

A Niger - The color of the mass which is usually grey or black is mainly

determined by the type of fungus concerned Its appearance is like wet

newspaper or blotting paper or a cotton wool It has a peculiar musty odor In

this infection fruiting heads may be seen as black specks in the debris

Occasionally as inactive form occurs in which the canal is lined by mold giving

a fluffy appearance due to the presence of tiny mycelia

Candida ndash Candida infections generally show as white deposits on magenta

colored skin when the debris is removed it rapidly recovers in 24 hrs

The underlying canal skin is often inflamed and granular due to invasion by

fungal mycelia and be seen in all cases In rare cases excoriation and

ulceration with marked extensive shedding of the epithelium and deep

ulceration can be seen usually associated with a flavus and with pathogenic

bacteria[92]

Otoscope Appearance

1 Aspergillus Niger ndash Black headed

2 Aspergillus Fumigators ndash pale blue or green

3 Candida Albicans ndash White- or cream-colored deposits

Page | 57

4 Auricle is normal in most cases In severe cases small ulceration with crust

formation may be present on lateral surface

5 Tympanic Membrane

In most cases it is normal with normal mobility and normal hearing In a few

cases the surface of the tympanic membrane is congested and scaly There is

erosion or ulceration of the external epithelial layer and the membrane itself

may be edematous

Diagnosis

1 Above mentioned symptoms and signs

2 In the stage at which patient with otitis externa usually first present

themselves mycelia threads conidiophors not visible to naked eye may

sometimes be identified with the microscope

3 Confirmed by culture

Page | 58

Fig7 Aspergillus Niger Fig8 Candida Albicans

Fig9 Aspergillus Fumigators Fig 10 Wet Paper like appearance

Page | 59

Treatment

1 Antibiotic or steroid drops should be discontinued if they are being instilled

since long time

2 Removal of fungal mass epithelial debris and discharge from the external

canal or mastoid cavity repeatedly and thoroughly by forcepa or suction or

syringing or cautiously blow a stream of air into the canal through a fine

cannula and dry thoroughly by swabbing liquid petroleum on swab used in

cleaning the ear lessens the burning sensation when metacresy acetate is to

be employed in the subsequent treatment

Furuncle is developed as a complication if there is no gentleness in cleaning

Cleansing may have to be delayed until local sensitiveness is lessened which

can usually be accomplished within twenty-four hours If there is excessive

epithelial debris along with otomycosis then metacresyl acetate which is a

keratolytic in introduction into the external auditory canal on cotton wick and

is allowed to remain for twenty-four hours After twenty-four hours the cotton

wick is removed at which time the canal can usually be cleansed with little

discomfort as the medication is also anesthetic The epithelium of the canal

was white from contact with the drug The top layer was detached and this

epithelial debris can be easily wiped away The wick is reinserted and wet with

metacresyl acetate

The treatment is employed for three to four days in succession and then a

bland application is substituted Icthyol iodine is of value at this stage Iodine

ointment 2 in combination with Tannic acid 2 is also an excellent local

application following cresatin treatment

Next one of the fungicides may be applied

Page | 60

1 Nystin Effective for candida infection but less active against aspergillus

group Nystatin in boric powder consisting of 100000units of nystatingm of

powder 3 times week for 3 weeks

2 Clotrimazole Available as 11 cream or drops or lotions Phenyl

(zchlorophenyl) 1 ndash imidazole ndash methane is a chlorinated trityl imidazol 1

effective against candida and dermatophytes and for aspergilli infection

3 Amphotericin B Available as cream and as 3 solution and 015 drops

for topical application Very effective for candida infection can be fungistatic

or fungicidal

4 Econazole Available as solution (Econazole nitrate) and as cream (1)

Broad spectrum ndash more effective for Aspergillus Also active against some

gram-positive bacteria (Staphylococci and Streptococci and Dermatophytes)

5 Miconazole Highly effective against dermatophytes and candida infections

used as a 21 cream applied once or twice a day for 10 days

6 Gentian violet 21 Available as drops (recently some evidence of

carcinogenicity) Discolors the ear canal and this interfere with clinical

examination

Other topical antifungal agents are ketoconazole Natamycin Tolciclat Bifonas

zole Fenticonzole Oxiconazole Tioconazole ciclopiroxolomine Tolnafate

Haloprogin Flucytosine Acetic acid Whit field ointment selenium sulfide

undcyclenic acid triacetin etc

Page | 61

Minimal length of treatment

A month of drug treatment is usually required because the antifungal agents

used are not sporicidal and it is necessary that the period of treatment covers

germination time It may be advisable to give short gaps in the period of

treatment to ensure all spores have germinated before deciding to terminate

therapy

Prevention

Accomplished by strict attention to the predisposing causes

1 Water should be prevented from entering the ear

2 Avoidance of external ear trauma

3 Use of alcohol medicated or plain in the ears after swimming mercuric

cyanide (15000) in ethyl alcohol (70) is a satisfactory liquid to use

Ear stoppers do no good unless their use is followed by some antiseptic in the

canal Divers exposed to water for long periods of time may also use acidic

alcohol

4 During Summer months with their high humidity special efforts are needed

to maintain ear dry 5 Indiscriminate use of topical antibiotics steroid

preparations should be avoided

Page | 62

DRUG REVIEW

1 GUGGULA

Fig11 - Guggula

Historical review of Guggula [93]

bull Atharvaveda one of the well-known Vedas of Hindus The earliest

reference given by Atharvaveda medicinal and therapeutic properties of

Guggula Guggula has long history of use in Ayurveda

bull Acharya Charaka Sushruta and Vagbhata describe detail regarding the

actions uses and indication as well as the variety of Guggula

Page | 63

bull Various Nighantus (Medical lexicons) were written between 12th and 14th

centuries AD was based on the Ayurvedic literature also describes

Guggula

bull The explanation of word Guggula is that Gunjo Vyadhegurdti Rakshati

which means to relief against different diseases

bull Guggula is the best medicine because it develops through the rays of

hot sun on specific circumstances

bull Guggula has an aromatic odor

गगलो कणवदौगवररधय िपन शरटठमछयत[94]

स उ २२११२

Latin name- Commiphora mukul

Family ndash Burseraceae

Rasa- Tikta Katu

Guna ndash Laghu Rukshasukshma vishada sara

Veerya ndash Ushna

Vipaka ndash Katu

Action- Rasayana Lekhana

Doshaghanta - Tridoshhara

Page | 64

Chemical composition [95]

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Oleoresin-Z-Guggulsterone E-Guggulsterone

Gum- guggulignans 1 and 2 guggula Tetrols mukulol allylcembrol c

27

Guggulusterol 1 2 ans 3 Z and E ndash guggulusterol

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Parts Used ndash Gum oleoresin

Guggula purity test

1 Yellowish brown emulsion is obtained when Guggula is triturated with

water

2 An ethereal solution of the drug attains reddish colour when treated

with br2 vapors and purple colour when moistened with nitric acid

Biochemical action ndash Antiseptic Anti-inflammatory Disinfectant Diuretic

Immunostimulant stimulating expectorant Ant suppurative Antipyretic

Enhance phagocytosis

Karma- Rasayana cardiovascular disease

Page | 65

2 AGARU-

Fig 12 Agaru

Historical review of Agaru [96]

bull The word Agaru literally means the one which is the heaviest and no

aromatic wood is heavier than it Since thousands of years Agaru lsquoThe

wood of Godrsquo has been used for multiple purpose like commercial

medicinal spiritual aromatic historical

bull The medicinal use of Agaru have been recorded in many pieces of India

Greek Roman Chinese Middle eastern and European since ancient times

bull Acharya Charaka used Agaru and pest of Rasna to counteract the effect of

cold in Agraya Dravyas

bull Acharya Sushruta used Agaru as a Dhoopana Dravya along with Guggula

Ral and Shoma in the treatment of Karnasweda and Vrana

Page | 66

Types-

bull Dhanwantsri Nighantu describes Kaleyaka as a type of Agaru

bull Sodhala Nighantu describes three types of Agaru ndash Agaru Krishna

Agaru Kakatunda Agaru

bull Raj Nighantu describes five types of Agaru ndash Krishna Agaru Kasht

Agaru Daha Agaru Mangalya Agaru and Agurusaar

bull Arthashasstra describes three Agaru wood product

1 Jongaka ndash Black or variegated black in colour and having variegated

spots

2 Dongaka ndash Black in color

3 Parasamudraka- Black in colour and smells like Navamallika

अगर उटण कि तपछय ततकत ततकषण च वपततलम

लघ कणाविरोगघन शीत ात कफपरणत

िापर २१ [97]

Family- Thymelaccensis

Latin name- Aquilaria agallocha

Guna- Laghu Ruksha Tikshan

Rasa- Katu Tikta

Vipaka ndash Katu

Virya ndash Ushna

Karma- Sheetaprasasmana Vranaorasadan Tvachya Pittavardhaka

Shirovirechana Mangalya Sugandhik and Rochaka in properties [100]

Krishna Agaru karma- Katu Tikta rasa Ushna Sheeta when applied externally

and Pittahara when taken orally

Page | 67

Chemical Constituents -

Agaru hardwood is rich in essential oil resins alkaloids saponins Steroids

terpenoids tannins flavonoids and phenolic compound Agaru wood

predominantly contains 2-[-2-phenylethy]-4H-chromen-4-one derivatives and

sesquiterpenes Agaru oil contains selinene dihydroselinene agarnol b-

agarofuran vetispira-2(11)valerianol dihydrokaranone and tetradecanoic

acids[99]

Part Used ndash

Heartwood- Dark resinous wood which is formed when the plant becomes

infected with a type of fungus (ascomycetous mold) Species of Aspergillus

fusarium and penicillium are reported to be associated with the development

of infection Prior to infection the heartwood is odorless relatively light and

pale colored however as the infection progresses the tree produces a dark

aromatic resin in the heartwood The infected resin in response to the attack

which results in accumulation of a very dense dark resin in the heartwood

The infected resin embedded wood is known as Agarwood Infection is more

common on the trunk roots and the area when branches divide The formation

of Agarwood starts when the tree attains the age of 20 years On an average

approximately 30 ml oil is extracted from 100 kg of infected Agarwood[98]

Qualities of best Agaru-

It should be black in color

It should be extremely heavy and aromatic

It should be oily in appearance and test

It should be sink in water

It should burn easily with bright flame with a bright flame giving off a pleasant

smell

Page | 68

3 MADANA

Fig 13 MADANA

Madana consist of dried fruit of Xeromphis spinosa It is a deciduous thorny

shrub or a small tree reaching a high up to 9 m and girth about a meter

branches numerous thick and horizontal found in sub-Himalayan tracts[101]

मदनो मिरनदसततकतो ीयोटणो लखनो लघ

ानदरतिदवििीहर परततशयायवरणारतक

रि कटठकफ़ानाहशोथगलमवरणापह[102]

िा पर १६० १६1

Page | 69

Latin name-Randia dumetorum

Familly ndash Rubiaceae

Rasa - Madhura Tikta

Guna-Laghu Ruksha

Virya- Ushna

Vipaka ndash Katu

Karma- Vamana and Lekhana

Chemical Composition-

Essential Oil Valerianic acid Saponin tannin resin [103]

Page | 70

YAWA [104]

Fig 14 Yawa

1 In Samhitakala Aacharya Charaka Acharya Sushruta explain detail about

medicinal properties of Yawa

2The use of Yawa in Aaharya Dravya mainly described by Dhanwantari

Nighantu Raj Nighantu Bhavprakash Nighantu[105]

Macroscopic Description-

Fruit a caryopsis elliptical oblong Ovoid and tapering at both ends smooth

about 1cm long and 02- 03cm wide dorsally compressed and flattened on

the sides with a shallow longitudinal furrow 3-5 ridges having shallow

depression between them grains tightly enclosed and adhering the lemma

and palea pale greenish yellow odor not distinct taste sweetish acrid

Page | 71

Latin Name ndash Hordenum vulgare

Family- Poaceae

Rasa- Kashaya Madhura

Virya- Sita

Vipaka- Katu

Karma- Vatakrt Pittahara Kaphahara Medahara Balya Visrya

SthairyakaraLekhana

Page | 72

PROCEDURE REVIEW [105]

In Ayurvedic classics there are many references regarding Dhoopana Dravya

Dhoopana is administering Dhuma with the help of Dhoopana Dravya

In Kashyapa Samhita there are 40 types of Dhoopana advised for children

Anesthesia (Mohajananam Dhoopa) is also mentioned For this Dhoopana the

drug used were herbs hairs of animals legs horns old cloths of Buddhist

monks

From the references available regarding Dhoopana we can understand that

Karna can be protected from maggots (krimi) Bactria (Rakshogna) lice etc

References clearly indicate the analgesic and disinfectant effect of Dhoopana

Karma Dhoopana is mentioned for Dushta Vrana Chikitsa It reduces Vedana

Srava Pootigandha of Dushtavrana It also helps in Vranaropana

Dushtavrana Chikitsa is mentioned in the treatment of Karnasrava[106]

Origin of Dhoopana-

In ancient period children of sages were constantly harassed by the

Rakshasas Hence the sages approached lord Agni for shelter Agni in turn

gave them Dhoopana Dravya and asked sages to use the Dhoopana for

protection against Rakshasas bhutas pishachas

Classification of Dhoopana

1 It is classified into Dhupa Anudhupa Pratidhupa

2 On the basis of Origin it is classified into Jangama and Sthavara

Selection of Guggula for Dhoopana

Page | 73

bull Guggul is a best Vatahara

bull It is Krimighana

bull It contains Oleoresin

bull In Ashtang Hrudaya Guggula Dhoopana mentioned for Karnasrava

Selection of Agaru for Dhoopana

bull Agaru is Laghu Ruksha Katu Tikshna

bull Vranaorasadan Tvachya

bull It should burn easily with bright flame with a bright flame giving off a

pleasant smell

Karna Dhoopana Indication

1 Karnaarava

2 Putikarna

3 Krimikarna

4Vataj Karnashula

Contraindications

Especially for Karnadhoopan contraindication is not mentioned in classic texts

But Dhoopana is contraindicated in Pittaj vaydhi Sharad and Grishma Rutu

Page | 74

MATERIAL AND METHOD

Page | 75

For randomize comparative clinical trial to study the effect of Agaruwadi

Karnadhoopana and Guggula Karnadhoopana in Karnasrava following material

and method were required

Source of data

Patient irrespective of gender occupation religion social economic status

signs and symptoms of classical features of Karnasrava (Otomycosis) selected

from the OPD of Shalakyatantra department

Materials ndash

1Patients

2 Drugs-Agaruwadi Dhoopana

Guggula Dhoopana

3Torch

4Otoscope

5 Tuning fork

6Jobson horn probe

7Cotton

8Case record form

DRUG

Group A Trial Group

1Churana of Agaru Yawa Madan

2Ghrita

3Jala

Group B Control Group

1Googula Churna

Page | 76

Properties of Drug

Table no 1 Properties of Drug

Drug

Family

Rasa Veerya Vipaka Effect

on

Dosha

Guna Karma

Agaru

(Aquilegria

Agallocha)

Thymelaca

ceae

Katu

Tikta

Ushna Katu KV Laghu

Ruksha

Tikshna

Shitaprashamana

Shothahara

Vedanasthapak

Durghandhihara

Madan

(Randia

spinosa)

Rubiaceace

Kashaya

Madhur

Tikat

Katu

Ushna Katu KV Ruksha

Laghu

Vatakaphaghana

Shothahara

Vedanasthapak

Vranashodhak

Yawa

Poaceae

Hordeum

Vulgare

Kashaya

Madhur

Sheeta Madhur KP Ruksha

Laghu

Vataghana

Vernashodhana

Raktshodhaka

Guggula

Commiphora

Mukul

Burseracea

e

Tikta

Kashaya

Anushna Katu VPK Laghu

Ruksha

Shothahara

Vedanasthapaka

Kandughna

Ghrita Madhura Sheet Madhur VK Snigdha Vataghana

Shothahara

Vedanasthapaka

Page | 77

METHODOLOGY

SELECTION CRITERIA

1)INCLUSION CRITERIA

1 Patients having signs and symptoms of Karnasrava (Otomycosis) ie करणशल

( pain ) करणकणड ( Itching ) करणसतराव ( Discharge )बाधिरण ( conductive Loss of

hearing )

2 Patient from age group 19 to 70 years

3 Any Gender

2)EXCLUSION CRITERIA

1 Patients suffering from any systemic disease like DM TB HTN

2 Chronic suppurative otitis media (CSOM)

3 Acute supportive otitis media (ASOM)

3 Perforation of Tympanic membrane

4 Chronic otitis media

3)WITHDRAWAL CRITERIA

1If patient develops any adverse effect such as irritation pain burning

sensation in ear loss of hearing and such patients was withdrawn from trial

and receive prompt appropriate medical attention

2If patient shows aggravation in symptoms

3If patient refuses to continue with the treatment

Page | 78

STUDY SETTING

Types of study - Randomized Clinical comparative Trial

Place of work - OPD of Shalakyatantra

Duration of study - 18 months

Study Population - Patients of Karnasrava in Shalakyatantra OPD

SAMPLE SIZE CALCULATION

Sampling Method ndash Purposive sampling followed by random allocation in two

groups

Sample size calculation-

n = z2 p (1-p)

d2

Were

n = sample size

P = prevalence of disease=10

z = standard normal variable ie 196

d = error ie005

desired Sample Size would be

n = Z2 P(1-P)d2

= (196)2x (0021) x(0979)(005)2

= 34

Visiting ENT OPD (ShalakyaTantra) and IPD (ShalakyaTantra) 21 = 34

n raquo34

So one group includes 34patients

Page | 79

Sampling Method

Total 68 patient of Karnasrava are selected by Purposive sampling followed by

random allocation in two groups Written informed consent is taken prior to

commencement of trial They are divided in 2 groups

Group A (Trial Group) 34 patients treated with Agaruwadi Dhoopana for 7

days

Dose 5 minutes twice in a day

Group B (Control Group) 34 patients treated with Guggula Dhoopana for 7

days

Dose 5 minutes twice in a day

STUDY DESIGN ndash

Open labeled Randomized Comparative Clinical trial

STUDY DESIGN

Screening of patient

Inclusion criteria satisfied Exclusion criteria

Initial assessment Excluded

Counseling of patient Treated accordingly

Patient selection by Simple Random Sampling Method

Page | 80

68 Patients were divided in two groups lsquoArsquo and lsquoBrsquo

Trial group A-34 patients were given

Agaruwadi Dhoopana

Control group B- 34 patients were

given Guggul Dhoopana

Informed written consent

Treatment was given for 7 days

Assessment on 1st 4th and 7th day

Post assessments follow up on 15th day

Observation

Data Collection

Statistical analysis of data

Conclusion

Page | 81

(A) Agaruwadi Varti for group A (Trial group)

Table no 2

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

B) Guggula Varti for group B (Control group)

SOP of it is same as above Agaruwadi Varti

Table no 3

Drug Guggula Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

FOLLOW UP

For both groups follow ups were done on 1st 4th and 7th and post

assessment follow up15th day

EXAMINATIONS

Torch for Local examination of ear

Otoscope examination

Tuning fork Test

Page | 82

OBSERVATION TABLE

Table no 4

Sr no Subjective criteria Day 1 Day 4 Day 7 Day 15

1 करणशल

(pain)

2 करणकणड

(Itching)

3 करणसतराव (Discharge )

4 बाधिरण (Conductive Deafness)

OBSERVATIONS

a) करणशल (Pain) -

0 - Absent

1 ndash Present

b) करणकणड (Itching) -

0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

Page | 83

c) करणसतराव (Discharge)

0- Absent

1- Mild -Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाधिरण (conductive Loss of hearing)

0 - Absent

1- Present

Observations were carried out before and after completion of treatment and

during each follow up After observations the data collected and presented in

the form of graphs charts and table

Page | 84

TRIAL DRUG

Authentication and standardization of raw drug material done After

authentication and standardizing of raw drug material Agaruwadi Varti was

prepared by Varti as explained in Ayurvedic classics

Method of Varti preparations

Panchavidh Kashaya Kalpana that is five method of pharmaceutical

preparation constitutes the fundamental process of Ayurvedic pharmaceutics

which is well explained in Sushrut Samhita Varti Kalpana is one among them

which can be included in Kalka Kalpana

तीररसतरपतपतीनामपरककव तीत [106]

स डलहण शरच 151

Medicines are powered triturated and given the Varti shape that is like wick

of lamp so it is called as Varti Kalpana

Drug content Agaru Madan Yawa

Route of Administration Local

Dose Two times a day

Duration 7 days

Page | 85

Methodology

Standard operating procedure (SOP) of Agaruwadi Varti

Agaruwadi Varti is prepared according to the classical text

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization was done as recommended in pharmacy procedure The

raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 mixed together in

equal quantity to make Agaruwadi churn

Quantity of each churn is 4 grams all are mixed when the Varti get dry total

weight of Varti was 10gram

STEP 4 - Agaruwadi churn triturated with appropriate quantity of water or

Ghrita and prepared Varti in GMP Certified Ayurvedic pharmacy Standard

aseptic precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Varti was packed in sterile air packed container

STEP 6 - Agaruwadi Dhoopana was given with the help of Dhoopana yantra

Authentication and Standardization of raw drug of Agaruwadi Varti was done

Sterilization was done as recommended in pharmacy procedure Sterile

preparation packed in sterile container of suitable size Under all aseptic

precaution Karnadhoopana given to infected ear

Page | 86

Containers for packaging and their sterilization-

Sterilization of the containers for storing Varties was done by Ethylene Oxide

(Eto) method

Ethylene Oxide (Eto) procedure-

It includes exposure of materials to ethylene oxide gas under vacuum in a

sealed chamber It consists of four primary variables

1Gas Concentration

2Humidity

3Temperature

4 Time

EtO gas is an alkylating agent which disturbs the DNA of microorganism

preventing them from reproducing It penetrates the breathable packaging

and sterilizes all the accessible surface of the product to render products

sterility by alkylation of essentials proteins for cell reproduction

Most Eto sterilization methods involves three different stages These can be

separated into three different on the size or number of devices to treat

1Preconditioning stage-

First products are passed through a preconditioning phase to make

microorganism grow The batch load goes through a well time under a

controlled environment of temperature and humidity

2Sterilizer stage-

Performed using process phase specially designed to provide the required level

of EtO exposure to assure sterility for a device or family of devices

3Degasser Aerration stage-

Finally products need to go through a degassing phase to remove any residual

particles of Eto The batch load goes over well time under a temperature-

controlled environment

The sterile containers were then used to store Agaruwadi Varti and handed to

patients included in the study

Page | 87

Packing of Agaruwadi Varti

The ETO sterilize plastic container were used for packing of Agaruwadi Varti

Varti was filled into these sterilize containers (7 in each) In an aseptic

environment plugging and capping was done under aseptic precautions In this

way packing of Agaruwadi Varti done These Varti were given to patient and

advise to take two times a day under all hygienic precautions

History and Examination

bull Proper history and presenting complains was recorded on case record form

bull Ear examination with otoscope was done during initial assessment and each

follow up

bull Otoscopic examination was done during initial assessment and each follow

up

bull Systemic Examination that is Blood Pressure Temperature Respiration

rate Pulse was recorded on case record form

Page | 88

Raw material

Fig14 यव चरण Fig15 मदनफळ चरण

Fig16 अगर चरण Fig17 गगगळ चरण

Page | 89

Preparation of Agaruwadi Varti

Fig18 Preparation of Agaruwadi Varti

Fig19 अगरवादी वरती

Page | 90

Fig20 Instruments used for examination of Karnasrava

Fig19 Karnadhoopana Yantra

Page | 91

Karnadhoopana Procedure

Fig 22 Karnadhoopana Procedure

Page | 92

OBSERVATIONS AND RESULTS

Page | 93

BASED ON DRUGS

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 94

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

AUTHENTICATION CERTIFICATE

Page | 95

BASED ON STASTICIAL ANALYSIS OF DEMOGRAPHIC DATA

68 patients of Karnasrava ndash Otomycosis

Table no 5

No of Patients Total

Group A Group B

Registered 38 37 75

Completed 34 34 68

Discontinue 04 03 07

Total 68 patients were enrolled in study 38 patients registered in group A

amongst them 34 patients completed the treatment and04 patients

discontinued the treatment However in group B 37 patients completed the

treatment and 03 patients discontinued the treatment out of 37 registered

patients

Hence the total number of patients registered in the present study was 75

and out of which 68 patients were discontinued the treatment So they

dropped out from the study While 68 patients were successfully completed

the treatment So observations and result of 68 patients were given below

Here we are going to discuss the statistical analysis of the data obtained in

the form of master chart that was prepared in accordance with the data

collected from the patients that had been included in the study The purpose

of statistical analysis was to analyzed the relation between age gender

occupation diet addiction and education

Page | 96

1 Age wise distribution of patients

Table no 6

In trial group 10 (29412) patients were from age group 18-25 years 14

(41176) patients were from age group 25-35 years 8 (23529) patients

were from age group 35-45 years and 2 (58824) patients were from age

group 45-60 yearsIn control group 6 (17647) patients were from age group

18-25 years 14 (41176) patients were from age group 25-35 years 7

(20588) patients were from age group 35-45 years and 7 (20588)

patients were from age group 45-60 years

Fig 23 Age wise distribution of patients

0

2

4

6

8

10

12

14

15 -25 25-35 35-45 45-60

10

14

8

2

6

14

7 7

Age Distribution

Trial Group N Control Group N

Age Distribution

Trial Group Control Group

N N

18 -25 10 29412 6 17647

25-35 14 41176 14 41176

35-45 8 23529 7 20588

45-60 2 58824 7 20588

Total 34 100 34 100

Page | 97

1 Gender wise distribution of patients

Table no 7

Sex

Trial Group Control Group

N N

Female 23 67647 15 44118

Male 11 32353 19 55882

Total 34 100 34 100

In trial group 23 (67647) patients were female and 11 (32353) patients

were male

In Control group 15 (44118) patients were female and 19 (55882)

patients were male

Fig 24 Gender wise distribution of patients

0

5

10

15

20

25

N N

TRIAL GROUP CONTROL GROUP

23

15

11

19

Gender

Female Male

Page | 98

2 Education wise distribution of patients

Table no 8

Education

Trial Group Control Group

N N

Illiterate 4 11765 3 88235

SSC 4 11765 3 88235

HSC 8 23529 9 26471

Graduation 16 47059 10 29412

Primary 1 29412 3 88235

Post-Graduation 1 29412 6 17647

Total 34 100 34 100

In trial group 4 (11765) patients were illiterate 4 (11765) patients were

SSC educated 8 (23529) patients were HSC educated 16 (47059)

patients were graduated 1 (29412) patients were primary educated and

1(29412) patients were post graduated

In control grou 3 (88235) patients were illiterate 3 (88235) patients

were SSC educated 9 (26471) patients were HSC educated 10 (29412)

patients were graduated 3 (88235) patients were primary educated and

6 (17647) patients were post graduated

Page | 99

Fig 25 Education wise distribution of patients

0

2

4

6

8

10

12

14

16

ILLITERATE SSC HSC GRADUATION PRIMARY POST GRADUATION

4 4

8

16

1 1

3 3

910

3

6

Education

Trial Group N Control Group N

Page | 100

3 Occupation wise distribution of patients

Table no 9

Occupation

Trial Group Control Group

N N

Accountant 1 294 2 588

Housewife 11 3235 8 2353

Engineer 1 294 1 294

Job 1 294 4 1176

Labor 1 294 3 882

Mess 1 294 0 000

Naturotherapyst 1 294 0 000

Pharma 1 294 0 000

Shopkeeper 4 1176 2 588

Singer 1 294 0 000

Student 8 2353 4 1176

Tailor 1 294 1 294

Teacher 1 294 1 294

Worker 1 294 3 882

Farmer 0 000 1 294

Lab Tech 0 000 1 294

Page | 101

Daily Collection 0 000 1 294

Fruit seller 0 000 1 294

Bus Driver 0 000 1 294

Total 34 10000 34 10000

In trial group 11 (3235 ) were housewife 8(2353) were students

4(1176) were shopkeeper 1(294) was accountant 1(294) was

engineer 1(294) was doing job 1(294)was labour 1(294) was

catering 1(294) was Naturotherapyst 1(294) was Pharma 1(294)

was Singer 1(294) was Tailor 1(294) was Teacher and 1(294) was

worker

In Control group 8 (2353)were housewife 4(1176) were students

2(588) were shopkeeper 2(588) was accountant 1(294) was

engineer 4( 1176) was doing job 3(882)was labor 1(294) was

Farmer 1(294) was Lab tech 1(294) was Daily collection 1(294)

was Tailor 1(294) was Teacher and 3(882) was worker 1(294) was

Fruit seller and 1(294) Bus driver

Fig 26 Education wise distribution of patients

0

2

4

6

8

10

12

1

11

1 1 1 1 1 1

4

1

8

1 1 10 0 0 0 0

2

8

1

43

0 0 02

0

4

1 13

1 1 1 1 1

Occupation

Trial Group N Control Group N

Page | 102

4 Religion wise distribution of patients

Table no 10

Religion

Trial Group Control Group

N N

Hindu 31 9118 33 9706

Muslim 3 882 1 294

Total 34 10000 34 10000

In trial group 31 (9118) patients were Hindu and 3 (882) patients were

Muslim

In control group 33 (9706) patients were Hindu and 1 (294) patient

were Muslim

Fig 27 Religion wise distribution of patients

0

5

10

15

20

25

30

35

N N

TRIAL GROUP CONTROL GROUP

3133

31

Religion

Hindu Muslim

Page | 103

5 Diet wise distribution of patients

Table no 11

Diet

Trial Group Control Group

N N

Veg 14 4118 20 5882

Non-Veg 20 5882 14 4118

Total 34 10000 34 10000

In trial group 14 (4118) patients were vegetarian and 20 (5882)

patients were Non vegetarian

In control group 20 (5882) patients were vegetarian and 14 (4118)

patients were Non-Veg

Fig 28 Diet wise distribution of patients

0

5

10

15

20

N N

TRIAL GROUP CONTROL GROUP

14

2020

14

Diet

Veg Non Veg

Page | 104

6 Addiction wise distribution of patients

Table no 12

Addiction

Trial Group Control Group

N N

None 30 8824 27 7941

Alcohol 2 588 0 000

Tobacco 1 294 2 588

Mishri 0 000 1 294

Smoking 1 294 4 1176

Total 34 10000 34 10000

In trial group 30 (8824) patients have no addiction 2 (588) patients

have addiction of alcohol 1 (294) patients have addiction of Tobacco 0

(0) patients have addiction of Mishri and 1 (294) patients have addiction

of smoking

In control group 27 (7941) patients have no addiction 0 (0) patients

have addiction of alcohol 2 (588) patients have addiction of Tobacco 1

(294) patients have addiction of Mishri and 11 (1176) patients have

addiction of smoking

Page | 105

Fig 29 Addiction wise distribution of patients

0

5

10

15

20

25

30

NONE ALCOHOL TOBACCO MISHRI SMOKING

30

21

01

27

0

21

4

Addiction

Trial Group N Control Group N

Page | 106

Statistical Analysis and Results

Effect of study on Karnashoola-

Table no 13

Karnashoola

Group A Group B

BT AT BT AT

N N N N

Grade 2 0 000 0 000 0 000 0 000

Grade 1 30 10000 7 2333 32 10667 5 1667

Grade 0 4 1333 27 9000 2 667 29 9667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 30 Effect of study on Karnashoola

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

30

7

32

54

27

2

29

Karnashoola

Grade 2 Grade 1 Grade 0

Page | 107

Table no 14

Karnashoola Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 088 100 033 006

969 2829E-

08 7667 HS

AT 021 000 041 007

Group

B

BT 094 100 024 004

1037 7103E-

11 8438 HS

AT 015 000 036 007

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 31

000010020030040050060070080090100

BT AT BT AT

GROUP A GROUP B

088

021

094

015

Karnashoola

Mean

Page | 108

Table no 15

Karnashoola

Mean SD Effect

Group

A

Group

B Trial Control Trial Control

Day 1 088 094 033 024 000 000

Day 3 065 071 049 046 2667 2500

Day 5 024 038 043 049 7333 5938

Day 14 021 015 041 036 7667 8438

000

010

020

030

040

050

060

070

080

090

100

Day 1 Day 3 Day 5 Day 14

Karnashoola

Mean Group A Mean Group B

Page | 109

Table no 16

Karnashoola N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3250 110500

510000 275 Control group 34 3650 124100

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 110

Effect of study on Karnakandu

Table no 17

Karnakandu

Group A Group B

BT AT BT AT

N N N N

Grade 3 7 2333 0 000 4 1333 0 000

Grade 2 18 6000 0 000 18 6000 0 000

Grade 1 7 2333 7 2333 10 3333 15 5000

Grade 0 2 667 27 9000 2 667 19 6333

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 32 Effect of study on Karnakandu

0

5

10

15

20

25

30

N N N N

BT AT BT AT

GROUP A GROUP B

7

0

4

0

18

0

18

0

7 7

10

15

2

27

2

19

karnakandu

Grade 3 Grade 2 Grade 1 Grade 0

Page | 111

Table no 18

Karnakandu Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 188 200 081 015

1091 3119E-

10 8906 HS

AT 021 000 041 007

Group

B

BT 171 200 076 014

1032 4746E-

09 7414 HS

AT 044 000 050 009

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Page | 112

Fig 33

Table no 19

Karnakandu

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 188 171 081 076 000 000

Day 3 126 118 057 058 3281 3103

Day 5 071 074 046 051 6250 5690

Day 14 021 044 041 050 8906 7414

000

020

040

060

080

100

120

140

160

180

200

BT AT BT AT

GROUP A GROUP B

188

021

171

044

Karnakandu

Mean

Page | 113

Table no 20

Karnakandu N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 4051 137750

373500 006 Control group 34 2849 96850

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is less than

005 Hence we conclude that there is significant difference between Trial

Group and Control Group

000

020

040

060

080

100

120

140

160

180

200

Day 1 Day 3 Day 5 Day 14

Karnakandu

Mean Group A Mean Group B

Page | 114

Effect of study on Karnasrava

Table no 21

Karnasrava

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 11 3667 0 000 8 2667 0 000

Grade 1 23 7667 3 1000 26 8667 2 667

Grade 0 0 000 31 10333 0 000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 34

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

11

0

8

0

23

3

26

20

31

0

32

Karnasrava

Grade 3 Grade 2 Grade 1 Grade 0

Page | 115

Table no 22

Karnasrava Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 132 100 047 009

1122 4356E-

13 9333 HS

AT 009 000 029 005

Group

B

BT 124 100 043 008

1130 9364E-

14 9524 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 35

000

020

040

060

080

100

120

140

BT AT BT AT

GROUP A GROUP B

132

009

124

006

Karnasrava

Mean

Page | 116

Table no 23

Karnasrava

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 132 124 047 043 000 000

Day 3 100 100 025 025 2444 1905

Day 5 047 038 051 049 6444 6905

Day 14 009 006 029 024 9333 9524

000

020

040

060

080

100

120

140

Day 1 Day 3 Day 5 Day 14

Karnasrava

Mean Group A Mean Group B

Page | 117

Table no 24

Karnasrava N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3535 120200

549000 655 Control

group 34 3365 114400

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 118

Effect of study on Karnabadhirya

Table no 25

Karn

Badhirya

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 0 000 0 000 0 000 0 000

Grade 1 13 4333 0 000 16 5333 2 667

Grade 0 21 7000 34 11333 18 6000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 36

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 00 0 0 0

13

0

16

2

21

34

18

32

Karnabadhirya

Grade 3 Grade 2 Grade 1 Grade 0

Page | 119

Table no 26

Karn

Badhirya Mean Median SD SE

Wilcoxon

W P-Value

Effect Result

Group

A

BT 038 000 049 009

799 7173E-

05 10000 HS

AT 000 000 000 000

Group

B

BT 047 000 051 009

816 0000138 8750 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 38

000

005

010

015

020

025

030

035

040

045

050

BT AT BT AT

GROUP A GROUP B

038

000

047

006

Karnbadhirya

Mean

Page | 120

Table no 27

Karn

Badhirya

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 038 047 049 051 000 000

Day 3 009 006 029 024 7692 8750

Day 5 003 006 017 024 9231 8750

Day 14 000 006 000 024 10000 8750

000

005

010

015

020

025

030

035

040

045

050

Day 1 Day 3 Day 5 Day 14

Karn Badhirya

Mean Group A Mean Group B

Page | 121

Table no 28

Karn

Badhirya N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3400 115600

561000 806 Control

group 34 3500 119000

Total 68

Page | 122

COMPARISION BETWEEN GROUP A AND GROUP B

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Table no 29

Overall Effect

Trial Group Control Group

N N

Marked Improvement 21 6176 16 4706

Moderate Improvement 8 2353 13 3824

Mild Improvement 4 1176 5 1471

No Change 1 2941 0 0

TOTAL 34 100 34 100

Fig 39

0

5

10

15

20

25

MARKED IMPROVEMENT

MODERATE IMPROVEMENT

MILD IMPROVEMENT NO CHANGE

21

8

41

1613

5

0

Overall Effect

Trial Group N Control Group N

Page | 123

DISCUSSION

Page | 124

Discussion is nothing but the logical reasoning of observations In

every research work discussion part is very important because it brings into

light about the logical analysis which are helpful in filling the research gap in

the scientific world

The discussion is categorized into following ways for the ease of

understanding

1 Discussion on selection of topic

2 Discussion on review of literature

3 Discussion on drugs their mode of action on the disease mode of action

of Karnadhoopana

4 Discussion on observation and results

1 Discussion on selection of topic

Otomycosis is commonly encountered in day-to-day practice Majority

of Indian people affected with this pathology This disease commonly

manifests in developing countries low socio-economic standard and lack

of hygiene Now a days due to busy lifestyle people are not able to follow

the proper instruction of care of ear which may be responsible for the

recurrent nature of disease So for the management of this we use

Karnadhoopana with the help of Agaruwadi Varti Dhoopana is simple

easy cost-effective procedure which can be done even at OPD levelso

for the disease Karnasrava we selected Karna Dhoopana as therapeutic

procedure Karnadhoopana was done with Agaruwadi Varti and Guggula

Varti which was very effective for treatment

Page | 125

2 Discussion on review of literature

Karnasrava is one such disease among 28 Karnarogas mentioned by

Acharya Sushruta in the chapter named Karna Roga Vigyana Acharya

Charaka included Karnasrava as symptom under the four types of

Karnarogas due to vitiation of different doshas Acharya Vagbhata has

not described Karnasrava separately It is a fact that systemic

description of Karnarogas is available in all the ancients of pus from a

Vata afflicted ear may results from head injury or immersion in water

Karnasrava is a clinical entity which can be correlated with Otomycosis

Karnasrava is explained as symptom as well as a disease in Ayurveda

Nidana- Karnasrava occur due to Samanya Nidana and Vishesh Nidana

Vishesh Nidana like Shirobhighata Nimmajato jale Mithyayoga of Shashtra

The exact pathology behind Karnasrava is not understood clearly

Purvarupa ndash No specific Purvarupa are found for Karnasrava in classical

literature Acharya Madhukara describe Purvarupa as expression of

Rupa(lakshana) with less intensity that is less intensity itching sound in ear

may considered as Purvarupa of Lakshana

Samprapti- Aacharya Sushruta not explained the Samprapti of Karnasrava

separately and we must consider the general Samprapti of Karnaroga Due to

various aetiologias as cited above ear afflicted by Vata dosha causes Twak

Rakta Mamsa dushti results in Karnasrava According to Acharya Sushruta

Vata-Kapha dose is dominance in Karnasrava

Page | 126

Nidan

Nija Agantuja

Vata ndash kapha prakopak nidana Shirobhighata Nimmajato-jale

Mithya yoga of Shastra

Vata- kapha Prakopaka(Chaya prakopak) Vata-kapha prakopaka

( Achay prakopak)

Twak Rakta Mamsa dushti

Karnasrava

Page | 127

Chikitsa

The curative aspect and this must be done simultaneously giving due

importance to Nidan Parivarjana that is preventive measures So Nidan

Parivarjana that is avoidance of causative factors like Jalkrida Mithyayogen

shashtrasya Karnakandu Shirasnan Pratishaya is the first step in combating

the disease and form the part of line of treatment

Above Samprapti helps us to proceed towards the treatment of Karnasrava

The main protocol of treatment is removal of fungus and wound management

which include various measures to keep area day clean clear of microbes and

providing ideal condition for healing

Samany Chikitsa- Acharya Sushruta described general treatment for

Karnaroga as Snehapana (Drinking ghee) Rasayana (Rejuvenation therapy)

Bhramacharya Avoid excessive speaking Avoidance of physical exercise and

head bath

Vishesha Chikitsa ndash Acharya Sushruta mentioned some procedures in the

treatment of Karnasrava which is Shirovirechana Karnadhoopana

Karnapurana Karanpramarjana Dhavan Avachurnana Karnapurana Above

various procedures described in Ayurveda for management of fungus growth

in ear discharging ear fulfill these requirements of wound management

Page | 128

Discussion on observation and Result

Out of 68 patients 34 patients included for the trial The incidence of

Karnasrava is observed in trial and control groups

The statistical analysis provided the following data

AGE

Trial group- Maximum no of patients that is 14 (41176) patients were from

age group 25-35 years followed by 29412 patients were from age group

18-25 years 23529patients were from age group 35-45 years and

58824 patients were from age group 45-60 years

Control group - Maximum no of patients that is 14 (41176) patients were

from age group 25-35 years followed by 20588 patients were from age

group 35-45 years and 20588 patients were from age group 45-60 years

17647 patients were from age group 15-25 years

The maximum no of cases of Karnasrava found in age group between 25 to

35 years The reason behind this is repeated use of ear bud or emersed water

in ear More use of earphone or working more in cold environment

GENDER

Trial group ndash A higher prevalence seen in females 6764 and 3235 in

males

Control group - A higher prevalence seen in males 5588 and 4411 in

females

Females and males both are prone to disease

Page | 129

EDUCATION

Trial group-It is observed that amongst 34 patients maximum ie16

(47059) patients were graduated 8 (23529) patients were HSC

educated 4 (11765) patients were SSC educated 4 (11765) patients

were illiterate 1 (29412) patient were primary educated and 1(29412)

patient were post graduated

Control group- It is observed that 10 (29412) patients were graduated 9

(26471) patients were HSC educated 6 (17647) patients were post

graduated 3 (88235) patients were SSC educated 3 (88235) patients

were primary educated3 (88235) patients were illiterate

There is no direct relation between education and Otomycosis

RELIGION

Trial group- The incidence of patients of Hindu religion are 9118 and Muslim

religion are 882

Control group- The incidence of patients of Hindu religion are 9706 and

Muslim religion are 294

There is no probable explanation for this maximum number of patients in

Hindu religion it depends upon the patients attend the hospital and

community residing there

Page | 130

DIET

Trial group It was found that maximum ie5882 patients were taking

mixed diet while 4118 were taking vegetarian diet

Control group It was found that maximum ie5882 were taking

vegetarian diet while 4118 patients were taking mixed diet

The dietary habit of person is based on choice availability and religious

customs of the person

ADDICTION-

Trial group- It was found that maximum ie 30 (8824) patients have no

addiction 2 (588) patients have addiction of alcohol 1 (294) patients

have addiction of Tobacco 1 (294) patients have addiction of smoking and

0 (0) patients have addiction of Mishri

Control group - It was found that maximum ie 27 (7941) patients have

no addiction 4(1176) patients have addiction of smoking 2 (588)

patients have addiction of Tobacco 1 (294) patients have addiction of

Mishri and 0 (0) patients have addiction of alcohol

Very few patients were addicted to Alcohol Smoking Tobacco and Mishri

These factors can be taken as provoking factors for Otomycosis

Page | 131

Discussion based on probable Mode of action of Karnadhoopana

In Ayurveda classics Karna Dhoopana is therapeutic procedure explain for

Karnasrava Dhoopana is administration of Dhooma (Fumes) with the help of

Dhoopan Dravya References indicates that analgesic and disinfectant effect

of Dhoopana karma and mention for Dushta Vrana Chikitsa It reduces

Vedana Srava amp also does Vrana Ropana action

Various Dhoopanas and Dhoopan Dravas for different element in various

Samhitas of Ayurveda but there is a lacuna of availability of reference

regarding how to do it and method of procedure Matra Kala Contraindication

etc

Currently simple modified way of Karnadhoopana according to Yukti Praman

and experience but there is lac of standardization

Karnadhoopana is one among the topical Bahiparimajan type of treatment

Karna Parmarjana is procedure of cleaning ear with the help of cotton or gauze

piece soaked in honey

Page | 132

Dhoopan

The fumes coming out on burning Agaruwadi Varti

Administrated directly into external ear canal

Causes vasodilation

Due to this increase blood supply in external ear canal

It helps in absorption of drug

Fumes dries up Srava and bring the analgesic effect

Karnagata Kapha amp Avrut Vata Dosha Shaman

Decrease in signs and symptoms like karnasrava Karnshool Karnabadhirya amp

Karnandu

Page | 133

3 Discussion based on probable mode of action of Agaruwadi

Dhoopana

Agaru ndash

I Agaru is a fragrant tree aroma is a result of fungal pathogenesis when the

wood of tree is contaminated by fungi at wounds it develops scrap filled

with resin and turn out to be aroma Medicinal use of Agaru have been

recorded in ancient medicinal science in in inflammatory disease and some

infective disease

II Acharya Charaka has referred to Agaru as an Ushna dravya despite having

Tikta Rasa Ashtang Samgraha used Agaru as Dhupana Dravya along with

Madan and Yawa in Karnasrava Nighantu recommended is use as a

Dhoopana

III In various Samhitas and Nighantus Agaru described as Tikta Snighdha

Sheetaprashamana Vranaprasadana Tvachya Due to these properties

Agaru is used in the treatment of Karna-Akashi Roga and Dushta Vrana

Shodhaka

IV Agaru is reported to have Antimicrobial Analgesic Antioxidants

Antihistaminic and anxiolytic properties Its Antihistaminic property gives

relief from itching which is cardinal feature of Otomycosis Due to Katu

Ushna Tikta Guna improves blood circulation Bheda stage develop It is

Niram Awastha of Dosha Karnagata kapha and vata get decrease and

symptoms like karnashoolakarnasrava get decrease Agaru also have a

Antioxidant properties

V Chemically Agaru Contain 2-(2-Phenylethyl) Chromones Terpenoids

Flavonoids

VI Natural Agarwood had inhibitive activities towards Staphylococcus Aures

The chloroform extract of Agarwood prolongs the pain threshold[108]

Page | 134

Madan

I Madanphala have therapeutic properties like Anti-inflammatory

Antiallergic Analgesic and Wound healing

II It is Useful in treatment of disease like Shotha (inflammation) Vidradhi

(Abscess) Pratishaya (Common cold) Kushta(Skin disease)

III Extract of Madanphala mainly contain Glcosides Tritorpenct

Glycosides Saponin

IV Saponin glycosides are act as fire extinguisher This property is helpful

for vartiIt also act as a detergent which clean the surface of fungus

V Tritorpenct act as a anti-inflammatory antimicrobial and

immunomodulator compound Interaction of glycosides with sterol

causes disturbance of selective permeability in plasmic membraneso

exudates and discharge get decrease

VI Pharmacological activity [109]

Antibacterial Activity The preliminary antibacterial activity of Methanolic

extract of Randia D lam was done on some standard and wild pathogenic

strains The inhibition of the bacterial growth was more pronounced on E coli

as compared to the other tested organism This shows the antibacterial action

of Randia D secondary infection can prevent

Anti-Allergic Activity In Ayurveda Randia D Extract and its fraction of milk

induced leukocytosis and eosinophilia in mice

Anti-Inflammatory Activity The crude methanol extract of fruit of Randia D

effectively reduced the carrageenin induced oedema in hind paw of the rats

significant reduction in granular tissue formation was recorded This activity

seems to be significant at various acute phases of inflammation and om

formation of granular tissue This proves action of Madanaphala in shopa

(inflammation)

Page | 135

Analgesic Activity Analgesic activity was tested in mice weighing between 20-

250 with six number of animals in each group Methanlic extract of fruit Randia

d give analgesic activity in both models This proves its Shoolanashaka (pain

killer) action

Immunomodulatory Activity Randia D has immunostimulant activity and

chloroform fraction which strongly affected immune system seems to be

bioactive fraction of this plant

The overall effect of Agaru Mandanphala Yawa having Anti-inflammatory

Antiseptic Antimicrobial Property Active ingredient shows these properties

Agaru Yawa Madanphala

Vatakaphaghna

Act as

Vranashodhak

Vedanasthapaka

Sheetaprashamana

Shothara

Avarana of Vata get decrease so helps to Shaman of Vata dosha

Karnakandu Karnashoola Karnasrava

Prashamana

Page | 136

This fact can be taken into consideration and probably acknowledge that

Karnadhoopana with Agaruwadi Varti had not leave any residue in the ear

Removal of fibrin keratinocyte migration and in growth of epithelial tissue

plays a major role in healing It is technique of fumigation of ear with the

smoke of anti-infective drug In Karnadhoopana Sthanik Swedana increase the

blood supply and helps in absorption of the drug reduce Karnakandu amp

Karnshoola associated with infection

Page | 137

SUMMARY AND CONCLUSION

Page | 138

The dissertation entitled randomize comparative clinical trial to study the

effect of Agaruwadi Karnadhoopan and Guggula Karnadhoopan In Karnasrava

wsr to Otomycosis

The dissertation is divided into fallowing parts

Introduction

Review of literature

Ayurvedic review

Modern Review

Drug review

Procedure review

Material and Method

Observation and result

Discussion

Summary and conclusion

bull INTRODUCTION

It includes importance of Shalakyatantra in Sushrut Samhita Charka

Samhita And Ashtang Samgraha

Common and specific causes of Karnasrava

Karnasrava is a clinical entity which can be corelate with Otomycosis

In Ashtang Samgraha stated the procedure like Karnadhoopana with

Agaru Yawa Madanphala in Karnasrava

Page | 139

bull REVIEW OF LITERATURE

1 Ayurvedic review

2 Modern review

3 Drug review

Ayurvedic review-

It includes Rachana-Sharir and Kriya-Sharir of Karna detail description of

Karnaroga and its types Karnaroga Samanya hetu Poorvaroopa Rupa

Samprapti Upadrava Pathya-Apathya of Karnasrava Vishesh Nidan and

Chikitsa of Karnasrava Detail description of Karnadhoopana according to

various Acharays have been mentioned

Modern review-

It includes anatomy and physiology of Ear brief anatomy of ear anatomy of

External middle and Internal ear Detail description of the disease

Otomycosis mechanism of fungal infection in external canal pathophysiology

investigations diagnosis and management

Drug review-

Detail description of Agaru Yawa Madan Guggula and its synonyms

Ayurvedic properties Karma uses Pharmacological action and their

pharmacodynamic properties

Page | 140

MATERIAL AND METHOD

It includes description regarding materials required for the study Preparation

of Agaruwadi Varti its Standardization Sterilization and packaging

Plan of study

1 Total 68 patients completed the treatment Age criteria was kept

between 18-60 years Patient selection was done by done by simple

random sampling method and divided into two groups A (Trial) and

Group B (Control) 34 patients in each group

2 Patients in Group A were treated with Karnadhoopana with Agaruwadi

Varti for 7 days two times in a day while patients in Group B were treated

with Karnadhoopana with Guggula for 7 days two times in a day

3 Clinical examination done during each follow up ie 0th 4rd 7th and

observation were recorded

Page | 141

OBSERVATIONS AND RESULTS

Page | 142

1 It was observed that higher incidence of disease Karnasrava ie

Otomycosis found in age group 25-35 years

2 Disease otomycosis was equal in both male and female

3 The trial group there was significant relief in Karnakandu (8906)

Karnasrava(9333) Karnashoola(7667) and karnabadhirya(100)

4 In control group there was significant relief in Karnakandu (7414)

Karnasrava(9524) Karnashoola(8438) and

karnabadhirya(8750)

Page | 143

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Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2143page

no

82 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publication Krnarogadhikara adhaya page no-

318

83 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary

Madhyamkhand Vatkalpana shlok no- 782-83 page no- 137

84 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 72-77 page no- 651

85 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya page no-

316

86 Vd Shree Laxmipatishastri Yogratnakara

87 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

Karnarogadhikara Shlok no- 808182 page no- 652

88 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 83 page no- 652

89 (PDF) Otomycosis A Comprehensive Review (researchgatenet)

90 httpswwwncbinlmnihgovpubmed24948980

91 A Simon Carney Scott-Browns Otorhinolaryngology Head and Neck

Surgery CRC press 8th publication Otitis externa and otomycosis

92 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition Diseases of external ear

Chapter no Page no -

93 wwwguggulipidcomtradhtm

Page | 154

94 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

95 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 1 chapter no-28 page no-

43

96 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009Agaru page

no726-728

97 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishra chapter Karpuradi varga Shlok no-31-

43 Page no- 116

98 httpswwwthiemeinimagecatlogsample_chapter_GOMPpdf

99 (PDF) Chemical Constituents and Pharmacological Activity of Agarwood

and Aquilaria Plants (researchgatenet)

100 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 4 chapter no-2 page no-4

101 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 chapter no-152 Madanpage

no376-379

102 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

103 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 1 chapter no-54 page no-

84

104 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 page no697-699

patol-yawa

Page | 155

105 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

106 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

Dhoompanvidhi page no- 252-254

107 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012Chikitasasthan Shlok

no- 151page no-406

108 httpswwwmdpicom1420-3049232342pdf

109 httpswwwijamcoinindexphpijamarticledownload0610201530

0

Page | 156

BIBILOGRAPHY

Page | 157

1 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

2 Scott-Brown WG Diseases of the EarNose and Throat Landon

Botterworth and co(publishers) Ltd1952 Volume 2

3 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012

4 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009

5 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi commantry

Purvakhand and Madhyamkhand

6 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

7 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-Tatva-

Sandipika hindi commentary Published by Chaukhamba Sanskrit

SansthanVaranasi

8 The Ayurvedic Pharmacopeia of India Ministry of Health and family welfare

department of Ayush Part 1 and part 4

9 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005

10 Acharya Trivedi Raguveer Prasad Ashtang sangrah published by

Vaidyanath Ayurveda bhavan pvt

11 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition

12 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary published by Chaukhamba

Orientalia

Page | 158

ANNEXURE

Page | 159

ANNEXURE- 1

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

CASE RECORD FORM

RESEARCH PROFORMA FOR MS (AYU) DESSERTATION

DEPARTMENT OF SHALAKYATANTRA

NAME -

ADDRESS -

GENDER - AGE - OCCUPATION-

RELIGION - EDUCATION - MARITAL STATUS-

OPD IPD NO-

DATE OF ADMISSIONCOMMESEMENT-

DATE OF DISCHARGECOMPLITION-

DATE OF COUNSELLING-

TEL NO-

CHIEF COMPLAINTS-

PAST MEDICAL AND SURGICAL HISTORY-

TREATMENT HISTORY-

FAMILY HISTORY-

Page | 160

PERSONAL HISTORY-

a) Ahar(Diet)

b) Vihar

c) History of addiction

GENERAL EXAMINATION

PULSE - MIN BP - mm of hg

TEMP - 0F RR - MIN

ASHATAVIDHA PARIKSHANA

Nadi- Mutra- Mala-

Jivha- Shabda- Sparsha-

Drik- Aakruti-

SYSTEMIC EXAMINATION

RS ndash

CNS-

CVS ndash

Page | 161

LOCAL EXAMINATION (KARNA PARIKSHAN)

OBSERVATION TABLE FOR SUBJECTIVE CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching )

RIGHT EAR LEFT EAR

KARNASHASHUKULI

KARNAPUTRAK

KARNAPALI

KARNAKUHARA -

SRAVA

GANDH

VARNA

SWARUPA

KARNAPATALA (TM)

Page | 162

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

Hearing Test

1Renne Test ndash

2 Weber Test -

Examination of Ear-

Pathological Investigation-

Other Examination-

Nidan Panchak-

1Hetu-

2Purvarup-

3Rupa-

4Upashayanupashaya-

5Samprapti

Signature of Guide Signature of Doctor(Researcher)

Page | 163

ANNEXURE 12

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Dhoopana Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization were done as recommended in pharmacy procedure

The raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 were mixed together

in equal quantity to make Agaruwadi churn

STEP 4 - Agaruwadi churn were triturated with appropriate quantity of water

and prepared Varti in GMP Certified Ayurvedic pharmacy Standard aseptic

precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Dhoopana Varti was packed in sterile air packed

container

STEP 6 - Agaruwadi Dhoopan was given with the help of Dhoopan yantra

TREATMENT DETAIL-

Purvakarma -

1 The patient is asked to sit comfortably on chair having sufficient light and

less amount of dust

2 The EAC is cleaned thoroughly by Pichu Varti (cotton swab) to remove the

discharge and other debris

Pradhankarma -

1 The patient is asked to relax completely on the chair

Page | 164

2 Fumes are passed to the ear with Dhoopana Yantra

3 Dhoopana yantra is funnel shaped and its one end will keep the ear covered

for the passage of Dhooma into the ear canal and other end where Agaruwadi

Dhoopana Varti were placed which produces fumes

4 This Dhoopana was given for 5 min

Pashchat karma -

1 The patient were advised to avoid cold refrigerated food drinks cold water

bath cold wind fog and prevent water from entering the ear

(A) Agaruwadi Dhoopana Varti

B) Guggula Dhoopana Varti SOP of it is same as above Agaruwadi Dhoopana

Varti

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Page | 165

ANNEXURE 21

INFORMED CONSENT DOCUMENT

Study Title

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

Introduction

- You are invited to take part in a research study RANDOMSIED COMPARATIVE

CLINICAL TRIAL TO STUDY THE EFFECT OF AGARUWADI DHOOPANA AND

GUGGULA DHOOPANA IN KARNASRAVA

- Before you decide it is important for you to understand why the

research is being done and what it will involve

- Please take time to read the following information carefully and discuss

it with friends relatives and your doctor if you wish

- Ask us if there is anything that is not clear or if you would like more

information

Purpose amp Nature of Study

- In this research project by examine you and ldquoKarnasravardquo (Otomycosis)

disease were treated

- In the part of treatment Agaruwadi Dhoopana or Guggula Dhoopan were

given

- Dhoopana means medicated drug fumes were given in ear with the help of

Dhoopan Yantra

Page | 166

- Treatment was given for 7 days

Study Duration

7days

Participation

- Your participation is entirely voluntary

- If you do decide to take part you were given this information sheet to keep

and be asked to sign a informed consent form

- If you decide to take part you are still free to withdraw at any time and

without giving a reason This will not affect the standard of current or future

medical care you may receive

Confidentiality

- All information which is collected about you during the research were

kept strictly confidential

- Any information about you which is collected from the center will have

your identity in the form of a code number so that it will remain confidential

Benefits Of Study

- The results obtained from this study would be helpful for providing better

quality of treatment amp other essential facilities for Karnasrava (Discharge)

patients

- You will get clinical benefit from the study

Page | 167

Risks Of Study

- In this treatment there are few chances of Irritation of Ear Nose and

congestion at EAC if any of these happens then treatment were given

Results Of Study

- If the Results obtained are profitable then they may get published

without disclosing your details

Signature of patient

Date

Time

Phone no of Researcher

Page | 168

रण मादहती पतरक

सशोिनाच शीषवक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE

EFFECT OF AGARUWADI DHOOPANA AND GUGGULA DHOOPANA

IN KARNASRAVA

परसतताना

- आपणास या सशोिनातपमक अभयासात सहिागी होणय़ाच आाहन करणयात यत आह

- सशोिनातील सहिाग तननदशचत करणयापी सशोिनाच उददश समजन घया

- खालील मादहती काळजीपवक ाचा आणण आशयक ािलयास आपलया डॉकिराशी कका

दहतशरचतकाशी चचाव करा

- काही सददिता असलयास कका आणखी मादहती ही असलयास आमछयाशी चचाव करा

सशोिनाच उददीटि सतरप

- सदर सशोिन परकलपामरधय आपलयाला तपासणी करन कणवसरा या वयाशरिची शरचककतपसा दणयात

यणार आह

- सदर वयाशरिची शरचककतपसा महणन आपणास अगरादी िपन कका गगल िपन

दणयात यणार आह

- सदर औषि आपणास 7 ददस घयायाच आह

Page | 169

कालािी

- 7 ददस

सहिाग

- आपला सहिाग हा पणवपण ऎनदछिक आह

- आपला सहिाग तननदशचत असलयास आपणास ही मादहती पतरतरका दणयात यईल आपणास यातील

समती पतरकार सही कराी लागल

- सहिाग तननदशचत असनही आपण कोणतपयाही ळस कोणतही कारण न दता माघार घ शकता

याचा आपलया दयकीय सविर कोणताही पररणाम होणार नाही

गोपनीयता

- सशोिना दरमयान गोळा कलली आपलया वषयाची सव मादहती गोपनीय ठणयात यईल

- आपली यनदकतक मादहती साकततक सतरपात गोपनीय ठणयात यईल

सशोिनाच फ़ायद

- सशोिनाच तनटकषव कणवसरा बाशरित रणाछया दयकीय इतर सविाचा दजाव सिारणयास

फायदशीर ठरतील

सशोिनातील जोणखम

- य़ा शरचककतपसमरधय कान दखण डॊळय़ातन नाकातन पाणी य़ण नाकात जळजळण डोक जड

होण ही लिण ददस शकतात यापकी लिण तनमावण झालयास तपयाची शरचककतपसा कली जाईल

Page | 170

सशोिनाच तनटकषव

सशोिनाच तनटकषव फ़ायदशीर ठरलयास आपली मादहती गोपनीय ठन परकाशशत करणय़ात यईल

रण सतािरी-

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

Page | 171

ANNEXURE 31

INFORMED CONSENT FORM

Patient OPD no __________

Subjectrsquos Identifier

Date of Birth Age Gender

I _____________________________________ age___________ years

exercising my free power of choice hereby give my consent to be included

as a participant in the clinical study entitled

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

1 I confirm that I have read have been read and understood the information

sheet for the above study and can ask questions

2 I understand that my participation in the study is voluntary and that I am

free to withdraw at any time without giving any reason without affecting my

medical care or legal rights

3 I understand that the Ethics Committee members investigators and study

doctors will not need my permission to look at my health records both in

respect of the current study and any further research that may be conducted

in relation to it even if I withdraw from the trial I agree to his access

However I understand that my identity will not be revealed in information

released to third parties or published

4I agree not to restrict the use of any data or results that arisefrom this study

provided such a use only for scientific purpose

5 I agree to take part in the above study

Page | 172

signature with Date-

Left hand thumb impression

Name amp signature of the witness ndash

Name amp signature of the student ndash

Page | 173

ANNEXURE 32

समतीपतरक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

वयकतीच य

ददनाक जरमददनाक

1) मी ह तननदशचत कररत आह ककसदर सशोिन परकलपाबाबतची सपणव मदहती मी ाचली असनमला ती

समजली आहतपयाबददल मला परशन वचारणयाची पणव मिा आह सदर मादहतीन माझ समािान झाल

आह

2) मी सदर सशोिनातन माझया मजीनसार किीही बाहर पड शकतो या माझया अशरिकाराची मला कलपना

आह

3) माझी दयककय मादहती तपासणयाची कागदपतर कळ सशोिनाकररता ापरली जाणार आहत याची

मला मादहती आहसदर सशोिन परकलपातील सबशरित घिकाना माझी दयककय मादहती पाहणयाची मी

समती दत आहतरावप या सदिावतील माझी ओळख दशववणारी मादहती कोणासही ददली जाणार नाहीयाची

मला कलपना दणयात आली आह

4) सदर अभयासातन शमळणारी मादहती अरा तनटकषव कळ शासततरीय हतसाठी ापरल जाणयासाठी माझी

समती आह

5) रील अभयासात सहिागी होणयास माझी समती आह

रण सतािरी-

Page | 174

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

ASSESSMENT CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching)

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

a) कणवशल ( pain )- 0 - Absent

1 ndash Present

Page | 175

b) कणवकणड (Itching)- 0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

c) कणवसततरा ( Discharge )

0- Absent

1-Mild- Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाशरियव ( conductive Loss of hearing )

0 - Present

1 - Absent

Page | 176

Page | 177

Page | 178

Page | 179

Page | 180

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

Page | 181

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 182

AUTHENTIFICATION CERTIFICATE

Page | 4

inflammatory process exudates were produced which will mix up with

fungal colonies and appear as discharge In initial stage of disease ear

discharge is watery but if there is secondary bacterial infection occur it

becomes mucopurulent Ear blockage and conductive type of hearing loss

are due to accumulation of fungal mass in external auditory canal

Fungal mass appears white or black or brown and is like a wet piece

of filter paper Examination with otoscope Aspergillus Niger appears black

headed filaments growth Aspergillus fumigates as a pale blue or green and

candida as a white or creamy deposit[9]

Otomycosis is a common condition and it mostly occurs in humid

area According to American academy of otolaryngology prevalence of

otomycosis is 52 all over a world and 09 in India 5-25 otitis externa

cases are due to otomycosis Nearly 61 types of fungal species being involve

in otitis externa 90 of fungal infection cases involve Aspergillus species

and the rest candida species[10]

In Ayurveda The common treatment Principle for all is Ghritapana

Rasayana Bhramacharaya Avyayama (Excessive exercise)

Ashirasnana(Head bath) Atibhashashya(Excessive speaking) This can be

used for the prevention and management of Karnaroga[11] Acharya

Sushruta explain specific treatment modality for Karnasrava is

Karnaprakshalana Karnapoorana Karnadhoopana Shirovirechana

Karnadhavana[12]These therapeutic procedure can be updated according to

different stages of these condition

In routine OPD it is observed that patient of otomycosis respond

more frequently to topical therapy than to systemic therapy Among all the

treatment modality Karnadhoopana is an effective and simple procedure

In this regard Karnadhoopana with Agaruwadi Varti or uggula had explain

in Ashtang Samgraha Agaruwadi Varti contain Agaru Yawa Madanphala

All these contains of Agaruwadi Varti and Guggula acts as Ruksha Ushna

Teekshana Laghu Guna acts as effective Shodhaka keeps ear dry reduce

Page | 5

pain discharge foul smell and thus control the infection Dhoopana is also

useful as Adhidaivika Chikitsa to protect the patient from external attack of

visible and invisible organism The principal treatment modality adopted in

Allopathic system of medicine is oral antibiotics and topical antibiotic drop

Long term use of oral antibiotic causes adverse effect like gastric irritation

reduce immunity and resistance to drug Long term use of topical antibiotic

drops cause Ph change in external canal which become prone to fungal

infection

Hence the therapeutic procedure with Guggula or Agaruwadi Varti

Karnadhoopana are cost effective safe and easy procedure and it can be

used more effectively

Page | 6

AIM OF STUDY

To evaluate the effect of Agaruwadi Varti Dhoopana and Guggula Varti

Dhoopana in management of Karnasrava

OBJECTIVE

To compare the efficacy of Agaruwadi Dhoopana and Guggula Dhoopana in

Karnasrava

HYPOTHESIS

NULL HYPOTHESIS -

H0- Agaruwadi Dhoopana is not effective than Guggula Dhoopana in

Karnasrava

ALTERNATE HYPOTHESIS -

H1- Agaruwadi Dhoopana is more or equally effective than Guggula

Dhoopana in Karnasrava

RESEARCH QUESTION

Whether there is significant difference between Agaruwadi Dhoopana and

Guggula Dhoopana in Karnasrava

Page | 7

PREVIOUS WORK DONE -

1 Anupama Patra B Effect Of Arka Taila In The Management Of

Karnasrava With Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching amp Research in Ayurveda

Gujarat Ayurved University Jamnagar 2007

2 Palmer Komalben K Further Study On Role Of Arka Taila In The

Management Of Karnasrava With Special Reference To

Otomycosis Shalakya Tantra Institute for Post Graduate Teaching amp

Research in Ayurveda Gujarat Ayurved University Jamnagar 2010

3 Sathisha Shankar B Management Of Karnasrava With Sthanika

Guggulu Dhoopana And Rasnaadi Guggulu-A Comparitive Study Shalakya

Tantra Government Ayurvedic Medical College Bangalore 2011

4 Shashikala DK Comparative Study On The Efficacy Of Vacha

Lashunaadi Taila Karna Pichu And Nimba Patraadi Dhoopana In The

Management Of Karna Srava Shalakya Tantra Government Ayurvedic

Medical College Bangalore 2014

5 Javale Anant A Clinical Study On The Efficacy Of Arka Taila In The

Management Of Karna-Srava Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching amp Research in Ayurveda

Gujarat Ayurved University Jamnagar 2005

6 Pournima V Koti Management Of Karnasrava With Priyangvadi Taila

Pichu With And Without Saarivadi Vati Shalakya Tantra Sri Jagadguru

Gavisiddeswar Ayurvedic Medical College Koppal 2015

7 Amisha Patel A Clinical Evaluation Of Honey In The Management Of

Karna Shoola With Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching and Research in Ayurveda

Gujarat Ayurved University Jamnagar 2016

Page | 8

REVIEW OF LITRATURE

Page | 9

Ayurvedic literature Ayurveda is a science of life practice since

thousands of years The ancient Indian system of medicine and surgery is

commonly known as Ayurveda This was given the status of Upaveda or

fifth Veda in the next stage of growth Among the available literature three

Samhita that is Charaka Samhita Sushrut Samhita Ashtang Hrudayam and

Ashtang Samgraha are the chief source of knowledge of Ayurveda

Ayurveda consist of eight branches Shalakyatantra is one among them

Shalakyatantra is one of its specialized branch deals with science of

ophthalmology otorhinolaryngology Oro dental surgery and head Acharya

Sushruta himself a practical surgeon was the first to advocate dissection of

dead bodies is indispensable for a successful student of surgery He had

described gross anatomy in the first chapter of Uttartantra Shalakyatantra

define by different Acharys as follows

शालाकय नामोरधवजतरगताना रोगाणा शरणनयनदनघराणाददसशरशरताना वयाशरिनामपशमनारव

स स ११०

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत [13]

चस १७१२

Shalakya Tantra Nirukti and Parichaya

शलाकायााः कमव शालाकय ततपपरिान शलाकयम डलहण [14]

The term Shalakyatantra is derived from Shalakya and Tantra

The word Shalakya means A probe and Tantra denotes teaching and

practices found in scripturesThe compendium in which application of

Shalaka in various surgical procedures is principally described is called as

Shalakya tantra

दनदटिवशारदााः शालाककनाः डलहण ( सउ ११३)[15]

An eye specialist is termed as Shalaki by Dalhana

Page | 10

Synonyms of Shalakya Tantra

Uttamanga Chikitsa Jatrurdhwa Chikitsa Urdhwang Chikitsa Shalakya

Chikitsa

Importance of Shalakyatantra-

Life of living being and all the Indriyas are situated in the head hence it is

known as Uttamanga

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत

चस १७१२

The treatment given to this part of the body is described specially in

Shalakya tantra While describing the importance of Shiras Vagbhata

correlates it to the root of tree (Urdhwa Mula) and body to the trunk of tree

(Adha Shaka)

Sushruta has deal with Mukha Roga in Nidan Shan and its treatment in

Chikitsasthan The description regarding the disease of eye ear nose and

head are found only in UttaraSthan Sushruta specially describes the

disease of Shalakyatantra as told by Videha in the beginning of Uttartantra

itself[16]

Shalakyatantra Itihas-

India Exhibits traditional of more than thousands of years in art literature

language logic and philosophy etc The convention was in its sophisticated

and advanced attire throughout the Vedic period

Vedic period ndash

1 Natush was treated for deafness by Ashwinikumars (Rigveda)

2 Rujaswa and Kanva were treated for blindness by Ashwani Kumaras

(Rigvedas)

Page | 11

3 There are several prayers mentioned for normal functioning of sense

organs (Yajurveda)

4 Structures and functions of Mastishka are described (Atharveda)

5 Mantras having reference to disease of Eye Ear Oral cavity etc are

found (Atharvaveda)

Upanishada Period ndash

1 Samhita Period

a) Sushrut Samhita ndash

bull Explanation regarding Netra Nasa and Shirorogas (Uttartantra 1-

26th chapter)

bull Details regarding Mukha and Karna Roga Nidan and

Chikitsa(Nidansthan 16th and Chikitsasthan 22nd chapter)

bull Description regarding Karna Chedana Sandhana Nasa

Ostasandhana Sutra Sthan 16th chapter

b) Charaka Samhita -

bull Explanation regarding Shirorogas (Sutrasthan 17th chapter)

bull Explanation of Gala rogas like Upajivika Galshundi and Rohini

bull Nasa Shiro Mukha Karna and Netra Chikitsa (Chikitsa sthan 26th

chapter)

bull Description regarding Lakshana and Chikitsa of Shankhaka

Ardhavbhedaka Shirovirechana and Shiro basti (siddhi sthan 9th

chapter)

c)Ashtnga Sangraha ndash

bull Detailed description regarding Shalakyatantara (Uttartantra 11-28

chapter)

bull Description of Kriyakalpa (Sutrasthan 32nd and 33rd)

Page | 12

d)Ashtang Hrudayam

bull Detailed description on Shalakya Tantra (Uttar tantra 8-24 chapters)

bull Kriyakalpas (Sutrasthan 23rd and 24th chapter)

e) Bhela Samhita

bull Chakshushya Vaisheshik and Buddhi Vaisheshik Alochaka pitta

f) Harita Samhita- Branch of Medical science offering elaborating

information about the procedure like Nasya Anjan Gandusha etc

comprehended with their applications in disease of Head Eyes Ears

Eyebrows Throat Temporal region and cervical spine is known as

Shalakyatantara

शशरोरोगा नतररोगा कणवरोगा वशषताः भरकरठशङकमरयास य रोगा समिनदरत दह १३

तषा परततकारकम व नसतयतपयवणजनातन च अभयङगमखगणडषकियााः शालकयसशमतााः १४

इतत शालाकयनाम [17]

Documentation of different ancient literature gives various references

regarding all aspects of Karnasrava in various periods It is very much

important to know the history of Karnasrava from Vedic Pauranic Samhita

and Samgraha period

Vedic period ndash The Vedas being the oldest source of knowledge have no

direct mentioning of Karnasrava

Page | 13

Samhita and Samgraha period ndash

Aacharya Sushruta described about Karnaroga Karnasrava Nidan

Roopa and Chikitsa The detail description is available in Sushrut

Samhita Uttartantra 20 and 21st chapters

Aacharya Charaka did not specify Karnasrava but mentioned 4 types

of Karnarogas that is Vataj Pittaj Kaphaja and Sannipataja and their

treatment in 26th chapter of Chikitsasthan

In Ashtang Hrudaya karnasrava is not explained as a separate disease

but Chikitsa is mentioned in 18th chapter of Astanga Hrudaya

uttartantra

In Ashtang Samgraha Chikitsa is mentioned in 22nd chapter of Astang

Samgraha Uttartantra

The details about Karnasrava are explained in Bhavprakasha

Madhyamakhanda 64th chapter

Madhavakara has explained about Karnasrava in 57th chapter of

Madhymakhanda

Karnasrava is also explained in Sharangadara Samhita Uttarkhand 11th

chapter

The reference for treatment of Karnasrava is available in

Yogaratnakara

In Gadhnigraha Karnasrava and its treatment is mentioned in

Karnarogadhikara Adhaya

Vangasena had mentioned about the disease and treatment in 69th

chapter

Chakradatta explained Karnasrava in 57th chapter

Dalhana has given commentary on Sushrut Samhita Uttartantra 20th

and 21st chapter

Sankhya Samprapti of Karnasrava ndash

Aachary Sushruta explains 28 Karnaroga in Uttaratantra Karnaroga

Vigyniyam Aadhaya Aacharya charaka explain 4 Karnaroga in

Page | 14

Karnarohvigyniyam Adhaya based on doshas Acharya Vagabhata in

Ashtang Hrudaya explain 25 Karnaroga in Adhyaya

कणवशल परणादशरच बाशरियव कषड ए च

कणवसरााः कणवकणडाः कणव चवसतततर च

कशमकणवपरततनाहौ विशरिदवविसततरा

कणवपाकाः पततकणवसततराशवशरचतवविम

कणावबवद सपतवि शोफशरचावप चतवविाः

ऎत कणवगता रोगा अटिावशततरीररतााः

स उ २०- ३ त ५[18]

ातकणवरोग वपततकणवरोग कफकणवरोग

रकतकणवरोग सनदरनपातकणवरोग कणवनाद

बशरिरतप परततनाह कणडाः शोफ पततकणवक

किशमकणवक उियरपविरधयअशो अबवद

कशरचकणवक वपपपली वदाररका पाळीशोष

ततिका पररपोिो उतपपातो उरमरर दाःखिवन

शलहाखयााः परचवशनदरतकणवरोगा उकतााः

इदिीका अ स उ २१ [19]

चतपाराः कणवरोगााः

च स [20]

Page | 15

KARNA

Karna ndash करोतत शबद गरहण [21]

The organ of hearing

Karnasrava- कणवसतय कणवयोाव ससराा [22]

Discharge from the ear is referred as Karnasrava

KARNA SHAREERA

bull Nirukti

कणयवत अकणयवत अनन इती [23]

It means reception and conduction of sound waves

These are the functions of external and middle ear

bull Nirukti of Sravanam

शरयत अनन इती शरणम[24]

It means perception of sound

It can be attributed to the internal ear function

bull Karna Utpatti-

Karna is an organ formed by Akash Mahabhuta[25]

The fundamental characteristic is as follows

Indriya ndash Srotram [26]

Indriya Adhisthan ndash Karna [27]

Indriya Dravy ndash Akasha [28]

Indriya Arth ndashShabdha [29]

Indriya buddhi ndash Srotobyddhi

Page | 16

bull Paryaya of Karna- Shabdapatha Srotrapatha Sravanam shruti

Kuhuram Dwanigraham etc

bull Definition of Karna-

कणवशटकलयनदछिरनमिटिोपगरदहत शरोतरमछयत [30]

मा तन ५७१

The definition of Karna is stated in Madhav Nidanam Indriya which is not

seen with naked eye along with Shashkuli is called Shrotra that is Karna

Indriya is so minute that it is not perceived with any sense organ

In Charak Samhita the word Karna explain as the Indriya Adhisthan of

Shabdha Karna is described as one of the Prathyangas of the body He

emphasizes that all Indriyas manifest during the 3rd month of gestation

period

Acharya Sushruta while describing formation of Purusha from Prakriti or

Avyakta narrated that all Indriyas are developing from the Vikarika and

Taijas Ahankara Both Vagabhata and Sushruta stated that Karna as one of

the Bahirsrotas

शरण नयन दन घराण गदमढराणण न सततरोताशसराणा बदहमवखातन [31]

स शा ५-१०

In Ashtang Hradaya Vagbhata has states that all Indriyas are Atmaja

According to him lower lobule elevated helix projected posterior portion

fleshy and adherent ear are indications of long span of life[32]

ततरखातखातन दह अनदसतमन शरोतर शबद ववकतता [33]

ा शा ३-३

शबदाः शबदनदरिय सवनदछििसमहो ववकतता [34]

स शा १-२६

Page | 17

Ear has the prominence of Akash Mahabhuta The prominent dosha of ear

is Vata It is important seat of Vata The prominent Dhatus are Asthi and

Mamsa Karna is one of the Panchgnanendriyas and it meant for hearing

Sushruta narrated that Karnasthita Asthi and Sandhi

घराणकणवगरीाकषिकोषष तरणातन [35]

सशा ५-२२

शरोतरशरगािकष शखाताव [36]

सशा ५-३२

गडकणवशखटककम [37]

स शा ५-२२

One Sandhi and one Tarunasthi in ear

Sandhi ndash Karna contain two Sandhi one in each ear Type of Sandhi is

Shankhavartha which is present in Shringataka

Mansapeshi ndash 2[38]

Siras ndash 10 [39]

Vataj Sira - 4

Pittaj sira - 2

Kaphaj sira - 2

Raktaj Sira - 2

Avedhya sira-

कणवयोदवश तासा शबदादहनीनामकका पररहरत

सशा ७-२५[40]

Amongst above mentioned ten Siras each Karna lodges one Shabdavaha

Sira It is Avedhya

Page | 18

Dhamani -2

Length of ear is 4 Angula

Karna moola ndash 2 Angula

कणाविरतर चतदवशअगलम

स शा ३५-१४[41]

The distance between two ears through the back of the neck is 14 Angula

bull Marmas of Karna-

1 Vidhuras-

कणवपटठतो अिाःसशरशरत विर ततर बशरियवम

सशा ६-३७[42]

कणतपयादद सतनायममवणी ककनदचचनदरनममनाकर कलयकररणणच

डलहणाचयव[43]

अिसततात कणवयोतनवमन विर शरततहाररणण

ा शा ४-२९[44]

Sankhya-2

Vistara- frac12 Angula

Type- Snayumarma (Susha)

- Dhamanimarma(AH)

- Vaikalykar

Sthana- It is situated in the depressed portion in the back of the ear

Injury to them causes loss of hearing

Page | 19

2 Shringataka marma-

नदजवहाकषिनाशसकाशरोतरखचतटियसरमम

तालरयासतयातन चतपारर सरोतसा तष ममवस

वदि शरगातकाखयष सददसततपयजतत जीवतम

मा तन ५७१ [45]

Sankhya- 4

Type- Siramarma

Sthana- It is in head that is amidst Siras (blood vessels) nursing sense

organ

A palm size area near Talu

Injury to this Marma causes death

In modern anatomy ear divides into Bhayakarna or External ear Mdhyakarn

or Middle ear Antahkarna or Internal ear This is extremely appropriate

Even though the ear is divided into three divisions in the point of modern

anatomy Ayurveda denotes ear organ is one Ayurveda treats disease by

way of assessing Dosha and Dushya Here Dushya is one that is Karnendria

Dosha difference will call for different treatment for different disease Hence

treating the vitiated Dosha will cure the disease irrespective whether it is in

external middle or internal ear The thought is based on different

fundamental principle from Ayurveda

bull Parts of Karna

In Ayurveda classics detailed description about anatomy of ear is not

available But the various parts are mentioned as follows

Bhayakarna- External ear

Mdhyakarna ndash Middle ear

Antahkarna- Internal ear

Page | 20

द कणवशटकशलक दॊ कणवपतरकौ

च शा 7-11[46]

कणवशटकशलक कणवगतातवकौ कणवपतरकौ त बाहयकणा

चिदतत च शा 7-11[47]

शटकली बाहयपालयाशरिटिानम

डलहन- स शरच 25-1 12[48]

Karna Shashkulika ndash It is also called as Karna Shashakuli Charaka has

mentioned this term while describing different Pratyngas of the body

Acharaya Gananatha sen has given the clarification for it as a pinna or

auricle[49]

Karnapali ndash It is popularly known as lobule of the ear Daivakrita Chidra is

present in it

Karnaputrika- Ayurvedic scholars accepted two terms in this cortex They

are Karnaputrika and Karnaputrika The former is considered as Tragus and

antitragus[50]

Karna Prushtha- It can be taken as the cranial surface of mastoid or

auricle[51]

Karnapeetha- Aacharaya Sushruta firstly mention the term Karnapeetha

It is mentioned first by Sushruta while describing the procedure of

Karnavyadana Vagbhata has mentioned that it is Adhobhaga of Karna

Dalhana has clarified that it is the region above the Karnaputrika that is the

region which is at the bottom of the concha

Karnamoola ndash It can be considered as parotid region[52]

Karna lathika ndashAcharaya Dalhana mentioned lobule as a Karna Lathika

Page | 21

Karnaavatu ndashThis term is used by Sushruta while describing the

measurements of different Angapratyangas where he has mentioned that

the distance between the Karnaavatu is 14 Angul Dalhana has comments

that it can be taken as the distance between two ears from behind[53]

Shabdhavahasrotas ndash It also called as Shabdapatha or Srotapatha The

whole passage through which the sound waves pass can be taken as

Shabdavahasrotas[54]

Shrotashringataka ndash It can be taken as the labyrinth of ear[55]

bull Dosha in context to Karna-

Karna is principal location of Vayu

1 Prana Vayu- Prana Vayu circulating in oral cavity is responsible for

Dehadhruka that is keeping all body parts active Indriyadruka that is

keeping all Dnyanendriya healthy by proper nourishment (Purana) helps in

deglutition of food material and convey the stimulation of Indriyabuddhi

and atma

2 Udana Vayu- Bala(strength) Varna speech singing are its function It

is responsible for facial expressions due to pleasure sorrow anger love

frustration etc in general its circulation and actions are just opposite to

Pranavayu

3 Vyana Vayu- Its principal functions are circulation of Rasa and Rakta

through body and various movements Its main location is Hrudaya Five

types of movements for which it is responsible are expansion contraction

upward downward and oblique other activities are opening closure of

eyelid yawning perspiration During circulation if it gets obstructed due

to Srotodushti it generates disease of that Srotas Vyana Vayu gets vitiated

by disease of Rasa Rakta Oja and Chetanadhatu

Page | 22

4 Samana Vayu- It is circulating in the vicinity of stomach and intestine

and helps in keeping the Jatharagni (digestive juices and enzymes) in

equilibrium Disturbance in Jatharagni precipitates disease

5 Tarpaka Kapha- Entire body functions movements are controlled and

executed by various centers in the brain Sensation perceived by sense

organs is conveyed to Mann and Aatma residing in Hrudaya The motor

signals from them are then conveyed to the functioning

organsKarmendriya through Prana Vayu Shira head is therefore a

location of continuous activities motions of Vata All these centers are in

unctuous Majjadhatu in the Shira For stabilizing this ever-active Vata and

to nourish the Majja dhatu very unctuous Tarpaka Kapha situated in Shira

plays an important role

bull Ayurvedic aspect of sound perception [56]

According to Ayurveda Pratyaksha Dnyan or Perception of any sensation

including Shabda occurs due to interaction of the Karnendriya and the

Indriya- Arth -Karma resulting in Sravana

External Environmental acquaintance with living body is executed by five

sense organs namely Netra Karna Nasa Jivha and Twaka All

Dnyanendriya that is sense organ are Panchmahabhautic combination

Despite this fact every Indrya sense organ perceives object Tanmatra of

that Mahabhuta only from which it is originated from Akash Mahabhuta and

hence perceives Shabd only that is audio perception Shrotrendriya is one

of the principal locations of Vata and its function is to perceive Shabda that

is sound waves This sensation is conveyed through Shabdavahi Dhamanis

to Mana and Atma through Pranavayu and the sequence is responsible for

perception of sound in this way external sound is perceived and interpreted

when Atma is linked with Mann Mann is linked with Indriyabuddhi that is

minute virtual Dnyanendriya located in brain Indriyabuddhi is linked with

Adhishthana with prominent Mahabhuta and lastly with Indriya

ArthShabdatanmatra that is sense object Once this sequence is completed

Page | 23

the meaning of a particular sound is interpreted and understood In this

entire process of perception and interpretation of sound waves Pranavayu

and Tarpaka Kapha located in Shira play extremely important role Hence

the healthy status of all the sense organ depends upon the normal

physiologically homeostatic condition of Pranavayu and Tarpaka Kapha

MANAS

ATAMA

BUDDHI

AHANKARA

ARTHA

Page | 24

EAR ANATOMY

bull Embryology of the Ear [57]

1 The sound conducting apparatus develops from the branchial apparatus

whereas the sound perceptive apparatus from the ectodermal otocyst

2 The pinna develops from the six hillocks around the 1st branchial cleft

3 External auditory canal develops from 1st branchial cleft

4 The outpouching of the 1st pharyngeal pouch gives rise to a proximal

narrow part that forms the eustachian tube and distal dilated part that

forms the middle ear cavity

5 Prussakrsquos space is a potential space lateral to the Shrapnellrsquos membrane

and medically by the neck of malleus that can be involved during the

extension of cholesteatoma

6 Development starts in the 3rd week of the intrauterine life and is

completed by 16th week of intrauterine life Membranous and boney

labyrinth develops from the otic capsule

The Ear is divided into

1 External Ear

2 Middle Ear

3 Internal Ear or the labyrinth

Page | 25

Fig 1 Ear Anatomy

EXTERNAL EAR [58]

The outside ear contains pinna and lobule

Pinna is the noticeable piece of outer ear made from single sheet of yellow

flexible ligament covered by subcutaneous tissue and skin It has two

surfaces average and parallel It is intently disciple to perichondrium on its

sidelong surface while it is somewhat free on average surface Pinna

incorporates tragus helix against helix fossa three-sided scaphoid fossa

incisura terminalis

External auditory Canal ndash It extends from the bottom of the conchea to

the tympanic membrane and measures about 24 mm along its posterior

wallit is S shaped

Parts 1 Cartilaginous part

2 Bony part

Page | 26

Cartilaginous part ndash The outer one third is cartilaginous consist of fibro

cartilage is directed first inward backward and upward It has Fissure of

Santorium The skin of this part of the canal contains hair follicles

sebaceous gland and cruminous gland

Bony part ndash The inner two third part is boney It goes forward downward

and medially skin lined in this part is very thin Isthmus is the narrowest

part of the canal lying medial to junction of bony and cartilaginous part

nearly 5 mm lateral to tympanic membrane

The roof and posterior wall of the external auditory canal shorter than floor

and anterior wall The skin lining the tympanic membrane and boney canal

has a self-cleansing property due to migration of keratin layer of epithelium

from drum towards the cartilaginous portion

Relations- Anteriorly- Temporomandibular joint and parotid gland

Superiorly- Middle cranial fossa

Inferiorly- parotid gland

Posterior- Mastoid antrum mastoid air cells and facial nerve

Nerve supply ndashSensory nerve supply of the external ear The auricle

supplied by fibers of the great auricular nerve (C2 and C3) and lesser

occipital nerve (C2) Auriculo temporal branch of the 5th cranial nerve and

auricle branch of the vagus (Arnoldrsquos nerve) supply external canal Facial

nerve has small sensory contribution on posterior-inferior wall

Tympanic Membrane -It is the partition between EAC and middle ear It

is a thin semitranslucent membrane pearly white in colored lying obliquely

in the medial end of EAC with the angle of 55 It is forming major part of

lateral wall of middle ear Annulus tympanicus is attached at its

circumference to the sulcus The TM is oval shape It measures

approximately 10 mm in vertical diameter and 90 mm in horizontal

diameter

Page | 27

Layers ndash Tympanic membrane consist of three layers

1 Outer Epithelium or cuticular layer which is continuous with skin of

external ear

2 Middle fibrous layer has both circular and radial fibers middle layer

missing in upper part

3 Inner layer- Inner mucosal layer which is continuous with middle ear

mucosa

Parts ndash Tympanic membrane consist of two parts

1 Pars tensa -It is largest part below the malleolar folds The inner

surface at the center attached to the handle of malleus Angle of cone

is most illuminated part in the pars tensa at anteroinferior part of pars

tensa

2 Pars flaccida Sharpnells membrane -it is triangular area above the

malleolar folds which are thin and devoid of fibrous tissue and

annulus It fits into notch of Rivinous

Nerve supply 1 Anterior half of lateral surface Auriculotemporal V3

2 Posterior half of lateral surface Auricular branch of vagus cn 10

3 Medial Surface Tympanic branch of CN 9 (Jacobsons nerve)

Fig 2 Tympanic membrane of ear

Page | 28

MIDDLE EAR [59]

The middle ear or tympanic cavity is an irregular laterally compressed

space within the temporal bone It is filled with air that is supplied to you

from the nasal part of the throat through the ear canal It contains a chain

of mobile bones that connect its side with the medial wall and serve to

transmit vibrations transmitted to the eardrum through the cavity to the

inner ear Including the parapet the vertical and anteroposterior diameters

of the cavity are each approximately 15 mm The transverse diameter

measures about 6mm at the top and 4mm at the bottom Compared to the

eardrum it is only about 2mm The eardrum is limited laterally by the

eardrum medially by the lateral wall of the inner ear It communicates

behind with the tympanic antrum and through it with the air cells of the

mastoid and in front with the auditory canal The middle ear together with

the Eustachian tube aditus antral and mastoid air cells is called the

middle ear cleft It is lined by mucus membrane and filled with air

It is divided into 3 parts

1 Mesotympanum (located in front of the pars tensa)

2 Epitympanum or attic (located above the pars tensa but medial to

Sharpnells membrane and the lateral bony wall of the attic)

3 Hypotympanum (located under pars tensa) The middle ear is like a

hexagonal box with a roof

Carotid or Anterior wall- It separates middle ear cavity from internal

carotid artery The various structure passing through anterior wall of

tympanic cavity

bull Canal of chorda tympani nerve

bull Canal of tensor tympani muscle

bull Eustachian tube

bull Anterior malleolar ligament

bull Anterior tympanic artery

Page | 29

Posterior or mastoid wall ndash The upper part of the back wall shows the

opening of the auditorium Below the auditory is a triangular bony

projection known as the pyramidalis processors The stapedial tendon is

transmitted through the apex of the pyramidalis processes The vertical

portion of the facial nerve descends along the posterior wall until it opens

into the stylomastoid foramen

Roof or Tegmental wall (Pars terminalis)- It is formed by a thin bone

plate called the tegman tympanum that separates the skull and tympanic

cavities It is located on the anterior surface of the rocky part of the

temporal bone near the junction with the temporal shell it extends back to

the roof in the tympanic membrane and anteriorly to cover the half canal

of the tensor tympanic muscle The lateral border corresponds to the

remains of the Petro scaly suture

Floor ndash It is formed by a thin plate of bone which separate middle ear from

the bulb of the internal jugular vein lodged in the jugular fossa

Lateral wall ndash It is formed by tympanic membrane and partly by a portion

of squamous part of the temporal bone It separates the middle ear from

external ear

Medial wall- It separates the middle ear from the inner ear

bull The promontory is the most prominent and convex part formed by the

basal rotation of the cochlea

bull The bony lateral semicircular canal is postero-superior to the promontory

above the oval window

bull The oval window is located between the middle ear and the vestibular

slope of the cochlea It is closed by the stirrup footrest and the annular

ligament

Page | 30

bull The round window is located under and behind the cape The round

window recess is directed to the rear It is closed by the secondary eardrum

and separates the middle ear of the Scala tympani from the cochlea

bull The facial nerve passes through the bony fallopian tube above the oval

window

Mastoid Antrum ndash It is a large space with air in the upper part of the

mastoid and communicates with the attic through the aditus The roof is

formed by the antri tegmen which extends and separates the tympani

tegmen from the middle cranial fossa The lateral wall of the antrum is

formed by a bony plate that is on average 15 cm thick in adults It is

marked externally on the surface of the mastoid by the suprameatal triangle

(MacEwen)

Aditus and Antrum- Aditus is a gap through which the attic communicates

with the antrum The boney prominence of the horizontal canal lies on its

medial aspect even as the fossa incudes to thats attaches the quick system

of incus lies laterally Facial nerve publications simply underneath the

aditus

The mastoid and its air cell system-

The mastoid consists of bone cortex with a honeycomb of air cell

underneath Depending on development of air cell three types of mastoids

have been described

1Well-pneumatized or cellular- Mastoid cells are well developed and

intervening septa are thin

2Diploetic- Mastoid consist of marrow spaces and a few air cells

3Sclerotic or acellular ndash There are no cells or marrow spaces

With any type of mastoid pneumatization antrum is always present In

sclerotic mastoids antrum is usually small and the sigmoid sinus is

anteposed

Page | 31

Depending on the location mastoid air cells are divided into

1 Zygomatic cells (In the root of zygoma)

2 Tegman cell (Extending into tegmen tympani)

3 Perisinus cells (overlying the sinus plate)

4 Retrofecial cells (round the facial nerve)

5 Peri labyrinthine cells (located above below and behind the

labyrinthine some of them pass through the arch of superior

semicircular canal These cells may communicate with the petrous

apex)

6 Peritubal (around the Eustachian tube Along with hypotymoanic

cells they also communicate with the petrous apex)

7 Tip cells (which are quite large and lie medial and lateral to the

digastric ridge in the tip of mastoid)

8 Marginal cells (Lying behind the sinus plate and may extend into

the occipital bone)

9 Squamosal cells (Lying in the squamous part of temporal bone)

Development of Mastoid ndash

The mastoid develops from the scaly petrous bone The petrosquamosal

suture may persist in the form of a bone plate - Korners septum which

separates the superficial squamosal cells from the deep rock cells Korners

septum is surgically important because it can cause problems locating the

antrum and deeper cells and thus lead to incomplete removal of the disease

during mastoidectomy The mastoid antrum can only be reached if Korners

septum is removed

Page | 32

Fig 3 Cross section of Mastoid

Contents of the middle ear

Ossicles ndash Three tiny bones which conduct the sound from eardrum to oval

window

Malleus ndash It is the largest and most lateral ossicle measuring 8 mm in

length It has head neck handle anterior and lateral processes The head

is situated in the epitympanum A lateral process project laterally from the

neck while the handle is firmly fixed to the pars tensa of the ear drum

Incus- It has a body short process and long process The body short

process and long process The body articulate with the head of mallelus in

the attic and the short process project into the attic The long process

projects downwards behind the handle of malleus running parallel to it and

articulate with the head of the stapes via the lenticular process

Stapes ndash It is the smallest ossicle measuring about 35 mm and consist of

head neck footplate and anterior and posterior curcura The footplate of

stapes is held to the oval window by the annular ligament

Page | 33

Muscles ndash

1Tensor tympani ndash It is inserted is a branch of the facial nerve which carries

the sense of taste It is first arch muscle supplied by branch of mandibular

nerve V3

2 Stapedious muscles ndash It is inserted to the neck of stapes It is the second

arch muscle supplied by branch of facial nerve that is nerve to stapedius

Fig 4 Contents of the middle ear

Blood supply of Middle Ear

bull Anterior tympanic branch of maxillary artery which supplies tympanic

membrane

bull Stylomastoid branch of posterior auricular artery which supplies middle

ear and mastoid air cells

Page | 34

Four minor vessels are

bull Petrosal branch of middle meningeal artery runs along greater petrosal

nerve

bull Superior tympanic branch of middle meningeal srtery traversing along

the canal for tensor tympanic muscle

bull Branch of artery of pterygoid carotid

bull Tympanic branch of internal carotid

Lymphatic Drainage of Ear

Lymphatics from the middle ear drain into retropharyngeal and parotid

nodes while those of the Surgical Importance ndash Eustachian tube drain into

retropharyngeal group

1 The middle ear is part of contiguous organs including nose nasopharynx

Eustachian tube and mastoid bone lined by respiratory mucosa Any

respiratory infection or allergy is likely to pass to middle is likely to pass to

middle ear

2 Moreover middle ear suppurative disease may spread to adjacent organs

and produce complication eg Labyrinthitis meningitis facial nerve palsy

etc

3 Lenticular process is vulnerable in suppurative ear diseases and causes

ocular disruption

4 Prussac space is the site of primary acquired cholesteatoma

Page | 35

INNER EAR [60]

Inner ear is divided into two parts

1 Bony Labyrinth

2 Membranous labyrinth

Anatomy of bony labyrinth

It is divided into two parts

1 Vestibule

2 Cochlea

3 Semicircular canal

The vestibule is located between the medial wall of the middle ear and the

lateral to internal acoustic meatus anterior to the semicircular canal and

posterior to the cochlea The vestibule is the central part of the inner ear

On its side is the oval window opening which is closed by the bracket foot

plate The bony cochlea is located in front of the vestibule It has 275 turns

wound around a bony axis called a modiolus The cochlea is about 30 mm

long The hollow center of the modiolus is a spiral canal that contains the

fibers and ganglion cells of the cochlear nerve A thin bony sheet the bony

lamina winda around the modiolus This divides the cochlear duct into two

galleries the Scala vestibuli above and the scala tympani below

There are three semicircular canals superior posterior and lateral They

are semicircular in shape and open into the vestibule One end of the

semicircle is enlarged and is known as the sphere

The membranous labyrinth is in the bony labyrinth It is connected to the

bony labyrinth by fibrous trabeculae and is surrounded by perilymph The

endolymph is located in the membranous labyrinth

Page | 36

The utricle is in the upper part of the vestibule while the saccule is found

below Both the utricle and saccule contain a single sensory patch called

the macula Each macula is covered with a neuroepithelium made up of

neuroepithelium made up of sensory hair cells and support cells these cells

are separated by a basement membrane Fibers of the vestibulo-cochlear

nerve enter the macula and pierce the basement membrane to terminate

at the base of the hair cell or cell bodies The utricle and the saccule with

their macula are called otolith organs Membrane semicircular canals are

the membrane canals of the corresponding bony semicircular canals They

open into the utricle through five openings One end of the opening of each

channel is dilated called the sphere in which the sensory organ of each

channel is located The cross section of the Scala standard looks like a right

angle The base is formed by the basilar membrane Sensory cells are

arranged on the surface of the basilar membrane These sensory cells with

their supporting cells form a complex neuroepithelium called the basilar

papilla or the cortical organ named after an Italian microscopist The

organs of the corti have a gelatinous membrane called the tectorial

membrane and they are supported by the pillar of the corti The cortical

pillars enclose a space called the corti tunnel which contains a fluid called

cortical lymph Vestibule is lies between the medial wall of the middle ear

and lateral to internal acoustic meatus anterior to semicircular canal and

posterior to the cochlea Vestibule is the central part of the internal ear On

its lateral surface is the opening of oval window which is closed by the foot

plate of stapes Boney cochlea lies in front of the vestibule It has 275 turns

coiling around boney axis called modiolus Cochlea is approximately 30 mm

in length The hollow center of the modiolus is a spiral canal containing the

fibers and ganglion cells of cochlear nerve A thin boney sheet the osseous

lamina winda around the modiolus This divides the cochlear canal into two

galleries the Scala vestibuli above and the scala tympani below

Page | 37

Semicircular canals are three in number superior posterior and lateral

They are semicircular in shape and opens into the vestibule One of the

ends of the semicircular is enlarged and is known as ampulla

Membranous labyrinth is situated within the boney labyrinth It is connected

to the bony labyrinth by fibrous trabeculae and is surrounded by perilymph

Endolymph is situated within the membranous labyrinth

The utricle lies in the upper part of the vestibule while the saccule lies below

Utricle and saccule both contain single sensory patch called macula Each

macula is covered by neuroepithelium consist of Neuroepithelium consists

of sensory hair cells and supporting cells these cells are separated by

basement membrane Fibers from the vestibulo cochlear nerve enter the

macula and pierce the basement membrane to end either at the base of the

hair cell or cell bodies The utricle and saccule with their macula are referred

to as otolith organs Membranous semicircular ducts are the membranous

ducts in the corresponding bony semicircular canals They open into the

utricle by five openings One end of the opening of each canal is dilated

called ampulla in which the sensory organ of each canal is located The

cross section of Scala media resembles a right angle Its base is formed by

basilar membrane Upon the surface of the basilar membrane the sensory

cells are arranged These sensory cells with their supporting cells form a

complex neuroepithelium called the basilar papilla or Organ of corti named

after an Italian Microscopist Organ of corti has a gelatinous membrane

called tectorial membrane and they are supported by pillar of corti The

pillars of corti enclose a space called tunnel of corti which contains fluid

called corti lymph

Page | 38

Fig 5 Inner Ear

Blood supply of labyrinth

Labyrinthine artery

Common cochlear Anterior vestibular Artery

Vestibulocochlear artery Main cochlear artery

Cochlear branch posterior vestibular artery

Page | 39

PHYSIOLOGY OF HEARING [61]

A sound signal in the environment is collected by the pinna passes through

external auditory canal and strikes the tympanic membrane Vibrations of

the tympanic membrane are transmitted to stapes footplate through a chain

of ossicles coupled to the tympanic membrane Movements of stapes foot

plate cause pressure changes in labyrinthine fluids which move the basilar

membrane This stimulates the hair cells of the Organ of corti It is these

hair cells which act as transducers and convert mechanical energy to

electrical impulses which travel along the auditory nerve

Thus the mechanism of hearing can be broadly divided into

bull Mechanical conduction of sound (conductive apparatus)

bull Transduction of mechanical energy to electrical impulses (sensory

system of cochlea)

bull Conduction of electrical impulses to brain (neural

Fig 6 PHYSIOLOGY OF HEARING

Page | 40

Conduction of sound

Under the surface of water we cannot hear the sound made in air because

9995 of sound energy are reflected away from the surface of water because

of the impedance offered by it A similar situation exists in the ear when

air-conducted sound must travel to cochlear fluids Nature has

compensated for this loss of sound energy by interposing the middle ear

which converts sound of greater amplitude but lesser force to that of lesser

amplitude and greater force This function of middle ear is called impedance

matching mechanism or the transformer action It is accompanied by

a) Lever action of the ossicles

Handle of malleus is 13 times longer than long process of incus providing

a mechanical advantage of 13

b) Hydraulic action of tympanic membrane

The area of tympanic membrane is much larger than the area of stapes foot

plate the average ratio between the two beings 211 As the effective

vibratory area of the tympanic membrane is only two- thirds the effective

areal ratio is reduced to 141 and this is the mechanical advantage

provided by the tympanic membrane

c) curved membrane effect

Movements of tympanic membrane are more at the periphery than at the

center where handle of malleus is attached This too provides some

leverage

Transduction of mechanical energy to electrical impulses

Movements of stapes footplate transmitted to cochlear fluids move the

basilar membrane setting up shearing force between the tectorial

membrane and hair cells The distraction of hair cells gives rise to cochlear

microphonics which triggers the nerve impulse

Page | 41

Neural pathways

Hair cells get innervation from bipolar cells of spiral ganglion Central axons

of these cells collect to form cochlear nerve which goes to ventral and dorsal

cochlear nuclei From there both crossed and uncrossed fibers travel to

superior olivary nucleus lateral lemniscus inferior colliculus and medial

geniculate body and finally reach the auditory cortex of the temporal lobe

Page | 42

DISEASES REVIEW

करणसराव

Nirukti - करणसय कणवयोाव ससराा [62]

Nidana- Acharya Sushruta and Vagbhata describe the common etiological

factors for the Karnaroga

अशयाय जलिीडा कणवकणडयन मरत

शमथययोगन शसततरसतय कवपतो अरय च कोपन ||

सउ २० १२

1 Avashaya or Pratishaya

(Excessive exposure to cold)

2 Jalakrida

(Excessive swimming)

3 Karnakandunyanum

(Excessive scracing due to itching)

4 Mithyayogena Shatrasya

(Improper instrumentation during wax removal or foreign body removal)

5Shabdasya

(Louder sound for long durationperverted contact of sound)

6 Abhighata (Trauma)

7 Vitiation of Tridoshas

Page | 43

Samanya Nidana according to different Samhita

Vishesh Nidan of Karnasrava

Acharya Charaka has not mentioned any kind of Nidana regarding Karnaroga

but has described Utapati of Karnaroga from Siroroga in Karnasirasym

Adhyaya[67]

शशरोअशिघातादरा तनमजजतो जल परपकादरा अवप विि

सरतत पय शरणॊ अतनलात स कणवससरा इतत परककतीत

सउ २० १०

असस ३७२५ [68]

1 Shiroabhighatat - Head Injury-Fracture of middle cranial fossa

2 Jala nimajjana - CSF otorrhoea fracture of middle cranial fossa

3 Karnaprapaka

4 Karna Vidhradhi -Puyasrava

Sr

no

Samanya Nidana SU AH[63] AS[64] YR[65] MN[66]

1 Avashaya + + +

2 Pratishaya + +

3 Shabdha

mithyayoga

+

4 Shashtra

mithyayoga

+ + +

5 Karnakandooyan + + + + +

6 Jalkrida + + + + +

7 Abhighata + + +

Page | 44

Samanya samprapti

परापय शरोतरशसरा कयावत शल शरोतशस गान

त कणवगता रोगा अटिावशततरीता

सउ २० १२

Due to common and specific etiology factors the vitiated Doshas gets

Sthanasamshraya in Karna and causes Karnasrava It is the stages of

Samprapti were Doshas gets lodged in Srotas and start processes of Dosh

Dushya Sammurchsna Due to Shiroabhighata Jalanimmajana Karna Paka

Karna Vidhradi vitiated Vata Dosha and Karna becomes Avruta by Vata and

results in Karnasrava Normal physiology of Dosha Dhatus and Malas entirely

depends on the normality of Srotas Dosh Dushya Sammurchana or

manifestation of diseases will not take place if only vitiation of Doshas take

place without deformity of Srotas Here in Karnasrava vitiation of Srotas are

Atipravritti Sanga and Vimargagamana take place Atipravritti is being excess

production of fungus Sanga is obstruction in external acoustic canal

Vimargagamana is the propagation of discharge through ear

Vishesh Samprapti

Karnasrava occurs due to Nij nidana is Pratishaya while Agantuja nidanas are

Avashya Jalkrida and Karnakanduyan Due to etiological factors which are

Vata-Kapha provocative in nature gradual vitiation of Doshas will occur After

vitiation they get accumulated (Sthan samshraya) in external auditory canal

In other hand when patient does Sevana of Agantuj Nidan like water enter in

external ear scratching of ear unsterile instrumentation leads to Dosh

Prakopa These cause Twak and Mamsa Dhatu Dushti which leads to

discontinuity of epithelium of ear canal which creates suitable atmosphere for

fungal pathogen to grow The vitiated Vata will produce symptoms such as

Page | 45

pain hearing impairment and vitiated Kapha causes symptoms like itching

discharge ear blockage By assessing the symptoms it can be said that Kapha

Avrita Vata Dosha is responsible for the manifestation of clinical features like

pain itching discharge Which are seen in Karnasrava that is otomycosis

Acharya Charaka has mentioned while explaining Samanya Chikitsa of

Karnaroga that it should be treated like Vrana when Paka and Srava is present

as a symptom Fungal spores invade in the epithelial layer of EAC In response

to infection inflammatory process is start This is a Paka Avastha After

removing the fungal mass ulceration in external acoustic canal is commonly

seen As a result of infection process exudates was produced which will mix

up- with fungal colonies and appear as discharge As per Dosha involvement

in Vrana Shoola Srava can be differ According to Acharya Sushruta Ruk is

the Samanya Lakshana of Vrana and Vishesha Lakshana of Vrana includes

pain discharge discoloration itching etc according to Dosha involvement

which are also seen in otomycosis In otomycosis mainly watery and purulent

type of discharge is present which indicates Paka avastha If there is Dosha

involve in Vrana is called Dushta Vrana Acharya Sushruta and Acharya

Vagabhata have mentioned verity of Srava in Twak and Mamsa Vranavastu

which is found in otomycosis Based on this description otomycosis can be

correlated with Karnasrava

Page | 46

Representing the Samprapti of Karnasrava

Vishesh Nidana ndash Shiroabhighatat

Jala nimajjana

Prapaka Vidhradhi

Vitited vata

Avarana by kapha

Vimargagamana of Vata

Karnasrava

Samprapti Ghataka

Dosha ndash Kapha and Vata

Dushya ndash Rasa Rakta and Mansa

Strotodushti ndash Vimargagamana and Sang

Adhishthana ndash Karna (Bhayakarna)

Rogmarga ndash Madhyama

Page | 47

Purvarupa

The Purvarupa of Karnasrava are not mentioned separately in any ayurvedic

classics In routine practice cretin Purvarupa are noted

1 Karnakandu

2 Karnagurutwa

3 Alpa karnashoola

4 Discomfort in ear

Rupa

1 Karnashoola

2 Karnakandu

3 Karnasrava

4 karnabadhirya

5 Cotton wool like or wet newspaper like grayish brown or black colored mass

is seen

6 External auditory canal skin appears edematous and red

Upashaya and Anupashaya

Appropriate application of Aushadhi Ahara and Vihara when produces relief in

the symptom is called as Upashaya and when aggravates the symptoms is

called Anaupashaya There is not any reference available in the classics about

the Upashaya and Anupashaya of karnasrava

Sadhyasadhyata

Sushruta has not mentioned specially the Sadhyasadhyata of Karnarogas But

Vagbhata has mentioned Karnasrava as a Sadhyavyadhi[69]

Sadhysadhyatagives the clear picture of prognosis of the disease It depends

on many factors like nature of disease severity of disease Vaya Prakriti Bala

of the patient etc

Page | 48

Upadrava of Karnasrava

In Samhita there is no reference available regarding the Upadrava of

Karnasrava

Samanya Chikitsa ndash

The common treatment principle for all Karnaroga is Ghritapana Use of

Rasayana Bhrahmacharya Avyayama Shirasnana and Atibhashaya

सामरय कणवरोगष घतपान रसयनम

अवयायमो शशराःसतनान बरमहचयवम कतपरनम

स उ२१३

Ghratapana - Ghrita is a Yogavahi and follow Sanskara in addition to these

acquired properties and capable of retaining its own properties So Ghritapana

is effective in Karnasrava

Rasayana - Rasayana represent the basic approach of Ayurveda which

comprise preventive promotive and curative aspect of health

Brahmacharyaapalana -It is like Sadvrittapalana and is equals to Rasayana

effect

Vyayama - It leads to vitiation if Vatas a Karna is a Sthana of vata and

exercise causes Kshayaj Samprapti hence it is important to avoid exercise in

Karnasrava

Shirasnana- In Shirasnana water enters in external acoustic canal it changes

the PH of meatus skin from acid to alkali which favors the growth of pathogens

Atibhashya - Excessive speaking causes Vata Prakopa and Vatapraokopa is

basic Samprapti for Karnasrava as the preventive aspect avoidance of

excessive speaking is necessary

Page | 49

Ghritapana Rasayana and Brahmacharyapalana should be followed for

preservation of dhatu Samyata and restriction of vitiation of Vata Vayayama

Shirasnana and Atibhashaya should be avoided in Karnasrava to protect the

Siras from the affliction of Vata and Kapha

Vishesha Chikitsa ndash

The general treatment principle of Karnasrava described in classics is closely

related to Dushtavrana Chikitsa

शशरोवरचन च ए िपन परण तरा

परमाजवन िान च ीकषय ीकषय़ाचारत [70]

स उ २१४०

कणवसततरा ोददत कयावत पततकशमकणवयो [71]

ाउ १८३५

उपददि च सततरोत साय परात वपचततवशि परमजय

य अगर मदन सघत गगलना ा िपतयतपा मिना परयत [72]

असउ २२४२४३

In addition to that Shirovirechana Karnadhoopana Karnapurana

karnapramarjana Karnadhavana are also indicated

Page | 50

Treatment is also mentioned for Karnasrava

1 Karnaprakshalana Yoga - with Aargawadadi Gana Kashaya and Surasadi

Gana Kashaya [73]

2 Avachurnana Yoga ndash with Aargawadadi Gana Churna and Surasadi Gana

Churna[74]

3 Karnapoorna Yoga ndash

bull Rasanjana Laksha with Sarjachoorna[75]

bull Panchkashaya with Kapittha swarasa and Madhu[76]

bull Jambu AmrapallavShivalaKshuodra Mahavriksha and Madhuki all are

taken in equal quantity and Kalka is prepared and 4 times Taila is taken

and 16 parts of Kwatha is added and Taila Paka is done[77]

bull Sarjatwak Choorna with Karpashiphalarasa and Madhu[78]

bull Abhaya LodraTindukaSamanga(Manjista) Kwatha of this Dravyas mixed

with Madhu and Kapittha Rasa[79]

bull Yogratnakara mention the following drugs for Karnapoorana-

a Samudraphena Churna[80]

b Jambwambpatra Yoga

4 Karnadhoopana Yoga ndash

bull Dhoopana with Churna of Bilvapatra Haridra Palandu[81]

bull Vartak Dhoopana [82]

5 Internal Medications-

bull Rasnadi Guggula [83]

bull Triphala Guggula [84]

bull Sarivadi Vati [85]

bull Gandhaka Rasayana [86]

Page | 51

According to Vagbhata-

Ear should be cleaned with the Pichu and Varti followed by Guggula Dhoopana

and then Karnapoorana with Madhu Followed by Avachurnanana with

Sukshmachootana of Surasadigana

Pathyaapathya ndash Pathya and Apathy mentioned for Samanya Karnaroga is

recommended in Karnasrava also

पथय[87]

सतदो वरको मन नसतय िमाः शशरावयिाः

गोिमाः शालयो मदगााः याशच परतन हवाः 80

लाो मयरो हररणानदसततततरो नकककिाः

पिोल शशगर ातावक सतनषराण कदठललकम

रसायनातन सवणण बरमहचयवमिाषणाम |

उपयकत यरादोषशमद कणावमय दहतम ||81||

िापर २१

Aharaja Upacharaja

bull Godhuma bull Vamana

bull Shala bull Virechana

bull Mudga bull Nasya

bull Yava bull Dhoomapana

bull Puranagitra bull Kavala

bull Lava Harina Tittiramamsa

Page | 52

अपथय[88]

दरत काटठ शशरसतनान वययाम शलटमल गर

कणडयन तषारशच कणवरोगी पररतपयजत

िापर २१

Viharaja

bull Patola ShigruVartaka bull Bhramacharaya

bull Sunishannaka bull Avyayama

bull Katthlika bull Aakthanam

bull All types of Rasayana bull Upacharaja

bull Vamana

Apathyas

bull Abhishyandakara Aharas

bull Shirasnana

bull Karna kandooyana

bull Tushara sevana

bull Guru Kaphakaraka Aaharas

bull Dantdhavana

Page | 53

OTOMYCOSIS

Definition-

Otomycosis is a superficial acute sub-acute or chronic infection of external

ear canal It is mostly unilateral It is characterized by inflammation purities

and scaling Otomycosis is a common condition encountered in ENT practice

more in chronic and persistent ear infection

The Fungal infections are not communicable in the usual sense but the

humans become an accidental host by their introduction into tissue trauma

The virulence factors favoring colonization of fungus in human host are yet to

be identified Ability of the fungus to grow at 37 C and elaboration of a variety

of enzymes and toxins are speculated to contribute to virulence Only 100 to

150 species are generally recognized as a cause of disease in humans[89]

Prevalence-

Otomycosis is a word wide in distribution and in various record stated that 5

to 20 of all cases of infective otitis externa Otomycosis prevalent is more in

warm and humid climates It is one of the commonest manifestations in India

during rainy season It occurs mostly in humid atmosphere otitis externa due

to fungal infection may resembles the desquamative form of diffuse infective

otitis externa The incidence in temperature climates has increased in

proportion to the use of topical antibiotics which have a medium sterilized of

other organism in which the fungus may flourish

Page | 54

Predisposing factors- [90]

1 Environmental factors such as climate contagious and polluting hygiene

more frequently during rainy season as the humidity increases

2 Individual susceptibility ndashGeneral Immunological status of the Individual

eg HIV infection Radiotherapy chemotherapy Diabetes mellitus

3 Self-inflicted trauma that is use of pins to clean the itching ear or use of ear

bud to clean the wax

4 Wide spread of topical antibiotics steroid preparations which have medium

sterilized of other organism in which the fungus may grow

5 Failure of defense mechanism in External auditory canal

6 During swimming or head bath water enters in External acoustic canal

causes quantitative and qualitative change in ear wax It causes change in pH

7 Long term use of hearing aids

Pathophysiology ndash

The life cycle of the average mold encountered in the ear may be reckoned

as two weeks and flare ups may be anticipated at such intervals Swimming is

held responsible for infection in many cases The sequence sequence of

pathogenic changes produced by molds in the external ear is as follows ndash

1 Implantation of the organism in external ear

2 Growth of organism follows the rate depending on condition of temperature

moisture or preexisting irritation

3 Invasion of epithelium occurs with attendant itching and discomfort which

may be quite severe

Page | 55

4 Exfoliation of epithelium occurs as nature attempts to overcome the

infection by casting off upper most cells

5 Denudation occurs from exfoliation as the top layers of epithelium are cast

off and the canal becomes filled with debris

6 Superficial ulceration and lizematoid dermatitis results if the pathologic

process goes for enough The changes do not always proceed through the

entire sequence sometimes the molds produce changes of the mildest

imaginable character which may be overlooked[91]

Clinical features -

Symptoms-

1 Irritation and itching ndash Irritation is mostly found when the infective

organism is aspergillus niger There is sensation of discomfort which is more

diffuse in the ear canal then localized in the deeper part Candida infection

causes marked itching In external ear it is intense and worse at night

2 Discharge through ear- Intermittent scanty colorless discharge through

ear Mucus being a fungal metabolic product appears as discharge Excessive

discharge is associated with mixed infection

3 Pain and discomfort ndash Mild to severe pain in the ear occasionally Mostly

seen in cases where ear is infected with Aspergillus flavus mixed infection

with gram negative organism or mixed infection with candida and aspergillus

Headache is sometimes associated with pain

4 Deafness- Varying degree of mild to moderate conductive deafness

5 A sensation of fullness in ear

6 Tinnitus 7 Vertigo

Page | 56

Signs ndash

1 The external acoustic meatus may contain a mass formed of epithelial

debris exudates cerumen and fungus

2 Erythematous external canal

Fungal appearance

A Niger - The color of the mass which is usually grey or black is mainly

determined by the type of fungus concerned Its appearance is like wet

newspaper or blotting paper or a cotton wool It has a peculiar musty odor In

this infection fruiting heads may be seen as black specks in the debris

Occasionally as inactive form occurs in which the canal is lined by mold giving

a fluffy appearance due to the presence of tiny mycelia

Candida ndash Candida infections generally show as white deposits on magenta

colored skin when the debris is removed it rapidly recovers in 24 hrs

The underlying canal skin is often inflamed and granular due to invasion by

fungal mycelia and be seen in all cases In rare cases excoriation and

ulceration with marked extensive shedding of the epithelium and deep

ulceration can be seen usually associated with a flavus and with pathogenic

bacteria[92]

Otoscope Appearance

1 Aspergillus Niger ndash Black headed

2 Aspergillus Fumigators ndash pale blue or green

3 Candida Albicans ndash White- or cream-colored deposits

Page | 57

4 Auricle is normal in most cases In severe cases small ulceration with crust

formation may be present on lateral surface

5 Tympanic Membrane

In most cases it is normal with normal mobility and normal hearing In a few

cases the surface of the tympanic membrane is congested and scaly There is

erosion or ulceration of the external epithelial layer and the membrane itself

may be edematous

Diagnosis

1 Above mentioned symptoms and signs

2 In the stage at which patient with otitis externa usually first present

themselves mycelia threads conidiophors not visible to naked eye may

sometimes be identified with the microscope

3 Confirmed by culture

Page | 58

Fig7 Aspergillus Niger Fig8 Candida Albicans

Fig9 Aspergillus Fumigators Fig 10 Wet Paper like appearance

Page | 59

Treatment

1 Antibiotic or steroid drops should be discontinued if they are being instilled

since long time

2 Removal of fungal mass epithelial debris and discharge from the external

canal or mastoid cavity repeatedly and thoroughly by forcepa or suction or

syringing or cautiously blow a stream of air into the canal through a fine

cannula and dry thoroughly by swabbing liquid petroleum on swab used in

cleaning the ear lessens the burning sensation when metacresy acetate is to

be employed in the subsequent treatment

Furuncle is developed as a complication if there is no gentleness in cleaning

Cleansing may have to be delayed until local sensitiveness is lessened which

can usually be accomplished within twenty-four hours If there is excessive

epithelial debris along with otomycosis then metacresyl acetate which is a

keratolytic in introduction into the external auditory canal on cotton wick and

is allowed to remain for twenty-four hours After twenty-four hours the cotton

wick is removed at which time the canal can usually be cleansed with little

discomfort as the medication is also anesthetic The epithelium of the canal

was white from contact with the drug The top layer was detached and this

epithelial debris can be easily wiped away The wick is reinserted and wet with

metacresyl acetate

The treatment is employed for three to four days in succession and then a

bland application is substituted Icthyol iodine is of value at this stage Iodine

ointment 2 in combination with Tannic acid 2 is also an excellent local

application following cresatin treatment

Next one of the fungicides may be applied

Page | 60

1 Nystin Effective for candida infection but less active against aspergillus

group Nystatin in boric powder consisting of 100000units of nystatingm of

powder 3 times week for 3 weeks

2 Clotrimazole Available as 11 cream or drops or lotions Phenyl

(zchlorophenyl) 1 ndash imidazole ndash methane is a chlorinated trityl imidazol 1

effective against candida and dermatophytes and for aspergilli infection

3 Amphotericin B Available as cream and as 3 solution and 015 drops

for topical application Very effective for candida infection can be fungistatic

or fungicidal

4 Econazole Available as solution (Econazole nitrate) and as cream (1)

Broad spectrum ndash more effective for Aspergillus Also active against some

gram-positive bacteria (Staphylococci and Streptococci and Dermatophytes)

5 Miconazole Highly effective against dermatophytes and candida infections

used as a 21 cream applied once or twice a day for 10 days

6 Gentian violet 21 Available as drops (recently some evidence of

carcinogenicity) Discolors the ear canal and this interfere with clinical

examination

Other topical antifungal agents are ketoconazole Natamycin Tolciclat Bifonas

zole Fenticonzole Oxiconazole Tioconazole ciclopiroxolomine Tolnafate

Haloprogin Flucytosine Acetic acid Whit field ointment selenium sulfide

undcyclenic acid triacetin etc

Page | 61

Minimal length of treatment

A month of drug treatment is usually required because the antifungal agents

used are not sporicidal and it is necessary that the period of treatment covers

germination time It may be advisable to give short gaps in the period of

treatment to ensure all spores have germinated before deciding to terminate

therapy

Prevention

Accomplished by strict attention to the predisposing causes

1 Water should be prevented from entering the ear

2 Avoidance of external ear trauma

3 Use of alcohol medicated or plain in the ears after swimming mercuric

cyanide (15000) in ethyl alcohol (70) is a satisfactory liquid to use

Ear stoppers do no good unless their use is followed by some antiseptic in the

canal Divers exposed to water for long periods of time may also use acidic

alcohol

4 During Summer months with their high humidity special efforts are needed

to maintain ear dry 5 Indiscriminate use of topical antibiotics steroid

preparations should be avoided

Page | 62

DRUG REVIEW

1 GUGGULA

Fig11 - Guggula

Historical review of Guggula [93]

bull Atharvaveda one of the well-known Vedas of Hindus The earliest

reference given by Atharvaveda medicinal and therapeutic properties of

Guggula Guggula has long history of use in Ayurveda

bull Acharya Charaka Sushruta and Vagbhata describe detail regarding the

actions uses and indication as well as the variety of Guggula

Page | 63

bull Various Nighantus (Medical lexicons) were written between 12th and 14th

centuries AD was based on the Ayurvedic literature also describes

Guggula

bull The explanation of word Guggula is that Gunjo Vyadhegurdti Rakshati

which means to relief against different diseases

bull Guggula is the best medicine because it develops through the rays of

hot sun on specific circumstances

bull Guggula has an aromatic odor

गगलो कणवदौगवररधय िपन शरटठमछयत[94]

स उ २२११२

Latin name- Commiphora mukul

Family ndash Burseraceae

Rasa- Tikta Katu

Guna ndash Laghu Rukshasukshma vishada sara

Veerya ndash Ushna

Vipaka ndash Katu

Action- Rasayana Lekhana

Doshaghanta - Tridoshhara

Page | 64

Chemical composition [95]

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Oleoresin-Z-Guggulsterone E-Guggulsterone

Gum- guggulignans 1 and 2 guggula Tetrols mukulol allylcembrol c

27

Guggulusterol 1 2 ans 3 Z and E ndash guggulusterol

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Parts Used ndash Gum oleoresin

Guggula purity test

1 Yellowish brown emulsion is obtained when Guggula is triturated with

water

2 An ethereal solution of the drug attains reddish colour when treated

with br2 vapors and purple colour when moistened with nitric acid

Biochemical action ndash Antiseptic Anti-inflammatory Disinfectant Diuretic

Immunostimulant stimulating expectorant Ant suppurative Antipyretic

Enhance phagocytosis

Karma- Rasayana cardiovascular disease

Page | 65

2 AGARU-

Fig 12 Agaru

Historical review of Agaru [96]

bull The word Agaru literally means the one which is the heaviest and no

aromatic wood is heavier than it Since thousands of years Agaru lsquoThe

wood of Godrsquo has been used for multiple purpose like commercial

medicinal spiritual aromatic historical

bull The medicinal use of Agaru have been recorded in many pieces of India

Greek Roman Chinese Middle eastern and European since ancient times

bull Acharya Charaka used Agaru and pest of Rasna to counteract the effect of

cold in Agraya Dravyas

bull Acharya Sushruta used Agaru as a Dhoopana Dravya along with Guggula

Ral and Shoma in the treatment of Karnasweda and Vrana

Page | 66

Types-

bull Dhanwantsri Nighantu describes Kaleyaka as a type of Agaru

bull Sodhala Nighantu describes three types of Agaru ndash Agaru Krishna

Agaru Kakatunda Agaru

bull Raj Nighantu describes five types of Agaru ndash Krishna Agaru Kasht

Agaru Daha Agaru Mangalya Agaru and Agurusaar

bull Arthashasstra describes three Agaru wood product

1 Jongaka ndash Black or variegated black in colour and having variegated

spots

2 Dongaka ndash Black in color

3 Parasamudraka- Black in colour and smells like Navamallika

अगर उटण कि तपछय ततकत ततकषण च वपततलम

लघ कणाविरोगघन शीत ात कफपरणत

िापर २१ [97]

Family- Thymelaccensis

Latin name- Aquilaria agallocha

Guna- Laghu Ruksha Tikshan

Rasa- Katu Tikta

Vipaka ndash Katu

Virya ndash Ushna

Karma- Sheetaprasasmana Vranaorasadan Tvachya Pittavardhaka

Shirovirechana Mangalya Sugandhik and Rochaka in properties [100]

Krishna Agaru karma- Katu Tikta rasa Ushna Sheeta when applied externally

and Pittahara when taken orally

Page | 67

Chemical Constituents -

Agaru hardwood is rich in essential oil resins alkaloids saponins Steroids

terpenoids tannins flavonoids and phenolic compound Agaru wood

predominantly contains 2-[-2-phenylethy]-4H-chromen-4-one derivatives and

sesquiterpenes Agaru oil contains selinene dihydroselinene agarnol b-

agarofuran vetispira-2(11)valerianol dihydrokaranone and tetradecanoic

acids[99]

Part Used ndash

Heartwood- Dark resinous wood which is formed when the plant becomes

infected with a type of fungus (ascomycetous mold) Species of Aspergillus

fusarium and penicillium are reported to be associated with the development

of infection Prior to infection the heartwood is odorless relatively light and

pale colored however as the infection progresses the tree produces a dark

aromatic resin in the heartwood The infected resin in response to the attack

which results in accumulation of a very dense dark resin in the heartwood

The infected resin embedded wood is known as Agarwood Infection is more

common on the trunk roots and the area when branches divide The formation

of Agarwood starts when the tree attains the age of 20 years On an average

approximately 30 ml oil is extracted from 100 kg of infected Agarwood[98]

Qualities of best Agaru-

It should be black in color

It should be extremely heavy and aromatic

It should be oily in appearance and test

It should be sink in water

It should burn easily with bright flame with a bright flame giving off a pleasant

smell

Page | 68

3 MADANA

Fig 13 MADANA

Madana consist of dried fruit of Xeromphis spinosa It is a deciduous thorny

shrub or a small tree reaching a high up to 9 m and girth about a meter

branches numerous thick and horizontal found in sub-Himalayan tracts[101]

मदनो मिरनदसततकतो ीयोटणो लखनो लघ

ानदरतिदवििीहर परततशयायवरणारतक

रि कटठकफ़ानाहशोथगलमवरणापह[102]

िा पर १६० १६1

Page | 69

Latin name-Randia dumetorum

Familly ndash Rubiaceae

Rasa - Madhura Tikta

Guna-Laghu Ruksha

Virya- Ushna

Vipaka ndash Katu

Karma- Vamana and Lekhana

Chemical Composition-

Essential Oil Valerianic acid Saponin tannin resin [103]

Page | 70

YAWA [104]

Fig 14 Yawa

1 In Samhitakala Aacharya Charaka Acharya Sushruta explain detail about

medicinal properties of Yawa

2The use of Yawa in Aaharya Dravya mainly described by Dhanwantari

Nighantu Raj Nighantu Bhavprakash Nighantu[105]

Macroscopic Description-

Fruit a caryopsis elliptical oblong Ovoid and tapering at both ends smooth

about 1cm long and 02- 03cm wide dorsally compressed and flattened on

the sides with a shallow longitudinal furrow 3-5 ridges having shallow

depression between them grains tightly enclosed and adhering the lemma

and palea pale greenish yellow odor not distinct taste sweetish acrid

Page | 71

Latin Name ndash Hordenum vulgare

Family- Poaceae

Rasa- Kashaya Madhura

Virya- Sita

Vipaka- Katu

Karma- Vatakrt Pittahara Kaphahara Medahara Balya Visrya

SthairyakaraLekhana

Page | 72

PROCEDURE REVIEW [105]

In Ayurvedic classics there are many references regarding Dhoopana Dravya

Dhoopana is administering Dhuma with the help of Dhoopana Dravya

In Kashyapa Samhita there are 40 types of Dhoopana advised for children

Anesthesia (Mohajananam Dhoopa) is also mentioned For this Dhoopana the

drug used were herbs hairs of animals legs horns old cloths of Buddhist

monks

From the references available regarding Dhoopana we can understand that

Karna can be protected from maggots (krimi) Bactria (Rakshogna) lice etc

References clearly indicate the analgesic and disinfectant effect of Dhoopana

Karma Dhoopana is mentioned for Dushta Vrana Chikitsa It reduces Vedana

Srava Pootigandha of Dushtavrana It also helps in Vranaropana

Dushtavrana Chikitsa is mentioned in the treatment of Karnasrava[106]

Origin of Dhoopana-

In ancient period children of sages were constantly harassed by the

Rakshasas Hence the sages approached lord Agni for shelter Agni in turn

gave them Dhoopana Dravya and asked sages to use the Dhoopana for

protection against Rakshasas bhutas pishachas

Classification of Dhoopana

1 It is classified into Dhupa Anudhupa Pratidhupa

2 On the basis of Origin it is classified into Jangama and Sthavara

Selection of Guggula for Dhoopana

Page | 73

bull Guggul is a best Vatahara

bull It is Krimighana

bull It contains Oleoresin

bull In Ashtang Hrudaya Guggula Dhoopana mentioned for Karnasrava

Selection of Agaru for Dhoopana

bull Agaru is Laghu Ruksha Katu Tikshna

bull Vranaorasadan Tvachya

bull It should burn easily with bright flame with a bright flame giving off a

pleasant smell

Karna Dhoopana Indication

1 Karnaarava

2 Putikarna

3 Krimikarna

4Vataj Karnashula

Contraindications

Especially for Karnadhoopan contraindication is not mentioned in classic texts

But Dhoopana is contraindicated in Pittaj vaydhi Sharad and Grishma Rutu

Page | 74

MATERIAL AND METHOD

Page | 75

For randomize comparative clinical trial to study the effect of Agaruwadi

Karnadhoopana and Guggula Karnadhoopana in Karnasrava following material

and method were required

Source of data

Patient irrespective of gender occupation religion social economic status

signs and symptoms of classical features of Karnasrava (Otomycosis) selected

from the OPD of Shalakyatantra department

Materials ndash

1Patients

2 Drugs-Agaruwadi Dhoopana

Guggula Dhoopana

3Torch

4Otoscope

5 Tuning fork

6Jobson horn probe

7Cotton

8Case record form

DRUG

Group A Trial Group

1Churana of Agaru Yawa Madan

2Ghrita

3Jala

Group B Control Group

1Googula Churna

Page | 76

Properties of Drug

Table no 1 Properties of Drug

Drug

Family

Rasa Veerya Vipaka Effect

on

Dosha

Guna Karma

Agaru

(Aquilegria

Agallocha)

Thymelaca

ceae

Katu

Tikta

Ushna Katu KV Laghu

Ruksha

Tikshna

Shitaprashamana

Shothahara

Vedanasthapak

Durghandhihara

Madan

(Randia

spinosa)

Rubiaceace

Kashaya

Madhur

Tikat

Katu

Ushna Katu KV Ruksha

Laghu

Vatakaphaghana

Shothahara

Vedanasthapak

Vranashodhak

Yawa

Poaceae

Hordeum

Vulgare

Kashaya

Madhur

Sheeta Madhur KP Ruksha

Laghu

Vataghana

Vernashodhana

Raktshodhaka

Guggula

Commiphora

Mukul

Burseracea

e

Tikta

Kashaya

Anushna Katu VPK Laghu

Ruksha

Shothahara

Vedanasthapaka

Kandughna

Ghrita Madhura Sheet Madhur VK Snigdha Vataghana

Shothahara

Vedanasthapaka

Page | 77

METHODOLOGY

SELECTION CRITERIA

1)INCLUSION CRITERIA

1 Patients having signs and symptoms of Karnasrava (Otomycosis) ie करणशल

( pain ) करणकणड ( Itching ) करणसतराव ( Discharge )बाधिरण ( conductive Loss of

hearing )

2 Patient from age group 19 to 70 years

3 Any Gender

2)EXCLUSION CRITERIA

1 Patients suffering from any systemic disease like DM TB HTN

2 Chronic suppurative otitis media (CSOM)

3 Acute supportive otitis media (ASOM)

3 Perforation of Tympanic membrane

4 Chronic otitis media

3)WITHDRAWAL CRITERIA

1If patient develops any adverse effect such as irritation pain burning

sensation in ear loss of hearing and such patients was withdrawn from trial

and receive prompt appropriate medical attention

2If patient shows aggravation in symptoms

3If patient refuses to continue with the treatment

Page | 78

STUDY SETTING

Types of study - Randomized Clinical comparative Trial

Place of work - OPD of Shalakyatantra

Duration of study - 18 months

Study Population - Patients of Karnasrava in Shalakyatantra OPD

SAMPLE SIZE CALCULATION

Sampling Method ndash Purposive sampling followed by random allocation in two

groups

Sample size calculation-

n = z2 p (1-p)

d2

Were

n = sample size

P = prevalence of disease=10

z = standard normal variable ie 196

d = error ie005

desired Sample Size would be

n = Z2 P(1-P)d2

= (196)2x (0021) x(0979)(005)2

= 34

Visiting ENT OPD (ShalakyaTantra) and IPD (ShalakyaTantra) 21 = 34

n raquo34

So one group includes 34patients

Page | 79

Sampling Method

Total 68 patient of Karnasrava are selected by Purposive sampling followed by

random allocation in two groups Written informed consent is taken prior to

commencement of trial They are divided in 2 groups

Group A (Trial Group) 34 patients treated with Agaruwadi Dhoopana for 7

days

Dose 5 minutes twice in a day

Group B (Control Group) 34 patients treated with Guggula Dhoopana for 7

days

Dose 5 minutes twice in a day

STUDY DESIGN ndash

Open labeled Randomized Comparative Clinical trial

STUDY DESIGN

Screening of patient

Inclusion criteria satisfied Exclusion criteria

Initial assessment Excluded

Counseling of patient Treated accordingly

Patient selection by Simple Random Sampling Method

Page | 80

68 Patients were divided in two groups lsquoArsquo and lsquoBrsquo

Trial group A-34 patients were given

Agaruwadi Dhoopana

Control group B- 34 patients were

given Guggul Dhoopana

Informed written consent

Treatment was given for 7 days

Assessment on 1st 4th and 7th day

Post assessments follow up on 15th day

Observation

Data Collection

Statistical analysis of data

Conclusion

Page | 81

(A) Agaruwadi Varti for group A (Trial group)

Table no 2

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

B) Guggula Varti for group B (Control group)

SOP of it is same as above Agaruwadi Varti

Table no 3

Drug Guggula Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

FOLLOW UP

For both groups follow ups were done on 1st 4th and 7th and post

assessment follow up15th day

EXAMINATIONS

Torch for Local examination of ear

Otoscope examination

Tuning fork Test

Page | 82

OBSERVATION TABLE

Table no 4

Sr no Subjective criteria Day 1 Day 4 Day 7 Day 15

1 करणशल

(pain)

2 करणकणड

(Itching)

3 करणसतराव (Discharge )

4 बाधिरण (Conductive Deafness)

OBSERVATIONS

a) करणशल (Pain) -

0 - Absent

1 ndash Present

b) करणकणड (Itching) -

0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

Page | 83

c) करणसतराव (Discharge)

0- Absent

1- Mild -Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाधिरण (conductive Loss of hearing)

0 - Absent

1- Present

Observations were carried out before and after completion of treatment and

during each follow up After observations the data collected and presented in

the form of graphs charts and table

Page | 84

TRIAL DRUG

Authentication and standardization of raw drug material done After

authentication and standardizing of raw drug material Agaruwadi Varti was

prepared by Varti as explained in Ayurvedic classics

Method of Varti preparations

Panchavidh Kashaya Kalpana that is five method of pharmaceutical

preparation constitutes the fundamental process of Ayurvedic pharmaceutics

which is well explained in Sushrut Samhita Varti Kalpana is one among them

which can be included in Kalka Kalpana

तीररसतरपतपतीनामपरककव तीत [106]

स डलहण शरच 151

Medicines are powered triturated and given the Varti shape that is like wick

of lamp so it is called as Varti Kalpana

Drug content Agaru Madan Yawa

Route of Administration Local

Dose Two times a day

Duration 7 days

Page | 85

Methodology

Standard operating procedure (SOP) of Agaruwadi Varti

Agaruwadi Varti is prepared according to the classical text

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization was done as recommended in pharmacy procedure The

raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 mixed together in

equal quantity to make Agaruwadi churn

Quantity of each churn is 4 grams all are mixed when the Varti get dry total

weight of Varti was 10gram

STEP 4 - Agaruwadi churn triturated with appropriate quantity of water or

Ghrita and prepared Varti in GMP Certified Ayurvedic pharmacy Standard

aseptic precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Varti was packed in sterile air packed container

STEP 6 - Agaruwadi Dhoopana was given with the help of Dhoopana yantra

Authentication and Standardization of raw drug of Agaruwadi Varti was done

Sterilization was done as recommended in pharmacy procedure Sterile

preparation packed in sterile container of suitable size Under all aseptic

precaution Karnadhoopana given to infected ear

Page | 86

Containers for packaging and their sterilization-

Sterilization of the containers for storing Varties was done by Ethylene Oxide

(Eto) method

Ethylene Oxide (Eto) procedure-

It includes exposure of materials to ethylene oxide gas under vacuum in a

sealed chamber It consists of four primary variables

1Gas Concentration

2Humidity

3Temperature

4 Time

EtO gas is an alkylating agent which disturbs the DNA of microorganism

preventing them from reproducing It penetrates the breathable packaging

and sterilizes all the accessible surface of the product to render products

sterility by alkylation of essentials proteins for cell reproduction

Most Eto sterilization methods involves three different stages These can be

separated into three different on the size or number of devices to treat

1Preconditioning stage-

First products are passed through a preconditioning phase to make

microorganism grow The batch load goes through a well time under a

controlled environment of temperature and humidity

2Sterilizer stage-

Performed using process phase specially designed to provide the required level

of EtO exposure to assure sterility for a device or family of devices

3Degasser Aerration stage-

Finally products need to go through a degassing phase to remove any residual

particles of Eto The batch load goes over well time under a temperature-

controlled environment

The sterile containers were then used to store Agaruwadi Varti and handed to

patients included in the study

Page | 87

Packing of Agaruwadi Varti

The ETO sterilize plastic container were used for packing of Agaruwadi Varti

Varti was filled into these sterilize containers (7 in each) In an aseptic

environment plugging and capping was done under aseptic precautions In this

way packing of Agaruwadi Varti done These Varti were given to patient and

advise to take two times a day under all hygienic precautions

History and Examination

bull Proper history and presenting complains was recorded on case record form

bull Ear examination with otoscope was done during initial assessment and each

follow up

bull Otoscopic examination was done during initial assessment and each follow

up

bull Systemic Examination that is Blood Pressure Temperature Respiration

rate Pulse was recorded on case record form

Page | 88

Raw material

Fig14 यव चरण Fig15 मदनफळ चरण

Fig16 अगर चरण Fig17 गगगळ चरण

Page | 89

Preparation of Agaruwadi Varti

Fig18 Preparation of Agaruwadi Varti

Fig19 अगरवादी वरती

Page | 90

Fig20 Instruments used for examination of Karnasrava

Fig19 Karnadhoopana Yantra

Page | 91

Karnadhoopana Procedure

Fig 22 Karnadhoopana Procedure

Page | 92

OBSERVATIONS AND RESULTS

Page | 93

BASED ON DRUGS

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 94

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

AUTHENTICATION CERTIFICATE

Page | 95

BASED ON STASTICIAL ANALYSIS OF DEMOGRAPHIC DATA

68 patients of Karnasrava ndash Otomycosis

Table no 5

No of Patients Total

Group A Group B

Registered 38 37 75

Completed 34 34 68

Discontinue 04 03 07

Total 68 patients were enrolled in study 38 patients registered in group A

amongst them 34 patients completed the treatment and04 patients

discontinued the treatment However in group B 37 patients completed the

treatment and 03 patients discontinued the treatment out of 37 registered

patients

Hence the total number of patients registered in the present study was 75

and out of which 68 patients were discontinued the treatment So they

dropped out from the study While 68 patients were successfully completed

the treatment So observations and result of 68 patients were given below

Here we are going to discuss the statistical analysis of the data obtained in

the form of master chart that was prepared in accordance with the data

collected from the patients that had been included in the study The purpose

of statistical analysis was to analyzed the relation between age gender

occupation diet addiction and education

Page | 96

1 Age wise distribution of patients

Table no 6

In trial group 10 (29412) patients were from age group 18-25 years 14

(41176) patients were from age group 25-35 years 8 (23529) patients

were from age group 35-45 years and 2 (58824) patients were from age

group 45-60 yearsIn control group 6 (17647) patients were from age group

18-25 years 14 (41176) patients were from age group 25-35 years 7

(20588) patients were from age group 35-45 years and 7 (20588)

patients were from age group 45-60 years

Fig 23 Age wise distribution of patients

0

2

4

6

8

10

12

14

15 -25 25-35 35-45 45-60

10

14

8

2

6

14

7 7

Age Distribution

Trial Group N Control Group N

Age Distribution

Trial Group Control Group

N N

18 -25 10 29412 6 17647

25-35 14 41176 14 41176

35-45 8 23529 7 20588

45-60 2 58824 7 20588

Total 34 100 34 100

Page | 97

1 Gender wise distribution of patients

Table no 7

Sex

Trial Group Control Group

N N

Female 23 67647 15 44118

Male 11 32353 19 55882

Total 34 100 34 100

In trial group 23 (67647) patients were female and 11 (32353) patients

were male

In Control group 15 (44118) patients were female and 19 (55882)

patients were male

Fig 24 Gender wise distribution of patients

0

5

10

15

20

25

N N

TRIAL GROUP CONTROL GROUP

23

15

11

19

Gender

Female Male

Page | 98

2 Education wise distribution of patients

Table no 8

Education

Trial Group Control Group

N N

Illiterate 4 11765 3 88235

SSC 4 11765 3 88235

HSC 8 23529 9 26471

Graduation 16 47059 10 29412

Primary 1 29412 3 88235

Post-Graduation 1 29412 6 17647

Total 34 100 34 100

In trial group 4 (11765) patients were illiterate 4 (11765) patients were

SSC educated 8 (23529) patients were HSC educated 16 (47059)

patients were graduated 1 (29412) patients were primary educated and

1(29412) patients were post graduated

In control grou 3 (88235) patients were illiterate 3 (88235) patients

were SSC educated 9 (26471) patients were HSC educated 10 (29412)

patients were graduated 3 (88235) patients were primary educated and

6 (17647) patients were post graduated

Page | 99

Fig 25 Education wise distribution of patients

0

2

4

6

8

10

12

14

16

ILLITERATE SSC HSC GRADUATION PRIMARY POST GRADUATION

4 4

8

16

1 1

3 3

910

3

6

Education

Trial Group N Control Group N

Page | 100

3 Occupation wise distribution of patients

Table no 9

Occupation

Trial Group Control Group

N N

Accountant 1 294 2 588

Housewife 11 3235 8 2353

Engineer 1 294 1 294

Job 1 294 4 1176

Labor 1 294 3 882

Mess 1 294 0 000

Naturotherapyst 1 294 0 000

Pharma 1 294 0 000

Shopkeeper 4 1176 2 588

Singer 1 294 0 000

Student 8 2353 4 1176

Tailor 1 294 1 294

Teacher 1 294 1 294

Worker 1 294 3 882

Farmer 0 000 1 294

Lab Tech 0 000 1 294

Page | 101

Daily Collection 0 000 1 294

Fruit seller 0 000 1 294

Bus Driver 0 000 1 294

Total 34 10000 34 10000

In trial group 11 (3235 ) were housewife 8(2353) were students

4(1176) were shopkeeper 1(294) was accountant 1(294) was

engineer 1(294) was doing job 1(294)was labour 1(294) was

catering 1(294) was Naturotherapyst 1(294) was Pharma 1(294)

was Singer 1(294) was Tailor 1(294) was Teacher and 1(294) was

worker

In Control group 8 (2353)were housewife 4(1176) were students

2(588) were shopkeeper 2(588) was accountant 1(294) was

engineer 4( 1176) was doing job 3(882)was labor 1(294) was

Farmer 1(294) was Lab tech 1(294) was Daily collection 1(294)

was Tailor 1(294) was Teacher and 3(882) was worker 1(294) was

Fruit seller and 1(294) Bus driver

Fig 26 Education wise distribution of patients

0

2

4

6

8

10

12

1

11

1 1 1 1 1 1

4

1

8

1 1 10 0 0 0 0

2

8

1

43

0 0 02

0

4

1 13

1 1 1 1 1

Occupation

Trial Group N Control Group N

Page | 102

4 Religion wise distribution of patients

Table no 10

Religion

Trial Group Control Group

N N

Hindu 31 9118 33 9706

Muslim 3 882 1 294

Total 34 10000 34 10000

In trial group 31 (9118) patients were Hindu and 3 (882) patients were

Muslim

In control group 33 (9706) patients were Hindu and 1 (294) patient

were Muslim

Fig 27 Religion wise distribution of patients

0

5

10

15

20

25

30

35

N N

TRIAL GROUP CONTROL GROUP

3133

31

Religion

Hindu Muslim

Page | 103

5 Diet wise distribution of patients

Table no 11

Diet

Trial Group Control Group

N N

Veg 14 4118 20 5882

Non-Veg 20 5882 14 4118

Total 34 10000 34 10000

In trial group 14 (4118) patients were vegetarian and 20 (5882)

patients were Non vegetarian

In control group 20 (5882) patients were vegetarian and 14 (4118)

patients were Non-Veg

Fig 28 Diet wise distribution of patients

0

5

10

15

20

N N

TRIAL GROUP CONTROL GROUP

14

2020

14

Diet

Veg Non Veg

Page | 104

6 Addiction wise distribution of patients

Table no 12

Addiction

Trial Group Control Group

N N

None 30 8824 27 7941

Alcohol 2 588 0 000

Tobacco 1 294 2 588

Mishri 0 000 1 294

Smoking 1 294 4 1176

Total 34 10000 34 10000

In trial group 30 (8824) patients have no addiction 2 (588) patients

have addiction of alcohol 1 (294) patients have addiction of Tobacco 0

(0) patients have addiction of Mishri and 1 (294) patients have addiction

of smoking

In control group 27 (7941) patients have no addiction 0 (0) patients

have addiction of alcohol 2 (588) patients have addiction of Tobacco 1

(294) patients have addiction of Mishri and 11 (1176) patients have

addiction of smoking

Page | 105

Fig 29 Addiction wise distribution of patients

0

5

10

15

20

25

30

NONE ALCOHOL TOBACCO MISHRI SMOKING

30

21

01

27

0

21

4

Addiction

Trial Group N Control Group N

Page | 106

Statistical Analysis and Results

Effect of study on Karnashoola-

Table no 13

Karnashoola

Group A Group B

BT AT BT AT

N N N N

Grade 2 0 000 0 000 0 000 0 000

Grade 1 30 10000 7 2333 32 10667 5 1667

Grade 0 4 1333 27 9000 2 667 29 9667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 30 Effect of study on Karnashoola

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

30

7

32

54

27

2

29

Karnashoola

Grade 2 Grade 1 Grade 0

Page | 107

Table no 14

Karnashoola Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 088 100 033 006

969 2829E-

08 7667 HS

AT 021 000 041 007

Group

B

BT 094 100 024 004

1037 7103E-

11 8438 HS

AT 015 000 036 007

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 31

000010020030040050060070080090100

BT AT BT AT

GROUP A GROUP B

088

021

094

015

Karnashoola

Mean

Page | 108

Table no 15

Karnashoola

Mean SD Effect

Group

A

Group

B Trial Control Trial Control

Day 1 088 094 033 024 000 000

Day 3 065 071 049 046 2667 2500

Day 5 024 038 043 049 7333 5938

Day 14 021 015 041 036 7667 8438

000

010

020

030

040

050

060

070

080

090

100

Day 1 Day 3 Day 5 Day 14

Karnashoola

Mean Group A Mean Group B

Page | 109

Table no 16

Karnashoola N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3250 110500

510000 275 Control group 34 3650 124100

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 110

Effect of study on Karnakandu

Table no 17

Karnakandu

Group A Group B

BT AT BT AT

N N N N

Grade 3 7 2333 0 000 4 1333 0 000

Grade 2 18 6000 0 000 18 6000 0 000

Grade 1 7 2333 7 2333 10 3333 15 5000

Grade 0 2 667 27 9000 2 667 19 6333

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 32 Effect of study on Karnakandu

0

5

10

15

20

25

30

N N N N

BT AT BT AT

GROUP A GROUP B

7

0

4

0

18

0

18

0

7 7

10

15

2

27

2

19

karnakandu

Grade 3 Grade 2 Grade 1 Grade 0

Page | 111

Table no 18

Karnakandu Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 188 200 081 015

1091 3119E-

10 8906 HS

AT 021 000 041 007

Group

B

BT 171 200 076 014

1032 4746E-

09 7414 HS

AT 044 000 050 009

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Page | 112

Fig 33

Table no 19

Karnakandu

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 188 171 081 076 000 000

Day 3 126 118 057 058 3281 3103

Day 5 071 074 046 051 6250 5690

Day 14 021 044 041 050 8906 7414

000

020

040

060

080

100

120

140

160

180

200

BT AT BT AT

GROUP A GROUP B

188

021

171

044

Karnakandu

Mean

Page | 113

Table no 20

Karnakandu N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 4051 137750

373500 006 Control group 34 2849 96850

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is less than

005 Hence we conclude that there is significant difference between Trial

Group and Control Group

000

020

040

060

080

100

120

140

160

180

200

Day 1 Day 3 Day 5 Day 14

Karnakandu

Mean Group A Mean Group B

Page | 114

Effect of study on Karnasrava

Table no 21

Karnasrava

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 11 3667 0 000 8 2667 0 000

Grade 1 23 7667 3 1000 26 8667 2 667

Grade 0 0 000 31 10333 0 000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 34

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

11

0

8

0

23

3

26

20

31

0

32

Karnasrava

Grade 3 Grade 2 Grade 1 Grade 0

Page | 115

Table no 22

Karnasrava Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 132 100 047 009

1122 4356E-

13 9333 HS

AT 009 000 029 005

Group

B

BT 124 100 043 008

1130 9364E-

14 9524 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 35

000

020

040

060

080

100

120

140

BT AT BT AT

GROUP A GROUP B

132

009

124

006

Karnasrava

Mean

Page | 116

Table no 23

Karnasrava

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 132 124 047 043 000 000

Day 3 100 100 025 025 2444 1905

Day 5 047 038 051 049 6444 6905

Day 14 009 006 029 024 9333 9524

000

020

040

060

080

100

120

140

Day 1 Day 3 Day 5 Day 14

Karnasrava

Mean Group A Mean Group B

Page | 117

Table no 24

Karnasrava N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3535 120200

549000 655 Control

group 34 3365 114400

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 118

Effect of study on Karnabadhirya

Table no 25

Karn

Badhirya

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 0 000 0 000 0 000 0 000

Grade 1 13 4333 0 000 16 5333 2 667

Grade 0 21 7000 34 11333 18 6000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 36

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 00 0 0 0

13

0

16

2

21

34

18

32

Karnabadhirya

Grade 3 Grade 2 Grade 1 Grade 0

Page | 119

Table no 26

Karn

Badhirya Mean Median SD SE

Wilcoxon

W P-Value

Effect Result

Group

A

BT 038 000 049 009

799 7173E-

05 10000 HS

AT 000 000 000 000

Group

B

BT 047 000 051 009

816 0000138 8750 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 38

000

005

010

015

020

025

030

035

040

045

050

BT AT BT AT

GROUP A GROUP B

038

000

047

006

Karnbadhirya

Mean

Page | 120

Table no 27

Karn

Badhirya

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 038 047 049 051 000 000

Day 3 009 006 029 024 7692 8750

Day 5 003 006 017 024 9231 8750

Day 14 000 006 000 024 10000 8750

000

005

010

015

020

025

030

035

040

045

050

Day 1 Day 3 Day 5 Day 14

Karn Badhirya

Mean Group A Mean Group B

Page | 121

Table no 28

Karn

Badhirya N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3400 115600

561000 806 Control

group 34 3500 119000

Total 68

Page | 122

COMPARISION BETWEEN GROUP A AND GROUP B

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Table no 29

Overall Effect

Trial Group Control Group

N N

Marked Improvement 21 6176 16 4706

Moderate Improvement 8 2353 13 3824

Mild Improvement 4 1176 5 1471

No Change 1 2941 0 0

TOTAL 34 100 34 100

Fig 39

0

5

10

15

20

25

MARKED IMPROVEMENT

MODERATE IMPROVEMENT

MILD IMPROVEMENT NO CHANGE

21

8

41

1613

5

0

Overall Effect

Trial Group N Control Group N

Page | 123

DISCUSSION

Page | 124

Discussion is nothing but the logical reasoning of observations In

every research work discussion part is very important because it brings into

light about the logical analysis which are helpful in filling the research gap in

the scientific world

The discussion is categorized into following ways for the ease of

understanding

1 Discussion on selection of topic

2 Discussion on review of literature

3 Discussion on drugs their mode of action on the disease mode of action

of Karnadhoopana

4 Discussion on observation and results

1 Discussion on selection of topic

Otomycosis is commonly encountered in day-to-day practice Majority

of Indian people affected with this pathology This disease commonly

manifests in developing countries low socio-economic standard and lack

of hygiene Now a days due to busy lifestyle people are not able to follow

the proper instruction of care of ear which may be responsible for the

recurrent nature of disease So for the management of this we use

Karnadhoopana with the help of Agaruwadi Varti Dhoopana is simple

easy cost-effective procedure which can be done even at OPD levelso

for the disease Karnasrava we selected Karna Dhoopana as therapeutic

procedure Karnadhoopana was done with Agaruwadi Varti and Guggula

Varti which was very effective for treatment

Page | 125

2 Discussion on review of literature

Karnasrava is one such disease among 28 Karnarogas mentioned by

Acharya Sushruta in the chapter named Karna Roga Vigyana Acharya

Charaka included Karnasrava as symptom under the four types of

Karnarogas due to vitiation of different doshas Acharya Vagbhata has

not described Karnasrava separately It is a fact that systemic

description of Karnarogas is available in all the ancients of pus from a

Vata afflicted ear may results from head injury or immersion in water

Karnasrava is a clinical entity which can be correlated with Otomycosis

Karnasrava is explained as symptom as well as a disease in Ayurveda

Nidana- Karnasrava occur due to Samanya Nidana and Vishesh Nidana

Vishesh Nidana like Shirobhighata Nimmajato jale Mithyayoga of Shashtra

The exact pathology behind Karnasrava is not understood clearly

Purvarupa ndash No specific Purvarupa are found for Karnasrava in classical

literature Acharya Madhukara describe Purvarupa as expression of

Rupa(lakshana) with less intensity that is less intensity itching sound in ear

may considered as Purvarupa of Lakshana

Samprapti- Aacharya Sushruta not explained the Samprapti of Karnasrava

separately and we must consider the general Samprapti of Karnaroga Due to

various aetiologias as cited above ear afflicted by Vata dosha causes Twak

Rakta Mamsa dushti results in Karnasrava According to Acharya Sushruta

Vata-Kapha dose is dominance in Karnasrava

Page | 126

Nidan

Nija Agantuja

Vata ndash kapha prakopak nidana Shirobhighata Nimmajato-jale

Mithya yoga of Shastra

Vata- kapha Prakopaka(Chaya prakopak) Vata-kapha prakopaka

( Achay prakopak)

Twak Rakta Mamsa dushti

Karnasrava

Page | 127

Chikitsa

The curative aspect and this must be done simultaneously giving due

importance to Nidan Parivarjana that is preventive measures So Nidan

Parivarjana that is avoidance of causative factors like Jalkrida Mithyayogen

shashtrasya Karnakandu Shirasnan Pratishaya is the first step in combating

the disease and form the part of line of treatment

Above Samprapti helps us to proceed towards the treatment of Karnasrava

The main protocol of treatment is removal of fungus and wound management

which include various measures to keep area day clean clear of microbes and

providing ideal condition for healing

Samany Chikitsa- Acharya Sushruta described general treatment for

Karnaroga as Snehapana (Drinking ghee) Rasayana (Rejuvenation therapy)

Bhramacharya Avoid excessive speaking Avoidance of physical exercise and

head bath

Vishesha Chikitsa ndash Acharya Sushruta mentioned some procedures in the

treatment of Karnasrava which is Shirovirechana Karnadhoopana

Karnapurana Karanpramarjana Dhavan Avachurnana Karnapurana Above

various procedures described in Ayurveda for management of fungus growth

in ear discharging ear fulfill these requirements of wound management

Page | 128

Discussion on observation and Result

Out of 68 patients 34 patients included for the trial The incidence of

Karnasrava is observed in trial and control groups

The statistical analysis provided the following data

AGE

Trial group- Maximum no of patients that is 14 (41176) patients were from

age group 25-35 years followed by 29412 patients were from age group

18-25 years 23529patients were from age group 35-45 years and

58824 patients were from age group 45-60 years

Control group - Maximum no of patients that is 14 (41176) patients were

from age group 25-35 years followed by 20588 patients were from age

group 35-45 years and 20588 patients were from age group 45-60 years

17647 patients were from age group 15-25 years

The maximum no of cases of Karnasrava found in age group between 25 to

35 years The reason behind this is repeated use of ear bud or emersed water

in ear More use of earphone or working more in cold environment

GENDER

Trial group ndash A higher prevalence seen in females 6764 and 3235 in

males

Control group - A higher prevalence seen in males 5588 and 4411 in

females

Females and males both are prone to disease

Page | 129

EDUCATION

Trial group-It is observed that amongst 34 patients maximum ie16

(47059) patients were graduated 8 (23529) patients were HSC

educated 4 (11765) patients were SSC educated 4 (11765) patients

were illiterate 1 (29412) patient were primary educated and 1(29412)

patient were post graduated

Control group- It is observed that 10 (29412) patients were graduated 9

(26471) patients were HSC educated 6 (17647) patients were post

graduated 3 (88235) patients were SSC educated 3 (88235) patients

were primary educated3 (88235) patients were illiterate

There is no direct relation between education and Otomycosis

RELIGION

Trial group- The incidence of patients of Hindu religion are 9118 and Muslim

religion are 882

Control group- The incidence of patients of Hindu religion are 9706 and

Muslim religion are 294

There is no probable explanation for this maximum number of patients in

Hindu religion it depends upon the patients attend the hospital and

community residing there

Page | 130

DIET

Trial group It was found that maximum ie5882 patients were taking

mixed diet while 4118 were taking vegetarian diet

Control group It was found that maximum ie5882 were taking

vegetarian diet while 4118 patients were taking mixed diet

The dietary habit of person is based on choice availability and religious

customs of the person

ADDICTION-

Trial group- It was found that maximum ie 30 (8824) patients have no

addiction 2 (588) patients have addiction of alcohol 1 (294) patients

have addiction of Tobacco 1 (294) patients have addiction of smoking and

0 (0) patients have addiction of Mishri

Control group - It was found that maximum ie 27 (7941) patients have

no addiction 4(1176) patients have addiction of smoking 2 (588)

patients have addiction of Tobacco 1 (294) patients have addiction of

Mishri and 0 (0) patients have addiction of alcohol

Very few patients were addicted to Alcohol Smoking Tobacco and Mishri

These factors can be taken as provoking factors for Otomycosis

Page | 131

Discussion based on probable Mode of action of Karnadhoopana

In Ayurveda classics Karna Dhoopana is therapeutic procedure explain for

Karnasrava Dhoopana is administration of Dhooma (Fumes) with the help of

Dhoopan Dravya References indicates that analgesic and disinfectant effect

of Dhoopana karma and mention for Dushta Vrana Chikitsa It reduces

Vedana Srava amp also does Vrana Ropana action

Various Dhoopanas and Dhoopan Dravas for different element in various

Samhitas of Ayurveda but there is a lacuna of availability of reference

regarding how to do it and method of procedure Matra Kala Contraindication

etc

Currently simple modified way of Karnadhoopana according to Yukti Praman

and experience but there is lac of standardization

Karnadhoopana is one among the topical Bahiparimajan type of treatment

Karna Parmarjana is procedure of cleaning ear with the help of cotton or gauze

piece soaked in honey

Page | 132

Dhoopan

The fumes coming out on burning Agaruwadi Varti

Administrated directly into external ear canal

Causes vasodilation

Due to this increase blood supply in external ear canal

It helps in absorption of drug

Fumes dries up Srava and bring the analgesic effect

Karnagata Kapha amp Avrut Vata Dosha Shaman

Decrease in signs and symptoms like karnasrava Karnshool Karnabadhirya amp

Karnandu

Page | 133

3 Discussion based on probable mode of action of Agaruwadi

Dhoopana

Agaru ndash

I Agaru is a fragrant tree aroma is a result of fungal pathogenesis when the

wood of tree is contaminated by fungi at wounds it develops scrap filled

with resin and turn out to be aroma Medicinal use of Agaru have been

recorded in ancient medicinal science in in inflammatory disease and some

infective disease

II Acharya Charaka has referred to Agaru as an Ushna dravya despite having

Tikta Rasa Ashtang Samgraha used Agaru as Dhupana Dravya along with

Madan and Yawa in Karnasrava Nighantu recommended is use as a

Dhoopana

III In various Samhitas and Nighantus Agaru described as Tikta Snighdha

Sheetaprashamana Vranaprasadana Tvachya Due to these properties

Agaru is used in the treatment of Karna-Akashi Roga and Dushta Vrana

Shodhaka

IV Agaru is reported to have Antimicrobial Analgesic Antioxidants

Antihistaminic and anxiolytic properties Its Antihistaminic property gives

relief from itching which is cardinal feature of Otomycosis Due to Katu

Ushna Tikta Guna improves blood circulation Bheda stage develop It is

Niram Awastha of Dosha Karnagata kapha and vata get decrease and

symptoms like karnashoolakarnasrava get decrease Agaru also have a

Antioxidant properties

V Chemically Agaru Contain 2-(2-Phenylethyl) Chromones Terpenoids

Flavonoids

VI Natural Agarwood had inhibitive activities towards Staphylococcus Aures

The chloroform extract of Agarwood prolongs the pain threshold[108]

Page | 134

Madan

I Madanphala have therapeutic properties like Anti-inflammatory

Antiallergic Analgesic and Wound healing

II It is Useful in treatment of disease like Shotha (inflammation) Vidradhi

(Abscess) Pratishaya (Common cold) Kushta(Skin disease)

III Extract of Madanphala mainly contain Glcosides Tritorpenct

Glycosides Saponin

IV Saponin glycosides are act as fire extinguisher This property is helpful

for vartiIt also act as a detergent which clean the surface of fungus

V Tritorpenct act as a anti-inflammatory antimicrobial and

immunomodulator compound Interaction of glycosides with sterol

causes disturbance of selective permeability in plasmic membraneso

exudates and discharge get decrease

VI Pharmacological activity [109]

Antibacterial Activity The preliminary antibacterial activity of Methanolic

extract of Randia D lam was done on some standard and wild pathogenic

strains The inhibition of the bacterial growth was more pronounced on E coli

as compared to the other tested organism This shows the antibacterial action

of Randia D secondary infection can prevent

Anti-Allergic Activity In Ayurveda Randia D Extract and its fraction of milk

induced leukocytosis and eosinophilia in mice

Anti-Inflammatory Activity The crude methanol extract of fruit of Randia D

effectively reduced the carrageenin induced oedema in hind paw of the rats

significant reduction in granular tissue formation was recorded This activity

seems to be significant at various acute phases of inflammation and om

formation of granular tissue This proves action of Madanaphala in shopa

(inflammation)

Page | 135

Analgesic Activity Analgesic activity was tested in mice weighing between 20-

250 with six number of animals in each group Methanlic extract of fruit Randia

d give analgesic activity in both models This proves its Shoolanashaka (pain

killer) action

Immunomodulatory Activity Randia D has immunostimulant activity and

chloroform fraction which strongly affected immune system seems to be

bioactive fraction of this plant

The overall effect of Agaru Mandanphala Yawa having Anti-inflammatory

Antiseptic Antimicrobial Property Active ingredient shows these properties

Agaru Yawa Madanphala

Vatakaphaghna

Act as

Vranashodhak

Vedanasthapaka

Sheetaprashamana

Shothara

Avarana of Vata get decrease so helps to Shaman of Vata dosha

Karnakandu Karnashoola Karnasrava

Prashamana

Page | 136

This fact can be taken into consideration and probably acknowledge that

Karnadhoopana with Agaruwadi Varti had not leave any residue in the ear

Removal of fibrin keratinocyte migration and in growth of epithelial tissue

plays a major role in healing It is technique of fumigation of ear with the

smoke of anti-infective drug In Karnadhoopana Sthanik Swedana increase the

blood supply and helps in absorption of the drug reduce Karnakandu amp

Karnshoola associated with infection

Page | 137

SUMMARY AND CONCLUSION

Page | 138

The dissertation entitled randomize comparative clinical trial to study the

effect of Agaruwadi Karnadhoopan and Guggula Karnadhoopan In Karnasrava

wsr to Otomycosis

The dissertation is divided into fallowing parts

Introduction

Review of literature

Ayurvedic review

Modern Review

Drug review

Procedure review

Material and Method

Observation and result

Discussion

Summary and conclusion

bull INTRODUCTION

It includes importance of Shalakyatantra in Sushrut Samhita Charka

Samhita And Ashtang Samgraha

Common and specific causes of Karnasrava

Karnasrava is a clinical entity which can be corelate with Otomycosis

In Ashtang Samgraha stated the procedure like Karnadhoopana with

Agaru Yawa Madanphala in Karnasrava

Page | 139

bull REVIEW OF LITERATURE

1 Ayurvedic review

2 Modern review

3 Drug review

Ayurvedic review-

It includes Rachana-Sharir and Kriya-Sharir of Karna detail description of

Karnaroga and its types Karnaroga Samanya hetu Poorvaroopa Rupa

Samprapti Upadrava Pathya-Apathya of Karnasrava Vishesh Nidan and

Chikitsa of Karnasrava Detail description of Karnadhoopana according to

various Acharays have been mentioned

Modern review-

It includes anatomy and physiology of Ear brief anatomy of ear anatomy of

External middle and Internal ear Detail description of the disease

Otomycosis mechanism of fungal infection in external canal pathophysiology

investigations diagnosis and management

Drug review-

Detail description of Agaru Yawa Madan Guggula and its synonyms

Ayurvedic properties Karma uses Pharmacological action and their

pharmacodynamic properties

Page | 140

MATERIAL AND METHOD

It includes description regarding materials required for the study Preparation

of Agaruwadi Varti its Standardization Sterilization and packaging

Plan of study

1 Total 68 patients completed the treatment Age criteria was kept

between 18-60 years Patient selection was done by done by simple

random sampling method and divided into two groups A (Trial) and

Group B (Control) 34 patients in each group

2 Patients in Group A were treated with Karnadhoopana with Agaruwadi

Varti for 7 days two times in a day while patients in Group B were treated

with Karnadhoopana with Guggula for 7 days two times in a day

3 Clinical examination done during each follow up ie 0th 4rd 7th and

observation were recorded

Page | 141

OBSERVATIONS AND RESULTS

Page | 142

1 It was observed that higher incidence of disease Karnasrava ie

Otomycosis found in age group 25-35 years

2 Disease otomycosis was equal in both male and female

3 The trial group there was significant relief in Karnakandu (8906)

Karnasrava(9333) Karnashoola(7667) and karnabadhirya(100)

4 In control group there was significant relief in Karnakandu (7414)

Karnasrava(9524) Karnashoola(8438) and

karnabadhirya(8750)

Page | 143

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Page no- 117

106 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

Dhoompanvidhi page no- 252-254

107 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012Chikitasasthan Shlok

no- 151page no-406

108 httpswwwmdpicom1420-3049232342pdf

109 httpswwwijamcoinindexphpijamarticledownload0610201530

0

Page | 156

BIBILOGRAPHY

Page | 157

1 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

2 Scott-Brown WG Diseases of the EarNose and Throat Landon

Botterworth and co(publishers) Ltd1952 Volume 2

3 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012

4 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009

5 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi commantry

Purvakhand and Madhyamkhand

6 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

7 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-Tatva-

Sandipika hindi commentary Published by Chaukhamba Sanskrit

SansthanVaranasi

8 The Ayurvedic Pharmacopeia of India Ministry of Health and family welfare

department of Ayush Part 1 and part 4

9 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005

10 Acharya Trivedi Raguveer Prasad Ashtang sangrah published by

Vaidyanath Ayurveda bhavan pvt

11 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition

12 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary published by Chaukhamba

Orientalia

Page | 158

ANNEXURE

Page | 159

ANNEXURE- 1

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

CASE RECORD FORM

RESEARCH PROFORMA FOR MS (AYU) DESSERTATION

DEPARTMENT OF SHALAKYATANTRA

NAME -

ADDRESS -

GENDER - AGE - OCCUPATION-

RELIGION - EDUCATION - MARITAL STATUS-

OPD IPD NO-

DATE OF ADMISSIONCOMMESEMENT-

DATE OF DISCHARGECOMPLITION-

DATE OF COUNSELLING-

TEL NO-

CHIEF COMPLAINTS-

PAST MEDICAL AND SURGICAL HISTORY-

TREATMENT HISTORY-

FAMILY HISTORY-

Page | 160

PERSONAL HISTORY-

a) Ahar(Diet)

b) Vihar

c) History of addiction

GENERAL EXAMINATION

PULSE - MIN BP - mm of hg

TEMP - 0F RR - MIN

ASHATAVIDHA PARIKSHANA

Nadi- Mutra- Mala-

Jivha- Shabda- Sparsha-

Drik- Aakruti-

SYSTEMIC EXAMINATION

RS ndash

CNS-

CVS ndash

Page | 161

LOCAL EXAMINATION (KARNA PARIKSHAN)

OBSERVATION TABLE FOR SUBJECTIVE CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching )

RIGHT EAR LEFT EAR

KARNASHASHUKULI

KARNAPUTRAK

KARNAPALI

KARNAKUHARA -

SRAVA

GANDH

VARNA

SWARUPA

KARNAPATALA (TM)

Page | 162

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

Hearing Test

1Renne Test ndash

2 Weber Test -

Examination of Ear-

Pathological Investigation-

Other Examination-

Nidan Panchak-

1Hetu-

2Purvarup-

3Rupa-

4Upashayanupashaya-

5Samprapti

Signature of Guide Signature of Doctor(Researcher)

Page | 163

ANNEXURE 12

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Dhoopana Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization were done as recommended in pharmacy procedure

The raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 were mixed together

in equal quantity to make Agaruwadi churn

STEP 4 - Agaruwadi churn were triturated with appropriate quantity of water

and prepared Varti in GMP Certified Ayurvedic pharmacy Standard aseptic

precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Dhoopana Varti was packed in sterile air packed

container

STEP 6 - Agaruwadi Dhoopan was given with the help of Dhoopan yantra

TREATMENT DETAIL-

Purvakarma -

1 The patient is asked to sit comfortably on chair having sufficient light and

less amount of dust

2 The EAC is cleaned thoroughly by Pichu Varti (cotton swab) to remove the

discharge and other debris

Pradhankarma -

1 The patient is asked to relax completely on the chair

Page | 164

2 Fumes are passed to the ear with Dhoopana Yantra

3 Dhoopana yantra is funnel shaped and its one end will keep the ear covered

for the passage of Dhooma into the ear canal and other end where Agaruwadi

Dhoopana Varti were placed which produces fumes

4 This Dhoopana was given for 5 min

Pashchat karma -

1 The patient were advised to avoid cold refrigerated food drinks cold water

bath cold wind fog and prevent water from entering the ear

(A) Agaruwadi Dhoopana Varti

B) Guggula Dhoopana Varti SOP of it is same as above Agaruwadi Dhoopana

Varti

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Page | 165

ANNEXURE 21

INFORMED CONSENT DOCUMENT

Study Title

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

Introduction

- You are invited to take part in a research study RANDOMSIED COMPARATIVE

CLINICAL TRIAL TO STUDY THE EFFECT OF AGARUWADI DHOOPANA AND

GUGGULA DHOOPANA IN KARNASRAVA

- Before you decide it is important for you to understand why the

research is being done and what it will involve

- Please take time to read the following information carefully and discuss

it with friends relatives and your doctor if you wish

- Ask us if there is anything that is not clear or if you would like more

information

Purpose amp Nature of Study

- In this research project by examine you and ldquoKarnasravardquo (Otomycosis)

disease were treated

- In the part of treatment Agaruwadi Dhoopana or Guggula Dhoopan were

given

- Dhoopana means medicated drug fumes were given in ear with the help of

Dhoopan Yantra

Page | 166

- Treatment was given for 7 days

Study Duration

7days

Participation

- Your participation is entirely voluntary

- If you do decide to take part you were given this information sheet to keep

and be asked to sign a informed consent form

- If you decide to take part you are still free to withdraw at any time and

without giving a reason This will not affect the standard of current or future

medical care you may receive

Confidentiality

- All information which is collected about you during the research were

kept strictly confidential

- Any information about you which is collected from the center will have

your identity in the form of a code number so that it will remain confidential

Benefits Of Study

- The results obtained from this study would be helpful for providing better

quality of treatment amp other essential facilities for Karnasrava (Discharge)

patients

- You will get clinical benefit from the study

Page | 167

Risks Of Study

- In this treatment there are few chances of Irritation of Ear Nose and

congestion at EAC if any of these happens then treatment were given

Results Of Study

- If the Results obtained are profitable then they may get published

without disclosing your details

Signature of patient

Date

Time

Phone no of Researcher

Page | 168

रण मादहती पतरक

सशोिनाच शीषवक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE

EFFECT OF AGARUWADI DHOOPANA AND GUGGULA DHOOPANA

IN KARNASRAVA

परसतताना

- आपणास या सशोिनातपमक अभयासात सहिागी होणय़ाच आाहन करणयात यत आह

- सशोिनातील सहिाग तननदशचत करणयापी सशोिनाच उददश समजन घया

- खालील मादहती काळजीपवक ाचा आणण आशयक ािलयास आपलया डॉकिराशी कका

दहतशरचतकाशी चचाव करा

- काही सददिता असलयास कका आणखी मादहती ही असलयास आमछयाशी चचाव करा

सशोिनाच उददीटि सतरप

- सदर सशोिन परकलपामरधय आपलयाला तपासणी करन कणवसरा या वयाशरिची शरचककतपसा दणयात

यणार आह

- सदर वयाशरिची शरचककतपसा महणन आपणास अगरादी िपन कका गगल िपन

दणयात यणार आह

- सदर औषि आपणास 7 ददस घयायाच आह

Page | 169

कालािी

- 7 ददस

सहिाग

- आपला सहिाग हा पणवपण ऎनदछिक आह

- आपला सहिाग तननदशचत असलयास आपणास ही मादहती पतरतरका दणयात यईल आपणास यातील

समती पतरकार सही कराी लागल

- सहिाग तननदशचत असनही आपण कोणतपयाही ळस कोणतही कारण न दता माघार घ शकता

याचा आपलया दयकीय सविर कोणताही पररणाम होणार नाही

गोपनीयता

- सशोिना दरमयान गोळा कलली आपलया वषयाची सव मादहती गोपनीय ठणयात यईल

- आपली यनदकतक मादहती साकततक सतरपात गोपनीय ठणयात यईल

सशोिनाच फ़ायद

- सशोिनाच तनटकषव कणवसरा बाशरित रणाछया दयकीय इतर सविाचा दजाव सिारणयास

फायदशीर ठरतील

सशोिनातील जोणखम

- य़ा शरचककतपसमरधय कान दखण डॊळय़ातन नाकातन पाणी य़ण नाकात जळजळण डोक जड

होण ही लिण ददस शकतात यापकी लिण तनमावण झालयास तपयाची शरचककतपसा कली जाईल

Page | 170

सशोिनाच तनटकषव

सशोिनाच तनटकषव फ़ायदशीर ठरलयास आपली मादहती गोपनीय ठन परकाशशत करणय़ात यईल

रण सतािरी-

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

Page | 171

ANNEXURE 31

INFORMED CONSENT FORM

Patient OPD no __________

Subjectrsquos Identifier

Date of Birth Age Gender

I _____________________________________ age___________ years

exercising my free power of choice hereby give my consent to be included

as a participant in the clinical study entitled

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

1 I confirm that I have read have been read and understood the information

sheet for the above study and can ask questions

2 I understand that my participation in the study is voluntary and that I am

free to withdraw at any time without giving any reason without affecting my

medical care or legal rights

3 I understand that the Ethics Committee members investigators and study

doctors will not need my permission to look at my health records both in

respect of the current study and any further research that may be conducted

in relation to it even if I withdraw from the trial I agree to his access

However I understand that my identity will not be revealed in information

released to third parties or published

4I agree not to restrict the use of any data or results that arisefrom this study

provided such a use only for scientific purpose

5 I agree to take part in the above study

Page | 172

signature with Date-

Left hand thumb impression

Name amp signature of the witness ndash

Name amp signature of the student ndash

Page | 173

ANNEXURE 32

समतीपतरक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

वयकतीच य

ददनाक जरमददनाक

1) मी ह तननदशचत कररत आह ककसदर सशोिन परकलपाबाबतची सपणव मदहती मी ाचली असनमला ती

समजली आहतपयाबददल मला परशन वचारणयाची पणव मिा आह सदर मादहतीन माझ समािान झाल

आह

2) मी सदर सशोिनातन माझया मजीनसार किीही बाहर पड शकतो या माझया अशरिकाराची मला कलपना

आह

3) माझी दयककय मादहती तपासणयाची कागदपतर कळ सशोिनाकररता ापरली जाणार आहत याची

मला मादहती आहसदर सशोिन परकलपातील सबशरित घिकाना माझी दयककय मादहती पाहणयाची मी

समती दत आहतरावप या सदिावतील माझी ओळख दशववणारी मादहती कोणासही ददली जाणार नाहीयाची

मला कलपना दणयात आली आह

4) सदर अभयासातन शमळणारी मादहती अरा तनटकषव कळ शासततरीय हतसाठी ापरल जाणयासाठी माझी

समती आह

5) रील अभयासात सहिागी होणयास माझी समती आह

रण सतािरी-

Page | 174

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

ASSESSMENT CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching)

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

a) कणवशल ( pain )- 0 - Absent

1 ndash Present

Page | 175

b) कणवकणड (Itching)- 0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

c) कणवसततरा ( Discharge )

0- Absent

1-Mild- Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाशरियव ( conductive Loss of hearing )

0 - Present

1 - Absent

Page | 176

Page | 177

Page | 178

Page | 179

Page | 180

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

Page | 181

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 182

AUTHENTIFICATION CERTIFICATE

Page | 5

pain discharge foul smell and thus control the infection Dhoopana is also

useful as Adhidaivika Chikitsa to protect the patient from external attack of

visible and invisible organism The principal treatment modality adopted in

Allopathic system of medicine is oral antibiotics and topical antibiotic drop

Long term use of oral antibiotic causes adverse effect like gastric irritation

reduce immunity and resistance to drug Long term use of topical antibiotic

drops cause Ph change in external canal which become prone to fungal

infection

Hence the therapeutic procedure with Guggula or Agaruwadi Varti

Karnadhoopana are cost effective safe and easy procedure and it can be

used more effectively

Page | 6

AIM OF STUDY

To evaluate the effect of Agaruwadi Varti Dhoopana and Guggula Varti

Dhoopana in management of Karnasrava

OBJECTIVE

To compare the efficacy of Agaruwadi Dhoopana and Guggula Dhoopana in

Karnasrava

HYPOTHESIS

NULL HYPOTHESIS -

H0- Agaruwadi Dhoopana is not effective than Guggula Dhoopana in

Karnasrava

ALTERNATE HYPOTHESIS -

H1- Agaruwadi Dhoopana is more or equally effective than Guggula

Dhoopana in Karnasrava

RESEARCH QUESTION

Whether there is significant difference between Agaruwadi Dhoopana and

Guggula Dhoopana in Karnasrava

Page | 7

PREVIOUS WORK DONE -

1 Anupama Patra B Effect Of Arka Taila In The Management Of

Karnasrava With Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching amp Research in Ayurveda

Gujarat Ayurved University Jamnagar 2007

2 Palmer Komalben K Further Study On Role Of Arka Taila In The

Management Of Karnasrava With Special Reference To

Otomycosis Shalakya Tantra Institute for Post Graduate Teaching amp

Research in Ayurveda Gujarat Ayurved University Jamnagar 2010

3 Sathisha Shankar B Management Of Karnasrava With Sthanika

Guggulu Dhoopana And Rasnaadi Guggulu-A Comparitive Study Shalakya

Tantra Government Ayurvedic Medical College Bangalore 2011

4 Shashikala DK Comparative Study On The Efficacy Of Vacha

Lashunaadi Taila Karna Pichu And Nimba Patraadi Dhoopana In The

Management Of Karna Srava Shalakya Tantra Government Ayurvedic

Medical College Bangalore 2014

5 Javale Anant A Clinical Study On The Efficacy Of Arka Taila In The

Management Of Karna-Srava Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching amp Research in Ayurveda

Gujarat Ayurved University Jamnagar 2005

6 Pournima V Koti Management Of Karnasrava With Priyangvadi Taila

Pichu With And Without Saarivadi Vati Shalakya Tantra Sri Jagadguru

Gavisiddeswar Ayurvedic Medical College Koppal 2015

7 Amisha Patel A Clinical Evaluation Of Honey In The Management Of

Karna Shoola With Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching and Research in Ayurveda

Gujarat Ayurved University Jamnagar 2016

Page | 8

REVIEW OF LITRATURE

Page | 9

Ayurvedic literature Ayurveda is a science of life practice since

thousands of years The ancient Indian system of medicine and surgery is

commonly known as Ayurveda This was given the status of Upaveda or

fifth Veda in the next stage of growth Among the available literature three

Samhita that is Charaka Samhita Sushrut Samhita Ashtang Hrudayam and

Ashtang Samgraha are the chief source of knowledge of Ayurveda

Ayurveda consist of eight branches Shalakyatantra is one among them

Shalakyatantra is one of its specialized branch deals with science of

ophthalmology otorhinolaryngology Oro dental surgery and head Acharya

Sushruta himself a practical surgeon was the first to advocate dissection of

dead bodies is indispensable for a successful student of surgery He had

described gross anatomy in the first chapter of Uttartantra Shalakyatantra

define by different Acharys as follows

शालाकय नामोरधवजतरगताना रोगाणा शरणनयनदनघराणाददसशरशरताना वयाशरिनामपशमनारव

स स ११०

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत [13]

चस १७१२

Shalakya Tantra Nirukti and Parichaya

शलाकायााः कमव शालाकय ततपपरिान शलाकयम डलहण [14]

The term Shalakyatantra is derived from Shalakya and Tantra

The word Shalakya means A probe and Tantra denotes teaching and

practices found in scripturesThe compendium in which application of

Shalaka in various surgical procedures is principally described is called as

Shalakya tantra

दनदटिवशारदााः शालाककनाः डलहण ( सउ ११३)[15]

An eye specialist is termed as Shalaki by Dalhana

Page | 10

Synonyms of Shalakya Tantra

Uttamanga Chikitsa Jatrurdhwa Chikitsa Urdhwang Chikitsa Shalakya

Chikitsa

Importance of Shalakyatantra-

Life of living being and all the Indriyas are situated in the head hence it is

known as Uttamanga

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत

चस १७१२

The treatment given to this part of the body is described specially in

Shalakya tantra While describing the importance of Shiras Vagbhata

correlates it to the root of tree (Urdhwa Mula) and body to the trunk of tree

(Adha Shaka)

Sushruta has deal with Mukha Roga in Nidan Shan and its treatment in

Chikitsasthan The description regarding the disease of eye ear nose and

head are found only in UttaraSthan Sushruta specially describes the

disease of Shalakyatantra as told by Videha in the beginning of Uttartantra

itself[16]

Shalakyatantra Itihas-

India Exhibits traditional of more than thousands of years in art literature

language logic and philosophy etc The convention was in its sophisticated

and advanced attire throughout the Vedic period

Vedic period ndash

1 Natush was treated for deafness by Ashwinikumars (Rigveda)

2 Rujaswa and Kanva were treated for blindness by Ashwani Kumaras

(Rigvedas)

Page | 11

3 There are several prayers mentioned for normal functioning of sense

organs (Yajurveda)

4 Structures and functions of Mastishka are described (Atharveda)

5 Mantras having reference to disease of Eye Ear Oral cavity etc are

found (Atharvaveda)

Upanishada Period ndash

1 Samhita Period

a) Sushrut Samhita ndash

bull Explanation regarding Netra Nasa and Shirorogas (Uttartantra 1-

26th chapter)

bull Details regarding Mukha and Karna Roga Nidan and

Chikitsa(Nidansthan 16th and Chikitsasthan 22nd chapter)

bull Description regarding Karna Chedana Sandhana Nasa

Ostasandhana Sutra Sthan 16th chapter

b) Charaka Samhita -

bull Explanation regarding Shirorogas (Sutrasthan 17th chapter)

bull Explanation of Gala rogas like Upajivika Galshundi and Rohini

bull Nasa Shiro Mukha Karna and Netra Chikitsa (Chikitsa sthan 26th

chapter)

bull Description regarding Lakshana and Chikitsa of Shankhaka

Ardhavbhedaka Shirovirechana and Shiro basti (siddhi sthan 9th

chapter)

c)Ashtnga Sangraha ndash

bull Detailed description regarding Shalakyatantara (Uttartantra 11-28

chapter)

bull Description of Kriyakalpa (Sutrasthan 32nd and 33rd)

Page | 12

d)Ashtang Hrudayam

bull Detailed description on Shalakya Tantra (Uttar tantra 8-24 chapters)

bull Kriyakalpas (Sutrasthan 23rd and 24th chapter)

e) Bhela Samhita

bull Chakshushya Vaisheshik and Buddhi Vaisheshik Alochaka pitta

f) Harita Samhita- Branch of Medical science offering elaborating

information about the procedure like Nasya Anjan Gandusha etc

comprehended with their applications in disease of Head Eyes Ears

Eyebrows Throat Temporal region and cervical spine is known as

Shalakyatantara

शशरोरोगा नतररोगा कणवरोगा वशषताः भरकरठशङकमरयास य रोगा समिनदरत दह १३

तषा परततकारकम व नसतयतपयवणजनातन च अभयङगमखगणडषकियााः शालकयसशमतााः १४

इतत शालाकयनाम [17]

Documentation of different ancient literature gives various references

regarding all aspects of Karnasrava in various periods It is very much

important to know the history of Karnasrava from Vedic Pauranic Samhita

and Samgraha period

Vedic period ndash The Vedas being the oldest source of knowledge have no

direct mentioning of Karnasrava

Page | 13

Samhita and Samgraha period ndash

Aacharya Sushruta described about Karnaroga Karnasrava Nidan

Roopa and Chikitsa The detail description is available in Sushrut

Samhita Uttartantra 20 and 21st chapters

Aacharya Charaka did not specify Karnasrava but mentioned 4 types

of Karnarogas that is Vataj Pittaj Kaphaja and Sannipataja and their

treatment in 26th chapter of Chikitsasthan

In Ashtang Hrudaya karnasrava is not explained as a separate disease

but Chikitsa is mentioned in 18th chapter of Astanga Hrudaya

uttartantra

In Ashtang Samgraha Chikitsa is mentioned in 22nd chapter of Astang

Samgraha Uttartantra

The details about Karnasrava are explained in Bhavprakasha

Madhyamakhanda 64th chapter

Madhavakara has explained about Karnasrava in 57th chapter of

Madhymakhanda

Karnasrava is also explained in Sharangadara Samhita Uttarkhand 11th

chapter

The reference for treatment of Karnasrava is available in

Yogaratnakara

In Gadhnigraha Karnasrava and its treatment is mentioned in

Karnarogadhikara Adhaya

Vangasena had mentioned about the disease and treatment in 69th

chapter

Chakradatta explained Karnasrava in 57th chapter

Dalhana has given commentary on Sushrut Samhita Uttartantra 20th

and 21st chapter

Sankhya Samprapti of Karnasrava ndash

Aachary Sushruta explains 28 Karnaroga in Uttaratantra Karnaroga

Vigyniyam Aadhaya Aacharya charaka explain 4 Karnaroga in

Page | 14

Karnarohvigyniyam Adhaya based on doshas Acharya Vagabhata in

Ashtang Hrudaya explain 25 Karnaroga in Adhyaya

कणवशल परणादशरच बाशरियव कषड ए च

कणवसरााः कणवकणडाः कणव चवसतततर च

कशमकणवपरततनाहौ विशरिदवविसततरा

कणवपाकाः पततकणवसततराशवशरचतवविम

कणावबवद सपतवि शोफशरचावप चतवविाः

ऎत कणवगता रोगा अटिावशततरीररतााः

स उ २०- ३ त ५[18]

ातकणवरोग वपततकणवरोग कफकणवरोग

रकतकणवरोग सनदरनपातकणवरोग कणवनाद

बशरिरतप परततनाह कणडाः शोफ पततकणवक

किशमकणवक उियरपविरधयअशो अबवद

कशरचकणवक वपपपली वदाररका पाळीशोष

ततिका पररपोिो उतपपातो उरमरर दाःखिवन

शलहाखयााः परचवशनदरतकणवरोगा उकतााः

इदिीका अ स उ २१ [19]

चतपाराः कणवरोगााः

च स [20]

Page | 15

KARNA

Karna ndash करोतत शबद गरहण [21]

The organ of hearing

Karnasrava- कणवसतय कणवयोाव ससराा [22]

Discharge from the ear is referred as Karnasrava

KARNA SHAREERA

bull Nirukti

कणयवत अकणयवत अनन इती [23]

It means reception and conduction of sound waves

These are the functions of external and middle ear

bull Nirukti of Sravanam

शरयत अनन इती शरणम[24]

It means perception of sound

It can be attributed to the internal ear function

bull Karna Utpatti-

Karna is an organ formed by Akash Mahabhuta[25]

The fundamental characteristic is as follows

Indriya ndash Srotram [26]

Indriya Adhisthan ndash Karna [27]

Indriya Dravy ndash Akasha [28]

Indriya Arth ndashShabdha [29]

Indriya buddhi ndash Srotobyddhi

Page | 16

bull Paryaya of Karna- Shabdapatha Srotrapatha Sravanam shruti

Kuhuram Dwanigraham etc

bull Definition of Karna-

कणवशटकलयनदछिरनमिटिोपगरदहत शरोतरमछयत [30]

मा तन ५७१

The definition of Karna is stated in Madhav Nidanam Indriya which is not

seen with naked eye along with Shashkuli is called Shrotra that is Karna

Indriya is so minute that it is not perceived with any sense organ

In Charak Samhita the word Karna explain as the Indriya Adhisthan of

Shabdha Karna is described as one of the Prathyangas of the body He

emphasizes that all Indriyas manifest during the 3rd month of gestation

period

Acharya Sushruta while describing formation of Purusha from Prakriti or

Avyakta narrated that all Indriyas are developing from the Vikarika and

Taijas Ahankara Both Vagabhata and Sushruta stated that Karna as one of

the Bahirsrotas

शरण नयन दन घराण गदमढराणण न सततरोताशसराणा बदहमवखातन [31]

स शा ५-१०

In Ashtang Hradaya Vagbhata has states that all Indriyas are Atmaja

According to him lower lobule elevated helix projected posterior portion

fleshy and adherent ear are indications of long span of life[32]

ततरखातखातन दह अनदसतमन शरोतर शबद ववकतता [33]

ा शा ३-३

शबदाः शबदनदरिय सवनदछििसमहो ववकतता [34]

स शा १-२६

Page | 17

Ear has the prominence of Akash Mahabhuta The prominent dosha of ear

is Vata It is important seat of Vata The prominent Dhatus are Asthi and

Mamsa Karna is one of the Panchgnanendriyas and it meant for hearing

Sushruta narrated that Karnasthita Asthi and Sandhi

घराणकणवगरीाकषिकोषष तरणातन [35]

सशा ५-२२

शरोतरशरगािकष शखाताव [36]

सशा ५-३२

गडकणवशखटककम [37]

स शा ५-२२

One Sandhi and one Tarunasthi in ear

Sandhi ndash Karna contain two Sandhi one in each ear Type of Sandhi is

Shankhavartha which is present in Shringataka

Mansapeshi ndash 2[38]

Siras ndash 10 [39]

Vataj Sira - 4

Pittaj sira - 2

Kaphaj sira - 2

Raktaj Sira - 2

Avedhya sira-

कणवयोदवश तासा शबदादहनीनामकका पररहरत

सशा ७-२५[40]

Amongst above mentioned ten Siras each Karna lodges one Shabdavaha

Sira It is Avedhya

Page | 18

Dhamani -2

Length of ear is 4 Angula

Karna moola ndash 2 Angula

कणाविरतर चतदवशअगलम

स शा ३५-१४[41]

The distance between two ears through the back of the neck is 14 Angula

bull Marmas of Karna-

1 Vidhuras-

कणवपटठतो अिाःसशरशरत विर ततर बशरियवम

सशा ६-३७[42]

कणतपयादद सतनायममवणी ककनदचचनदरनममनाकर कलयकररणणच

डलहणाचयव[43]

अिसततात कणवयोतनवमन विर शरततहाररणण

ा शा ४-२९[44]

Sankhya-2

Vistara- frac12 Angula

Type- Snayumarma (Susha)

- Dhamanimarma(AH)

- Vaikalykar

Sthana- It is situated in the depressed portion in the back of the ear

Injury to them causes loss of hearing

Page | 19

2 Shringataka marma-

नदजवहाकषिनाशसकाशरोतरखचतटियसरमम

तालरयासतयातन चतपारर सरोतसा तष ममवस

वदि शरगातकाखयष सददसततपयजतत जीवतम

मा तन ५७१ [45]

Sankhya- 4

Type- Siramarma

Sthana- It is in head that is amidst Siras (blood vessels) nursing sense

organ

A palm size area near Talu

Injury to this Marma causes death

In modern anatomy ear divides into Bhayakarna or External ear Mdhyakarn

or Middle ear Antahkarna or Internal ear This is extremely appropriate

Even though the ear is divided into three divisions in the point of modern

anatomy Ayurveda denotes ear organ is one Ayurveda treats disease by

way of assessing Dosha and Dushya Here Dushya is one that is Karnendria

Dosha difference will call for different treatment for different disease Hence

treating the vitiated Dosha will cure the disease irrespective whether it is in

external middle or internal ear The thought is based on different

fundamental principle from Ayurveda

bull Parts of Karna

In Ayurveda classics detailed description about anatomy of ear is not

available But the various parts are mentioned as follows

Bhayakarna- External ear

Mdhyakarna ndash Middle ear

Antahkarna- Internal ear

Page | 20

द कणवशटकशलक दॊ कणवपतरकौ

च शा 7-11[46]

कणवशटकशलक कणवगतातवकौ कणवपतरकौ त बाहयकणा

चिदतत च शा 7-11[47]

शटकली बाहयपालयाशरिटिानम

डलहन- स शरच 25-1 12[48]

Karna Shashkulika ndash It is also called as Karna Shashakuli Charaka has

mentioned this term while describing different Pratyngas of the body

Acharaya Gananatha sen has given the clarification for it as a pinna or

auricle[49]

Karnapali ndash It is popularly known as lobule of the ear Daivakrita Chidra is

present in it

Karnaputrika- Ayurvedic scholars accepted two terms in this cortex They

are Karnaputrika and Karnaputrika The former is considered as Tragus and

antitragus[50]

Karna Prushtha- It can be taken as the cranial surface of mastoid or

auricle[51]

Karnapeetha- Aacharaya Sushruta firstly mention the term Karnapeetha

It is mentioned first by Sushruta while describing the procedure of

Karnavyadana Vagbhata has mentioned that it is Adhobhaga of Karna

Dalhana has clarified that it is the region above the Karnaputrika that is the

region which is at the bottom of the concha

Karnamoola ndash It can be considered as parotid region[52]

Karna lathika ndashAcharaya Dalhana mentioned lobule as a Karna Lathika

Page | 21

Karnaavatu ndashThis term is used by Sushruta while describing the

measurements of different Angapratyangas where he has mentioned that

the distance between the Karnaavatu is 14 Angul Dalhana has comments

that it can be taken as the distance between two ears from behind[53]

Shabdhavahasrotas ndash It also called as Shabdapatha or Srotapatha The

whole passage through which the sound waves pass can be taken as

Shabdavahasrotas[54]

Shrotashringataka ndash It can be taken as the labyrinth of ear[55]

bull Dosha in context to Karna-

Karna is principal location of Vayu

1 Prana Vayu- Prana Vayu circulating in oral cavity is responsible for

Dehadhruka that is keeping all body parts active Indriyadruka that is

keeping all Dnyanendriya healthy by proper nourishment (Purana) helps in

deglutition of food material and convey the stimulation of Indriyabuddhi

and atma

2 Udana Vayu- Bala(strength) Varna speech singing are its function It

is responsible for facial expressions due to pleasure sorrow anger love

frustration etc in general its circulation and actions are just opposite to

Pranavayu

3 Vyana Vayu- Its principal functions are circulation of Rasa and Rakta

through body and various movements Its main location is Hrudaya Five

types of movements for which it is responsible are expansion contraction

upward downward and oblique other activities are opening closure of

eyelid yawning perspiration During circulation if it gets obstructed due

to Srotodushti it generates disease of that Srotas Vyana Vayu gets vitiated

by disease of Rasa Rakta Oja and Chetanadhatu

Page | 22

4 Samana Vayu- It is circulating in the vicinity of stomach and intestine

and helps in keeping the Jatharagni (digestive juices and enzymes) in

equilibrium Disturbance in Jatharagni precipitates disease

5 Tarpaka Kapha- Entire body functions movements are controlled and

executed by various centers in the brain Sensation perceived by sense

organs is conveyed to Mann and Aatma residing in Hrudaya The motor

signals from them are then conveyed to the functioning

organsKarmendriya through Prana Vayu Shira head is therefore a

location of continuous activities motions of Vata All these centers are in

unctuous Majjadhatu in the Shira For stabilizing this ever-active Vata and

to nourish the Majja dhatu very unctuous Tarpaka Kapha situated in Shira

plays an important role

bull Ayurvedic aspect of sound perception [56]

According to Ayurveda Pratyaksha Dnyan or Perception of any sensation

including Shabda occurs due to interaction of the Karnendriya and the

Indriya- Arth -Karma resulting in Sravana

External Environmental acquaintance with living body is executed by five

sense organs namely Netra Karna Nasa Jivha and Twaka All

Dnyanendriya that is sense organ are Panchmahabhautic combination

Despite this fact every Indrya sense organ perceives object Tanmatra of

that Mahabhuta only from which it is originated from Akash Mahabhuta and

hence perceives Shabd only that is audio perception Shrotrendriya is one

of the principal locations of Vata and its function is to perceive Shabda that

is sound waves This sensation is conveyed through Shabdavahi Dhamanis

to Mana and Atma through Pranavayu and the sequence is responsible for

perception of sound in this way external sound is perceived and interpreted

when Atma is linked with Mann Mann is linked with Indriyabuddhi that is

minute virtual Dnyanendriya located in brain Indriyabuddhi is linked with

Adhishthana with prominent Mahabhuta and lastly with Indriya

ArthShabdatanmatra that is sense object Once this sequence is completed

Page | 23

the meaning of a particular sound is interpreted and understood In this

entire process of perception and interpretation of sound waves Pranavayu

and Tarpaka Kapha located in Shira play extremely important role Hence

the healthy status of all the sense organ depends upon the normal

physiologically homeostatic condition of Pranavayu and Tarpaka Kapha

MANAS

ATAMA

BUDDHI

AHANKARA

ARTHA

Page | 24

EAR ANATOMY

bull Embryology of the Ear [57]

1 The sound conducting apparatus develops from the branchial apparatus

whereas the sound perceptive apparatus from the ectodermal otocyst

2 The pinna develops from the six hillocks around the 1st branchial cleft

3 External auditory canal develops from 1st branchial cleft

4 The outpouching of the 1st pharyngeal pouch gives rise to a proximal

narrow part that forms the eustachian tube and distal dilated part that

forms the middle ear cavity

5 Prussakrsquos space is a potential space lateral to the Shrapnellrsquos membrane

and medically by the neck of malleus that can be involved during the

extension of cholesteatoma

6 Development starts in the 3rd week of the intrauterine life and is

completed by 16th week of intrauterine life Membranous and boney

labyrinth develops from the otic capsule

The Ear is divided into

1 External Ear

2 Middle Ear

3 Internal Ear or the labyrinth

Page | 25

Fig 1 Ear Anatomy

EXTERNAL EAR [58]

The outside ear contains pinna and lobule

Pinna is the noticeable piece of outer ear made from single sheet of yellow

flexible ligament covered by subcutaneous tissue and skin It has two

surfaces average and parallel It is intently disciple to perichondrium on its

sidelong surface while it is somewhat free on average surface Pinna

incorporates tragus helix against helix fossa three-sided scaphoid fossa

incisura terminalis

External auditory Canal ndash It extends from the bottom of the conchea to

the tympanic membrane and measures about 24 mm along its posterior

wallit is S shaped

Parts 1 Cartilaginous part

2 Bony part

Page | 26

Cartilaginous part ndash The outer one third is cartilaginous consist of fibro

cartilage is directed first inward backward and upward It has Fissure of

Santorium The skin of this part of the canal contains hair follicles

sebaceous gland and cruminous gland

Bony part ndash The inner two third part is boney It goes forward downward

and medially skin lined in this part is very thin Isthmus is the narrowest

part of the canal lying medial to junction of bony and cartilaginous part

nearly 5 mm lateral to tympanic membrane

The roof and posterior wall of the external auditory canal shorter than floor

and anterior wall The skin lining the tympanic membrane and boney canal

has a self-cleansing property due to migration of keratin layer of epithelium

from drum towards the cartilaginous portion

Relations- Anteriorly- Temporomandibular joint and parotid gland

Superiorly- Middle cranial fossa

Inferiorly- parotid gland

Posterior- Mastoid antrum mastoid air cells and facial nerve

Nerve supply ndashSensory nerve supply of the external ear The auricle

supplied by fibers of the great auricular nerve (C2 and C3) and lesser

occipital nerve (C2) Auriculo temporal branch of the 5th cranial nerve and

auricle branch of the vagus (Arnoldrsquos nerve) supply external canal Facial

nerve has small sensory contribution on posterior-inferior wall

Tympanic Membrane -It is the partition between EAC and middle ear It

is a thin semitranslucent membrane pearly white in colored lying obliquely

in the medial end of EAC with the angle of 55 It is forming major part of

lateral wall of middle ear Annulus tympanicus is attached at its

circumference to the sulcus The TM is oval shape It measures

approximately 10 mm in vertical diameter and 90 mm in horizontal

diameter

Page | 27

Layers ndash Tympanic membrane consist of three layers

1 Outer Epithelium or cuticular layer which is continuous with skin of

external ear

2 Middle fibrous layer has both circular and radial fibers middle layer

missing in upper part

3 Inner layer- Inner mucosal layer which is continuous with middle ear

mucosa

Parts ndash Tympanic membrane consist of two parts

1 Pars tensa -It is largest part below the malleolar folds The inner

surface at the center attached to the handle of malleus Angle of cone

is most illuminated part in the pars tensa at anteroinferior part of pars

tensa

2 Pars flaccida Sharpnells membrane -it is triangular area above the

malleolar folds which are thin and devoid of fibrous tissue and

annulus It fits into notch of Rivinous

Nerve supply 1 Anterior half of lateral surface Auriculotemporal V3

2 Posterior half of lateral surface Auricular branch of vagus cn 10

3 Medial Surface Tympanic branch of CN 9 (Jacobsons nerve)

Fig 2 Tympanic membrane of ear

Page | 28

MIDDLE EAR [59]

The middle ear or tympanic cavity is an irregular laterally compressed

space within the temporal bone It is filled with air that is supplied to you

from the nasal part of the throat through the ear canal It contains a chain

of mobile bones that connect its side with the medial wall and serve to

transmit vibrations transmitted to the eardrum through the cavity to the

inner ear Including the parapet the vertical and anteroposterior diameters

of the cavity are each approximately 15 mm The transverse diameter

measures about 6mm at the top and 4mm at the bottom Compared to the

eardrum it is only about 2mm The eardrum is limited laterally by the

eardrum medially by the lateral wall of the inner ear It communicates

behind with the tympanic antrum and through it with the air cells of the

mastoid and in front with the auditory canal The middle ear together with

the Eustachian tube aditus antral and mastoid air cells is called the

middle ear cleft It is lined by mucus membrane and filled with air

It is divided into 3 parts

1 Mesotympanum (located in front of the pars tensa)

2 Epitympanum or attic (located above the pars tensa but medial to

Sharpnells membrane and the lateral bony wall of the attic)

3 Hypotympanum (located under pars tensa) The middle ear is like a

hexagonal box with a roof

Carotid or Anterior wall- It separates middle ear cavity from internal

carotid artery The various structure passing through anterior wall of

tympanic cavity

bull Canal of chorda tympani nerve

bull Canal of tensor tympani muscle

bull Eustachian tube

bull Anterior malleolar ligament

bull Anterior tympanic artery

Page | 29

Posterior or mastoid wall ndash The upper part of the back wall shows the

opening of the auditorium Below the auditory is a triangular bony

projection known as the pyramidalis processors The stapedial tendon is

transmitted through the apex of the pyramidalis processes The vertical

portion of the facial nerve descends along the posterior wall until it opens

into the stylomastoid foramen

Roof or Tegmental wall (Pars terminalis)- It is formed by a thin bone

plate called the tegman tympanum that separates the skull and tympanic

cavities It is located on the anterior surface of the rocky part of the

temporal bone near the junction with the temporal shell it extends back to

the roof in the tympanic membrane and anteriorly to cover the half canal

of the tensor tympanic muscle The lateral border corresponds to the

remains of the Petro scaly suture

Floor ndash It is formed by a thin plate of bone which separate middle ear from

the bulb of the internal jugular vein lodged in the jugular fossa

Lateral wall ndash It is formed by tympanic membrane and partly by a portion

of squamous part of the temporal bone It separates the middle ear from

external ear

Medial wall- It separates the middle ear from the inner ear

bull The promontory is the most prominent and convex part formed by the

basal rotation of the cochlea

bull The bony lateral semicircular canal is postero-superior to the promontory

above the oval window

bull The oval window is located between the middle ear and the vestibular

slope of the cochlea It is closed by the stirrup footrest and the annular

ligament

Page | 30

bull The round window is located under and behind the cape The round

window recess is directed to the rear It is closed by the secondary eardrum

and separates the middle ear of the Scala tympani from the cochlea

bull The facial nerve passes through the bony fallopian tube above the oval

window

Mastoid Antrum ndash It is a large space with air in the upper part of the

mastoid and communicates with the attic through the aditus The roof is

formed by the antri tegmen which extends and separates the tympani

tegmen from the middle cranial fossa The lateral wall of the antrum is

formed by a bony plate that is on average 15 cm thick in adults It is

marked externally on the surface of the mastoid by the suprameatal triangle

(MacEwen)

Aditus and Antrum- Aditus is a gap through which the attic communicates

with the antrum The boney prominence of the horizontal canal lies on its

medial aspect even as the fossa incudes to thats attaches the quick system

of incus lies laterally Facial nerve publications simply underneath the

aditus

The mastoid and its air cell system-

The mastoid consists of bone cortex with a honeycomb of air cell

underneath Depending on development of air cell three types of mastoids

have been described

1Well-pneumatized or cellular- Mastoid cells are well developed and

intervening septa are thin

2Diploetic- Mastoid consist of marrow spaces and a few air cells

3Sclerotic or acellular ndash There are no cells or marrow spaces

With any type of mastoid pneumatization antrum is always present In

sclerotic mastoids antrum is usually small and the sigmoid sinus is

anteposed

Page | 31

Depending on the location mastoid air cells are divided into

1 Zygomatic cells (In the root of zygoma)

2 Tegman cell (Extending into tegmen tympani)

3 Perisinus cells (overlying the sinus plate)

4 Retrofecial cells (round the facial nerve)

5 Peri labyrinthine cells (located above below and behind the

labyrinthine some of them pass through the arch of superior

semicircular canal These cells may communicate with the petrous

apex)

6 Peritubal (around the Eustachian tube Along with hypotymoanic

cells they also communicate with the petrous apex)

7 Tip cells (which are quite large and lie medial and lateral to the

digastric ridge in the tip of mastoid)

8 Marginal cells (Lying behind the sinus plate and may extend into

the occipital bone)

9 Squamosal cells (Lying in the squamous part of temporal bone)

Development of Mastoid ndash

The mastoid develops from the scaly petrous bone The petrosquamosal

suture may persist in the form of a bone plate - Korners septum which

separates the superficial squamosal cells from the deep rock cells Korners

septum is surgically important because it can cause problems locating the

antrum and deeper cells and thus lead to incomplete removal of the disease

during mastoidectomy The mastoid antrum can only be reached if Korners

septum is removed

Page | 32

Fig 3 Cross section of Mastoid

Contents of the middle ear

Ossicles ndash Three tiny bones which conduct the sound from eardrum to oval

window

Malleus ndash It is the largest and most lateral ossicle measuring 8 mm in

length It has head neck handle anterior and lateral processes The head

is situated in the epitympanum A lateral process project laterally from the

neck while the handle is firmly fixed to the pars tensa of the ear drum

Incus- It has a body short process and long process The body short

process and long process The body articulate with the head of mallelus in

the attic and the short process project into the attic The long process

projects downwards behind the handle of malleus running parallel to it and

articulate with the head of the stapes via the lenticular process

Stapes ndash It is the smallest ossicle measuring about 35 mm and consist of

head neck footplate and anterior and posterior curcura The footplate of

stapes is held to the oval window by the annular ligament

Page | 33

Muscles ndash

1Tensor tympani ndash It is inserted is a branch of the facial nerve which carries

the sense of taste It is first arch muscle supplied by branch of mandibular

nerve V3

2 Stapedious muscles ndash It is inserted to the neck of stapes It is the second

arch muscle supplied by branch of facial nerve that is nerve to stapedius

Fig 4 Contents of the middle ear

Blood supply of Middle Ear

bull Anterior tympanic branch of maxillary artery which supplies tympanic

membrane

bull Stylomastoid branch of posterior auricular artery which supplies middle

ear and mastoid air cells

Page | 34

Four minor vessels are

bull Petrosal branch of middle meningeal artery runs along greater petrosal

nerve

bull Superior tympanic branch of middle meningeal srtery traversing along

the canal for tensor tympanic muscle

bull Branch of artery of pterygoid carotid

bull Tympanic branch of internal carotid

Lymphatic Drainage of Ear

Lymphatics from the middle ear drain into retropharyngeal and parotid

nodes while those of the Surgical Importance ndash Eustachian tube drain into

retropharyngeal group

1 The middle ear is part of contiguous organs including nose nasopharynx

Eustachian tube and mastoid bone lined by respiratory mucosa Any

respiratory infection or allergy is likely to pass to middle is likely to pass to

middle ear

2 Moreover middle ear suppurative disease may spread to adjacent organs

and produce complication eg Labyrinthitis meningitis facial nerve palsy

etc

3 Lenticular process is vulnerable in suppurative ear diseases and causes

ocular disruption

4 Prussac space is the site of primary acquired cholesteatoma

Page | 35

INNER EAR [60]

Inner ear is divided into two parts

1 Bony Labyrinth

2 Membranous labyrinth

Anatomy of bony labyrinth

It is divided into two parts

1 Vestibule

2 Cochlea

3 Semicircular canal

The vestibule is located between the medial wall of the middle ear and the

lateral to internal acoustic meatus anterior to the semicircular canal and

posterior to the cochlea The vestibule is the central part of the inner ear

On its side is the oval window opening which is closed by the bracket foot

plate The bony cochlea is located in front of the vestibule It has 275 turns

wound around a bony axis called a modiolus The cochlea is about 30 mm

long The hollow center of the modiolus is a spiral canal that contains the

fibers and ganglion cells of the cochlear nerve A thin bony sheet the bony

lamina winda around the modiolus This divides the cochlear duct into two

galleries the Scala vestibuli above and the scala tympani below

There are three semicircular canals superior posterior and lateral They

are semicircular in shape and open into the vestibule One end of the

semicircle is enlarged and is known as the sphere

The membranous labyrinth is in the bony labyrinth It is connected to the

bony labyrinth by fibrous trabeculae and is surrounded by perilymph The

endolymph is located in the membranous labyrinth

Page | 36

The utricle is in the upper part of the vestibule while the saccule is found

below Both the utricle and saccule contain a single sensory patch called

the macula Each macula is covered with a neuroepithelium made up of

neuroepithelium made up of sensory hair cells and support cells these cells

are separated by a basement membrane Fibers of the vestibulo-cochlear

nerve enter the macula and pierce the basement membrane to terminate

at the base of the hair cell or cell bodies The utricle and the saccule with

their macula are called otolith organs Membrane semicircular canals are

the membrane canals of the corresponding bony semicircular canals They

open into the utricle through five openings One end of the opening of each

channel is dilated called the sphere in which the sensory organ of each

channel is located The cross section of the Scala standard looks like a right

angle The base is formed by the basilar membrane Sensory cells are

arranged on the surface of the basilar membrane These sensory cells with

their supporting cells form a complex neuroepithelium called the basilar

papilla or the cortical organ named after an Italian microscopist The

organs of the corti have a gelatinous membrane called the tectorial

membrane and they are supported by the pillar of the corti The cortical

pillars enclose a space called the corti tunnel which contains a fluid called

cortical lymph Vestibule is lies between the medial wall of the middle ear

and lateral to internal acoustic meatus anterior to semicircular canal and

posterior to the cochlea Vestibule is the central part of the internal ear On

its lateral surface is the opening of oval window which is closed by the foot

plate of stapes Boney cochlea lies in front of the vestibule It has 275 turns

coiling around boney axis called modiolus Cochlea is approximately 30 mm

in length The hollow center of the modiolus is a spiral canal containing the

fibers and ganglion cells of cochlear nerve A thin boney sheet the osseous

lamina winda around the modiolus This divides the cochlear canal into two

galleries the Scala vestibuli above and the scala tympani below

Page | 37

Semicircular canals are three in number superior posterior and lateral

They are semicircular in shape and opens into the vestibule One of the

ends of the semicircular is enlarged and is known as ampulla

Membranous labyrinth is situated within the boney labyrinth It is connected

to the bony labyrinth by fibrous trabeculae and is surrounded by perilymph

Endolymph is situated within the membranous labyrinth

The utricle lies in the upper part of the vestibule while the saccule lies below

Utricle and saccule both contain single sensory patch called macula Each

macula is covered by neuroepithelium consist of Neuroepithelium consists

of sensory hair cells and supporting cells these cells are separated by

basement membrane Fibers from the vestibulo cochlear nerve enter the

macula and pierce the basement membrane to end either at the base of the

hair cell or cell bodies The utricle and saccule with their macula are referred

to as otolith organs Membranous semicircular ducts are the membranous

ducts in the corresponding bony semicircular canals They open into the

utricle by five openings One end of the opening of each canal is dilated

called ampulla in which the sensory organ of each canal is located The

cross section of Scala media resembles a right angle Its base is formed by

basilar membrane Upon the surface of the basilar membrane the sensory

cells are arranged These sensory cells with their supporting cells form a

complex neuroepithelium called the basilar papilla or Organ of corti named

after an Italian Microscopist Organ of corti has a gelatinous membrane

called tectorial membrane and they are supported by pillar of corti The

pillars of corti enclose a space called tunnel of corti which contains fluid

called corti lymph

Page | 38

Fig 5 Inner Ear

Blood supply of labyrinth

Labyrinthine artery

Common cochlear Anterior vestibular Artery

Vestibulocochlear artery Main cochlear artery

Cochlear branch posterior vestibular artery

Page | 39

PHYSIOLOGY OF HEARING [61]

A sound signal in the environment is collected by the pinna passes through

external auditory canal and strikes the tympanic membrane Vibrations of

the tympanic membrane are transmitted to stapes footplate through a chain

of ossicles coupled to the tympanic membrane Movements of stapes foot

plate cause pressure changes in labyrinthine fluids which move the basilar

membrane This stimulates the hair cells of the Organ of corti It is these

hair cells which act as transducers and convert mechanical energy to

electrical impulses which travel along the auditory nerve

Thus the mechanism of hearing can be broadly divided into

bull Mechanical conduction of sound (conductive apparatus)

bull Transduction of mechanical energy to electrical impulses (sensory

system of cochlea)

bull Conduction of electrical impulses to brain (neural

Fig 6 PHYSIOLOGY OF HEARING

Page | 40

Conduction of sound

Under the surface of water we cannot hear the sound made in air because

9995 of sound energy are reflected away from the surface of water because

of the impedance offered by it A similar situation exists in the ear when

air-conducted sound must travel to cochlear fluids Nature has

compensated for this loss of sound energy by interposing the middle ear

which converts sound of greater amplitude but lesser force to that of lesser

amplitude and greater force This function of middle ear is called impedance

matching mechanism or the transformer action It is accompanied by

a) Lever action of the ossicles

Handle of malleus is 13 times longer than long process of incus providing

a mechanical advantage of 13

b) Hydraulic action of tympanic membrane

The area of tympanic membrane is much larger than the area of stapes foot

plate the average ratio between the two beings 211 As the effective

vibratory area of the tympanic membrane is only two- thirds the effective

areal ratio is reduced to 141 and this is the mechanical advantage

provided by the tympanic membrane

c) curved membrane effect

Movements of tympanic membrane are more at the periphery than at the

center where handle of malleus is attached This too provides some

leverage

Transduction of mechanical energy to electrical impulses

Movements of stapes footplate transmitted to cochlear fluids move the

basilar membrane setting up shearing force between the tectorial

membrane and hair cells The distraction of hair cells gives rise to cochlear

microphonics which triggers the nerve impulse

Page | 41

Neural pathways

Hair cells get innervation from bipolar cells of spiral ganglion Central axons

of these cells collect to form cochlear nerve which goes to ventral and dorsal

cochlear nuclei From there both crossed and uncrossed fibers travel to

superior olivary nucleus lateral lemniscus inferior colliculus and medial

geniculate body and finally reach the auditory cortex of the temporal lobe

Page | 42

DISEASES REVIEW

करणसराव

Nirukti - करणसय कणवयोाव ससराा [62]

Nidana- Acharya Sushruta and Vagbhata describe the common etiological

factors for the Karnaroga

अशयाय जलिीडा कणवकणडयन मरत

शमथययोगन शसततरसतय कवपतो अरय च कोपन ||

सउ २० १२

1 Avashaya or Pratishaya

(Excessive exposure to cold)

2 Jalakrida

(Excessive swimming)

3 Karnakandunyanum

(Excessive scracing due to itching)

4 Mithyayogena Shatrasya

(Improper instrumentation during wax removal or foreign body removal)

5Shabdasya

(Louder sound for long durationperverted contact of sound)

6 Abhighata (Trauma)

7 Vitiation of Tridoshas

Page | 43

Samanya Nidana according to different Samhita

Vishesh Nidan of Karnasrava

Acharya Charaka has not mentioned any kind of Nidana regarding Karnaroga

but has described Utapati of Karnaroga from Siroroga in Karnasirasym

Adhyaya[67]

शशरोअशिघातादरा तनमजजतो जल परपकादरा अवप विि

सरतत पय शरणॊ अतनलात स कणवससरा इतत परककतीत

सउ २० १०

असस ३७२५ [68]

1 Shiroabhighatat - Head Injury-Fracture of middle cranial fossa

2 Jala nimajjana - CSF otorrhoea fracture of middle cranial fossa

3 Karnaprapaka

4 Karna Vidhradhi -Puyasrava

Sr

no

Samanya Nidana SU AH[63] AS[64] YR[65] MN[66]

1 Avashaya + + +

2 Pratishaya + +

3 Shabdha

mithyayoga

+

4 Shashtra

mithyayoga

+ + +

5 Karnakandooyan + + + + +

6 Jalkrida + + + + +

7 Abhighata + + +

Page | 44

Samanya samprapti

परापय शरोतरशसरा कयावत शल शरोतशस गान

त कणवगता रोगा अटिावशततरीता

सउ २० १२

Due to common and specific etiology factors the vitiated Doshas gets

Sthanasamshraya in Karna and causes Karnasrava It is the stages of

Samprapti were Doshas gets lodged in Srotas and start processes of Dosh

Dushya Sammurchsna Due to Shiroabhighata Jalanimmajana Karna Paka

Karna Vidhradi vitiated Vata Dosha and Karna becomes Avruta by Vata and

results in Karnasrava Normal physiology of Dosha Dhatus and Malas entirely

depends on the normality of Srotas Dosh Dushya Sammurchana or

manifestation of diseases will not take place if only vitiation of Doshas take

place without deformity of Srotas Here in Karnasrava vitiation of Srotas are

Atipravritti Sanga and Vimargagamana take place Atipravritti is being excess

production of fungus Sanga is obstruction in external acoustic canal

Vimargagamana is the propagation of discharge through ear

Vishesh Samprapti

Karnasrava occurs due to Nij nidana is Pratishaya while Agantuja nidanas are

Avashya Jalkrida and Karnakanduyan Due to etiological factors which are

Vata-Kapha provocative in nature gradual vitiation of Doshas will occur After

vitiation they get accumulated (Sthan samshraya) in external auditory canal

In other hand when patient does Sevana of Agantuj Nidan like water enter in

external ear scratching of ear unsterile instrumentation leads to Dosh

Prakopa These cause Twak and Mamsa Dhatu Dushti which leads to

discontinuity of epithelium of ear canal which creates suitable atmosphere for

fungal pathogen to grow The vitiated Vata will produce symptoms such as

Page | 45

pain hearing impairment and vitiated Kapha causes symptoms like itching

discharge ear blockage By assessing the symptoms it can be said that Kapha

Avrita Vata Dosha is responsible for the manifestation of clinical features like

pain itching discharge Which are seen in Karnasrava that is otomycosis

Acharya Charaka has mentioned while explaining Samanya Chikitsa of

Karnaroga that it should be treated like Vrana when Paka and Srava is present

as a symptom Fungal spores invade in the epithelial layer of EAC In response

to infection inflammatory process is start This is a Paka Avastha After

removing the fungal mass ulceration in external acoustic canal is commonly

seen As a result of infection process exudates was produced which will mix

up- with fungal colonies and appear as discharge As per Dosha involvement

in Vrana Shoola Srava can be differ According to Acharya Sushruta Ruk is

the Samanya Lakshana of Vrana and Vishesha Lakshana of Vrana includes

pain discharge discoloration itching etc according to Dosha involvement

which are also seen in otomycosis In otomycosis mainly watery and purulent

type of discharge is present which indicates Paka avastha If there is Dosha

involve in Vrana is called Dushta Vrana Acharya Sushruta and Acharya

Vagabhata have mentioned verity of Srava in Twak and Mamsa Vranavastu

which is found in otomycosis Based on this description otomycosis can be

correlated with Karnasrava

Page | 46

Representing the Samprapti of Karnasrava

Vishesh Nidana ndash Shiroabhighatat

Jala nimajjana

Prapaka Vidhradhi

Vitited vata

Avarana by kapha

Vimargagamana of Vata

Karnasrava

Samprapti Ghataka

Dosha ndash Kapha and Vata

Dushya ndash Rasa Rakta and Mansa

Strotodushti ndash Vimargagamana and Sang

Adhishthana ndash Karna (Bhayakarna)

Rogmarga ndash Madhyama

Page | 47

Purvarupa

The Purvarupa of Karnasrava are not mentioned separately in any ayurvedic

classics In routine practice cretin Purvarupa are noted

1 Karnakandu

2 Karnagurutwa

3 Alpa karnashoola

4 Discomfort in ear

Rupa

1 Karnashoola

2 Karnakandu

3 Karnasrava

4 karnabadhirya

5 Cotton wool like or wet newspaper like grayish brown or black colored mass

is seen

6 External auditory canal skin appears edematous and red

Upashaya and Anupashaya

Appropriate application of Aushadhi Ahara and Vihara when produces relief in

the symptom is called as Upashaya and when aggravates the symptoms is

called Anaupashaya There is not any reference available in the classics about

the Upashaya and Anupashaya of karnasrava

Sadhyasadhyata

Sushruta has not mentioned specially the Sadhyasadhyata of Karnarogas But

Vagbhata has mentioned Karnasrava as a Sadhyavyadhi[69]

Sadhysadhyatagives the clear picture of prognosis of the disease It depends

on many factors like nature of disease severity of disease Vaya Prakriti Bala

of the patient etc

Page | 48

Upadrava of Karnasrava

In Samhita there is no reference available regarding the Upadrava of

Karnasrava

Samanya Chikitsa ndash

The common treatment principle for all Karnaroga is Ghritapana Use of

Rasayana Bhrahmacharya Avyayama Shirasnana and Atibhashaya

सामरय कणवरोगष घतपान रसयनम

अवयायमो शशराःसतनान बरमहचयवम कतपरनम

स उ२१३

Ghratapana - Ghrita is a Yogavahi and follow Sanskara in addition to these

acquired properties and capable of retaining its own properties So Ghritapana

is effective in Karnasrava

Rasayana - Rasayana represent the basic approach of Ayurveda which

comprise preventive promotive and curative aspect of health

Brahmacharyaapalana -It is like Sadvrittapalana and is equals to Rasayana

effect

Vyayama - It leads to vitiation if Vatas a Karna is a Sthana of vata and

exercise causes Kshayaj Samprapti hence it is important to avoid exercise in

Karnasrava

Shirasnana- In Shirasnana water enters in external acoustic canal it changes

the PH of meatus skin from acid to alkali which favors the growth of pathogens

Atibhashya - Excessive speaking causes Vata Prakopa and Vatapraokopa is

basic Samprapti for Karnasrava as the preventive aspect avoidance of

excessive speaking is necessary

Page | 49

Ghritapana Rasayana and Brahmacharyapalana should be followed for

preservation of dhatu Samyata and restriction of vitiation of Vata Vayayama

Shirasnana and Atibhashaya should be avoided in Karnasrava to protect the

Siras from the affliction of Vata and Kapha

Vishesha Chikitsa ndash

The general treatment principle of Karnasrava described in classics is closely

related to Dushtavrana Chikitsa

शशरोवरचन च ए िपन परण तरा

परमाजवन िान च ीकषय ीकषय़ाचारत [70]

स उ २१४०

कणवसततरा ोददत कयावत पततकशमकणवयो [71]

ाउ १८३५

उपददि च सततरोत साय परात वपचततवशि परमजय

य अगर मदन सघत गगलना ा िपतयतपा मिना परयत [72]

असउ २२४२४३

In addition to that Shirovirechana Karnadhoopana Karnapurana

karnapramarjana Karnadhavana are also indicated

Page | 50

Treatment is also mentioned for Karnasrava

1 Karnaprakshalana Yoga - with Aargawadadi Gana Kashaya and Surasadi

Gana Kashaya [73]

2 Avachurnana Yoga ndash with Aargawadadi Gana Churna and Surasadi Gana

Churna[74]

3 Karnapoorna Yoga ndash

bull Rasanjana Laksha with Sarjachoorna[75]

bull Panchkashaya with Kapittha swarasa and Madhu[76]

bull Jambu AmrapallavShivalaKshuodra Mahavriksha and Madhuki all are

taken in equal quantity and Kalka is prepared and 4 times Taila is taken

and 16 parts of Kwatha is added and Taila Paka is done[77]

bull Sarjatwak Choorna with Karpashiphalarasa and Madhu[78]

bull Abhaya LodraTindukaSamanga(Manjista) Kwatha of this Dravyas mixed

with Madhu and Kapittha Rasa[79]

bull Yogratnakara mention the following drugs for Karnapoorana-

a Samudraphena Churna[80]

b Jambwambpatra Yoga

4 Karnadhoopana Yoga ndash

bull Dhoopana with Churna of Bilvapatra Haridra Palandu[81]

bull Vartak Dhoopana [82]

5 Internal Medications-

bull Rasnadi Guggula [83]

bull Triphala Guggula [84]

bull Sarivadi Vati [85]

bull Gandhaka Rasayana [86]

Page | 51

According to Vagbhata-

Ear should be cleaned with the Pichu and Varti followed by Guggula Dhoopana

and then Karnapoorana with Madhu Followed by Avachurnanana with

Sukshmachootana of Surasadigana

Pathyaapathya ndash Pathya and Apathy mentioned for Samanya Karnaroga is

recommended in Karnasrava also

पथय[87]

सतदो वरको मन नसतय िमाः शशरावयिाः

गोिमाः शालयो मदगााः याशच परतन हवाः 80

लाो मयरो हररणानदसततततरो नकककिाः

पिोल शशगर ातावक सतनषराण कदठललकम

रसायनातन सवणण बरमहचयवमिाषणाम |

उपयकत यरादोषशमद कणावमय दहतम ||81||

िापर २१

Aharaja Upacharaja

bull Godhuma bull Vamana

bull Shala bull Virechana

bull Mudga bull Nasya

bull Yava bull Dhoomapana

bull Puranagitra bull Kavala

bull Lava Harina Tittiramamsa

Page | 52

अपथय[88]

दरत काटठ शशरसतनान वययाम शलटमल गर

कणडयन तषारशच कणवरोगी पररतपयजत

िापर २१

Viharaja

bull Patola ShigruVartaka bull Bhramacharaya

bull Sunishannaka bull Avyayama

bull Katthlika bull Aakthanam

bull All types of Rasayana bull Upacharaja

bull Vamana

Apathyas

bull Abhishyandakara Aharas

bull Shirasnana

bull Karna kandooyana

bull Tushara sevana

bull Guru Kaphakaraka Aaharas

bull Dantdhavana

Page | 53

OTOMYCOSIS

Definition-

Otomycosis is a superficial acute sub-acute or chronic infection of external

ear canal It is mostly unilateral It is characterized by inflammation purities

and scaling Otomycosis is a common condition encountered in ENT practice

more in chronic and persistent ear infection

The Fungal infections are not communicable in the usual sense but the

humans become an accidental host by their introduction into tissue trauma

The virulence factors favoring colonization of fungus in human host are yet to

be identified Ability of the fungus to grow at 37 C and elaboration of a variety

of enzymes and toxins are speculated to contribute to virulence Only 100 to

150 species are generally recognized as a cause of disease in humans[89]

Prevalence-

Otomycosis is a word wide in distribution and in various record stated that 5

to 20 of all cases of infective otitis externa Otomycosis prevalent is more in

warm and humid climates It is one of the commonest manifestations in India

during rainy season It occurs mostly in humid atmosphere otitis externa due

to fungal infection may resembles the desquamative form of diffuse infective

otitis externa The incidence in temperature climates has increased in

proportion to the use of topical antibiotics which have a medium sterilized of

other organism in which the fungus may flourish

Page | 54

Predisposing factors- [90]

1 Environmental factors such as climate contagious and polluting hygiene

more frequently during rainy season as the humidity increases

2 Individual susceptibility ndashGeneral Immunological status of the Individual

eg HIV infection Radiotherapy chemotherapy Diabetes mellitus

3 Self-inflicted trauma that is use of pins to clean the itching ear or use of ear

bud to clean the wax

4 Wide spread of topical antibiotics steroid preparations which have medium

sterilized of other organism in which the fungus may grow

5 Failure of defense mechanism in External auditory canal

6 During swimming or head bath water enters in External acoustic canal

causes quantitative and qualitative change in ear wax It causes change in pH

7 Long term use of hearing aids

Pathophysiology ndash

The life cycle of the average mold encountered in the ear may be reckoned

as two weeks and flare ups may be anticipated at such intervals Swimming is

held responsible for infection in many cases The sequence sequence of

pathogenic changes produced by molds in the external ear is as follows ndash

1 Implantation of the organism in external ear

2 Growth of organism follows the rate depending on condition of temperature

moisture or preexisting irritation

3 Invasion of epithelium occurs with attendant itching and discomfort which

may be quite severe

Page | 55

4 Exfoliation of epithelium occurs as nature attempts to overcome the

infection by casting off upper most cells

5 Denudation occurs from exfoliation as the top layers of epithelium are cast

off and the canal becomes filled with debris

6 Superficial ulceration and lizematoid dermatitis results if the pathologic

process goes for enough The changes do not always proceed through the

entire sequence sometimes the molds produce changes of the mildest

imaginable character which may be overlooked[91]

Clinical features -

Symptoms-

1 Irritation and itching ndash Irritation is mostly found when the infective

organism is aspergillus niger There is sensation of discomfort which is more

diffuse in the ear canal then localized in the deeper part Candida infection

causes marked itching In external ear it is intense and worse at night

2 Discharge through ear- Intermittent scanty colorless discharge through

ear Mucus being a fungal metabolic product appears as discharge Excessive

discharge is associated with mixed infection

3 Pain and discomfort ndash Mild to severe pain in the ear occasionally Mostly

seen in cases where ear is infected with Aspergillus flavus mixed infection

with gram negative organism or mixed infection with candida and aspergillus

Headache is sometimes associated with pain

4 Deafness- Varying degree of mild to moderate conductive deafness

5 A sensation of fullness in ear

6 Tinnitus 7 Vertigo

Page | 56

Signs ndash

1 The external acoustic meatus may contain a mass formed of epithelial

debris exudates cerumen and fungus

2 Erythematous external canal

Fungal appearance

A Niger - The color of the mass which is usually grey or black is mainly

determined by the type of fungus concerned Its appearance is like wet

newspaper or blotting paper or a cotton wool It has a peculiar musty odor In

this infection fruiting heads may be seen as black specks in the debris

Occasionally as inactive form occurs in which the canal is lined by mold giving

a fluffy appearance due to the presence of tiny mycelia

Candida ndash Candida infections generally show as white deposits on magenta

colored skin when the debris is removed it rapidly recovers in 24 hrs

The underlying canal skin is often inflamed and granular due to invasion by

fungal mycelia and be seen in all cases In rare cases excoriation and

ulceration with marked extensive shedding of the epithelium and deep

ulceration can be seen usually associated with a flavus and with pathogenic

bacteria[92]

Otoscope Appearance

1 Aspergillus Niger ndash Black headed

2 Aspergillus Fumigators ndash pale blue or green

3 Candida Albicans ndash White- or cream-colored deposits

Page | 57

4 Auricle is normal in most cases In severe cases small ulceration with crust

formation may be present on lateral surface

5 Tympanic Membrane

In most cases it is normal with normal mobility and normal hearing In a few

cases the surface of the tympanic membrane is congested and scaly There is

erosion or ulceration of the external epithelial layer and the membrane itself

may be edematous

Diagnosis

1 Above mentioned symptoms and signs

2 In the stage at which patient with otitis externa usually first present

themselves mycelia threads conidiophors not visible to naked eye may

sometimes be identified with the microscope

3 Confirmed by culture

Page | 58

Fig7 Aspergillus Niger Fig8 Candida Albicans

Fig9 Aspergillus Fumigators Fig 10 Wet Paper like appearance

Page | 59

Treatment

1 Antibiotic or steroid drops should be discontinued if they are being instilled

since long time

2 Removal of fungal mass epithelial debris and discharge from the external

canal or mastoid cavity repeatedly and thoroughly by forcepa or suction or

syringing or cautiously blow a stream of air into the canal through a fine

cannula and dry thoroughly by swabbing liquid petroleum on swab used in

cleaning the ear lessens the burning sensation when metacresy acetate is to

be employed in the subsequent treatment

Furuncle is developed as a complication if there is no gentleness in cleaning

Cleansing may have to be delayed until local sensitiveness is lessened which

can usually be accomplished within twenty-four hours If there is excessive

epithelial debris along with otomycosis then metacresyl acetate which is a

keratolytic in introduction into the external auditory canal on cotton wick and

is allowed to remain for twenty-four hours After twenty-four hours the cotton

wick is removed at which time the canal can usually be cleansed with little

discomfort as the medication is also anesthetic The epithelium of the canal

was white from contact with the drug The top layer was detached and this

epithelial debris can be easily wiped away The wick is reinserted and wet with

metacresyl acetate

The treatment is employed for three to four days in succession and then a

bland application is substituted Icthyol iodine is of value at this stage Iodine

ointment 2 in combination with Tannic acid 2 is also an excellent local

application following cresatin treatment

Next one of the fungicides may be applied

Page | 60

1 Nystin Effective for candida infection but less active against aspergillus

group Nystatin in boric powder consisting of 100000units of nystatingm of

powder 3 times week for 3 weeks

2 Clotrimazole Available as 11 cream or drops or lotions Phenyl

(zchlorophenyl) 1 ndash imidazole ndash methane is a chlorinated trityl imidazol 1

effective against candida and dermatophytes and for aspergilli infection

3 Amphotericin B Available as cream and as 3 solution and 015 drops

for topical application Very effective for candida infection can be fungistatic

or fungicidal

4 Econazole Available as solution (Econazole nitrate) and as cream (1)

Broad spectrum ndash more effective for Aspergillus Also active against some

gram-positive bacteria (Staphylococci and Streptococci and Dermatophytes)

5 Miconazole Highly effective against dermatophytes and candida infections

used as a 21 cream applied once or twice a day for 10 days

6 Gentian violet 21 Available as drops (recently some evidence of

carcinogenicity) Discolors the ear canal and this interfere with clinical

examination

Other topical antifungal agents are ketoconazole Natamycin Tolciclat Bifonas

zole Fenticonzole Oxiconazole Tioconazole ciclopiroxolomine Tolnafate

Haloprogin Flucytosine Acetic acid Whit field ointment selenium sulfide

undcyclenic acid triacetin etc

Page | 61

Minimal length of treatment

A month of drug treatment is usually required because the antifungal agents

used are not sporicidal and it is necessary that the period of treatment covers

germination time It may be advisable to give short gaps in the period of

treatment to ensure all spores have germinated before deciding to terminate

therapy

Prevention

Accomplished by strict attention to the predisposing causes

1 Water should be prevented from entering the ear

2 Avoidance of external ear trauma

3 Use of alcohol medicated or plain in the ears after swimming mercuric

cyanide (15000) in ethyl alcohol (70) is a satisfactory liquid to use

Ear stoppers do no good unless their use is followed by some antiseptic in the

canal Divers exposed to water for long periods of time may also use acidic

alcohol

4 During Summer months with their high humidity special efforts are needed

to maintain ear dry 5 Indiscriminate use of topical antibiotics steroid

preparations should be avoided

Page | 62

DRUG REVIEW

1 GUGGULA

Fig11 - Guggula

Historical review of Guggula [93]

bull Atharvaveda one of the well-known Vedas of Hindus The earliest

reference given by Atharvaveda medicinal and therapeutic properties of

Guggula Guggula has long history of use in Ayurveda

bull Acharya Charaka Sushruta and Vagbhata describe detail regarding the

actions uses and indication as well as the variety of Guggula

Page | 63

bull Various Nighantus (Medical lexicons) were written between 12th and 14th

centuries AD was based on the Ayurvedic literature also describes

Guggula

bull The explanation of word Guggula is that Gunjo Vyadhegurdti Rakshati

which means to relief against different diseases

bull Guggula is the best medicine because it develops through the rays of

hot sun on specific circumstances

bull Guggula has an aromatic odor

गगलो कणवदौगवररधय िपन शरटठमछयत[94]

स उ २२११२

Latin name- Commiphora mukul

Family ndash Burseraceae

Rasa- Tikta Katu

Guna ndash Laghu Rukshasukshma vishada sara

Veerya ndash Ushna

Vipaka ndash Katu

Action- Rasayana Lekhana

Doshaghanta - Tridoshhara

Page | 64

Chemical composition [95]

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Oleoresin-Z-Guggulsterone E-Guggulsterone

Gum- guggulignans 1 and 2 guggula Tetrols mukulol allylcembrol c

27

Guggulusterol 1 2 ans 3 Z and E ndash guggulusterol

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Parts Used ndash Gum oleoresin

Guggula purity test

1 Yellowish brown emulsion is obtained when Guggula is triturated with

water

2 An ethereal solution of the drug attains reddish colour when treated

with br2 vapors and purple colour when moistened with nitric acid

Biochemical action ndash Antiseptic Anti-inflammatory Disinfectant Diuretic

Immunostimulant stimulating expectorant Ant suppurative Antipyretic

Enhance phagocytosis

Karma- Rasayana cardiovascular disease

Page | 65

2 AGARU-

Fig 12 Agaru

Historical review of Agaru [96]

bull The word Agaru literally means the one which is the heaviest and no

aromatic wood is heavier than it Since thousands of years Agaru lsquoThe

wood of Godrsquo has been used for multiple purpose like commercial

medicinal spiritual aromatic historical

bull The medicinal use of Agaru have been recorded in many pieces of India

Greek Roman Chinese Middle eastern and European since ancient times

bull Acharya Charaka used Agaru and pest of Rasna to counteract the effect of

cold in Agraya Dravyas

bull Acharya Sushruta used Agaru as a Dhoopana Dravya along with Guggula

Ral and Shoma in the treatment of Karnasweda and Vrana

Page | 66

Types-

bull Dhanwantsri Nighantu describes Kaleyaka as a type of Agaru

bull Sodhala Nighantu describes three types of Agaru ndash Agaru Krishna

Agaru Kakatunda Agaru

bull Raj Nighantu describes five types of Agaru ndash Krishna Agaru Kasht

Agaru Daha Agaru Mangalya Agaru and Agurusaar

bull Arthashasstra describes three Agaru wood product

1 Jongaka ndash Black or variegated black in colour and having variegated

spots

2 Dongaka ndash Black in color

3 Parasamudraka- Black in colour and smells like Navamallika

अगर उटण कि तपछय ततकत ततकषण च वपततलम

लघ कणाविरोगघन शीत ात कफपरणत

िापर २१ [97]

Family- Thymelaccensis

Latin name- Aquilaria agallocha

Guna- Laghu Ruksha Tikshan

Rasa- Katu Tikta

Vipaka ndash Katu

Virya ndash Ushna

Karma- Sheetaprasasmana Vranaorasadan Tvachya Pittavardhaka

Shirovirechana Mangalya Sugandhik and Rochaka in properties [100]

Krishna Agaru karma- Katu Tikta rasa Ushna Sheeta when applied externally

and Pittahara when taken orally

Page | 67

Chemical Constituents -

Agaru hardwood is rich in essential oil resins alkaloids saponins Steroids

terpenoids tannins flavonoids and phenolic compound Agaru wood

predominantly contains 2-[-2-phenylethy]-4H-chromen-4-one derivatives and

sesquiterpenes Agaru oil contains selinene dihydroselinene agarnol b-

agarofuran vetispira-2(11)valerianol dihydrokaranone and tetradecanoic

acids[99]

Part Used ndash

Heartwood- Dark resinous wood which is formed when the plant becomes

infected with a type of fungus (ascomycetous mold) Species of Aspergillus

fusarium and penicillium are reported to be associated with the development

of infection Prior to infection the heartwood is odorless relatively light and

pale colored however as the infection progresses the tree produces a dark

aromatic resin in the heartwood The infected resin in response to the attack

which results in accumulation of a very dense dark resin in the heartwood

The infected resin embedded wood is known as Agarwood Infection is more

common on the trunk roots and the area when branches divide The formation

of Agarwood starts when the tree attains the age of 20 years On an average

approximately 30 ml oil is extracted from 100 kg of infected Agarwood[98]

Qualities of best Agaru-

It should be black in color

It should be extremely heavy and aromatic

It should be oily in appearance and test

It should be sink in water

It should burn easily with bright flame with a bright flame giving off a pleasant

smell

Page | 68

3 MADANA

Fig 13 MADANA

Madana consist of dried fruit of Xeromphis spinosa It is a deciduous thorny

shrub or a small tree reaching a high up to 9 m and girth about a meter

branches numerous thick and horizontal found in sub-Himalayan tracts[101]

मदनो मिरनदसततकतो ीयोटणो लखनो लघ

ानदरतिदवििीहर परततशयायवरणारतक

रि कटठकफ़ानाहशोथगलमवरणापह[102]

िा पर १६० १६1

Page | 69

Latin name-Randia dumetorum

Familly ndash Rubiaceae

Rasa - Madhura Tikta

Guna-Laghu Ruksha

Virya- Ushna

Vipaka ndash Katu

Karma- Vamana and Lekhana

Chemical Composition-

Essential Oil Valerianic acid Saponin tannin resin [103]

Page | 70

YAWA [104]

Fig 14 Yawa

1 In Samhitakala Aacharya Charaka Acharya Sushruta explain detail about

medicinal properties of Yawa

2The use of Yawa in Aaharya Dravya mainly described by Dhanwantari

Nighantu Raj Nighantu Bhavprakash Nighantu[105]

Macroscopic Description-

Fruit a caryopsis elliptical oblong Ovoid and tapering at both ends smooth

about 1cm long and 02- 03cm wide dorsally compressed and flattened on

the sides with a shallow longitudinal furrow 3-5 ridges having shallow

depression between them grains tightly enclosed and adhering the lemma

and palea pale greenish yellow odor not distinct taste sweetish acrid

Page | 71

Latin Name ndash Hordenum vulgare

Family- Poaceae

Rasa- Kashaya Madhura

Virya- Sita

Vipaka- Katu

Karma- Vatakrt Pittahara Kaphahara Medahara Balya Visrya

SthairyakaraLekhana

Page | 72

PROCEDURE REVIEW [105]

In Ayurvedic classics there are many references regarding Dhoopana Dravya

Dhoopana is administering Dhuma with the help of Dhoopana Dravya

In Kashyapa Samhita there are 40 types of Dhoopana advised for children

Anesthesia (Mohajananam Dhoopa) is also mentioned For this Dhoopana the

drug used were herbs hairs of animals legs horns old cloths of Buddhist

monks

From the references available regarding Dhoopana we can understand that

Karna can be protected from maggots (krimi) Bactria (Rakshogna) lice etc

References clearly indicate the analgesic and disinfectant effect of Dhoopana

Karma Dhoopana is mentioned for Dushta Vrana Chikitsa It reduces Vedana

Srava Pootigandha of Dushtavrana It also helps in Vranaropana

Dushtavrana Chikitsa is mentioned in the treatment of Karnasrava[106]

Origin of Dhoopana-

In ancient period children of sages were constantly harassed by the

Rakshasas Hence the sages approached lord Agni for shelter Agni in turn

gave them Dhoopana Dravya and asked sages to use the Dhoopana for

protection against Rakshasas bhutas pishachas

Classification of Dhoopana

1 It is classified into Dhupa Anudhupa Pratidhupa

2 On the basis of Origin it is classified into Jangama and Sthavara

Selection of Guggula for Dhoopana

Page | 73

bull Guggul is a best Vatahara

bull It is Krimighana

bull It contains Oleoresin

bull In Ashtang Hrudaya Guggula Dhoopana mentioned for Karnasrava

Selection of Agaru for Dhoopana

bull Agaru is Laghu Ruksha Katu Tikshna

bull Vranaorasadan Tvachya

bull It should burn easily with bright flame with a bright flame giving off a

pleasant smell

Karna Dhoopana Indication

1 Karnaarava

2 Putikarna

3 Krimikarna

4Vataj Karnashula

Contraindications

Especially for Karnadhoopan contraindication is not mentioned in classic texts

But Dhoopana is contraindicated in Pittaj vaydhi Sharad and Grishma Rutu

Page | 74

MATERIAL AND METHOD

Page | 75

For randomize comparative clinical trial to study the effect of Agaruwadi

Karnadhoopana and Guggula Karnadhoopana in Karnasrava following material

and method were required

Source of data

Patient irrespective of gender occupation religion social economic status

signs and symptoms of classical features of Karnasrava (Otomycosis) selected

from the OPD of Shalakyatantra department

Materials ndash

1Patients

2 Drugs-Agaruwadi Dhoopana

Guggula Dhoopana

3Torch

4Otoscope

5 Tuning fork

6Jobson horn probe

7Cotton

8Case record form

DRUG

Group A Trial Group

1Churana of Agaru Yawa Madan

2Ghrita

3Jala

Group B Control Group

1Googula Churna

Page | 76

Properties of Drug

Table no 1 Properties of Drug

Drug

Family

Rasa Veerya Vipaka Effect

on

Dosha

Guna Karma

Agaru

(Aquilegria

Agallocha)

Thymelaca

ceae

Katu

Tikta

Ushna Katu KV Laghu

Ruksha

Tikshna

Shitaprashamana

Shothahara

Vedanasthapak

Durghandhihara

Madan

(Randia

spinosa)

Rubiaceace

Kashaya

Madhur

Tikat

Katu

Ushna Katu KV Ruksha

Laghu

Vatakaphaghana

Shothahara

Vedanasthapak

Vranashodhak

Yawa

Poaceae

Hordeum

Vulgare

Kashaya

Madhur

Sheeta Madhur KP Ruksha

Laghu

Vataghana

Vernashodhana

Raktshodhaka

Guggula

Commiphora

Mukul

Burseracea

e

Tikta

Kashaya

Anushna Katu VPK Laghu

Ruksha

Shothahara

Vedanasthapaka

Kandughna

Ghrita Madhura Sheet Madhur VK Snigdha Vataghana

Shothahara

Vedanasthapaka

Page | 77

METHODOLOGY

SELECTION CRITERIA

1)INCLUSION CRITERIA

1 Patients having signs and symptoms of Karnasrava (Otomycosis) ie करणशल

( pain ) करणकणड ( Itching ) करणसतराव ( Discharge )बाधिरण ( conductive Loss of

hearing )

2 Patient from age group 19 to 70 years

3 Any Gender

2)EXCLUSION CRITERIA

1 Patients suffering from any systemic disease like DM TB HTN

2 Chronic suppurative otitis media (CSOM)

3 Acute supportive otitis media (ASOM)

3 Perforation of Tympanic membrane

4 Chronic otitis media

3)WITHDRAWAL CRITERIA

1If patient develops any adverse effect such as irritation pain burning

sensation in ear loss of hearing and such patients was withdrawn from trial

and receive prompt appropriate medical attention

2If patient shows aggravation in symptoms

3If patient refuses to continue with the treatment

Page | 78

STUDY SETTING

Types of study - Randomized Clinical comparative Trial

Place of work - OPD of Shalakyatantra

Duration of study - 18 months

Study Population - Patients of Karnasrava in Shalakyatantra OPD

SAMPLE SIZE CALCULATION

Sampling Method ndash Purposive sampling followed by random allocation in two

groups

Sample size calculation-

n = z2 p (1-p)

d2

Were

n = sample size

P = prevalence of disease=10

z = standard normal variable ie 196

d = error ie005

desired Sample Size would be

n = Z2 P(1-P)d2

= (196)2x (0021) x(0979)(005)2

= 34

Visiting ENT OPD (ShalakyaTantra) and IPD (ShalakyaTantra) 21 = 34

n raquo34

So one group includes 34patients

Page | 79

Sampling Method

Total 68 patient of Karnasrava are selected by Purposive sampling followed by

random allocation in two groups Written informed consent is taken prior to

commencement of trial They are divided in 2 groups

Group A (Trial Group) 34 patients treated with Agaruwadi Dhoopana for 7

days

Dose 5 minutes twice in a day

Group B (Control Group) 34 patients treated with Guggula Dhoopana for 7

days

Dose 5 minutes twice in a day

STUDY DESIGN ndash

Open labeled Randomized Comparative Clinical trial

STUDY DESIGN

Screening of patient

Inclusion criteria satisfied Exclusion criteria

Initial assessment Excluded

Counseling of patient Treated accordingly

Patient selection by Simple Random Sampling Method

Page | 80

68 Patients were divided in two groups lsquoArsquo and lsquoBrsquo

Trial group A-34 patients were given

Agaruwadi Dhoopana

Control group B- 34 patients were

given Guggul Dhoopana

Informed written consent

Treatment was given for 7 days

Assessment on 1st 4th and 7th day

Post assessments follow up on 15th day

Observation

Data Collection

Statistical analysis of data

Conclusion

Page | 81

(A) Agaruwadi Varti for group A (Trial group)

Table no 2

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

B) Guggula Varti for group B (Control group)

SOP of it is same as above Agaruwadi Varti

Table no 3

Drug Guggula Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

FOLLOW UP

For both groups follow ups were done on 1st 4th and 7th and post

assessment follow up15th day

EXAMINATIONS

Torch for Local examination of ear

Otoscope examination

Tuning fork Test

Page | 82

OBSERVATION TABLE

Table no 4

Sr no Subjective criteria Day 1 Day 4 Day 7 Day 15

1 करणशल

(pain)

2 करणकणड

(Itching)

3 करणसतराव (Discharge )

4 बाधिरण (Conductive Deafness)

OBSERVATIONS

a) करणशल (Pain) -

0 - Absent

1 ndash Present

b) करणकणड (Itching) -

0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

Page | 83

c) करणसतराव (Discharge)

0- Absent

1- Mild -Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाधिरण (conductive Loss of hearing)

0 - Absent

1- Present

Observations were carried out before and after completion of treatment and

during each follow up After observations the data collected and presented in

the form of graphs charts and table

Page | 84

TRIAL DRUG

Authentication and standardization of raw drug material done After

authentication and standardizing of raw drug material Agaruwadi Varti was

prepared by Varti as explained in Ayurvedic classics

Method of Varti preparations

Panchavidh Kashaya Kalpana that is five method of pharmaceutical

preparation constitutes the fundamental process of Ayurvedic pharmaceutics

which is well explained in Sushrut Samhita Varti Kalpana is one among them

which can be included in Kalka Kalpana

तीररसतरपतपतीनामपरककव तीत [106]

स डलहण शरच 151

Medicines are powered triturated and given the Varti shape that is like wick

of lamp so it is called as Varti Kalpana

Drug content Agaru Madan Yawa

Route of Administration Local

Dose Two times a day

Duration 7 days

Page | 85

Methodology

Standard operating procedure (SOP) of Agaruwadi Varti

Agaruwadi Varti is prepared according to the classical text

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization was done as recommended in pharmacy procedure The

raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 mixed together in

equal quantity to make Agaruwadi churn

Quantity of each churn is 4 grams all are mixed when the Varti get dry total

weight of Varti was 10gram

STEP 4 - Agaruwadi churn triturated with appropriate quantity of water or

Ghrita and prepared Varti in GMP Certified Ayurvedic pharmacy Standard

aseptic precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Varti was packed in sterile air packed container

STEP 6 - Agaruwadi Dhoopana was given with the help of Dhoopana yantra

Authentication and Standardization of raw drug of Agaruwadi Varti was done

Sterilization was done as recommended in pharmacy procedure Sterile

preparation packed in sterile container of suitable size Under all aseptic

precaution Karnadhoopana given to infected ear

Page | 86

Containers for packaging and their sterilization-

Sterilization of the containers for storing Varties was done by Ethylene Oxide

(Eto) method

Ethylene Oxide (Eto) procedure-

It includes exposure of materials to ethylene oxide gas under vacuum in a

sealed chamber It consists of four primary variables

1Gas Concentration

2Humidity

3Temperature

4 Time

EtO gas is an alkylating agent which disturbs the DNA of microorganism

preventing them from reproducing It penetrates the breathable packaging

and sterilizes all the accessible surface of the product to render products

sterility by alkylation of essentials proteins for cell reproduction

Most Eto sterilization methods involves three different stages These can be

separated into three different on the size or number of devices to treat

1Preconditioning stage-

First products are passed through a preconditioning phase to make

microorganism grow The batch load goes through a well time under a

controlled environment of temperature and humidity

2Sterilizer stage-

Performed using process phase specially designed to provide the required level

of EtO exposure to assure sterility for a device or family of devices

3Degasser Aerration stage-

Finally products need to go through a degassing phase to remove any residual

particles of Eto The batch load goes over well time under a temperature-

controlled environment

The sterile containers were then used to store Agaruwadi Varti and handed to

patients included in the study

Page | 87

Packing of Agaruwadi Varti

The ETO sterilize plastic container were used for packing of Agaruwadi Varti

Varti was filled into these sterilize containers (7 in each) In an aseptic

environment plugging and capping was done under aseptic precautions In this

way packing of Agaruwadi Varti done These Varti were given to patient and

advise to take two times a day under all hygienic precautions

History and Examination

bull Proper history and presenting complains was recorded on case record form

bull Ear examination with otoscope was done during initial assessment and each

follow up

bull Otoscopic examination was done during initial assessment and each follow

up

bull Systemic Examination that is Blood Pressure Temperature Respiration

rate Pulse was recorded on case record form

Page | 88

Raw material

Fig14 यव चरण Fig15 मदनफळ चरण

Fig16 अगर चरण Fig17 गगगळ चरण

Page | 89

Preparation of Agaruwadi Varti

Fig18 Preparation of Agaruwadi Varti

Fig19 अगरवादी वरती

Page | 90

Fig20 Instruments used for examination of Karnasrava

Fig19 Karnadhoopana Yantra

Page | 91

Karnadhoopana Procedure

Fig 22 Karnadhoopana Procedure

Page | 92

OBSERVATIONS AND RESULTS

Page | 93

BASED ON DRUGS

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 94

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

AUTHENTICATION CERTIFICATE

Page | 95

BASED ON STASTICIAL ANALYSIS OF DEMOGRAPHIC DATA

68 patients of Karnasrava ndash Otomycosis

Table no 5

No of Patients Total

Group A Group B

Registered 38 37 75

Completed 34 34 68

Discontinue 04 03 07

Total 68 patients were enrolled in study 38 patients registered in group A

amongst them 34 patients completed the treatment and04 patients

discontinued the treatment However in group B 37 patients completed the

treatment and 03 patients discontinued the treatment out of 37 registered

patients

Hence the total number of patients registered in the present study was 75

and out of which 68 patients were discontinued the treatment So they

dropped out from the study While 68 patients were successfully completed

the treatment So observations and result of 68 patients were given below

Here we are going to discuss the statistical analysis of the data obtained in

the form of master chart that was prepared in accordance with the data

collected from the patients that had been included in the study The purpose

of statistical analysis was to analyzed the relation between age gender

occupation diet addiction and education

Page | 96

1 Age wise distribution of patients

Table no 6

In trial group 10 (29412) patients were from age group 18-25 years 14

(41176) patients were from age group 25-35 years 8 (23529) patients

were from age group 35-45 years and 2 (58824) patients were from age

group 45-60 yearsIn control group 6 (17647) patients were from age group

18-25 years 14 (41176) patients were from age group 25-35 years 7

(20588) patients were from age group 35-45 years and 7 (20588)

patients were from age group 45-60 years

Fig 23 Age wise distribution of patients

0

2

4

6

8

10

12

14

15 -25 25-35 35-45 45-60

10

14

8

2

6

14

7 7

Age Distribution

Trial Group N Control Group N

Age Distribution

Trial Group Control Group

N N

18 -25 10 29412 6 17647

25-35 14 41176 14 41176

35-45 8 23529 7 20588

45-60 2 58824 7 20588

Total 34 100 34 100

Page | 97

1 Gender wise distribution of patients

Table no 7

Sex

Trial Group Control Group

N N

Female 23 67647 15 44118

Male 11 32353 19 55882

Total 34 100 34 100

In trial group 23 (67647) patients were female and 11 (32353) patients

were male

In Control group 15 (44118) patients were female and 19 (55882)

patients were male

Fig 24 Gender wise distribution of patients

0

5

10

15

20

25

N N

TRIAL GROUP CONTROL GROUP

23

15

11

19

Gender

Female Male

Page | 98

2 Education wise distribution of patients

Table no 8

Education

Trial Group Control Group

N N

Illiterate 4 11765 3 88235

SSC 4 11765 3 88235

HSC 8 23529 9 26471

Graduation 16 47059 10 29412

Primary 1 29412 3 88235

Post-Graduation 1 29412 6 17647

Total 34 100 34 100

In trial group 4 (11765) patients were illiterate 4 (11765) patients were

SSC educated 8 (23529) patients were HSC educated 16 (47059)

patients were graduated 1 (29412) patients were primary educated and

1(29412) patients were post graduated

In control grou 3 (88235) patients were illiterate 3 (88235) patients

were SSC educated 9 (26471) patients were HSC educated 10 (29412)

patients were graduated 3 (88235) patients were primary educated and

6 (17647) patients were post graduated

Page | 99

Fig 25 Education wise distribution of patients

0

2

4

6

8

10

12

14

16

ILLITERATE SSC HSC GRADUATION PRIMARY POST GRADUATION

4 4

8

16

1 1

3 3

910

3

6

Education

Trial Group N Control Group N

Page | 100

3 Occupation wise distribution of patients

Table no 9

Occupation

Trial Group Control Group

N N

Accountant 1 294 2 588

Housewife 11 3235 8 2353

Engineer 1 294 1 294

Job 1 294 4 1176

Labor 1 294 3 882

Mess 1 294 0 000

Naturotherapyst 1 294 0 000

Pharma 1 294 0 000

Shopkeeper 4 1176 2 588

Singer 1 294 0 000

Student 8 2353 4 1176

Tailor 1 294 1 294

Teacher 1 294 1 294

Worker 1 294 3 882

Farmer 0 000 1 294

Lab Tech 0 000 1 294

Page | 101

Daily Collection 0 000 1 294

Fruit seller 0 000 1 294

Bus Driver 0 000 1 294

Total 34 10000 34 10000

In trial group 11 (3235 ) were housewife 8(2353) were students

4(1176) were shopkeeper 1(294) was accountant 1(294) was

engineer 1(294) was doing job 1(294)was labour 1(294) was

catering 1(294) was Naturotherapyst 1(294) was Pharma 1(294)

was Singer 1(294) was Tailor 1(294) was Teacher and 1(294) was

worker

In Control group 8 (2353)were housewife 4(1176) were students

2(588) were shopkeeper 2(588) was accountant 1(294) was

engineer 4( 1176) was doing job 3(882)was labor 1(294) was

Farmer 1(294) was Lab tech 1(294) was Daily collection 1(294)

was Tailor 1(294) was Teacher and 3(882) was worker 1(294) was

Fruit seller and 1(294) Bus driver

Fig 26 Education wise distribution of patients

0

2

4

6

8

10

12

1

11

1 1 1 1 1 1

4

1

8

1 1 10 0 0 0 0

2

8

1

43

0 0 02

0

4

1 13

1 1 1 1 1

Occupation

Trial Group N Control Group N

Page | 102

4 Religion wise distribution of patients

Table no 10

Religion

Trial Group Control Group

N N

Hindu 31 9118 33 9706

Muslim 3 882 1 294

Total 34 10000 34 10000

In trial group 31 (9118) patients were Hindu and 3 (882) patients were

Muslim

In control group 33 (9706) patients were Hindu and 1 (294) patient

were Muslim

Fig 27 Religion wise distribution of patients

0

5

10

15

20

25

30

35

N N

TRIAL GROUP CONTROL GROUP

3133

31

Religion

Hindu Muslim

Page | 103

5 Diet wise distribution of patients

Table no 11

Diet

Trial Group Control Group

N N

Veg 14 4118 20 5882

Non-Veg 20 5882 14 4118

Total 34 10000 34 10000

In trial group 14 (4118) patients were vegetarian and 20 (5882)

patients were Non vegetarian

In control group 20 (5882) patients were vegetarian and 14 (4118)

patients were Non-Veg

Fig 28 Diet wise distribution of patients

0

5

10

15

20

N N

TRIAL GROUP CONTROL GROUP

14

2020

14

Diet

Veg Non Veg

Page | 104

6 Addiction wise distribution of patients

Table no 12

Addiction

Trial Group Control Group

N N

None 30 8824 27 7941

Alcohol 2 588 0 000

Tobacco 1 294 2 588

Mishri 0 000 1 294

Smoking 1 294 4 1176

Total 34 10000 34 10000

In trial group 30 (8824) patients have no addiction 2 (588) patients

have addiction of alcohol 1 (294) patients have addiction of Tobacco 0

(0) patients have addiction of Mishri and 1 (294) patients have addiction

of smoking

In control group 27 (7941) patients have no addiction 0 (0) patients

have addiction of alcohol 2 (588) patients have addiction of Tobacco 1

(294) patients have addiction of Mishri and 11 (1176) patients have

addiction of smoking

Page | 105

Fig 29 Addiction wise distribution of patients

0

5

10

15

20

25

30

NONE ALCOHOL TOBACCO MISHRI SMOKING

30

21

01

27

0

21

4

Addiction

Trial Group N Control Group N

Page | 106

Statistical Analysis and Results

Effect of study on Karnashoola-

Table no 13

Karnashoola

Group A Group B

BT AT BT AT

N N N N

Grade 2 0 000 0 000 0 000 0 000

Grade 1 30 10000 7 2333 32 10667 5 1667

Grade 0 4 1333 27 9000 2 667 29 9667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 30 Effect of study on Karnashoola

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

30

7

32

54

27

2

29

Karnashoola

Grade 2 Grade 1 Grade 0

Page | 107

Table no 14

Karnashoola Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 088 100 033 006

969 2829E-

08 7667 HS

AT 021 000 041 007

Group

B

BT 094 100 024 004

1037 7103E-

11 8438 HS

AT 015 000 036 007

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 31

000010020030040050060070080090100

BT AT BT AT

GROUP A GROUP B

088

021

094

015

Karnashoola

Mean

Page | 108

Table no 15

Karnashoola

Mean SD Effect

Group

A

Group

B Trial Control Trial Control

Day 1 088 094 033 024 000 000

Day 3 065 071 049 046 2667 2500

Day 5 024 038 043 049 7333 5938

Day 14 021 015 041 036 7667 8438

000

010

020

030

040

050

060

070

080

090

100

Day 1 Day 3 Day 5 Day 14

Karnashoola

Mean Group A Mean Group B

Page | 109

Table no 16

Karnashoola N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3250 110500

510000 275 Control group 34 3650 124100

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 110

Effect of study on Karnakandu

Table no 17

Karnakandu

Group A Group B

BT AT BT AT

N N N N

Grade 3 7 2333 0 000 4 1333 0 000

Grade 2 18 6000 0 000 18 6000 0 000

Grade 1 7 2333 7 2333 10 3333 15 5000

Grade 0 2 667 27 9000 2 667 19 6333

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 32 Effect of study on Karnakandu

0

5

10

15

20

25

30

N N N N

BT AT BT AT

GROUP A GROUP B

7

0

4

0

18

0

18

0

7 7

10

15

2

27

2

19

karnakandu

Grade 3 Grade 2 Grade 1 Grade 0

Page | 111

Table no 18

Karnakandu Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 188 200 081 015

1091 3119E-

10 8906 HS

AT 021 000 041 007

Group

B

BT 171 200 076 014

1032 4746E-

09 7414 HS

AT 044 000 050 009

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Page | 112

Fig 33

Table no 19

Karnakandu

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 188 171 081 076 000 000

Day 3 126 118 057 058 3281 3103

Day 5 071 074 046 051 6250 5690

Day 14 021 044 041 050 8906 7414

000

020

040

060

080

100

120

140

160

180

200

BT AT BT AT

GROUP A GROUP B

188

021

171

044

Karnakandu

Mean

Page | 113

Table no 20

Karnakandu N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 4051 137750

373500 006 Control group 34 2849 96850

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is less than

005 Hence we conclude that there is significant difference between Trial

Group and Control Group

000

020

040

060

080

100

120

140

160

180

200

Day 1 Day 3 Day 5 Day 14

Karnakandu

Mean Group A Mean Group B

Page | 114

Effect of study on Karnasrava

Table no 21

Karnasrava

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 11 3667 0 000 8 2667 0 000

Grade 1 23 7667 3 1000 26 8667 2 667

Grade 0 0 000 31 10333 0 000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 34

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

11

0

8

0

23

3

26

20

31

0

32

Karnasrava

Grade 3 Grade 2 Grade 1 Grade 0

Page | 115

Table no 22

Karnasrava Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 132 100 047 009

1122 4356E-

13 9333 HS

AT 009 000 029 005

Group

B

BT 124 100 043 008

1130 9364E-

14 9524 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 35

000

020

040

060

080

100

120

140

BT AT BT AT

GROUP A GROUP B

132

009

124

006

Karnasrava

Mean

Page | 116

Table no 23

Karnasrava

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 132 124 047 043 000 000

Day 3 100 100 025 025 2444 1905

Day 5 047 038 051 049 6444 6905

Day 14 009 006 029 024 9333 9524

000

020

040

060

080

100

120

140

Day 1 Day 3 Day 5 Day 14

Karnasrava

Mean Group A Mean Group B

Page | 117

Table no 24

Karnasrava N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3535 120200

549000 655 Control

group 34 3365 114400

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 118

Effect of study on Karnabadhirya

Table no 25

Karn

Badhirya

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 0 000 0 000 0 000 0 000

Grade 1 13 4333 0 000 16 5333 2 667

Grade 0 21 7000 34 11333 18 6000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 36

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 00 0 0 0

13

0

16

2

21

34

18

32

Karnabadhirya

Grade 3 Grade 2 Grade 1 Grade 0

Page | 119

Table no 26

Karn

Badhirya Mean Median SD SE

Wilcoxon

W P-Value

Effect Result

Group

A

BT 038 000 049 009

799 7173E-

05 10000 HS

AT 000 000 000 000

Group

B

BT 047 000 051 009

816 0000138 8750 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 38

000

005

010

015

020

025

030

035

040

045

050

BT AT BT AT

GROUP A GROUP B

038

000

047

006

Karnbadhirya

Mean

Page | 120

Table no 27

Karn

Badhirya

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 038 047 049 051 000 000

Day 3 009 006 029 024 7692 8750

Day 5 003 006 017 024 9231 8750

Day 14 000 006 000 024 10000 8750

000

005

010

015

020

025

030

035

040

045

050

Day 1 Day 3 Day 5 Day 14

Karn Badhirya

Mean Group A Mean Group B

Page | 121

Table no 28

Karn

Badhirya N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3400 115600

561000 806 Control

group 34 3500 119000

Total 68

Page | 122

COMPARISION BETWEEN GROUP A AND GROUP B

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Table no 29

Overall Effect

Trial Group Control Group

N N

Marked Improvement 21 6176 16 4706

Moderate Improvement 8 2353 13 3824

Mild Improvement 4 1176 5 1471

No Change 1 2941 0 0

TOTAL 34 100 34 100

Fig 39

0

5

10

15

20

25

MARKED IMPROVEMENT

MODERATE IMPROVEMENT

MILD IMPROVEMENT NO CHANGE

21

8

41

1613

5

0

Overall Effect

Trial Group N Control Group N

Page | 123

DISCUSSION

Page | 124

Discussion is nothing but the logical reasoning of observations In

every research work discussion part is very important because it brings into

light about the logical analysis which are helpful in filling the research gap in

the scientific world

The discussion is categorized into following ways for the ease of

understanding

1 Discussion on selection of topic

2 Discussion on review of literature

3 Discussion on drugs their mode of action on the disease mode of action

of Karnadhoopana

4 Discussion on observation and results

1 Discussion on selection of topic

Otomycosis is commonly encountered in day-to-day practice Majority

of Indian people affected with this pathology This disease commonly

manifests in developing countries low socio-economic standard and lack

of hygiene Now a days due to busy lifestyle people are not able to follow

the proper instruction of care of ear which may be responsible for the

recurrent nature of disease So for the management of this we use

Karnadhoopana with the help of Agaruwadi Varti Dhoopana is simple

easy cost-effective procedure which can be done even at OPD levelso

for the disease Karnasrava we selected Karna Dhoopana as therapeutic

procedure Karnadhoopana was done with Agaruwadi Varti and Guggula

Varti which was very effective for treatment

Page | 125

2 Discussion on review of literature

Karnasrava is one such disease among 28 Karnarogas mentioned by

Acharya Sushruta in the chapter named Karna Roga Vigyana Acharya

Charaka included Karnasrava as symptom under the four types of

Karnarogas due to vitiation of different doshas Acharya Vagbhata has

not described Karnasrava separately It is a fact that systemic

description of Karnarogas is available in all the ancients of pus from a

Vata afflicted ear may results from head injury or immersion in water

Karnasrava is a clinical entity which can be correlated with Otomycosis

Karnasrava is explained as symptom as well as a disease in Ayurveda

Nidana- Karnasrava occur due to Samanya Nidana and Vishesh Nidana

Vishesh Nidana like Shirobhighata Nimmajato jale Mithyayoga of Shashtra

The exact pathology behind Karnasrava is not understood clearly

Purvarupa ndash No specific Purvarupa are found for Karnasrava in classical

literature Acharya Madhukara describe Purvarupa as expression of

Rupa(lakshana) with less intensity that is less intensity itching sound in ear

may considered as Purvarupa of Lakshana

Samprapti- Aacharya Sushruta not explained the Samprapti of Karnasrava

separately and we must consider the general Samprapti of Karnaroga Due to

various aetiologias as cited above ear afflicted by Vata dosha causes Twak

Rakta Mamsa dushti results in Karnasrava According to Acharya Sushruta

Vata-Kapha dose is dominance in Karnasrava

Page | 126

Nidan

Nija Agantuja

Vata ndash kapha prakopak nidana Shirobhighata Nimmajato-jale

Mithya yoga of Shastra

Vata- kapha Prakopaka(Chaya prakopak) Vata-kapha prakopaka

( Achay prakopak)

Twak Rakta Mamsa dushti

Karnasrava

Page | 127

Chikitsa

The curative aspect and this must be done simultaneously giving due

importance to Nidan Parivarjana that is preventive measures So Nidan

Parivarjana that is avoidance of causative factors like Jalkrida Mithyayogen

shashtrasya Karnakandu Shirasnan Pratishaya is the first step in combating

the disease and form the part of line of treatment

Above Samprapti helps us to proceed towards the treatment of Karnasrava

The main protocol of treatment is removal of fungus and wound management

which include various measures to keep area day clean clear of microbes and

providing ideal condition for healing

Samany Chikitsa- Acharya Sushruta described general treatment for

Karnaroga as Snehapana (Drinking ghee) Rasayana (Rejuvenation therapy)

Bhramacharya Avoid excessive speaking Avoidance of physical exercise and

head bath

Vishesha Chikitsa ndash Acharya Sushruta mentioned some procedures in the

treatment of Karnasrava which is Shirovirechana Karnadhoopana

Karnapurana Karanpramarjana Dhavan Avachurnana Karnapurana Above

various procedures described in Ayurveda for management of fungus growth

in ear discharging ear fulfill these requirements of wound management

Page | 128

Discussion on observation and Result

Out of 68 patients 34 patients included for the trial The incidence of

Karnasrava is observed in trial and control groups

The statistical analysis provided the following data

AGE

Trial group- Maximum no of patients that is 14 (41176) patients were from

age group 25-35 years followed by 29412 patients were from age group

18-25 years 23529patients were from age group 35-45 years and

58824 patients were from age group 45-60 years

Control group - Maximum no of patients that is 14 (41176) patients were

from age group 25-35 years followed by 20588 patients were from age

group 35-45 years and 20588 patients were from age group 45-60 years

17647 patients were from age group 15-25 years

The maximum no of cases of Karnasrava found in age group between 25 to

35 years The reason behind this is repeated use of ear bud or emersed water

in ear More use of earphone or working more in cold environment

GENDER

Trial group ndash A higher prevalence seen in females 6764 and 3235 in

males

Control group - A higher prevalence seen in males 5588 and 4411 in

females

Females and males both are prone to disease

Page | 129

EDUCATION

Trial group-It is observed that amongst 34 patients maximum ie16

(47059) patients were graduated 8 (23529) patients were HSC

educated 4 (11765) patients were SSC educated 4 (11765) patients

were illiterate 1 (29412) patient were primary educated and 1(29412)

patient were post graduated

Control group- It is observed that 10 (29412) patients were graduated 9

(26471) patients were HSC educated 6 (17647) patients were post

graduated 3 (88235) patients were SSC educated 3 (88235) patients

were primary educated3 (88235) patients were illiterate

There is no direct relation between education and Otomycosis

RELIGION

Trial group- The incidence of patients of Hindu religion are 9118 and Muslim

religion are 882

Control group- The incidence of patients of Hindu religion are 9706 and

Muslim religion are 294

There is no probable explanation for this maximum number of patients in

Hindu religion it depends upon the patients attend the hospital and

community residing there

Page | 130

DIET

Trial group It was found that maximum ie5882 patients were taking

mixed diet while 4118 were taking vegetarian diet

Control group It was found that maximum ie5882 were taking

vegetarian diet while 4118 patients were taking mixed diet

The dietary habit of person is based on choice availability and religious

customs of the person

ADDICTION-

Trial group- It was found that maximum ie 30 (8824) patients have no

addiction 2 (588) patients have addiction of alcohol 1 (294) patients

have addiction of Tobacco 1 (294) patients have addiction of smoking and

0 (0) patients have addiction of Mishri

Control group - It was found that maximum ie 27 (7941) patients have

no addiction 4(1176) patients have addiction of smoking 2 (588)

patients have addiction of Tobacco 1 (294) patients have addiction of

Mishri and 0 (0) patients have addiction of alcohol

Very few patients were addicted to Alcohol Smoking Tobacco and Mishri

These factors can be taken as provoking factors for Otomycosis

Page | 131

Discussion based on probable Mode of action of Karnadhoopana

In Ayurveda classics Karna Dhoopana is therapeutic procedure explain for

Karnasrava Dhoopana is administration of Dhooma (Fumes) with the help of

Dhoopan Dravya References indicates that analgesic and disinfectant effect

of Dhoopana karma and mention for Dushta Vrana Chikitsa It reduces

Vedana Srava amp also does Vrana Ropana action

Various Dhoopanas and Dhoopan Dravas for different element in various

Samhitas of Ayurveda but there is a lacuna of availability of reference

regarding how to do it and method of procedure Matra Kala Contraindication

etc

Currently simple modified way of Karnadhoopana according to Yukti Praman

and experience but there is lac of standardization

Karnadhoopana is one among the topical Bahiparimajan type of treatment

Karna Parmarjana is procedure of cleaning ear with the help of cotton or gauze

piece soaked in honey

Page | 132

Dhoopan

The fumes coming out on burning Agaruwadi Varti

Administrated directly into external ear canal

Causes vasodilation

Due to this increase blood supply in external ear canal

It helps in absorption of drug

Fumes dries up Srava and bring the analgesic effect

Karnagata Kapha amp Avrut Vata Dosha Shaman

Decrease in signs and symptoms like karnasrava Karnshool Karnabadhirya amp

Karnandu

Page | 133

3 Discussion based on probable mode of action of Agaruwadi

Dhoopana

Agaru ndash

I Agaru is a fragrant tree aroma is a result of fungal pathogenesis when the

wood of tree is contaminated by fungi at wounds it develops scrap filled

with resin and turn out to be aroma Medicinal use of Agaru have been

recorded in ancient medicinal science in in inflammatory disease and some

infective disease

II Acharya Charaka has referred to Agaru as an Ushna dravya despite having

Tikta Rasa Ashtang Samgraha used Agaru as Dhupana Dravya along with

Madan and Yawa in Karnasrava Nighantu recommended is use as a

Dhoopana

III In various Samhitas and Nighantus Agaru described as Tikta Snighdha

Sheetaprashamana Vranaprasadana Tvachya Due to these properties

Agaru is used in the treatment of Karna-Akashi Roga and Dushta Vrana

Shodhaka

IV Agaru is reported to have Antimicrobial Analgesic Antioxidants

Antihistaminic and anxiolytic properties Its Antihistaminic property gives

relief from itching which is cardinal feature of Otomycosis Due to Katu

Ushna Tikta Guna improves blood circulation Bheda stage develop It is

Niram Awastha of Dosha Karnagata kapha and vata get decrease and

symptoms like karnashoolakarnasrava get decrease Agaru also have a

Antioxidant properties

V Chemically Agaru Contain 2-(2-Phenylethyl) Chromones Terpenoids

Flavonoids

VI Natural Agarwood had inhibitive activities towards Staphylococcus Aures

The chloroform extract of Agarwood prolongs the pain threshold[108]

Page | 134

Madan

I Madanphala have therapeutic properties like Anti-inflammatory

Antiallergic Analgesic and Wound healing

II It is Useful in treatment of disease like Shotha (inflammation) Vidradhi

(Abscess) Pratishaya (Common cold) Kushta(Skin disease)

III Extract of Madanphala mainly contain Glcosides Tritorpenct

Glycosides Saponin

IV Saponin glycosides are act as fire extinguisher This property is helpful

for vartiIt also act as a detergent which clean the surface of fungus

V Tritorpenct act as a anti-inflammatory antimicrobial and

immunomodulator compound Interaction of glycosides with sterol

causes disturbance of selective permeability in plasmic membraneso

exudates and discharge get decrease

VI Pharmacological activity [109]

Antibacterial Activity The preliminary antibacterial activity of Methanolic

extract of Randia D lam was done on some standard and wild pathogenic

strains The inhibition of the bacterial growth was more pronounced on E coli

as compared to the other tested organism This shows the antibacterial action

of Randia D secondary infection can prevent

Anti-Allergic Activity In Ayurveda Randia D Extract and its fraction of milk

induced leukocytosis and eosinophilia in mice

Anti-Inflammatory Activity The crude methanol extract of fruit of Randia D

effectively reduced the carrageenin induced oedema in hind paw of the rats

significant reduction in granular tissue formation was recorded This activity

seems to be significant at various acute phases of inflammation and om

formation of granular tissue This proves action of Madanaphala in shopa

(inflammation)

Page | 135

Analgesic Activity Analgesic activity was tested in mice weighing between 20-

250 with six number of animals in each group Methanlic extract of fruit Randia

d give analgesic activity in both models This proves its Shoolanashaka (pain

killer) action

Immunomodulatory Activity Randia D has immunostimulant activity and

chloroform fraction which strongly affected immune system seems to be

bioactive fraction of this plant

The overall effect of Agaru Mandanphala Yawa having Anti-inflammatory

Antiseptic Antimicrobial Property Active ingredient shows these properties

Agaru Yawa Madanphala

Vatakaphaghna

Act as

Vranashodhak

Vedanasthapaka

Sheetaprashamana

Shothara

Avarana of Vata get decrease so helps to Shaman of Vata dosha

Karnakandu Karnashoola Karnasrava

Prashamana

Page | 136

This fact can be taken into consideration and probably acknowledge that

Karnadhoopana with Agaruwadi Varti had not leave any residue in the ear

Removal of fibrin keratinocyte migration and in growth of epithelial tissue

plays a major role in healing It is technique of fumigation of ear with the

smoke of anti-infective drug In Karnadhoopana Sthanik Swedana increase the

blood supply and helps in absorption of the drug reduce Karnakandu amp

Karnshoola associated with infection

Page | 137

SUMMARY AND CONCLUSION

Page | 138

The dissertation entitled randomize comparative clinical trial to study the

effect of Agaruwadi Karnadhoopan and Guggula Karnadhoopan In Karnasrava

wsr to Otomycosis

The dissertation is divided into fallowing parts

Introduction

Review of literature

Ayurvedic review

Modern Review

Drug review

Procedure review

Material and Method

Observation and result

Discussion

Summary and conclusion

bull INTRODUCTION

It includes importance of Shalakyatantra in Sushrut Samhita Charka

Samhita And Ashtang Samgraha

Common and specific causes of Karnasrava

Karnasrava is a clinical entity which can be corelate with Otomycosis

In Ashtang Samgraha stated the procedure like Karnadhoopana with

Agaru Yawa Madanphala in Karnasrava

Page | 139

bull REVIEW OF LITERATURE

1 Ayurvedic review

2 Modern review

3 Drug review

Ayurvedic review-

It includes Rachana-Sharir and Kriya-Sharir of Karna detail description of

Karnaroga and its types Karnaroga Samanya hetu Poorvaroopa Rupa

Samprapti Upadrava Pathya-Apathya of Karnasrava Vishesh Nidan and

Chikitsa of Karnasrava Detail description of Karnadhoopana according to

various Acharays have been mentioned

Modern review-

It includes anatomy and physiology of Ear brief anatomy of ear anatomy of

External middle and Internal ear Detail description of the disease

Otomycosis mechanism of fungal infection in external canal pathophysiology

investigations diagnosis and management

Drug review-

Detail description of Agaru Yawa Madan Guggula and its synonyms

Ayurvedic properties Karma uses Pharmacological action and their

pharmacodynamic properties

Page | 140

MATERIAL AND METHOD

It includes description regarding materials required for the study Preparation

of Agaruwadi Varti its Standardization Sterilization and packaging

Plan of study

1 Total 68 patients completed the treatment Age criteria was kept

between 18-60 years Patient selection was done by done by simple

random sampling method and divided into two groups A (Trial) and

Group B (Control) 34 patients in each group

2 Patients in Group A were treated with Karnadhoopana with Agaruwadi

Varti for 7 days two times in a day while patients in Group B were treated

with Karnadhoopana with Guggula for 7 days two times in a day

3 Clinical examination done during each follow up ie 0th 4rd 7th and

observation were recorded

Page | 141

OBSERVATIONS AND RESULTS

Page | 142

1 It was observed that higher incidence of disease Karnasrava ie

Otomycosis found in age group 25-35 years

2 Disease otomycosis was equal in both male and female

3 The trial group there was significant relief in Karnakandu (8906)

Karnasrava(9333) Karnashoola(7667) and karnabadhirya(100)

4 In control group there was significant relief in Karnakandu (7414)

Karnasrava(9524) Karnashoola(8438) and

karnabadhirya(8750)

Page | 143

REFERANCES

Page | 144

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49 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sharirsthan published by

Chaukhamba Orientalia Sharirsankhyasharir Adhaya Shlok no 711 page

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50 Vd Harish chandra singh Kushwaha Charak Samhita edited with

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51 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

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66 Shree Yadunandanopadhyaya Madhavnidan with madhukosh

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70 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

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71 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005 Adhyay 18 shlok 35

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75 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

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76 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 34 page no- 649

77 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

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no 131

78 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 37 page no- 649

79 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2146page

no

80 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya page no-

316

81 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

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Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2143page

no

82 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

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83 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary

Madhyamkhand Vatkalpana shlok no- 782-83 page no- 137

84 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

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85 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya page no-

316

86 Vd Shree Laxmipatishastri Yogratnakara

87 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

Karnarogadhikara Shlok no- 808182 page no- 652

88 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 83 page no- 652

89 (PDF) Otomycosis A Comprehensive Review (researchgatenet)

90 httpswwwncbinlmnihgovpubmed24948980

91 A Simon Carney Scott-Browns Otorhinolaryngology Head and Neck

Surgery CRC press 8th publication Otitis externa and otomycosis

92 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition Diseases of external ear

Chapter no Page no -

93 wwwguggulipidcomtradhtm

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94 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

95 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 1 chapter no-28 page no-

43

96 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009Agaru page

no726-728

97 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishra chapter Karpuradi varga Shlok no-31-

43 Page no- 116

98 httpswwwthiemeinimagecatlogsample_chapter_GOMPpdf

99 (PDF) Chemical Constituents and Pharmacological Activity of Agarwood

and Aquilaria Plants (researchgatenet)

100 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 4 chapter no-2 page no-4

101 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 chapter no-152 Madanpage

no376-379

102 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

103 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 1 chapter no-54 page no-

84

104 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 page no697-699

patol-yawa

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105 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

106 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

Dhoompanvidhi page no- 252-254

107 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012Chikitasasthan Shlok

no- 151page no-406

108 httpswwwmdpicom1420-3049232342pdf

109 httpswwwijamcoinindexphpijamarticledownload0610201530

0

Page | 156

BIBILOGRAPHY

Page | 157

1 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

2 Scott-Brown WG Diseases of the EarNose and Throat Landon

Botterworth and co(publishers) Ltd1952 Volume 2

3 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012

4 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009

5 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi commantry

Purvakhand and Madhyamkhand

6 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

7 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-Tatva-

Sandipika hindi commentary Published by Chaukhamba Sanskrit

SansthanVaranasi

8 The Ayurvedic Pharmacopeia of India Ministry of Health and family welfare

department of Ayush Part 1 and part 4

9 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005

10 Acharya Trivedi Raguveer Prasad Ashtang sangrah published by

Vaidyanath Ayurveda bhavan pvt

11 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition

12 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary published by Chaukhamba

Orientalia

Page | 158

ANNEXURE

Page | 159

ANNEXURE- 1

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

CASE RECORD FORM

RESEARCH PROFORMA FOR MS (AYU) DESSERTATION

DEPARTMENT OF SHALAKYATANTRA

NAME -

ADDRESS -

GENDER - AGE - OCCUPATION-

RELIGION - EDUCATION - MARITAL STATUS-

OPD IPD NO-

DATE OF ADMISSIONCOMMESEMENT-

DATE OF DISCHARGECOMPLITION-

DATE OF COUNSELLING-

TEL NO-

CHIEF COMPLAINTS-

PAST MEDICAL AND SURGICAL HISTORY-

TREATMENT HISTORY-

FAMILY HISTORY-

Page | 160

PERSONAL HISTORY-

a) Ahar(Diet)

b) Vihar

c) History of addiction

GENERAL EXAMINATION

PULSE - MIN BP - mm of hg

TEMP - 0F RR - MIN

ASHATAVIDHA PARIKSHANA

Nadi- Mutra- Mala-

Jivha- Shabda- Sparsha-

Drik- Aakruti-

SYSTEMIC EXAMINATION

RS ndash

CNS-

CVS ndash

Page | 161

LOCAL EXAMINATION (KARNA PARIKSHAN)

OBSERVATION TABLE FOR SUBJECTIVE CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching )

RIGHT EAR LEFT EAR

KARNASHASHUKULI

KARNAPUTRAK

KARNAPALI

KARNAKUHARA -

SRAVA

GANDH

VARNA

SWARUPA

KARNAPATALA (TM)

Page | 162

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

Hearing Test

1Renne Test ndash

2 Weber Test -

Examination of Ear-

Pathological Investigation-

Other Examination-

Nidan Panchak-

1Hetu-

2Purvarup-

3Rupa-

4Upashayanupashaya-

5Samprapti

Signature of Guide Signature of Doctor(Researcher)

Page | 163

ANNEXURE 12

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Dhoopana Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization were done as recommended in pharmacy procedure

The raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 were mixed together

in equal quantity to make Agaruwadi churn

STEP 4 - Agaruwadi churn were triturated with appropriate quantity of water

and prepared Varti in GMP Certified Ayurvedic pharmacy Standard aseptic

precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Dhoopana Varti was packed in sterile air packed

container

STEP 6 - Agaruwadi Dhoopan was given with the help of Dhoopan yantra

TREATMENT DETAIL-

Purvakarma -

1 The patient is asked to sit comfortably on chair having sufficient light and

less amount of dust

2 The EAC is cleaned thoroughly by Pichu Varti (cotton swab) to remove the

discharge and other debris

Pradhankarma -

1 The patient is asked to relax completely on the chair

Page | 164

2 Fumes are passed to the ear with Dhoopana Yantra

3 Dhoopana yantra is funnel shaped and its one end will keep the ear covered

for the passage of Dhooma into the ear canal and other end where Agaruwadi

Dhoopana Varti were placed which produces fumes

4 This Dhoopana was given for 5 min

Pashchat karma -

1 The patient were advised to avoid cold refrigerated food drinks cold water

bath cold wind fog and prevent water from entering the ear

(A) Agaruwadi Dhoopana Varti

B) Guggula Dhoopana Varti SOP of it is same as above Agaruwadi Dhoopana

Varti

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Page | 165

ANNEXURE 21

INFORMED CONSENT DOCUMENT

Study Title

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

Introduction

- You are invited to take part in a research study RANDOMSIED COMPARATIVE

CLINICAL TRIAL TO STUDY THE EFFECT OF AGARUWADI DHOOPANA AND

GUGGULA DHOOPANA IN KARNASRAVA

- Before you decide it is important for you to understand why the

research is being done and what it will involve

- Please take time to read the following information carefully and discuss

it with friends relatives and your doctor if you wish

- Ask us if there is anything that is not clear or if you would like more

information

Purpose amp Nature of Study

- In this research project by examine you and ldquoKarnasravardquo (Otomycosis)

disease were treated

- In the part of treatment Agaruwadi Dhoopana or Guggula Dhoopan were

given

- Dhoopana means medicated drug fumes were given in ear with the help of

Dhoopan Yantra

Page | 166

- Treatment was given for 7 days

Study Duration

7days

Participation

- Your participation is entirely voluntary

- If you do decide to take part you were given this information sheet to keep

and be asked to sign a informed consent form

- If you decide to take part you are still free to withdraw at any time and

without giving a reason This will not affect the standard of current or future

medical care you may receive

Confidentiality

- All information which is collected about you during the research were

kept strictly confidential

- Any information about you which is collected from the center will have

your identity in the form of a code number so that it will remain confidential

Benefits Of Study

- The results obtained from this study would be helpful for providing better

quality of treatment amp other essential facilities for Karnasrava (Discharge)

patients

- You will get clinical benefit from the study

Page | 167

Risks Of Study

- In this treatment there are few chances of Irritation of Ear Nose and

congestion at EAC if any of these happens then treatment were given

Results Of Study

- If the Results obtained are profitable then they may get published

without disclosing your details

Signature of patient

Date

Time

Phone no of Researcher

Page | 168

रण मादहती पतरक

सशोिनाच शीषवक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE

EFFECT OF AGARUWADI DHOOPANA AND GUGGULA DHOOPANA

IN KARNASRAVA

परसतताना

- आपणास या सशोिनातपमक अभयासात सहिागी होणय़ाच आाहन करणयात यत आह

- सशोिनातील सहिाग तननदशचत करणयापी सशोिनाच उददश समजन घया

- खालील मादहती काळजीपवक ाचा आणण आशयक ािलयास आपलया डॉकिराशी कका

दहतशरचतकाशी चचाव करा

- काही सददिता असलयास कका आणखी मादहती ही असलयास आमछयाशी चचाव करा

सशोिनाच उददीटि सतरप

- सदर सशोिन परकलपामरधय आपलयाला तपासणी करन कणवसरा या वयाशरिची शरचककतपसा दणयात

यणार आह

- सदर वयाशरिची शरचककतपसा महणन आपणास अगरादी िपन कका गगल िपन

दणयात यणार आह

- सदर औषि आपणास 7 ददस घयायाच आह

Page | 169

कालािी

- 7 ददस

सहिाग

- आपला सहिाग हा पणवपण ऎनदछिक आह

- आपला सहिाग तननदशचत असलयास आपणास ही मादहती पतरतरका दणयात यईल आपणास यातील

समती पतरकार सही कराी लागल

- सहिाग तननदशचत असनही आपण कोणतपयाही ळस कोणतही कारण न दता माघार घ शकता

याचा आपलया दयकीय सविर कोणताही पररणाम होणार नाही

गोपनीयता

- सशोिना दरमयान गोळा कलली आपलया वषयाची सव मादहती गोपनीय ठणयात यईल

- आपली यनदकतक मादहती साकततक सतरपात गोपनीय ठणयात यईल

सशोिनाच फ़ायद

- सशोिनाच तनटकषव कणवसरा बाशरित रणाछया दयकीय इतर सविाचा दजाव सिारणयास

फायदशीर ठरतील

सशोिनातील जोणखम

- य़ा शरचककतपसमरधय कान दखण डॊळय़ातन नाकातन पाणी य़ण नाकात जळजळण डोक जड

होण ही लिण ददस शकतात यापकी लिण तनमावण झालयास तपयाची शरचककतपसा कली जाईल

Page | 170

सशोिनाच तनटकषव

सशोिनाच तनटकषव फ़ायदशीर ठरलयास आपली मादहती गोपनीय ठन परकाशशत करणय़ात यईल

रण सतािरी-

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

Page | 171

ANNEXURE 31

INFORMED CONSENT FORM

Patient OPD no __________

Subjectrsquos Identifier

Date of Birth Age Gender

I _____________________________________ age___________ years

exercising my free power of choice hereby give my consent to be included

as a participant in the clinical study entitled

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

1 I confirm that I have read have been read and understood the information

sheet for the above study and can ask questions

2 I understand that my participation in the study is voluntary and that I am

free to withdraw at any time without giving any reason without affecting my

medical care or legal rights

3 I understand that the Ethics Committee members investigators and study

doctors will not need my permission to look at my health records both in

respect of the current study and any further research that may be conducted

in relation to it even if I withdraw from the trial I agree to his access

However I understand that my identity will not be revealed in information

released to third parties or published

4I agree not to restrict the use of any data or results that arisefrom this study

provided such a use only for scientific purpose

5 I agree to take part in the above study

Page | 172

signature with Date-

Left hand thumb impression

Name amp signature of the witness ndash

Name amp signature of the student ndash

Page | 173

ANNEXURE 32

समतीपतरक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

वयकतीच य

ददनाक जरमददनाक

1) मी ह तननदशचत कररत आह ककसदर सशोिन परकलपाबाबतची सपणव मदहती मी ाचली असनमला ती

समजली आहतपयाबददल मला परशन वचारणयाची पणव मिा आह सदर मादहतीन माझ समािान झाल

आह

2) मी सदर सशोिनातन माझया मजीनसार किीही बाहर पड शकतो या माझया अशरिकाराची मला कलपना

आह

3) माझी दयककय मादहती तपासणयाची कागदपतर कळ सशोिनाकररता ापरली जाणार आहत याची

मला मादहती आहसदर सशोिन परकलपातील सबशरित घिकाना माझी दयककय मादहती पाहणयाची मी

समती दत आहतरावप या सदिावतील माझी ओळख दशववणारी मादहती कोणासही ददली जाणार नाहीयाची

मला कलपना दणयात आली आह

4) सदर अभयासातन शमळणारी मादहती अरा तनटकषव कळ शासततरीय हतसाठी ापरल जाणयासाठी माझी

समती आह

5) रील अभयासात सहिागी होणयास माझी समती आह

रण सतािरी-

Page | 174

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

ASSESSMENT CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching)

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

a) कणवशल ( pain )- 0 - Absent

1 ndash Present

Page | 175

b) कणवकणड (Itching)- 0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

c) कणवसततरा ( Discharge )

0- Absent

1-Mild- Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाशरियव ( conductive Loss of hearing )

0 - Present

1 - Absent

Page | 176

Page | 177

Page | 178

Page | 179

Page | 180

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

Page | 181

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 182

AUTHENTIFICATION CERTIFICATE

Page | 6

AIM OF STUDY

To evaluate the effect of Agaruwadi Varti Dhoopana and Guggula Varti

Dhoopana in management of Karnasrava

OBJECTIVE

To compare the efficacy of Agaruwadi Dhoopana and Guggula Dhoopana in

Karnasrava

HYPOTHESIS

NULL HYPOTHESIS -

H0- Agaruwadi Dhoopana is not effective than Guggula Dhoopana in

Karnasrava

ALTERNATE HYPOTHESIS -

H1- Agaruwadi Dhoopana is more or equally effective than Guggula

Dhoopana in Karnasrava

RESEARCH QUESTION

Whether there is significant difference between Agaruwadi Dhoopana and

Guggula Dhoopana in Karnasrava

Page | 7

PREVIOUS WORK DONE -

1 Anupama Patra B Effect Of Arka Taila In The Management Of

Karnasrava With Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching amp Research in Ayurveda

Gujarat Ayurved University Jamnagar 2007

2 Palmer Komalben K Further Study On Role Of Arka Taila In The

Management Of Karnasrava With Special Reference To

Otomycosis Shalakya Tantra Institute for Post Graduate Teaching amp

Research in Ayurveda Gujarat Ayurved University Jamnagar 2010

3 Sathisha Shankar B Management Of Karnasrava With Sthanika

Guggulu Dhoopana And Rasnaadi Guggulu-A Comparitive Study Shalakya

Tantra Government Ayurvedic Medical College Bangalore 2011

4 Shashikala DK Comparative Study On The Efficacy Of Vacha

Lashunaadi Taila Karna Pichu And Nimba Patraadi Dhoopana In The

Management Of Karna Srava Shalakya Tantra Government Ayurvedic

Medical College Bangalore 2014

5 Javale Anant A Clinical Study On The Efficacy Of Arka Taila In The

Management Of Karna-Srava Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching amp Research in Ayurveda

Gujarat Ayurved University Jamnagar 2005

6 Pournima V Koti Management Of Karnasrava With Priyangvadi Taila

Pichu With And Without Saarivadi Vati Shalakya Tantra Sri Jagadguru

Gavisiddeswar Ayurvedic Medical College Koppal 2015

7 Amisha Patel A Clinical Evaluation Of Honey In The Management Of

Karna Shoola With Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching and Research in Ayurveda

Gujarat Ayurved University Jamnagar 2016

Page | 8

REVIEW OF LITRATURE

Page | 9

Ayurvedic literature Ayurveda is a science of life practice since

thousands of years The ancient Indian system of medicine and surgery is

commonly known as Ayurveda This was given the status of Upaveda or

fifth Veda in the next stage of growth Among the available literature three

Samhita that is Charaka Samhita Sushrut Samhita Ashtang Hrudayam and

Ashtang Samgraha are the chief source of knowledge of Ayurveda

Ayurveda consist of eight branches Shalakyatantra is one among them

Shalakyatantra is one of its specialized branch deals with science of

ophthalmology otorhinolaryngology Oro dental surgery and head Acharya

Sushruta himself a practical surgeon was the first to advocate dissection of

dead bodies is indispensable for a successful student of surgery He had

described gross anatomy in the first chapter of Uttartantra Shalakyatantra

define by different Acharys as follows

शालाकय नामोरधवजतरगताना रोगाणा शरणनयनदनघराणाददसशरशरताना वयाशरिनामपशमनारव

स स ११०

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत [13]

चस १७१२

Shalakya Tantra Nirukti and Parichaya

शलाकायााः कमव शालाकय ततपपरिान शलाकयम डलहण [14]

The term Shalakyatantra is derived from Shalakya and Tantra

The word Shalakya means A probe and Tantra denotes teaching and

practices found in scripturesThe compendium in which application of

Shalaka in various surgical procedures is principally described is called as

Shalakya tantra

दनदटिवशारदााः शालाककनाः डलहण ( सउ ११३)[15]

An eye specialist is termed as Shalaki by Dalhana

Page | 10

Synonyms of Shalakya Tantra

Uttamanga Chikitsa Jatrurdhwa Chikitsa Urdhwang Chikitsa Shalakya

Chikitsa

Importance of Shalakyatantra-

Life of living being and all the Indriyas are situated in the head hence it is

known as Uttamanga

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत

चस १७१२

The treatment given to this part of the body is described specially in

Shalakya tantra While describing the importance of Shiras Vagbhata

correlates it to the root of tree (Urdhwa Mula) and body to the trunk of tree

(Adha Shaka)

Sushruta has deal with Mukha Roga in Nidan Shan and its treatment in

Chikitsasthan The description regarding the disease of eye ear nose and

head are found only in UttaraSthan Sushruta specially describes the

disease of Shalakyatantra as told by Videha in the beginning of Uttartantra

itself[16]

Shalakyatantra Itihas-

India Exhibits traditional of more than thousands of years in art literature

language logic and philosophy etc The convention was in its sophisticated

and advanced attire throughout the Vedic period

Vedic period ndash

1 Natush was treated for deafness by Ashwinikumars (Rigveda)

2 Rujaswa and Kanva were treated for blindness by Ashwani Kumaras

(Rigvedas)

Page | 11

3 There are several prayers mentioned for normal functioning of sense

organs (Yajurveda)

4 Structures and functions of Mastishka are described (Atharveda)

5 Mantras having reference to disease of Eye Ear Oral cavity etc are

found (Atharvaveda)

Upanishada Period ndash

1 Samhita Period

a) Sushrut Samhita ndash

bull Explanation regarding Netra Nasa and Shirorogas (Uttartantra 1-

26th chapter)

bull Details regarding Mukha and Karna Roga Nidan and

Chikitsa(Nidansthan 16th and Chikitsasthan 22nd chapter)

bull Description regarding Karna Chedana Sandhana Nasa

Ostasandhana Sutra Sthan 16th chapter

b) Charaka Samhita -

bull Explanation regarding Shirorogas (Sutrasthan 17th chapter)

bull Explanation of Gala rogas like Upajivika Galshundi and Rohini

bull Nasa Shiro Mukha Karna and Netra Chikitsa (Chikitsa sthan 26th

chapter)

bull Description regarding Lakshana and Chikitsa of Shankhaka

Ardhavbhedaka Shirovirechana and Shiro basti (siddhi sthan 9th

chapter)

c)Ashtnga Sangraha ndash

bull Detailed description regarding Shalakyatantara (Uttartantra 11-28

chapter)

bull Description of Kriyakalpa (Sutrasthan 32nd and 33rd)

Page | 12

d)Ashtang Hrudayam

bull Detailed description on Shalakya Tantra (Uttar tantra 8-24 chapters)

bull Kriyakalpas (Sutrasthan 23rd and 24th chapter)

e) Bhela Samhita

bull Chakshushya Vaisheshik and Buddhi Vaisheshik Alochaka pitta

f) Harita Samhita- Branch of Medical science offering elaborating

information about the procedure like Nasya Anjan Gandusha etc

comprehended with their applications in disease of Head Eyes Ears

Eyebrows Throat Temporal region and cervical spine is known as

Shalakyatantara

शशरोरोगा नतररोगा कणवरोगा वशषताः भरकरठशङकमरयास य रोगा समिनदरत दह १३

तषा परततकारकम व नसतयतपयवणजनातन च अभयङगमखगणडषकियााः शालकयसशमतााः १४

इतत शालाकयनाम [17]

Documentation of different ancient literature gives various references

regarding all aspects of Karnasrava in various periods It is very much

important to know the history of Karnasrava from Vedic Pauranic Samhita

and Samgraha period

Vedic period ndash The Vedas being the oldest source of knowledge have no

direct mentioning of Karnasrava

Page | 13

Samhita and Samgraha period ndash

Aacharya Sushruta described about Karnaroga Karnasrava Nidan

Roopa and Chikitsa The detail description is available in Sushrut

Samhita Uttartantra 20 and 21st chapters

Aacharya Charaka did not specify Karnasrava but mentioned 4 types

of Karnarogas that is Vataj Pittaj Kaphaja and Sannipataja and their

treatment in 26th chapter of Chikitsasthan

In Ashtang Hrudaya karnasrava is not explained as a separate disease

but Chikitsa is mentioned in 18th chapter of Astanga Hrudaya

uttartantra

In Ashtang Samgraha Chikitsa is mentioned in 22nd chapter of Astang

Samgraha Uttartantra

The details about Karnasrava are explained in Bhavprakasha

Madhyamakhanda 64th chapter

Madhavakara has explained about Karnasrava in 57th chapter of

Madhymakhanda

Karnasrava is also explained in Sharangadara Samhita Uttarkhand 11th

chapter

The reference for treatment of Karnasrava is available in

Yogaratnakara

In Gadhnigraha Karnasrava and its treatment is mentioned in

Karnarogadhikara Adhaya

Vangasena had mentioned about the disease and treatment in 69th

chapter

Chakradatta explained Karnasrava in 57th chapter

Dalhana has given commentary on Sushrut Samhita Uttartantra 20th

and 21st chapter

Sankhya Samprapti of Karnasrava ndash

Aachary Sushruta explains 28 Karnaroga in Uttaratantra Karnaroga

Vigyniyam Aadhaya Aacharya charaka explain 4 Karnaroga in

Page | 14

Karnarohvigyniyam Adhaya based on doshas Acharya Vagabhata in

Ashtang Hrudaya explain 25 Karnaroga in Adhyaya

कणवशल परणादशरच बाशरियव कषड ए च

कणवसरााः कणवकणडाः कणव चवसतततर च

कशमकणवपरततनाहौ विशरिदवविसततरा

कणवपाकाः पततकणवसततराशवशरचतवविम

कणावबवद सपतवि शोफशरचावप चतवविाः

ऎत कणवगता रोगा अटिावशततरीररतााः

स उ २०- ३ त ५[18]

ातकणवरोग वपततकणवरोग कफकणवरोग

रकतकणवरोग सनदरनपातकणवरोग कणवनाद

बशरिरतप परततनाह कणडाः शोफ पततकणवक

किशमकणवक उियरपविरधयअशो अबवद

कशरचकणवक वपपपली वदाररका पाळीशोष

ततिका पररपोिो उतपपातो उरमरर दाःखिवन

शलहाखयााः परचवशनदरतकणवरोगा उकतााः

इदिीका अ स उ २१ [19]

चतपाराः कणवरोगााः

च स [20]

Page | 15

KARNA

Karna ndash करोतत शबद गरहण [21]

The organ of hearing

Karnasrava- कणवसतय कणवयोाव ससराा [22]

Discharge from the ear is referred as Karnasrava

KARNA SHAREERA

bull Nirukti

कणयवत अकणयवत अनन इती [23]

It means reception and conduction of sound waves

These are the functions of external and middle ear

bull Nirukti of Sravanam

शरयत अनन इती शरणम[24]

It means perception of sound

It can be attributed to the internal ear function

bull Karna Utpatti-

Karna is an organ formed by Akash Mahabhuta[25]

The fundamental characteristic is as follows

Indriya ndash Srotram [26]

Indriya Adhisthan ndash Karna [27]

Indriya Dravy ndash Akasha [28]

Indriya Arth ndashShabdha [29]

Indriya buddhi ndash Srotobyddhi

Page | 16

bull Paryaya of Karna- Shabdapatha Srotrapatha Sravanam shruti

Kuhuram Dwanigraham etc

bull Definition of Karna-

कणवशटकलयनदछिरनमिटिोपगरदहत शरोतरमछयत [30]

मा तन ५७१

The definition of Karna is stated in Madhav Nidanam Indriya which is not

seen with naked eye along with Shashkuli is called Shrotra that is Karna

Indriya is so minute that it is not perceived with any sense organ

In Charak Samhita the word Karna explain as the Indriya Adhisthan of

Shabdha Karna is described as one of the Prathyangas of the body He

emphasizes that all Indriyas manifest during the 3rd month of gestation

period

Acharya Sushruta while describing formation of Purusha from Prakriti or

Avyakta narrated that all Indriyas are developing from the Vikarika and

Taijas Ahankara Both Vagabhata and Sushruta stated that Karna as one of

the Bahirsrotas

शरण नयन दन घराण गदमढराणण न सततरोताशसराणा बदहमवखातन [31]

स शा ५-१०

In Ashtang Hradaya Vagbhata has states that all Indriyas are Atmaja

According to him lower lobule elevated helix projected posterior portion

fleshy and adherent ear are indications of long span of life[32]

ततरखातखातन दह अनदसतमन शरोतर शबद ववकतता [33]

ा शा ३-३

शबदाः शबदनदरिय सवनदछििसमहो ववकतता [34]

स शा १-२६

Page | 17

Ear has the prominence of Akash Mahabhuta The prominent dosha of ear

is Vata It is important seat of Vata The prominent Dhatus are Asthi and

Mamsa Karna is one of the Panchgnanendriyas and it meant for hearing

Sushruta narrated that Karnasthita Asthi and Sandhi

घराणकणवगरीाकषिकोषष तरणातन [35]

सशा ५-२२

शरोतरशरगािकष शखाताव [36]

सशा ५-३२

गडकणवशखटककम [37]

स शा ५-२२

One Sandhi and one Tarunasthi in ear

Sandhi ndash Karna contain two Sandhi one in each ear Type of Sandhi is

Shankhavartha which is present in Shringataka

Mansapeshi ndash 2[38]

Siras ndash 10 [39]

Vataj Sira - 4

Pittaj sira - 2

Kaphaj sira - 2

Raktaj Sira - 2

Avedhya sira-

कणवयोदवश तासा शबदादहनीनामकका पररहरत

सशा ७-२५[40]

Amongst above mentioned ten Siras each Karna lodges one Shabdavaha

Sira It is Avedhya

Page | 18

Dhamani -2

Length of ear is 4 Angula

Karna moola ndash 2 Angula

कणाविरतर चतदवशअगलम

स शा ३५-१४[41]

The distance between two ears through the back of the neck is 14 Angula

bull Marmas of Karna-

1 Vidhuras-

कणवपटठतो अिाःसशरशरत विर ततर बशरियवम

सशा ६-३७[42]

कणतपयादद सतनायममवणी ककनदचचनदरनममनाकर कलयकररणणच

डलहणाचयव[43]

अिसततात कणवयोतनवमन विर शरततहाररणण

ा शा ४-२९[44]

Sankhya-2

Vistara- frac12 Angula

Type- Snayumarma (Susha)

- Dhamanimarma(AH)

- Vaikalykar

Sthana- It is situated in the depressed portion in the back of the ear

Injury to them causes loss of hearing

Page | 19

2 Shringataka marma-

नदजवहाकषिनाशसकाशरोतरखचतटियसरमम

तालरयासतयातन चतपारर सरोतसा तष ममवस

वदि शरगातकाखयष सददसततपयजतत जीवतम

मा तन ५७१ [45]

Sankhya- 4

Type- Siramarma

Sthana- It is in head that is amidst Siras (blood vessels) nursing sense

organ

A palm size area near Talu

Injury to this Marma causes death

In modern anatomy ear divides into Bhayakarna or External ear Mdhyakarn

or Middle ear Antahkarna or Internal ear This is extremely appropriate

Even though the ear is divided into three divisions in the point of modern

anatomy Ayurveda denotes ear organ is one Ayurveda treats disease by

way of assessing Dosha and Dushya Here Dushya is one that is Karnendria

Dosha difference will call for different treatment for different disease Hence

treating the vitiated Dosha will cure the disease irrespective whether it is in

external middle or internal ear The thought is based on different

fundamental principle from Ayurveda

bull Parts of Karna

In Ayurveda classics detailed description about anatomy of ear is not

available But the various parts are mentioned as follows

Bhayakarna- External ear

Mdhyakarna ndash Middle ear

Antahkarna- Internal ear

Page | 20

द कणवशटकशलक दॊ कणवपतरकौ

च शा 7-11[46]

कणवशटकशलक कणवगतातवकौ कणवपतरकौ त बाहयकणा

चिदतत च शा 7-11[47]

शटकली बाहयपालयाशरिटिानम

डलहन- स शरच 25-1 12[48]

Karna Shashkulika ndash It is also called as Karna Shashakuli Charaka has

mentioned this term while describing different Pratyngas of the body

Acharaya Gananatha sen has given the clarification for it as a pinna or

auricle[49]

Karnapali ndash It is popularly known as lobule of the ear Daivakrita Chidra is

present in it

Karnaputrika- Ayurvedic scholars accepted two terms in this cortex They

are Karnaputrika and Karnaputrika The former is considered as Tragus and

antitragus[50]

Karna Prushtha- It can be taken as the cranial surface of mastoid or

auricle[51]

Karnapeetha- Aacharaya Sushruta firstly mention the term Karnapeetha

It is mentioned first by Sushruta while describing the procedure of

Karnavyadana Vagbhata has mentioned that it is Adhobhaga of Karna

Dalhana has clarified that it is the region above the Karnaputrika that is the

region which is at the bottom of the concha

Karnamoola ndash It can be considered as parotid region[52]

Karna lathika ndashAcharaya Dalhana mentioned lobule as a Karna Lathika

Page | 21

Karnaavatu ndashThis term is used by Sushruta while describing the

measurements of different Angapratyangas where he has mentioned that

the distance between the Karnaavatu is 14 Angul Dalhana has comments

that it can be taken as the distance between two ears from behind[53]

Shabdhavahasrotas ndash It also called as Shabdapatha or Srotapatha The

whole passage through which the sound waves pass can be taken as

Shabdavahasrotas[54]

Shrotashringataka ndash It can be taken as the labyrinth of ear[55]

bull Dosha in context to Karna-

Karna is principal location of Vayu

1 Prana Vayu- Prana Vayu circulating in oral cavity is responsible for

Dehadhruka that is keeping all body parts active Indriyadruka that is

keeping all Dnyanendriya healthy by proper nourishment (Purana) helps in

deglutition of food material and convey the stimulation of Indriyabuddhi

and atma

2 Udana Vayu- Bala(strength) Varna speech singing are its function It

is responsible for facial expressions due to pleasure sorrow anger love

frustration etc in general its circulation and actions are just opposite to

Pranavayu

3 Vyana Vayu- Its principal functions are circulation of Rasa and Rakta

through body and various movements Its main location is Hrudaya Five

types of movements for which it is responsible are expansion contraction

upward downward and oblique other activities are opening closure of

eyelid yawning perspiration During circulation if it gets obstructed due

to Srotodushti it generates disease of that Srotas Vyana Vayu gets vitiated

by disease of Rasa Rakta Oja and Chetanadhatu

Page | 22

4 Samana Vayu- It is circulating in the vicinity of stomach and intestine

and helps in keeping the Jatharagni (digestive juices and enzymes) in

equilibrium Disturbance in Jatharagni precipitates disease

5 Tarpaka Kapha- Entire body functions movements are controlled and

executed by various centers in the brain Sensation perceived by sense

organs is conveyed to Mann and Aatma residing in Hrudaya The motor

signals from them are then conveyed to the functioning

organsKarmendriya through Prana Vayu Shira head is therefore a

location of continuous activities motions of Vata All these centers are in

unctuous Majjadhatu in the Shira For stabilizing this ever-active Vata and

to nourish the Majja dhatu very unctuous Tarpaka Kapha situated in Shira

plays an important role

bull Ayurvedic aspect of sound perception [56]

According to Ayurveda Pratyaksha Dnyan or Perception of any sensation

including Shabda occurs due to interaction of the Karnendriya and the

Indriya- Arth -Karma resulting in Sravana

External Environmental acquaintance with living body is executed by five

sense organs namely Netra Karna Nasa Jivha and Twaka All

Dnyanendriya that is sense organ are Panchmahabhautic combination

Despite this fact every Indrya sense organ perceives object Tanmatra of

that Mahabhuta only from which it is originated from Akash Mahabhuta and

hence perceives Shabd only that is audio perception Shrotrendriya is one

of the principal locations of Vata and its function is to perceive Shabda that

is sound waves This sensation is conveyed through Shabdavahi Dhamanis

to Mana and Atma through Pranavayu and the sequence is responsible for

perception of sound in this way external sound is perceived and interpreted

when Atma is linked with Mann Mann is linked with Indriyabuddhi that is

minute virtual Dnyanendriya located in brain Indriyabuddhi is linked with

Adhishthana with prominent Mahabhuta and lastly with Indriya

ArthShabdatanmatra that is sense object Once this sequence is completed

Page | 23

the meaning of a particular sound is interpreted and understood In this

entire process of perception and interpretation of sound waves Pranavayu

and Tarpaka Kapha located in Shira play extremely important role Hence

the healthy status of all the sense organ depends upon the normal

physiologically homeostatic condition of Pranavayu and Tarpaka Kapha

MANAS

ATAMA

BUDDHI

AHANKARA

ARTHA

Page | 24

EAR ANATOMY

bull Embryology of the Ear [57]

1 The sound conducting apparatus develops from the branchial apparatus

whereas the sound perceptive apparatus from the ectodermal otocyst

2 The pinna develops from the six hillocks around the 1st branchial cleft

3 External auditory canal develops from 1st branchial cleft

4 The outpouching of the 1st pharyngeal pouch gives rise to a proximal

narrow part that forms the eustachian tube and distal dilated part that

forms the middle ear cavity

5 Prussakrsquos space is a potential space lateral to the Shrapnellrsquos membrane

and medically by the neck of malleus that can be involved during the

extension of cholesteatoma

6 Development starts in the 3rd week of the intrauterine life and is

completed by 16th week of intrauterine life Membranous and boney

labyrinth develops from the otic capsule

The Ear is divided into

1 External Ear

2 Middle Ear

3 Internal Ear or the labyrinth

Page | 25

Fig 1 Ear Anatomy

EXTERNAL EAR [58]

The outside ear contains pinna and lobule

Pinna is the noticeable piece of outer ear made from single sheet of yellow

flexible ligament covered by subcutaneous tissue and skin It has two

surfaces average and parallel It is intently disciple to perichondrium on its

sidelong surface while it is somewhat free on average surface Pinna

incorporates tragus helix against helix fossa three-sided scaphoid fossa

incisura terminalis

External auditory Canal ndash It extends from the bottom of the conchea to

the tympanic membrane and measures about 24 mm along its posterior

wallit is S shaped

Parts 1 Cartilaginous part

2 Bony part

Page | 26

Cartilaginous part ndash The outer one third is cartilaginous consist of fibro

cartilage is directed first inward backward and upward It has Fissure of

Santorium The skin of this part of the canal contains hair follicles

sebaceous gland and cruminous gland

Bony part ndash The inner two third part is boney It goes forward downward

and medially skin lined in this part is very thin Isthmus is the narrowest

part of the canal lying medial to junction of bony and cartilaginous part

nearly 5 mm lateral to tympanic membrane

The roof and posterior wall of the external auditory canal shorter than floor

and anterior wall The skin lining the tympanic membrane and boney canal

has a self-cleansing property due to migration of keratin layer of epithelium

from drum towards the cartilaginous portion

Relations- Anteriorly- Temporomandibular joint and parotid gland

Superiorly- Middle cranial fossa

Inferiorly- parotid gland

Posterior- Mastoid antrum mastoid air cells and facial nerve

Nerve supply ndashSensory nerve supply of the external ear The auricle

supplied by fibers of the great auricular nerve (C2 and C3) and lesser

occipital nerve (C2) Auriculo temporal branch of the 5th cranial nerve and

auricle branch of the vagus (Arnoldrsquos nerve) supply external canal Facial

nerve has small sensory contribution on posterior-inferior wall

Tympanic Membrane -It is the partition between EAC and middle ear It

is a thin semitranslucent membrane pearly white in colored lying obliquely

in the medial end of EAC with the angle of 55 It is forming major part of

lateral wall of middle ear Annulus tympanicus is attached at its

circumference to the sulcus The TM is oval shape It measures

approximately 10 mm in vertical diameter and 90 mm in horizontal

diameter

Page | 27

Layers ndash Tympanic membrane consist of three layers

1 Outer Epithelium or cuticular layer which is continuous with skin of

external ear

2 Middle fibrous layer has both circular and radial fibers middle layer

missing in upper part

3 Inner layer- Inner mucosal layer which is continuous with middle ear

mucosa

Parts ndash Tympanic membrane consist of two parts

1 Pars tensa -It is largest part below the malleolar folds The inner

surface at the center attached to the handle of malleus Angle of cone

is most illuminated part in the pars tensa at anteroinferior part of pars

tensa

2 Pars flaccida Sharpnells membrane -it is triangular area above the

malleolar folds which are thin and devoid of fibrous tissue and

annulus It fits into notch of Rivinous

Nerve supply 1 Anterior half of lateral surface Auriculotemporal V3

2 Posterior half of lateral surface Auricular branch of vagus cn 10

3 Medial Surface Tympanic branch of CN 9 (Jacobsons nerve)

Fig 2 Tympanic membrane of ear

Page | 28

MIDDLE EAR [59]

The middle ear or tympanic cavity is an irregular laterally compressed

space within the temporal bone It is filled with air that is supplied to you

from the nasal part of the throat through the ear canal It contains a chain

of mobile bones that connect its side with the medial wall and serve to

transmit vibrations transmitted to the eardrum through the cavity to the

inner ear Including the parapet the vertical and anteroposterior diameters

of the cavity are each approximately 15 mm The transverse diameter

measures about 6mm at the top and 4mm at the bottom Compared to the

eardrum it is only about 2mm The eardrum is limited laterally by the

eardrum medially by the lateral wall of the inner ear It communicates

behind with the tympanic antrum and through it with the air cells of the

mastoid and in front with the auditory canal The middle ear together with

the Eustachian tube aditus antral and mastoid air cells is called the

middle ear cleft It is lined by mucus membrane and filled with air

It is divided into 3 parts

1 Mesotympanum (located in front of the pars tensa)

2 Epitympanum or attic (located above the pars tensa but medial to

Sharpnells membrane and the lateral bony wall of the attic)

3 Hypotympanum (located under pars tensa) The middle ear is like a

hexagonal box with a roof

Carotid or Anterior wall- It separates middle ear cavity from internal

carotid artery The various structure passing through anterior wall of

tympanic cavity

bull Canal of chorda tympani nerve

bull Canal of tensor tympani muscle

bull Eustachian tube

bull Anterior malleolar ligament

bull Anterior tympanic artery

Page | 29

Posterior or mastoid wall ndash The upper part of the back wall shows the

opening of the auditorium Below the auditory is a triangular bony

projection known as the pyramidalis processors The stapedial tendon is

transmitted through the apex of the pyramidalis processes The vertical

portion of the facial nerve descends along the posterior wall until it opens

into the stylomastoid foramen

Roof or Tegmental wall (Pars terminalis)- It is formed by a thin bone

plate called the tegman tympanum that separates the skull and tympanic

cavities It is located on the anterior surface of the rocky part of the

temporal bone near the junction with the temporal shell it extends back to

the roof in the tympanic membrane and anteriorly to cover the half canal

of the tensor tympanic muscle The lateral border corresponds to the

remains of the Petro scaly suture

Floor ndash It is formed by a thin plate of bone which separate middle ear from

the bulb of the internal jugular vein lodged in the jugular fossa

Lateral wall ndash It is formed by tympanic membrane and partly by a portion

of squamous part of the temporal bone It separates the middle ear from

external ear

Medial wall- It separates the middle ear from the inner ear

bull The promontory is the most prominent and convex part formed by the

basal rotation of the cochlea

bull The bony lateral semicircular canal is postero-superior to the promontory

above the oval window

bull The oval window is located between the middle ear and the vestibular

slope of the cochlea It is closed by the stirrup footrest and the annular

ligament

Page | 30

bull The round window is located under and behind the cape The round

window recess is directed to the rear It is closed by the secondary eardrum

and separates the middle ear of the Scala tympani from the cochlea

bull The facial nerve passes through the bony fallopian tube above the oval

window

Mastoid Antrum ndash It is a large space with air in the upper part of the

mastoid and communicates with the attic through the aditus The roof is

formed by the antri tegmen which extends and separates the tympani

tegmen from the middle cranial fossa The lateral wall of the antrum is

formed by a bony plate that is on average 15 cm thick in adults It is

marked externally on the surface of the mastoid by the suprameatal triangle

(MacEwen)

Aditus and Antrum- Aditus is a gap through which the attic communicates

with the antrum The boney prominence of the horizontal canal lies on its

medial aspect even as the fossa incudes to thats attaches the quick system

of incus lies laterally Facial nerve publications simply underneath the

aditus

The mastoid and its air cell system-

The mastoid consists of bone cortex with a honeycomb of air cell

underneath Depending on development of air cell three types of mastoids

have been described

1Well-pneumatized or cellular- Mastoid cells are well developed and

intervening septa are thin

2Diploetic- Mastoid consist of marrow spaces and a few air cells

3Sclerotic or acellular ndash There are no cells or marrow spaces

With any type of mastoid pneumatization antrum is always present In

sclerotic mastoids antrum is usually small and the sigmoid sinus is

anteposed

Page | 31

Depending on the location mastoid air cells are divided into

1 Zygomatic cells (In the root of zygoma)

2 Tegman cell (Extending into tegmen tympani)

3 Perisinus cells (overlying the sinus plate)

4 Retrofecial cells (round the facial nerve)

5 Peri labyrinthine cells (located above below and behind the

labyrinthine some of them pass through the arch of superior

semicircular canal These cells may communicate with the petrous

apex)

6 Peritubal (around the Eustachian tube Along with hypotymoanic

cells they also communicate with the petrous apex)

7 Tip cells (which are quite large and lie medial and lateral to the

digastric ridge in the tip of mastoid)

8 Marginal cells (Lying behind the sinus plate and may extend into

the occipital bone)

9 Squamosal cells (Lying in the squamous part of temporal bone)

Development of Mastoid ndash

The mastoid develops from the scaly petrous bone The petrosquamosal

suture may persist in the form of a bone plate - Korners septum which

separates the superficial squamosal cells from the deep rock cells Korners

septum is surgically important because it can cause problems locating the

antrum and deeper cells and thus lead to incomplete removal of the disease

during mastoidectomy The mastoid antrum can only be reached if Korners

septum is removed

Page | 32

Fig 3 Cross section of Mastoid

Contents of the middle ear

Ossicles ndash Three tiny bones which conduct the sound from eardrum to oval

window

Malleus ndash It is the largest and most lateral ossicle measuring 8 mm in

length It has head neck handle anterior and lateral processes The head

is situated in the epitympanum A lateral process project laterally from the

neck while the handle is firmly fixed to the pars tensa of the ear drum

Incus- It has a body short process and long process The body short

process and long process The body articulate with the head of mallelus in

the attic and the short process project into the attic The long process

projects downwards behind the handle of malleus running parallel to it and

articulate with the head of the stapes via the lenticular process

Stapes ndash It is the smallest ossicle measuring about 35 mm and consist of

head neck footplate and anterior and posterior curcura The footplate of

stapes is held to the oval window by the annular ligament

Page | 33

Muscles ndash

1Tensor tympani ndash It is inserted is a branch of the facial nerve which carries

the sense of taste It is first arch muscle supplied by branch of mandibular

nerve V3

2 Stapedious muscles ndash It is inserted to the neck of stapes It is the second

arch muscle supplied by branch of facial nerve that is nerve to stapedius

Fig 4 Contents of the middle ear

Blood supply of Middle Ear

bull Anterior tympanic branch of maxillary artery which supplies tympanic

membrane

bull Stylomastoid branch of posterior auricular artery which supplies middle

ear and mastoid air cells

Page | 34

Four minor vessels are

bull Petrosal branch of middle meningeal artery runs along greater petrosal

nerve

bull Superior tympanic branch of middle meningeal srtery traversing along

the canal for tensor tympanic muscle

bull Branch of artery of pterygoid carotid

bull Tympanic branch of internal carotid

Lymphatic Drainage of Ear

Lymphatics from the middle ear drain into retropharyngeal and parotid

nodes while those of the Surgical Importance ndash Eustachian tube drain into

retropharyngeal group

1 The middle ear is part of contiguous organs including nose nasopharynx

Eustachian tube and mastoid bone lined by respiratory mucosa Any

respiratory infection or allergy is likely to pass to middle is likely to pass to

middle ear

2 Moreover middle ear suppurative disease may spread to adjacent organs

and produce complication eg Labyrinthitis meningitis facial nerve palsy

etc

3 Lenticular process is vulnerable in suppurative ear diseases and causes

ocular disruption

4 Prussac space is the site of primary acquired cholesteatoma

Page | 35

INNER EAR [60]

Inner ear is divided into two parts

1 Bony Labyrinth

2 Membranous labyrinth

Anatomy of bony labyrinth

It is divided into two parts

1 Vestibule

2 Cochlea

3 Semicircular canal

The vestibule is located between the medial wall of the middle ear and the

lateral to internal acoustic meatus anterior to the semicircular canal and

posterior to the cochlea The vestibule is the central part of the inner ear

On its side is the oval window opening which is closed by the bracket foot

plate The bony cochlea is located in front of the vestibule It has 275 turns

wound around a bony axis called a modiolus The cochlea is about 30 mm

long The hollow center of the modiolus is a spiral canal that contains the

fibers and ganglion cells of the cochlear nerve A thin bony sheet the bony

lamina winda around the modiolus This divides the cochlear duct into two

galleries the Scala vestibuli above and the scala tympani below

There are three semicircular canals superior posterior and lateral They

are semicircular in shape and open into the vestibule One end of the

semicircle is enlarged and is known as the sphere

The membranous labyrinth is in the bony labyrinth It is connected to the

bony labyrinth by fibrous trabeculae and is surrounded by perilymph The

endolymph is located in the membranous labyrinth

Page | 36

The utricle is in the upper part of the vestibule while the saccule is found

below Both the utricle and saccule contain a single sensory patch called

the macula Each macula is covered with a neuroepithelium made up of

neuroepithelium made up of sensory hair cells and support cells these cells

are separated by a basement membrane Fibers of the vestibulo-cochlear

nerve enter the macula and pierce the basement membrane to terminate

at the base of the hair cell or cell bodies The utricle and the saccule with

their macula are called otolith organs Membrane semicircular canals are

the membrane canals of the corresponding bony semicircular canals They

open into the utricle through five openings One end of the opening of each

channel is dilated called the sphere in which the sensory organ of each

channel is located The cross section of the Scala standard looks like a right

angle The base is formed by the basilar membrane Sensory cells are

arranged on the surface of the basilar membrane These sensory cells with

their supporting cells form a complex neuroepithelium called the basilar

papilla or the cortical organ named after an Italian microscopist The

organs of the corti have a gelatinous membrane called the tectorial

membrane and they are supported by the pillar of the corti The cortical

pillars enclose a space called the corti tunnel which contains a fluid called

cortical lymph Vestibule is lies between the medial wall of the middle ear

and lateral to internal acoustic meatus anterior to semicircular canal and

posterior to the cochlea Vestibule is the central part of the internal ear On

its lateral surface is the opening of oval window which is closed by the foot

plate of stapes Boney cochlea lies in front of the vestibule It has 275 turns

coiling around boney axis called modiolus Cochlea is approximately 30 mm

in length The hollow center of the modiolus is a spiral canal containing the

fibers and ganglion cells of cochlear nerve A thin boney sheet the osseous

lamina winda around the modiolus This divides the cochlear canal into two

galleries the Scala vestibuli above and the scala tympani below

Page | 37

Semicircular canals are three in number superior posterior and lateral

They are semicircular in shape and opens into the vestibule One of the

ends of the semicircular is enlarged and is known as ampulla

Membranous labyrinth is situated within the boney labyrinth It is connected

to the bony labyrinth by fibrous trabeculae and is surrounded by perilymph

Endolymph is situated within the membranous labyrinth

The utricle lies in the upper part of the vestibule while the saccule lies below

Utricle and saccule both contain single sensory patch called macula Each

macula is covered by neuroepithelium consist of Neuroepithelium consists

of sensory hair cells and supporting cells these cells are separated by

basement membrane Fibers from the vestibulo cochlear nerve enter the

macula and pierce the basement membrane to end either at the base of the

hair cell or cell bodies The utricle and saccule with their macula are referred

to as otolith organs Membranous semicircular ducts are the membranous

ducts in the corresponding bony semicircular canals They open into the

utricle by five openings One end of the opening of each canal is dilated

called ampulla in which the sensory organ of each canal is located The

cross section of Scala media resembles a right angle Its base is formed by

basilar membrane Upon the surface of the basilar membrane the sensory

cells are arranged These sensory cells with their supporting cells form a

complex neuroepithelium called the basilar papilla or Organ of corti named

after an Italian Microscopist Organ of corti has a gelatinous membrane

called tectorial membrane and they are supported by pillar of corti The

pillars of corti enclose a space called tunnel of corti which contains fluid

called corti lymph

Page | 38

Fig 5 Inner Ear

Blood supply of labyrinth

Labyrinthine artery

Common cochlear Anterior vestibular Artery

Vestibulocochlear artery Main cochlear artery

Cochlear branch posterior vestibular artery

Page | 39

PHYSIOLOGY OF HEARING [61]

A sound signal in the environment is collected by the pinna passes through

external auditory canal and strikes the tympanic membrane Vibrations of

the tympanic membrane are transmitted to stapes footplate through a chain

of ossicles coupled to the tympanic membrane Movements of stapes foot

plate cause pressure changes in labyrinthine fluids which move the basilar

membrane This stimulates the hair cells of the Organ of corti It is these

hair cells which act as transducers and convert mechanical energy to

electrical impulses which travel along the auditory nerve

Thus the mechanism of hearing can be broadly divided into

bull Mechanical conduction of sound (conductive apparatus)

bull Transduction of mechanical energy to electrical impulses (sensory

system of cochlea)

bull Conduction of electrical impulses to brain (neural

Fig 6 PHYSIOLOGY OF HEARING

Page | 40

Conduction of sound

Under the surface of water we cannot hear the sound made in air because

9995 of sound energy are reflected away from the surface of water because

of the impedance offered by it A similar situation exists in the ear when

air-conducted sound must travel to cochlear fluids Nature has

compensated for this loss of sound energy by interposing the middle ear

which converts sound of greater amplitude but lesser force to that of lesser

amplitude and greater force This function of middle ear is called impedance

matching mechanism or the transformer action It is accompanied by

a) Lever action of the ossicles

Handle of malleus is 13 times longer than long process of incus providing

a mechanical advantage of 13

b) Hydraulic action of tympanic membrane

The area of tympanic membrane is much larger than the area of stapes foot

plate the average ratio between the two beings 211 As the effective

vibratory area of the tympanic membrane is only two- thirds the effective

areal ratio is reduced to 141 and this is the mechanical advantage

provided by the tympanic membrane

c) curved membrane effect

Movements of tympanic membrane are more at the periphery than at the

center where handle of malleus is attached This too provides some

leverage

Transduction of mechanical energy to electrical impulses

Movements of stapes footplate transmitted to cochlear fluids move the

basilar membrane setting up shearing force between the tectorial

membrane and hair cells The distraction of hair cells gives rise to cochlear

microphonics which triggers the nerve impulse

Page | 41

Neural pathways

Hair cells get innervation from bipolar cells of spiral ganglion Central axons

of these cells collect to form cochlear nerve which goes to ventral and dorsal

cochlear nuclei From there both crossed and uncrossed fibers travel to

superior olivary nucleus lateral lemniscus inferior colliculus and medial

geniculate body and finally reach the auditory cortex of the temporal lobe

Page | 42

DISEASES REVIEW

करणसराव

Nirukti - करणसय कणवयोाव ससराा [62]

Nidana- Acharya Sushruta and Vagbhata describe the common etiological

factors for the Karnaroga

अशयाय जलिीडा कणवकणडयन मरत

शमथययोगन शसततरसतय कवपतो अरय च कोपन ||

सउ २० १२

1 Avashaya or Pratishaya

(Excessive exposure to cold)

2 Jalakrida

(Excessive swimming)

3 Karnakandunyanum

(Excessive scracing due to itching)

4 Mithyayogena Shatrasya

(Improper instrumentation during wax removal or foreign body removal)

5Shabdasya

(Louder sound for long durationperverted contact of sound)

6 Abhighata (Trauma)

7 Vitiation of Tridoshas

Page | 43

Samanya Nidana according to different Samhita

Vishesh Nidan of Karnasrava

Acharya Charaka has not mentioned any kind of Nidana regarding Karnaroga

but has described Utapati of Karnaroga from Siroroga in Karnasirasym

Adhyaya[67]

शशरोअशिघातादरा तनमजजतो जल परपकादरा अवप विि

सरतत पय शरणॊ अतनलात स कणवससरा इतत परककतीत

सउ २० १०

असस ३७२५ [68]

1 Shiroabhighatat - Head Injury-Fracture of middle cranial fossa

2 Jala nimajjana - CSF otorrhoea fracture of middle cranial fossa

3 Karnaprapaka

4 Karna Vidhradhi -Puyasrava

Sr

no

Samanya Nidana SU AH[63] AS[64] YR[65] MN[66]

1 Avashaya + + +

2 Pratishaya + +

3 Shabdha

mithyayoga

+

4 Shashtra

mithyayoga

+ + +

5 Karnakandooyan + + + + +

6 Jalkrida + + + + +

7 Abhighata + + +

Page | 44

Samanya samprapti

परापय शरोतरशसरा कयावत शल शरोतशस गान

त कणवगता रोगा अटिावशततरीता

सउ २० १२

Due to common and specific etiology factors the vitiated Doshas gets

Sthanasamshraya in Karna and causes Karnasrava It is the stages of

Samprapti were Doshas gets lodged in Srotas and start processes of Dosh

Dushya Sammurchsna Due to Shiroabhighata Jalanimmajana Karna Paka

Karna Vidhradi vitiated Vata Dosha and Karna becomes Avruta by Vata and

results in Karnasrava Normal physiology of Dosha Dhatus and Malas entirely

depends on the normality of Srotas Dosh Dushya Sammurchana or

manifestation of diseases will not take place if only vitiation of Doshas take

place without deformity of Srotas Here in Karnasrava vitiation of Srotas are

Atipravritti Sanga and Vimargagamana take place Atipravritti is being excess

production of fungus Sanga is obstruction in external acoustic canal

Vimargagamana is the propagation of discharge through ear

Vishesh Samprapti

Karnasrava occurs due to Nij nidana is Pratishaya while Agantuja nidanas are

Avashya Jalkrida and Karnakanduyan Due to etiological factors which are

Vata-Kapha provocative in nature gradual vitiation of Doshas will occur After

vitiation they get accumulated (Sthan samshraya) in external auditory canal

In other hand when patient does Sevana of Agantuj Nidan like water enter in

external ear scratching of ear unsterile instrumentation leads to Dosh

Prakopa These cause Twak and Mamsa Dhatu Dushti which leads to

discontinuity of epithelium of ear canal which creates suitable atmosphere for

fungal pathogen to grow The vitiated Vata will produce symptoms such as

Page | 45

pain hearing impairment and vitiated Kapha causes symptoms like itching

discharge ear blockage By assessing the symptoms it can be said that Kapha

Avrita Vata Dosha is responsible for the manifestation of clinical features like

pain itching discharge Which are seen in Karnasrava that is otomycosis

Acharya Charaka has mentioned while explaining Samanya Chikitsa of

Karnaroga that it should be treated like Vrana when Paka and Srava is present

as a symptom Fungal spores invade in the epithelial layer of EAC In response

to infection inflammatory process is start This is a Paka Avastha After

removing the fungal mass ulceration in external acoustic canal is commonly

seen As a result of infection process exudates was produced which will mix

up- with fungal colonies and appear as discharge As per Dosha involvement

in Vrana Shoola Srava can be differ According to Acharya Sushruta Ruk is

the Samanya Lakshana of Vrana and Vishesha Lakshana of Vrana includes

pain discharge discoloration itching etc according to Dosha involvement

which are also seen in otomycosis In otomycosis mainly watery and purulent

type of discharge is present which indicates Paka avastha If there is Dosha

involve in Vrana is called Dushta Vrana Acharya Sushruta and Acharya

Vagabhata have mentioned verity of Srava in Twak and Mamsa Vranavastu

which is found in otomycosis Based on this description otomycosis can be

correlated with Karnasrava

Page | 46

Representing the Samprapti of Karnasrava

Vishesh Nidana ndash Shiroabhighatat

Jala nimajjana

Prapaka Vidhradhi

Vitited vata

Avarana by kapha

Vimargagamana of Vata

Karnasrava

Samprapti Ghataka

Dosha ndash Kapha and Vata

Dushya ndash Rasa Rakta and Mansa

Strotodushti ndash Vimargagamana and Sang

Adhishthana ndash Karna (Bhayakarna)

Rogmarga ndash Madhyama

Page | 47

Purvarupa

The Purvarupa of Karnasrava are not mentioned separately in any ayurvedic

classics In routine practice cretin Purvarupa are noted

1 Karnakandu

2 Karnagurutwa

3 Alpa karnashoola

4 Discomfort in ear

Rupa

1 Karnashoola

2 Karnakandu

3 Karnasrava

4 karnabadhirya

5 Cotton wool like or wet newspaper like grayish brown or black colored mass

is seen

6 External auditory canal skin appears edematous and red

Upashaya and Anupashaya

Appropriate application of Aushadhi Ahara and Vihara when produces relief in

the symptom is called as Upashaya and when aggravates the symptoms is

called Anaupashaya There is not any reference available in the classics about

the Upashaya and Anupashaya of karnasrava

Sadhyasadhyata

Sushruta has not mentioned specially the Sadhyasadhyata of Karnarogas But

Vagbhata has mentioned Karnasrava as a Sadhyavyadhi[69]

Sadhysadhyatagives the clear picture of prognosis of the disease It depends

on many factors like nature of disease severity of disease Vaya Prakriti Bala

of the patient etc

Page | 48

Upadrava of Karnasrava

In Samhita there is no reference available regarding the Upadrava of

Karnasrava

Samanya Chikitsa ndash

The common treatment principle for all Karnaroga is Ghritapana Use of

Rasayana Bhrahmacharya Avyayama Shirasnana and Atibhashaya

सामरय कणवरोगष घतपान रसयनम

अवयायमो शशराःसतनान बरमहचयवम कतपरनम

स उ२१३

Ghratapana - Ghrita is a Yogavahi and follow Sanskara in addition to these

acquired properties and capable of retaining its own properties So Ghritapana

is effective in Karnasrava

Rasayana - Rasayana represent the basic approach of Ayurveda which

comprise preventive promotive and curative aspect of health

Brahmacharyaapalana -It is like Sadvrittapalana and is equals to Rasayana

effect

Vyayama - It leads to vitiation if Vatas a Karna is a Sthana of vata and

exercise causes Kshayaj Samprapti hence it is important to avoid exercise in

Karnasrava

Shirasnana- In Shirasnana water enters in external acoustic canal it changes

the PH of meatus skin from acid to alkali which favors the growth of pathogens

Atibhashya - Excessive speaking causes Vata Prakopa and Vatapraokopa is

basic Samprapti for Karnasrava as the preventive aspect avoidance of

excessive speaking is necessary

Page | 49

Ghritapana Rasayana and Brahmacharyapalana should be followed for

preservation of dhatu Samyata and restriction of vitiation of Vata Vayayama

Shirasnana and Atibhashaya should be avoided in Karnasrava to protect the

Siras from the affliction of Vata and Kapha

Vishesha Chikitsa ndash

The general treatment principle of Karnasrava described in classics is closely

related to Dushtavrana Chikitsa

शशरोवरचन च ए िपन परण तरा

परमाजवन िान च ीकषय ीकषय़ाचारत [70]

स उ २१४०

कणवसततरा ोददत कयावत पततकशमकणवयो [71]

ाउ १८३५

उपददि च सततरोत साय परात वपचततवशि परमजय

य अगर मदन सघत गगलना ा िपतयतपा मिना परयत [72]

असउ २२४२४३

In addition to that Shirovirechana Karnadhoopana Karnapurana

karnapramarjana Karnadhavana are also indicated

Page | 50

Treatment is also mentioned for Karnasrava

1 Karnaprakshalana Yoga - with Aargawadadi Gana Kashaya and Surasadi

Gana Kashaya [73]

2 Avachurnana Yoga ndash with Aargawadadi Gana Churna and Surasadi Gana

Churna[74]

3 Karnapoorna Yoga ndash

bull Rasanjana Laksha with Sarjachoorna[75]

bull Panchkashaya with Kapittha swarasa and Madhu[76]

bull Jambu AmrapallavShivalaKshuodra Mahavriksha and Madhuki all are

taken in equal quantity and Kalka is prepared and 4 times Taila is taken

and 16 parts of Kwatha is added and Taila Paka is done[77]

bull Sarjatwak Choorna with Karpashiphalarasa and Madhu[78]

bull Abhaya LodraTindukaSamanga(Manjista) Kwatha of this Dravyas mixed

with Madhu and Kapittha Rasa[79]

bull Yogratnakara mention the following drugs for Karnapoorana-

a Samudraphena Churna[80]

b Jambwambpatra Yoga

4 Karnadhoopana Yoga ndash

bull Dhoopana with Churna of Bilvapatra Haridra Palandu[81]

bull Vartak Dhoopana [82]

5 Internal Medications-

bull Rasnadi Guggula [83]

bull Triphala Guggula [84]

bull Sarivadi Vati [85]

bull Gandhaka Rasayana [86]

Page | 51

According to Vagbhata-

Ear should be cleaned with the Pichu and Varti followed by Guggula Dhoopana

and then Karnapoorana with Madhu Followed by Avachurnanana with

Sukshmachootana of Surasadigana

Pathyaapathya ndash Pathya and Apathy mentioned for Samanya Karnaroga is

recommended in Karnasrava also

पथय[87]

सतदो वरको मन नसतय िमाः शशरावयिाः

गोिमाः शालयो मदगााः याशच परतन हवाः 80

लाो मयरो हररणानदसततततरो नकककिाः

पिोल शशगर ातावक सतनषराण कदठललकम

रसायनातन सवणण बरमहचयवमिाषणाम |

उपयकत यरादोषशमद कणावमय दहतम ||81||

िापर २१

Aharaja Upacharaja

bull Godhuma bull Vamana

bull Shala bull Virechana

bull Mudga bull Nasya

bull Yava bull Dhoomapana

bull Puranagitra bull Kavala

bull Lava Harina Tittiramamsa

Page | 52

अपथय[88]

दरत काटठ शशरसतनान वययाम शलटमल गर

कणडयन तषारशच कणवरोगी पररतपयजत

िापर २१

Viharaja

bull Patola ShigruVartaka bull Bhramacharaya

bull Sunishannaka bull Avyayama

bull Katthlika bull Aakthanam

bull All types of Rasayana bull Upacharaja

bull Vamana

Apathyas

bull Abhishyandakara Aharas

bull Shirasnana

bull Karna kandooyana

bull Tushara sevana

bull Guru Kaphakaraka Aaharas

bull Dantdhavana

Page | 53

OTOMYCOSIS

Definition-

Otomycosis is a superficial acute sub-acute or chronic infection of external

ear canal It is mostly unilateral It is characterized by inflammation purities

and scaling Otomycosis is a common condition encountered in ENT practice

more in chronic and persistent ear infection

The Fungal infections are not communicable in the usual sense but the

humans become an accidental host by their introduction into tissue trauma

The virulence factors favoring colonization of fungus in human host are yet to

be identified Ability of the fungus to grow at 37 C and elaboration of a variety

of enzymes and toxins are speculated to contribute to virulence Only 100 to

150 species are generally recognized as a cause of disease in humans[89]

Prevalence-

Otomycosis is a word wide in distribution and in various record stated that 5

to 20 of all cases of infective otitis externa Otomycosis prevalent is more in

warm and humid climates It is one of the commonest manifestations in India

during rainy season It occurs mostly in humid atmosphere otitis externa due

to fungal infection may resembles the desquamative form of diffuse infective

otitis externa The incidence in temperature climates has increased in

proportion to the use of topical antibiotics which have a medium sterilized of

other organism in which the fungus may flourish

Page | 54

Predisposing factors- [90]

1 Environmental factors such as climate contagious and polluting hygiene

more frequently during rainy season as the humidity increases

2 Individual susceptibility ndashGeneral Immunological status of the Individual

eg HIV infection Radiotherapy chemotherapy Diabetes mellitus

3 Self-inflicted trauma that is use of pins to clean the itching ear or use of ear

bud to clean the wax

4 Wide spread of topical antibiotics steroid preparations which have medium

sterilized of other organism in which the fungus may grow

5 Failure of defense mechanism in External auditory canal

6 During swimming or head bath water enters in External acoustic canal

causes quantitative and qualitative change in ear wax It causes change in pH

7 Long term use of hearing aids

Pathophysiology ndash

The life cycle of the average mold encountered in the ear may be reckoned

as two weeks and flare ups may be anticipated at such intervals Swimming is

held responsible for infection in many cases The sequence sequence of

pathogenic changes produced by molds in the external ear is as follows ndash

1 Implantation of the organism in external ear

2 Growth of organism follows the rate depending on condition of temperature

moisture or preexisting irritation

3 Invasion of epithelium occurs with attendant itching and discomfort which

may be quite severe

Page | 55

4 Exfoliation of epithelium occurs as nature attempts to overcome the

infection by casting off upper most cells

5 Denudation occurs from exfoliation as the top layers of epithelium are cast

off and the canal becomes filled with debris

6 Superficial ulceration and lizematoid dermatitis results if the pathologic

process goes for enough The changes do not always proceed through the

entire sequence sometimes the molds produce changes of the mildest

imaginable character which may be overlooked[91]

Clinical features -

Symptoms-

1 Irritation and itching ndash Irritation is mostly found when the infective

organism is aspergillus niger There is sensation of discomfort which is more

diffuse in the ear canal then localized in the deeper part Candida infection

causes marked itching In external ear it is intense and worse at night

2 Discharge through ear- Intermittent scanty colorless discharge through

ear Mucus being a fungal metabolic product appears as discharge Excessive

discharge is associated with mixed infection

3 Pain and discomfort ndash Mild to severe pain in the ear occasionally Mostly

seen in cases where ear is infected with Aspergillus flavus mixed infection

with gram negative organism or mixed infection with candida and aspergillus

Headache is sometimes associated with pain

4 Deafness- Varying degree of mild to moderate conductive deafness

5 A sensation of fullness in ear

6 Tinnitus 7 Vertigo

Page | 56

Signs ndash

1 The external acoustic meatus may contain a mass formed of epithelial

debris exudates cerumen and fungus

2 Erythematous external canal

Fungal appearance

A Niger - The color of the mass which is usually grey or black is mainly

determined by the type of fungus concerned Its appearance is like wet

newspaper or blotting paper or a cotton wool It has a peculiar musty odor In

this infection fruiting heads may be seen as black specks in the debris

Occasionally as inactive form occurs in which the canal is lined by mold giving

a fluffy appearance due to the presence of tiny mycelia

Candida ndash Candida infections generally show as white deposits on magenta

colored skin when the debris is removed it rapidly recovers in 24 hrs

The underlying canal skin is often inflamed and granular due to invasion by

fungal mycelia and be seen in all cases In rare cases excoriation and

ulceration with marked extensive shedding of the epithelium and deep

ulceration can be seen usually associated with a flavus and with pathogenic

bacteria[92]

Otoscope Appearance

1 Aspergillus Niger ndash Black headed

2 Aspergillus Fumigators ndash pale blue or green

3 Candida Albicans ndash White- or cream-colored deposits

Page | 57

4 Auricle is normal in most cases In severe cases small ulceration with crust

formation may be present on lateral surface

5 Tympanic Membrane

In most cases it is normal with normal mobility and normal hearing In a few

cases the surface of the tympanic membrane is congested and scaly There is

erosion or ulceration of the external epithelial layer and the membrane itself

may be edematous

Diagnosis

1 Above mentioned symptoms and signs

2 In the stage at which patient with otitis externa usually first present

themselves mycelia threads conidiophors not visible to naked eye may

sometimes be identified with the microscope

3 Confirmed by culture

Page | 58

Fig7 Aspergillus Niger Fig8 Candida Albicans

Fig9 Aspergillus Fumigators Fig 10 Wet Paper like appearance

Page | 59

Treatment

1 Antibiotic or steroid drops should be discontinued if they are being instilled

since long time

2 Removal of fungal mass epithelial debris and discharge from the external

canal or mastoid cavity repeatedly and thoroughly by forcepa or suction or

syringing or cautiously blow a stream of air into the canal through a fine

cannula and dry thoroughly by swabbing liquid petroleum on swab used in

cleaning the ear lessens the burning sensation when metacresy acetate is to

be employed in the subsequent treatment

Furuncle is developed as a complication if there is no gentleness in cleaning

Cleansing may have to be delayed until local sensitiveness is lessened which

can usually be accomplished within twenty-four hours If there is excessive

epithelial debris along with otomycosis then metacresyl acetate which is a

keratolytic in introduction into the external auditory canal on cotton wick and

is allowed to remain for twenty-four hours After twenty-four hours the cotton

wick is removed at which time the canal can usually be cleansed with little

discomfort as the medication is also anesthetic The epithelium of the canal

was white from contact with the drug The top layer was detached and this

epithelial debris can be easily wiped away The wick is reinserted and wet with

metacresyl acetate

The treatment is employed for three to four days in succession and then a

bland application is substituted Icthyol iodine is of value at this stage Iodine

ointment 2 in combination with Tannic acid 2 is also an excellent local

application following cresatin treatment

Next one of the fungicides may be applied

Page | 60

1 Nystin Effective for candida infection but less active against aspergillus

group Nystatin in boric powder consisting of 100000units of nystatingm of

powder 3 times week for 3 weeks

2 Clotrimazole Available as 11 cream or drops or lotions Phenyl

(zchlorophenyl) 1 ndash imidazole ndash methane is a chlorinated trityl imidazol 1

effective against candida and dermatophytes and for aspergilli infection

3 Amphotericin B Available as cream and as 3 solution and 015 drops

for topical application Very effective for candida infection can be fungistatic

or fungicidal

4 Econazole Available as solution (Econazole nitrate) and as cream (1)

Broad spectrum ndash more effective for Aspergillus Also active against some

gram-positive bacteria (Staphylococci and Streptococci and Dermatophytes)

5 Miconazole Highly effective against dermatophytes and candida infections

used as a 21 cream applied once or twice a day for 10 days

6 Gentian violet 21 Available as drops (recently some evidence of

carcinogenicity) Discolors the ear canal and this interfere with clinical

examination

Other topical antifungal agents are ketoconazole Natamycin Tolciclat Bifonas

zole Fenticonzole Oxiconazole Tioconazole ciclopiroxolomine Tolnafate

Haloprogin Flucytosine Acetic acid Whit field ointment selenium sulfide

undcyclenic acid triacetin etc

Page | 61

Minimal length of treatment

A month of drug treatment is usually required because the antifungal agents

used are not sporicidal and it is necessary that the period of treatment covers

germination time It may be advisable to give short gaps in the period of

treatment to ensure all spores have germinated before deciding to terminate

therapy

Prevention

Accomplished by strict attention to the predisposing causes

1 Water should be prevented from entering the ear

2 Avoidance of external ear trauma

3 Use of alcohol medicated or plain in the ears after swimming mercuric

cyanide (15000) in ethyl alcohol (70) is a satisfactory liquid to use

Ear stoppers do no good unless their use is followed by some antiseptic in the

canal Divers exposed to water for long periods of time may also use acidic

alcohol

4 During Summer months with their high humidity special efforts are needed

to maintain ear dry 5 Indiscriminate use of topical antibiotics steroid

preparations should be avoided

Page | 62

DRUG REVIEW

1 GUGGULA

Fig11 - Guggula

Historical review of Guggula [93]

bull Atharvaveda one of the well-known Vedas of Hindus The earliest

reference given by Atharvaveda medicinal and therapeutic properties of

Guggula Guggula has long history of use in Ayurveda

bull Acharya Charaka Sushruta and Vagbhata describe detail regarding the

actions uses and indication as well as the variety of Guggula

Page | 63

bull Various Nighantus (Medical lexicons) were written between 12th and 14th

centuries AD was based on the Ayurvedic literature also describes

Guggula

bull The explanation of word Guggula is that Gunjo Vyadhegurdti Rakshati

which means to relief against different diseases

bull Guggula is the best medicine because it develops through the rays of

hot sun on specific circumstances

bull Guggula has an aromatic odor

गगलो कणवदौगवररधय िपन शरटठमछयत[94]

स उ २२११२

Latin name- Commiphora mukul

Family ndash Burseraceae

Rasa- Tikta Katu

Guna ndash Laghu Rukshasukshma vishada sara

Veerya ndash Ushna

Vipaka ndash Katu

Action- Rasayana Lekhana

Doshaghanta - Tridoshhara

Page | 64

Chemical composition [95]

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Oleoresin-Z-Guggulsterone E-Guggulsterone

Gum- guggulignans 1 and 2 guggula Tetrols mukulol allylcembrol c

27

Guggulusterol 1 2 ans 3 Z and E ndash guggulusterol

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Parts Used ndash Gum oleoresin

Guggula purity test

1 Yellowish brown emulsion is obtained when Guggula is triturated with

water

2 An ethereal solution of the drug attains reddish colour when treated

with br2 vapors and purple colour when moistened with nitric acid

Biochemical action ndash Antiseptic Anti-inflammatory Disinfectant Diuretic

Immunostimulant stimulating expectorant Ant suppurative Antipyretic

Enhance phagocytosis

Karma- Rasayana cardiovascular disease

Page | 65

2 AGARU-

Fig 12 Agaru

Historical review of Agaru [96]

bull The word Agaru literally means the one which is the heaviest and no

aromatic wood is heavier than it Since thousands of years Agaru lsquoThe

wood of Godrsquo has been used for multiple purpose like commercial

medicinal spiritual aromatic historical

bull The medicinal use of Agaru have been recorded in many pieces of India

Greek Roman Chinese Middle eastern and European since ancient times

bull Acharya Charaka used Agaru and pest of Rasna to counteract the effect of

cold in Agraya Dravyas

bull Acharya Sushruta used Agaru as a Dhoopana Dravya along with Guggula

Ral and Shoma in the treatment of Karnasweda and Vrana

Page | 66

Types-

bull Dhanwantsri Nighantu describes Kaleyaka as a type of Agaru

bull Sodhala Nighantu describes three types of Agaru ndash Agaru Krishna

Agaru Kakatunda Agaru

bull Raj Nighantu describes five types of Agaru ndash Krishna Agaru Kasht

Agaru Daha Agaru Mangalya Agaru and Agurusaar

bull Arthashasstra describes three Agaru wood product

1 Jongaka ndash Black or variegated black in colour and having variegated

spots

2 Dongaka ndash Black in color

3 Parasamudraka- Black in colour and smells like Navamallika

अगर उटण कि तपछय ततकत ततकषण च वपततलम

लघ कणाविरोगघन शीत ात कफपरणत

िापर २१ [97]

Family- Thymelaccensis

Latin name- Aquilaria agallocha

Guna- Laghu Ruksha Tikshan

Rasa- Katu Tikta

Vipaka ndash Katu

Virya ndash Ushna

Karma- Sheetaprasasmana Vranaorasadan Tvachya Pittavardhaka

Shirovirechana Mangalya Sugandhik and Rochaka in properties [100]

Krishna Agaru karma- Katu Tikta rasa Ushna Sheeta when applied externally

and Pittahara when taken orally

Page | 67

Chemical Constituents -

Agaru hardwood is rich in essential oil resins alkaloids saponins Steroids

terpenoids tannins flavonoids and phenolic compound Agaru wood

predominantly contains 2-[-2-phenylethy]-4H-chromen-4-one derivatives and

sesquiterpenes Agaru oil contains selinene dihydroselinene agarnol b-

agarofuran vetispira-2(11)valerianol dihydrokaranone and tetradecanoic

acids[99]

Part Used ndash

Heartwood- Dark resinous wood which is formed when the plant becomes

infected with a type of fungus (ascomycetous mold) Species of Aspergillus

fusarium and penicillium are reported to be associated with the development

of infection Prior to infection the heartwood is odorless relatively light and

pale colored however as the infection progresses the tree produces a dark

aromatic resin in the heartwood The infected resin in response to the attack

which results in accumulation of a very dense dark resin in the heartwood

The infected resin embedded wood is known as Agarwood Infection is more

common on the trunk roots and the area when branches divide The formation

of Agarwood starts when the tree attains the age of 20 years On an average

approximately 30 ml oil is extracted from 100 kg of infected Agarwood[98]

Qualities of best Agaru-

It should be black in color

It should be extremely heavy and aromatic

It should be oily in appearance and test

It should be sink in water

It should burn easily with bright flame with a bright flame giving off a pleasant

smell

Page | 68

3 MADANA

Fig 13 MADANA

Madana consist of dried fruit of Xeromphis spinosa It is a deciduous thorny

shrub or a small tree reaching a high up to 9 m and girth about a meter

branches numerous thick and horizontal found in sub-Himalayan tracts[101]

मदनो मिरनदसततकतो ीयोटणो लखनो लघ

ानदरतिदवििीहर परततशयायवरणारतक

रि कटठकफ़ानाहशोथगलमवरणापह[102]

िा पर १६० १६1

Page | 69

Latin name-Randia dumetorum

Familly ndash Rubiaceae

Rasa - Madhura Tikta

Guna-Laghu Ruksha

Virya- Ushna

Vipaka ndash Katu

Karma- Vamana and Lekhana

Chemical Composition-

Essential Oil Valerianic acid Saponin tannin resin [103]

Page | 70

YAWA [104]

Fig 14 Yawa

1 In Samhitakala Aacharya Charaka Acharya Sushruta explain detail about

medicinal properties of Yawa

2The use of Yawa in Aaharya Dravya mainly described by Dhanwantari

Nighantu Raj Nighantu Bhavprakash Nighantu[105]

Macroscopic Description-

Fruit a caryopsis elliptical oblong Ovoid and tapering at both ends smooth

about 1cm long and 02- 03cm wide dorsally compressed and flattened on

the sides with a shallow longitudinal furrow 3-5 ridges having shallow

depression between them grains tightly enclosed and adhering the lemma

and palea pale greenish yellow odor not distinct taste sweetish acrid

Page | 71

Latin Name ndash Hordenum vulgare

Family- Poaceae

Rasa- Kashaya Madhura

Virya- Sita

Vipaka- Katu

Karma- Vatakrt Pittahara Kaphahara Medahara Balya Visrya

SthairyakaraLekhana

Page | 72

PROCEDURE REVIEW [105]

In Ayurvedic classics there are many references regarding Dhoopana Dravya

Dhoopana is administering Dhuma with the help of Dhoopana Dravya

In Kashyapa Samhita there are 40 types of Dhoopana advised for children

Anesthesia (Mohajananam Dhoopa) is also mentioned For this Dhoopana the

drug used were herbs hairs of animals legs horns old cloths of Buddhist

monks

From the references available regarding Dhoopana we can understand that

Karna can be protected from maggots (krimi) Bactria (Rakshogna) lice etc

References clearly indicate the analgesic and disinfectant effect of Dhoopana

Karma Dhoopana is mentioned for Dushta Vrana Chikitsa It reduces Vedana

Srava Pootigandha of Dushtavrana It also helps in Vranaropana

Dushtavrana Chikitsa is mentioned in the treatment of Karnasrava[106]

Origin of Dhoopana-

In ancient period children of sages were constantly harassed by the

Rakshasas Hence the sages approached lord Agni for shelter Agni in turn

gave them Dhoopana Dravya and asked sages to use the Dhoopana for

protection against Rakshasas bhutas pishachas

Classification of Dhoopana

1 It is classified into Dhupa Anudhupa Pratidhupa

2 On the basis of Origin it is classified into Jangama and Sthavara

Selection of Guggula for Dhoopana

Page | 73

bull Guggul is a best Vatahara

bull It is Krimighana

bull It contains Oleoresin

bull In Ashtang Hrudaya Guggula Dhoopana mentioned for Karnasrava

Selection of Agaru for Dhoopana

bull Agaru is Laghu Ruksha Katu Tikshna

bull Vranaorasadan Tvachya

bull It should burn easily with bright flame with a bright flame giving off a

pleasant smell

Karna Dhoopana Indication

1 Karnaarava

2 Putikarna

3 Krimikarna

4Vataj Karnashula

Contraindications

Especially for Karnadhoopan contraindication is not mentioned in classic texts

But Dhoopana is contraindicated in Pittaj vaydhi Sharad and Grishma Rutu

Page | 74

MATERIAL AND METHOD

Page | 75

For randomize comparative clinical trial to study the effect of Agaruwadi

Karnadhoopana and Guggula Karnadhoopana in Karnasrava following material

and method were required

Source of data

Patient irrespective of gender occupation religion social economic status

signs and symptoms of classical features of Karnasrava (Otomycosis) selected

from the OPD of Shalakyatantra department

Materials ndash

1Patients

2 Drugs-Agaruwadi Dhoopana

Guggula Dhoopana

3Torch

4Otoscope

5 Tuning fork

6Jobson horn probe

7Cotton

8Case record form

DRUG

Group A Trial Group

1Churana of Agaru Yawa Madan

2Ghrita

3Jala

Group B Control Group

1Googula Churna

Page | 76

Properties of Drug

Table no 1 Properties of Drug

Drug

Family

Rasa Veerya Vipaka Effect

on

Dosha

Guna Karma

Agaru

(Aquilegria

Agallocha)

Thymelaca

ceae

Katu

Tikta

Ushna Katu KV Laghu

Ruksha

Tikshna

Shitaprashamana

Shothahara

Vedanasthapak

Durghandhihara

Madan

(Randia

spinosa)

Rubiaceace

Kashaya

Madhur

Tikat

Katu

Ushna Katu KV Ruksha

Laghu

Vatakaphaghana

Shothahara

Vedanasthapak

Vranashodhak

Yawa

Poaceae

Hordeum

Vulgare

Kashaya

Madhur

Sheeta Madhur KP Ruksha

Laghu

Vataghana

Vernashodhana

Raktshodhaka

Guggula

Commiphora

Mukul

Burseracea

e

Tikta

Kashaya

Anushna Katu VPK Laghu

Ruksha

Shothahara

Vedanasthapaka

Kandughna

Ghrita Madhura Sheet Madhur VK Snigdha Vataghana

Shothahara

Vedanasthapaka

Page | 77

METHODOLOGY

SELECTION CRITERIA

1)INCLUSION CRITERIA

1 Patients having signs and symptoms of Karnasrava (Otomycosis) ie करणशल

( pain ) करणकणड ( Itching ) करणसतराव ( Discharge )बाधिरण ( conductive Loss of

hearing )

2 Patient from age group 19 to 70 years

3 Any Gender

2)EXCLUSION CRITERIA

1 Patients suffering from any systemic disease like DM TB HTN

2 Chronic suppurative otitis media (CSOM)

3 Acute supportive otitis media (ASOM)

3 Perforation of Tympanic membrane

4 Chronic otitis media

3)WITHDRAWAL CRITERIA

1If patient develops any adverse effect such as irritation pain burning

sensation in ear loss of hearing and such patients was withdrawn from trial

and receive prompt appropriate medical attention

2If patient shows aggravation in symptoms

3If patient refuses to continue with the treatment

Page | 78

STUDY SETTING

Types of study - Randomized Clinical comparative Trial

Place of work - OPD of Shalakyatantra

Duration of study - 18 months

Study Population - Patients of Karnasrava in Shalakyatantra OPD

SAMPLE SIZE CALCULATION

Sampling Method ndash Purposive sampling followed by random allocation in two

groups

Sample size calculation-

n = z2 p (1-p)

d2

Were

n = sample size

P = prevalence of disease=10

z = standard normal variable ie 196

d = error ie005

desired Sample Size would be

n = Z2 P(1-P)d2

= (196)2x (0021) x(0979)(005)2

= 34

Visiting ENT OPD (ShalakyaTantra) and IPD (ShalakyaTantra) 21 = 34

n raquo34

So one group includes 34patients

Page | 79

Sampling Method

Total 68 patient of Karnasrava are selected by Purposive sampling followed by

random allocation in two groups Written informed consent is taken prior to

commencement of trial They are divided in 2 groups

Group A (Trial Group) 34 patients treated with Agaruwadi Dhoopana for 7

days

Dose 5 minutes twice in a day

Group B (Control Group) 34 patients treated with Guggula Dhoopana for 7

days

Dose 5 minutes twice in a day

STUDY DESIGN ndash

Open labeled Randomized Comparative Clinical trial

STUDY DESIGN

Screening of patient

Inclusion criteria satisfied Exclusion criteria

Initial assessment Excluded

Counseling of patient Treated accordingly

Patient selection by Simple Random Sampling Method

Page | 80

68 Patients were divided in two groups lsquoArsquo and lsquoBrsquo

Trial group A-34 patients were given

Agaruwadi Dhoopana

Control group B- 34 patients were

given Guggul Dhoopana

Informed written consent

Treatment was given for 7 days

Assessment on 1st 4th and 7th day

Post assessments follow up on 15th day

Observation

Data Collection

Statistical analysis of data

Conclusion

Page | 81

(A) Agaruwadi Varti for group A (Trial group)

Table no 2

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

B) Guggula Varti for group B (Control group)

SOP of it is same as above Agaruwadi Varti

Table no 3

Drug Guggula Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

FOLLOW UP

For both groups follow ups were done on 1st 4th and 7th and post

assessment follow up15th day

EXAMINATIONS

Torch for Local examination of ear

Otoscope examination

Tuning fork Test

Page | 82

OBSERVATION TABLE

Table no 4

Sr no Subjective criteria Day 1 Day 4 Day 7 Day 15

1 करणशल

(pain)

2 करणकणड

(Itching)

3 करणसतराव (Discharge )

4 बाधिरण (Conductive Deafness)

OBSERVATIONS

a) करणशल (Pain) -

0 - Absent

1 ndash Present

b) करणकणड (Itching) -

0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

Page | 83

c) करणसतराव (Discharge)

0- Absent

1- Mild -Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाधिरण (conductive Loss of hearing)

0 - Absent

1- Present

Observations were carried out before and after completion of treatment and

during each follow up After observations the data collected and presented in

the form of graphs charts and table

Page | 84

TRIAL DRUG

Authentication and standardization of raw drug material done After

authentication and standardizing of raw drug material Agaruwadi Varti was

prepared by Varti as explained in Ayurvedic classics

Method of Varti preparations

Panchavidh Kashaya Kalpana that is five method of pharmaceutical

preparation constitutes the fundamental process of Ayurvedic pharmaceutics

which is well explained in Sushrut Samhita Varti Kalpana is one among them

which can be included in Kalka Kalpana

तीररसतरपतपतीनामपरककव तीत [106]

स डलहण शरच 151

Medicines are powered triturated and given the Varti shape that is like wick

of lamp so it is called as Varti Kalpana

Drug content Agaru Madan Yawa

Route of Administration Local

Dose Two times a day

Duration 7 days

Page | 85

Methodology

Standard operating procedure (SOP) of Agaruwadi Varti

Agaruwadi Varti is prepared according to the classical text

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization was done as recommended in pharmacy procedure The

raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 mixed together in

equal quantity to make Agaruwadi churn

Quantity of each churn is 4 grams all are mixed when the Varti get dry total

weight of Varti was 10gram

STEP 4 - Agaruwadi churn triturated with appropriate quantity of water or

Ghrita and prepared Varti in GMP Certified Ayurvedic pharmacy Standard

aseptic precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Varti was packed in sterile air packed container

STEP 6 - Agaruwadi Dhoopana was given with the help of Dhoopana yantra

Authentication and Standardization of raw drug of Agaruwadi Varti was done

Sterilization was done as recommended in pharmacy procedure Sterile

preparation packed in sterile container of suitable size Under all aseptic

precaution Karnadhoopana given to infected ear

Page | 86

Containers for packaging and their sterilization-

Sterilization of the containers for storing Varties was done by Ethylene Oxide

(Eto) method

Ethylene Oxide (Eto) procedure-

It includes exposure of materials to ethylene oxide gas under vacuum in a

sealed chamber It consists of four primary variables

1Gas Concentration

2Humidity

3Temperature

4 Time

EtO gas is an alkylating agent which disturbs the DNA of microorganism

preventing them from reproducing It penetrates the breathable packaging

and sterilizes all the accessible surface of the product to render products

sterility by alkylation of essentials proteins for cell reproduction

Most Eto sterilization methods involves three different stages These can be

separated into three different on the size or number of devices to treat

1Preconditioning stage-

First products are passed through a preconditioning phase to make

microorganism grow The batch load goes through a well time under a

controlled environment of temperature and humidity

2Sterilizer stage-

Performed using process phase specially designed to provide the required level

of EtO exposure to assure sterility for a device or family of devices

3Degasser Aerration stage-

Finally products need to go through a degassing phase to remove any residual

particles of Eto The batch load goes over well time under a temperature-

controlled environment

The sterile containers were then used to store Agaruwadi Varti and handed to

patients included in the study

Page | 87

Packing of Agaruwadi Varti

The ETO sterilize plastic container were used for packing of Agaruwadi Varti

Varti was filled into these sterilize containers (7 in each) In an aseptic

environment plugging and capping was done under aseptic precautions In this

way packing of Agaruwadi Varti done These Varti were given to patient and

advise to take two times a day under all hygienic precautions

History and Examination

bull Proper history and presenting complains was recorded on case record form

bull Ear examination with otoscope was done during initial assessment and each

follow up

bull Otoscopic examination was done during initial assessment and each follow

up

bull Systemic Examination that is Blood Pressure Temperature Respiration

rate Pulse was recorded on case record form

Page | 88

Raw material

Fig14 यव चरण Fig15 मदनफळ चरण

Fig16 अगर चरण Fig17 गगगळ चरण

Page | 89

Preparation of Agaruwadi Varti

Fig18 Preparation of Agaruwadi Varti

Fig19 अगरवादी वरती

Page | 90

Fig20 Instruments used for examination of Karnasrava

Fig19 Karnadhoopana Yantra

Page | 91

Karnadhoopana Procedure

Fig 22 Karnadhoopana Procedure

Page | 92

OBSERVATIONS AND RESULTS

Page | 93

BASED ON DRUGS

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 94

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

AUTHENTICATION CERTIFICATE

Page | 95

BASED ON STASTICIAL ANALYSIS OF DEMOGRAPHIC DATA

68 patients of Karnasrava ndash Otomycosis

Table no 5

No of Patients Total

Group A Group B

Registered 38 37 75

Completed 34 34 68

Discontinue 04 03 07

Total 68 patients were enrolled in study 38 patients registered in group A

amongst them 34 patients completed the treatment and04 patients

discontinued the treatment However in group B 37 patients completed the

treatment and 03 patients discontinued the treatment out of 37 registered

patients

Hence the total number of patients registered in the present study was 75

and out of which 68 patients were discontinued the treatment So they

dropped out from the study While 68 patients were successfully completed

the treatment So observations and result of 68 patients were given below

Here we are going to discuss the statistical analysis of the data obtained in

the form of master chart that was prepared in accordance with the data

collected from the patients that had been included in the study The purpose

of statistical analysis was to analyzed the relation between age gender

occupation diet addiction and education

Page | 96

1 Age wise distribution of patients

Table no 6

In trial group 10 (29412) patients were from age group 18-25 years 14

(41176) patients were from age group 25-35 years 8 (23529) patients

were from age group 35-45 years and 2 (58824) patients were from age

group 45-60 yearsIn control group 6 (17647) patients were from age group

18-25 years 14 (41176) patients were from age group 25-35 years 7

(20588) patients were from age group 35-45 years and 7 (20588)

patients were from age group 45-60 years

Fig 23 Age wise distribution of patients

0

2

4

6

8

10

12

14

15 -25 25-35 35-45 45-60

10

14

8

2

6

14

7 7

Age Distribution

Trial Group N Control Group N

Age Distribution

Trial Group Control Group

N N

18 -25 10 29412 6 17647

25-35 14 41176 14 41176

35-45 8 23529 7 20588

45-60 2 58824 7 20588

Total 34 100 34 100

Page | 97

1 Gender wise distribution of patients

Table no 7

Sex

Trial Group Control Group

N N

Female 23 67647 15 44118

Male 11 32353 19 55882

Total 34 100 34 100

In trial group 23 (67647) patients were female and 11 (32353) patients

were male

In Control group 15 (44118) patients were female and 19 (55882)

patients were male

Fig 24 Gender wise distribution of patients

0

5

10

15

20

25

N N

TRIAL GROUP CONTROL GROUP

23

15

11

19

Gender

Female Male

Page | 98

2 Education wise distribution of patients

Table no 8

Education

Trial Group Control Group

N N

Illiterate 4 11765 3 88235

SSC 4 11765 3 88235

HSC 8 23529 9 26471

Graduation 16 47059 10 29412

Primary 1 29412 3 88235

Post-Graduation 1 29412 6 17647

Total 34 100 34 100

In trial group 4 (11765) patients were illiterate 4 (11765) patients were

SSC educated 8 (23529) patients were HSC educated 16 (47059)

patients were graduated 1 (29412) patients were primary educated and

1(29412) patients were post graduated

In control grou 3 (88235) patients were illiterate 3 (88235) patients

were SSC educated 9 (26471) patients were HSC educated 10 (29412)

patients were graduated 3 (88235) patients were primary educated and

6 (17647) patients were post graduated

Page | 99

Fig 25 Education wise distribution of patients

0

2

4

6

8

10

12

14

16

ILLITERATE SSC HSC GRADUATION PRIMARY POST GRADUATION

4 4

8

16

1 1

3 3

910

3

6

Education

Trial Group N Control Group N

Page | 100

3 Occupation wise distribution of patients

Table no 9

Occupation

Trial Group Control Group

N N

Accountant 1 294 2 588

Housewife 11 3235 8 2353

Engineer 1 294 1 294

Job 1 294 4 1176

Labor 1 294 3 882

Mess 1 294 0 000

Naturotherapyst 1 294 0 000

Pharma 1 294 0 000

Shopkeeper 4 1176 2 588

Singer 1 294 0 000

Student 8 2353 4 1176

Tailor 1 294 1 294

Teacher 1 294 1 294

Worker 1 294 3 882

Farmer 0 000 1 294

Lab Tech 0 000 1 294

Page | 101

Daily Collection 0 000 1 294

Fruit seller 0 000 1 294

Bus Driver 0 000 1 294

Total 34 10000 34 10000

In trial group 11 (3235 ) were housewife 8(2353) were students

4(1176) were shopkeeper 1(294) was accountant 1(294) was

engineer 1(294) was doing job 1(294)was labour 1(294) was

catering 1(294) was Naturotherapyst 1(294) was Pharma 1(294)

was Singer 1(294) was Tailor 1(294) was Teacher and 1(294) was

worker

In Control group 8 (2353)were housewife 4(1176) were students

2(588) were shopkeeper 2(588) was accountant 1(294) was

engineer 4( 1176) was doing job 3(882)was labor 1(294) was

Farmer 1(294) was Lab tech 1(294) was Daily collection 1(294)

was Tailor 1(294) was Teacher and 3(882) was worker 1(294) was

Fruit seller and 1(294) Bus driver

Fig 26 Education wise distribution of patients

0

2

4

6

8

10

12

1

11

1 1 1 1 1 1

4

1

8

1 1 10 0 0 0 0

2

8

1

43

0 0 02

0

4

1 13

1 1 1 1 1

Occupation

Trial Group N Control Group N

Page | 102

4 Religion wise distribution of patients

Table no 10

Religion

Trial Group Control Group

N N

Hindu 31 9118 33 9706

Muslim 3 882 1 294

Total 34 10000 34 10000

In trial group 31 (9118) patients were Hindu and 3 (882) patients were

Muslim

In control group 33 (9706) patients were Hindu and 1 (294) patient

were Muslim

Fig 27 Religion wise distribution of patients

0

5

10

15

20

25

30

35

N N

TRIAL GROUP CONTROL GROUP

3133

31

Religion

Hindu Muslim

Page | 103

5 Diet wise distribution of patients

Table no 11

Diet

Trial Group Control Group

N N

Veg 14 4118 20 5882

Non-Veg 20 5882 14 4118

Total 34 10000 34 10000

In trial group 14 (4118) patients were vegetarian and 20 (5882)

patients were Non vegetarian

In control group 20 (5882) patients were vegetarian and 14 (4118)

patients were Non-Veg

Fig 28 Diet wise distribution of patients

0

5

10

15

20

N N

TRIAL GROUP CONTROL GROUP

14

2020

14

Diet

Veg Non Veg

Page | 104

6 Addiction wise distribution of patients

Table no 12

Addiction

Trial Group Control Group

N N

None 30 8824 27 7941

Alcohol 2 588 0 000

Tobacco 1 294 2 588

Mishri 0 000 1 294

Smoking 1 294 4 1176

Total 34 10000 34 10000

In trial group 30 (8824) patients have no addiction 2 (588) patients

have addiction of alcohol 1 (294) patients have addiction of Tobacco 0

(0) patients have addiction of Mishri and 1 (294) patients have addiction

of smoking

In control group 27 (7941) patients have no addiction 0 (0) patients

have addiction of alcohol 2 (588) patients have addiction of Tobacco 1

(294) patients have addiction of Mishri and 11 (1176) patients have

addiction of smoking

Page | 105

Fig 29 Addiction wise distribution of patients

0

5

10

15

20

25

30

NONE ALCOHOL TOBACCO MISHRI SMOKING

30

21

01

27

0

21

4

Addiction

Trial Group N Control Group N

Page | 106

Statistical Analysis and Results

Effect of study on Karnashoola-

Table no 13

Karnashoola

Group A Group B

BT AT BT AT

N N N N

Grade 2 0 000 0 000 0 000 0 000

Grade 1 30 10000 7 2333 32 10667 5 1667

Grade 0 4 1333 27 9000 2 667 29 9667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 30 Effect of study on Karnashoola

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

30

7

32

54

27

2

29

Karnashoola

Grade 2 Grade 1 Grade 0

Page | 107

Table no 14

Karnashoola Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 088 100 033 006

969 2829E-

08 7667 HS

AT 021 000 041 007

Group

B

BT 094 100 024 004

1037 7103E-

11 8438 HS

AT 015 000 036 007

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 31

000010020030040050060070080090100

BT AT BT AT

GROUP A GROUP B

088

021

094

015

Karnashoola

Mean

Page | 108

Table no 15

Karnashoola

Mean SD Effect

Group

A

Group

B Trial Control Trial Control

Day 1 088 094 033 024 000 000

Day 3 065 071 049 046 2667 2500

Day 5 024 038 043 049 7333 5938

Day 14 021 015 041 036 7667 8438

000

010

020

030

040

050

060

070

080

090

100

Day 1 Day 3 Day 5 Day 14

Karnashoola

Mean Group A Mean Group B

Page | 109

Table no 16

Karnashoola N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3250 110500

510000 275 Control group 34 3650 124100

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 110

Effect of study on Karnakandu

Table no 17

Karnakandu

Group A Group B

BT AT BT AT

N N N N

Grade 3 7 2333 0 000 4 1333 0 000

Grade 2 18 6000 0 000 18 6000 0 000

Grade 1 7 2333 7 2333 10 3333 15 5000

Grade 0 2 667 27 9000 2 667 19 6333

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 32 Effect of study on Karnakandu

0

5

10

15

20

25

30

N N N N

BT AT BT AT

GROUP A GROUP B

7

0

4

0

18

0

18

0

7 7

10

15

2

27

2

19

karnakandu

Grade 3 Grade 2 Grade 1 Grade 0

Page | 111

Table no 18

Karnakandu Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 188 200 081 015

1091 3119E-

10 8906 HS

AT 021 000 041 007

Group

B

BT 171 200 076 014

1032 4746E-

09 7414 HS

AT 044 000 050 009

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Page | 112

Fig 33

Table no 19

Karnakandu

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 188 171 081 076 000 000

Day 3 126 118 057 058 3281 3103

Day 5 071 074 046 051 6250 5690

Day 14 021 044 041 050 8906 7414

000

020

040

060

080

100

120

140

160

180

200

BT AT BT AT

GROUP A GROUP B

188

021

171

044

Karnakandu

Mean

Page | 113

Table no 20

Karnakandu N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 4051 137750

373500 006 Control group 34 2849 96850

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is less than

005 Hence we conclude that there is significant difference between Trial

Group and Control Group

000

020

040

060

080

100

120

140

160

180

200

Day 1 Day 3 Day 5 Day 14

Karnakandu

Mean Group A Mean Group B

Page | 114

Effect of study on Karnasrava

Table no 21

Karnasrava

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 11 3667 0 000 8 2667 0 000

Grade 1 23 7667 3 1000 26 8667 2 667

Grade 0 0 000 31 10333 0 000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 34

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

11

0

8

0

23

3

26

20

31

0

32

Karnasrava

Grade 3 Grade 2 Grade 1 Grade 0

Page | 115

Table no 22

Karnasrava Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 132 100 047 009

1122 4356E-

13 9333 HS

AT 009 000 029 005

Group

B

BT 124 100 043 008

1130 9364E-

14 9524 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 35

000

020

040

060

080

100

120

140

BT AT BT AT

GROUP A GROUP B

132

009

124

006

Karnasrava

Mean

Page | 116

Table no 23

Karnasrava

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 132 124 047 043 000 000

Day 3 100 100 025 025 2444 1905

Day 5 047 038 051 049 6444 6905

Day 14 009 006 029 024 9333 9524

000

020

040

060

080

100

120

140

Day 1 Day 3 Day 5 Day 14

Karnasrava

Mean Group A Mean Group B

Page | 117

Table no 24

Karnasrava N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3535 120200

549000 655 Control

group 34 3365 114400

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 118

Effect of study on Karnabadhirya

Table no 25

Karn

Badhirya

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 0 000 0 000 0 000 0 000

Grade 1 13 4333 0 000 16 5333 2 667

Grade 0 21 7000 34 11333 18 6000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 36

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 00 0 0 0

13

0

16

2

21

34

18

32

Karnabadhirya

Grade 3 Grade 2 Grade 1 Grade 0

Page | 119

Table no 26

Karn

Badhirya Mean Median SD SE

Wilcoxon

W P-Value

Effect Result

Group

A

BT 038 000 049 009

799 7173E-

05 10000 HS

AT 000 000 000 000

Group

B

BT 047 000 051 009

816 0000138 8750 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 38

000

005

010

015

020

025

030

035

040

045

050

BT AT BT AT

GROUP A GROUP B

038

000

047

006

Karnbadhirya

Mean

Page | 120

Table no 27

Karn

Badhirya

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 038 047 049 051 000 000

Day 3 009 006 029 024 7692 8750

Day 5 003 006 017 024 9231 8750

Day 14 000 006 000 024 10000 8750

000

005

010

015

020

025

030

035

040

045

050

Day 1 Day 3 Day 5 Day 14

Karn Badhirya

Mean Group A Mean Group B

Page | 121

Table no 28

Karn

Badhirya N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3400 115600

561000 806 Control

group 34 3500 119000

Total 68

Page | 122

COMPARISION BETWEEN GROUP A AND GROUP B

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Table no 29

Overall Effect

Trial Group Control Group

N N

Marked Improvement 21 6176 16 4706

Moderate Improvement 8 2353 13 3824

Mild Improvement 4 1176 5 1471

No Change 1 2941 0 0

TOTAL 34 100 34 100

Fig 39

0

5

10

15

20

25

MARKED IMPROVEMENT

MODERATE IMPROVEMENT

MILD IMPROVEMENT NO CHANGE

21

8

41

1613

5

0

Overall Effect

Trial Group N Control Group N

Page | 123

DISCUSSION

Page | 124

Discussion is nothing but the logical reasoning of observations In

every research work discussion part is very important because it brings into

light about the logical analysis which are helpful in filling the research gap in

the scientific world

The discussion is categorized into following ways for the ease of

understanding

1 Discussion on selection of topic

2 Discussion on review of literature

3 Discussion on drugs their mode of action on the disease mode of action

of Karnadhoopana

4 Discussion on observation and results

1 Discussion on selection of topic

Otomycosis is commonly encountered in day-to-day practice Majority

of Indian people affected with this pathology This disease commonly

manifests in developing countries low socio-economic standard and lack

of hygiene Now a days due to busy lifestyle people are not able to follow

the proper instruction of care of ear which may be responsible for the

recurrent nature of disease So for the management of this we use

Karnadhoopana with the help of Agaruwadi Varti Dhoopana is simple

easy cost-effective procedure which can be done even at OPD levelso

for the disease Karnasrava we selected Karna Dhoopana as therapeutic

procedure Karnadhoopana was done with Agaruwadi Varti and Guggula

Varti which was very effective for treatment

Page | 125

2 Discussion on review of literature

Karnasrava is one such disease among 28 Karnarogas mentioned by

Acharya Sushruta in the chapter named Karna Roga Vigyana Acharya

Charaka included Karnasrava as symptom under the four types of

Karnarogas due to vitiation of different doshas Acharya Vagbhata has

not described Karnasrava separately It is a fact that systemic

description of Karnarogas is available in all the ancients of pus from a

Vata afflicted ear may results from head injury or immersion in water

Karnasrava is a clinical entity which can be correlated with Otomycosis

Karnasrava is explained as symptom as well as a disease in Ayurveda

Nidana- Karnasrava occur due to Samanya Nidana and Vishesh Nidana

Vishesh Nidana like Shirobhighata Nimmajato jale Mithyayoga of Shashtra

The exact pathology behind Karnasrava is not understood clearly

Purvarupa ndash No specific Purvarupa are found for Karnasrava in classical

literature Acharya Madhukara describe Purvarupa as expression of

Rupa(lakshana) with less intensity that is less intensity itching sound in ear

may considered as Purvarupa of Lakshana

Samprapti- Aacharya Sushruta not explained the Samprapti of Karnasrava

separately and we must consider the general Samprapti of Karnaroga Due to

various aetiologias as cited above ear afflicted by Vata dosha causes Twak

Rakta Mamsa dushti results in Karnasrava According to Acharya Sushruta

Vata-Kapha dose is dominance in Karnasrava

Page | 126

Nidan

Nija Agantuja

Vata ndash kapha prakopak nidana Shirobhighata Nimmajato-jale

Mithya yoga of Shastra

Vata- kapha Prakopaka(Chaya prakopak) Vata-kapha prakopaka

( Achay prakopak)

Twak Rakta Mamsa dushti

Karnasrava

Page | 127

Chikitsa

The curative aspect and this must be done simultaneously giving due

importance to Nidan Parivarjana that is preventive measures So Nidan

Parivarjana that is avoidance of causative factors like Jalkrida Mithyayogen

shashtrasya Karnakandu Shirasnan Pratishaya is the first step in combating

the disease and form the part of line of treatment

Above Samprapti helps us to proceed towards the treatment of Karnasrava

The main protocol of treatment is removal of fungus and wound management

which include various measures to keep area day clean clear of microbes and

providing ideal condition for healing

Samany Chikitsa- Acharya Sushruta described general treatment for

Karnaroga as Snehapana (Drinking ghee) Rasayana (Rejuvenation therapy)

Bhramacharya Avoid excessive speaking Avoidance of physical exercise and

head bath

Vishesha Chikitsa ndash Acharya Sushruta mentioned some procedures in the

treatment of Karnasrava which is Shirovirechana Karnadhoopana

Karnapurana Karanpramarjana Dhavan Avachurnana Karnapurana Above

various procedures described in Ayurveda for management of fungus growth

in ear discharging ear fulfill these requirements of wound management

Page | 128

Discussion on observation and Result

Out of 68 patients 34 patients included for the trial The incidence of

Karnasrava is observed in trial and control groups

The statistical analysis provided the following data

AGE

Trial group- Maximum no of patients that is 14 (41176) patients were from

age group 25-35 years followed by 29412 patients were from age group

18-25 years 23529patients were from age group 35-45 years and

58824 patients were from age group 45-60 years

Control group - Maximum no of patients that is 14 (41176) patients were

from age group 25-35 years followed by 20588 patients were from age

group 35-45 years and 20588 patients were from age group 45-60 years

17647 patients were from age group 15-25 years

The maximum no of cases of Karnasrava found in age group between 25 to

35 years The reason behind this is repeated use of ear bud or emersed water

in ear More use of earphone or working more in cold environment

GENDER

Trial group ndash A higher prevalence seen in females 6764 and 3235 in

males

Control group - A higher prevalence seen in males 5588 and 4411 in

females

Females and males both are prone to disease

Page | 129

EDUCATION

Trial group-It is observed that amongst 34 patients maximum ie16

(47059) patients were graduated 8 (23529) patients were HSC

educated 4 (11765) patients were SSC educated 4 (11765) patients

were illiterate 1 (29412) patient were primary educated and 1(29412)

patient were post graduated

Control group- It is observed that 10 (29412) patients were graduated 9

(26471) patients were HSC educated 6 (17647) patients were post

graduated 3 (88235) patients were SSC educated 3 (88235) patients

were primary educated3 (88235) patients were illiterate

There is no direct relation between education and Otomycosis

RELIGION

Trial group- The incidence of patients of Hindu religion are 9118 and Muslim

religion are 882

Control group- The incidence of patients of Hindu religion are 9706 and

Muslim religion are 294

There is no probable explanation for this maximum number of patients in

Hindu religion it depends upon the patients attend the hospital and

community residing there

Page | 130

DIET

Trial group It was found that maximum ie5882 patients were taking

mixed diet while 4118 were taking vegetarian diet

Control group It was found that maximum ie5882 were taking

vegetarian diet while 4118 patients were taking mixed diet

The dietary habit of person is based on choice availability and religious

customs of the person

ADDICTION-

Trial group- It was found that maximum ie 30 (8824) patients have no

addiction 2 (588) patients have addiction of alcohol 1 (294) patients

have addiction of Tobacco 1 (294) patients have addiction of smoking and

0 (0) patients have addiction of Mishri

Control group - It was found that maximum ie 27 (7941) patients have

no addiction 4(1176) patients have addiction of smoking 2 (588)

patients have addiction of Tobacco 1 (294) patients have addiction of

Mishri and 0 (0) patients have addiction of alcohol

Very few patients were addicted to Alcohol Smoking Tobacco and Mishri

These factors can be taken as provoking factors for Otomycosis

Page | 131

Discussion based on probable Mode of action of Karnadhoopana

In Ayurveda classics Karna Dhoopana is therapeutic procedure explain for

Karnasrava Dhoopana is administration of Dhooma (Fumes) with the help of

Dhoopan Dravya References indicates that analgesic and disinfectant effect

of Dhoopana karma and mention for Dushta Vrana Chikitsa It reduces

Vedana Srava amp also does Vrana Ropana action

Various Dhoopanas and Dhoopan Dravas for different element in various

Samhitas of Ayurveda but there is a lacuna of availability of reference

regarding how to do it and method of procedure Matra Kala Contraindication

etc

Currently simple modified way of Karnadhoopana according to Yukti Praman

and experience but there is lac of standardization

Karnadhoopana is one among the topical Bahiparimajan type of treatment

Karna Parmarjana is procedure of cleaning ear with the help of cotton or gauze

piece soaked in honey

Page | 132

Dhoopan

The fumes coming out on burning Agaruwadi Varti

Administrated directly into external ear canal

Causes vasodilation

Due to this increase blood supply in external ear canal

It helps in absorption of drug

Fumes dries up Srava and bring the analgesic effect

Karnagata Kapha amp Avrut Vata Dosha Shaman

Decrease in signs and symptoms like karnasrava Karnshool Karnabadhirya amp

Karnandu

Page | 133

3 Discussion based on probable mode of action of Agaruwadi

Dhoopana

Agaru ndash

I Agaru is a fragrant tree aroma is a result of fungal pathogenesis when the

wood of tree is contaminated by fungi at wounds it develops scrap filled

with resin and turn out to be aroma Medicinal use of Agaru have been

recorded in ancient medicinal science in in inflammatory disease and some

infective disease

II Acharya Charaka has referred to Agaru as an Ushna dravya despite having

Tikta Rasa Ashtang Samgraha used Agaru as Dhupana Dravya along with

Madan and Yawa in Karnasrava Nighantu recommended is use as a

Dhoopana

III In various Samhitas and Nighantus Agaru described as Tikta Snighdha

Sheetaprashamana Vranaprasadana Tvachya Due to these properties

Agaru is used in the treatment of Karna-Akashi Roga and Dushta Vrana

Shodhaka

IV Agaru is reported to have Antimicrobial Analgesic Antioxidants

Antihistaminic and anxiolytic properties Its Antihistaminic property gives

relief from itching which is cardinal feature of Otomycosis Due to Katu

Ushna Tikta Guna improves blood circulation Bheda stage develop It is

Niram Awastha of Dosha Karnagata kapha and vata get decrease and

symptoms like karnashoolakarnasrava get decrease Agaru also have a

Antioxidant properties

V Chemically Agaru Contain 2-(2-Phenylethyl) Chromones Terpenoids

Flavonoids

VI Natural Agarwood had inhibitive activities towards Staphylococcus Aures

The chloroform extract of Agarwood prolongs the pain threshold[108]

Page | 134

Madan

I Madanphala have therapeutic properties like Anti-inflammatory

Antiallergic Analgesic and Wound healing

II It is Useful in treatment of disease like Shotha (inflammation) Vidradhi

(Abscess) Pratishaya (Common cold) Kushta(Skin disease)

III Extract of Madanphala mainly contain Glcosides Tritorpenct

Glycosides Saponin

IV Saponin glycosides are act as fire extinguisher This property is helpful

for vartiIt also act as a detergent which clean the surface of fungus

V Tritorpenct act as a anti-inflammatory antimicrobial and

immunomodulator compound Interaction of glycosides with sterol

causes disturbance of selective permeability in plasmic membraneso

exudates and discharge get decrease

VI Pharmacological activity [109]

Antibacterial Activity The preliminary antibacterial activity of Methanolic

extract of Randia D lam was done on some standard and wild pathogenic

strains The inhibition of the bacterial growth was more pronounced on E coli

as compared to the other tested organism This shows the antibacterial action

of Randia D secondary infection can prevent

Anti-Allergic Activity In Ayurveda Randia D Extract and its fraction of milk

induced leukocytosis and eosinophilia in mice

Anti-Inflammatory Activity The crude methanol extract of fruit of Randia D

effectively reduced the carrageenin induced oedema in hind paw of the rats

significant reduction in granular tissue formation was recorded This activity

seems to be significant at various acute phases of inflammation and om

formation of granular tissue This proves action of Madanaphala in shopa

(inflammation)

Page | 135

Analgesic Activity Analgesic activity was tested in mice weighing between 20-

250 with six number of animals in each group Methanlic extract of fruit Randia

d give analgesic activity in both models This proves its Shoolanashaka (pain

killer) action

Immunomodulatory Activity Randia D has immunostimulant activity and

chloroform fraction which strongly affected immune system seems to be

bioactive fraction of this plant

The overall effect of Agaru Mandanphala Yawa having Anti-inflammatory

Antiseptic Antimicrobial Property Active ingredient shows these properties

Agaru Yawa Madanphala

Vatakaphaghna

Act as

Vranashodhak

Vedanasthapaka

Sheetaprashamana

Shothara

Avarana of Vata get decrease so helps to Shaman of Vata dosha

Karnakandu Karnashoola Karnasrava

Prashamana

Page | 136

This fact can be taken into consideration and probably acknowledge that

Karnadhoopana with Agaruwadi Varti had not leave any residue in the ear

Removal of fibrin keratinocyte migration and in growth of epithelial tissue

plays a major role in healing It is technique of fumigation of ear with the

smoke of anti-infective drug In Karnadhoopana Sthanik Swedana increase the

blood supply and helps in absorption of the drug reduce Karnakandu amp

Karnshoola associated with infection

Page | 137

SUMMARY AND CONCLUSION

Page | 138

The dissertation entitled randomize comparative clinical trial to study the

effect of Agaruwadi Karnadhoopan and Guggula Karnadhoopan In Karnasrava

wsr to Otomycosis

The dissertation is divided into fallowing parts

Introduction

Review of literature

Ayurvedic review

Modern Review

Drug review

Procedure review

Material and Method

Observation and result

Discussion

Summary and conclusion

bull INTRODUCTION

It includes importance of Shalakyatantra in Sushrut Samhita Charka

Samhita And Ashtang Samgraha

Common and specific causes of Karnasrava

Karnasrava is a clinical entity which can be corelate with Otomycosis

In Ashtang Samgraha stated the procedure like Karnadhoopana with

Agaru Yawa Madanphala in Karnasrava

Page | 139

bull REVIEW OF LITERATURE

1 Ayurvedic review

2 Modern review

3 Drug review

Ayurvedic review-

It includes Rachana-Sharir and Kriya-Sharir of Karna detail description of

Karnaroga and its types Karnaroga Samanya hetu Poorvaroopa Rupa

Samprapti Upadrava Pathya-Apathya of Karnasrava Vishesh Nidan and

Chikitsa of Karnasrava Detail description of Karnadhoopana according to

various Acharays have been mentioned

Modern review-

It includes anatomy and physiology of Ear brief anatomy of ear anatomy of

External middle and Internal ear Detail description of the disease

Otomycosis mechanism of fungal infection in external canal pathophysiology

investigations diagnosis and management

Drug review-

Detail description of Agaru Yawa Madan Guggula and its synonyms

Ayurvedic properties Karma uses Pharmacological action and their

pharmacodynamic properties

Page | 140

MATERIAL AND METHOD

It includes description regarding materials required for the study Preparation

of Agaruwadi Varti its Standardization Sterilization and packaging

Plan of study

1 Total 68 patients completed the treatment Age criteria was kept

between 18-60 years Patient selection was done by done by simple

random sampling method and divided into two groups A (Trial) and

Group B (Control) 34 patients in each group

2 Patients in Group A were treated with Karnadhoopana with Agaruwadi

Varti for 7 days two times in a day while patients in Group B were treated

with Karnadhoopana with Guggula for 7 days two times in a day

3 Clinical examination done during each follow up ie 0th 4rd 7th and

observation were recorded

Page | 141

OBSERVATIONS AND RESULTS

Page | 142

1 It was observed that higher incidence of disease Karnasrava ie

Otomycosis found in age group 25-35 years

2 Disease otomycosis was equal in both male and female

3 The trial group there was significant relief in Karnakandu (8906)

Karnasrava(9333) Karnashoola(7667) and karnabadhirya(100)

4 In control group there was significant relief in Karnakandu (7414)

Karnasrava(9524) Karnashoola(8438) and

karnabadhirya(8750)

Page | 143

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Page | 144

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Chaukhamba Orientalia Sharirsankhyasharir Adhaya Shlok no 716 page

no- 850

26 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sharirsthan published by

Chaukhamba Orientalia Sharirsankhyasharir Adhaya Shlok no 77 page

no- 847

27 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sharirsthan published by

Chaukhamba Orientalia Sharirsankhyasharir Adhaya Shlok no 77 page

no- 847

28 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sharirsthan published by

Page | 147

Chaukhamba Orientalia Sharirsankhyasharir Adhaya Shlok no 716 page

no- 850

29 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sutrasthan published by

Chaukhamba Orientalia Indriyaopakramaniya Adhaya Shlok no 811

page no- 125

30 Shree Yadunandanopadhyaya Madhavnidan with madhukosh

teekapublished by Chaukhamba Prakashana571 page no- 243

31 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Chaukhamba Sanskrit SansthanVaranasi Sharirsankhyavykaransharir

Adhaya Shlok no-510 page no56

32 VdBramhand Tripathi Ashtanghradaya Sharirsthan Published by

Chaukhamba prakashana 2005 Shlok no3108 page no- 385

33 VdBramhand Tripathi Ashtanghradaya Sharirsthan Published by

Chaukhamba prakashana 2005 Shlok no33 page no- 366

34 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Chaukhamba Sanskrit SansthanVaranasi Sarvabhutachintasharir Adhaya

Shlok no-126 page no9

35 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Chaukhamba Sanskrit SansthanVaranasi Sharirsankhyavykaransharir

Adhaya Shlok no-522 page no60

36 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Chaukhamba Sanskrit SansthanVaranasi Sharirsankhyavykaransharir

Adhaya Shlok no-532 page no61

37 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Page | 148

Chaukhamba Sanskrit SansthanVaranasi Sharirsankhyavykaransharir

Adhaya Shlok no-521page no58

38 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Chaukhamba Sanskrit SansthanVaranasi Sharirsankhyavykaransharir

Adhaya Shlok no-527 page no61

39 VdBramhand Tripathi Ashtanghradaya Sharirsthansthan Published by

Chaukhamba prakashana 2005 Shlok no331 page no-372

40 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Chaukhamba Sanskrit SansthanVaranasi Siravarnavibhaktisharir Adhaya

Shlok no-725 page no83

41 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sutrasthan Published by Chaukhamba

Sanskrit SansthanVaranasi Sharirsankhyavykaransharir Adhaya Shlok

no-512

42 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Chaukhamba Sanskrit SansthanVaranasi Pratekmarmanirdeshsharir

Adhaya Shlok no-628 page no75

43 Vaidya Yadavaji trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri Dalhanacharya Published by-

Chaukhamba Sanskrit sansthanEdition reprinted 2012

44 VdBramhand Tripathi Ashtanghradaya Sharirsthan Published by

Chaukhamba prakashana 2005 Marmasharirsthan Shlok no429 page

no- 393

45 Shree Yadunandanopadhyaya Madhavnidan with madhukosh

teekapublished by Chaukhamba Prakashana571 page no- 243244

Page | 149

46 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sharirsthan published by

Chaukhamba Orientalia Sharirsankhyasharir Adhaya Shlok no 711 page

no- 847

47 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sharirsthan pu blished by

Chaukhamba Orientalia Sharirsankhyasharir Adhaya Shlok no 711

48 Vaidya Yadavaji trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri Dalhanacharya Published by-

Chaukhamba Sanskrit sansthanEdition reprinted 2012

49 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sharirsthan published by

Chaukhamba Orientalia Sharirsankhyasharir Adhaya Shlok no 711 page

no- 847

50 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sutrasthan published by

Chaukhamba Orientalia Shlok no 711 page no- 847

51 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sutrasthan Published by Chaukhamba

Sanskrit SansthanVaranasi Adhaya Shlok no-628 page no- 75

52 VdBramhand Tripathi Ashtanghradaya Sutrasthan Published by

Chaukhamba prakashana 2005 Gandushavidhiadhaya Shlok no2232

page no- 261

53 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sutrasthan Published by Chaukhamba

Sanskrit SansthanVaranasi Karnavydhbandhvidhi Adhaya Shlok no-

1611 page no- 86

54 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Nidansthan Published by Chaukhamba

Page | 150

Sanskrit SansthanVaranasi Vatvydhinidansa Adhaya Shlok no183 page

no- 304

55 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Chaukhamba Sanskrit SansthanVaranasi Sharirsankhyavaykaransharir

Adhaya Shlok no-532 page no61

56 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sutrasthan published by

Chaukhamba Orientalia Tristaisniya adhaya Shlok no 1120 page no-

163

57 P Hazarika Dr Nayaka R Balkrishnan Textbook of EarNoseThroat and

Head-Neck Surgery CBS Publication Anatomy of Ear

58 DrKB Bhargava DrSKBhargava DrTMShaha A short book of ENT

Diseases Published by Usha Publication 10th edition page no10

59 MrSalah Mansour MrJacques MagnanMr Hassan Haidar MrKaren

Nicolas MRStephan Louryan Comprehensive and clinical anatomy of the

Middle Ear Published by Springer publication Chapter -Middle Ear cavity

Page no 19 to 121

60 DrPLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition Diseases of external ear

Chapter no 7

61 James OPickles An introduction to Physiology of Hearing Published by

Emerald publication 4th edition page no- 1 to 265

62 Raja Radhakantadeva Shabdakalpadruma Naga PublicationsDelhi 3rd

edition -2006 Volume 2 Page no 42

63 VdBramhand Tripathi Ashtanghradaya Uttarsthan Published by

Chaukhamba prakashana 2005 Karnaroga vigyniyam adhaya Shlok

no1713 page no- 998

Page | 151

64 Acharya Trivedi Raguveer Prasad Ashtang sangrah uttartantra

published by Vaidyanath Ayurveda bhavan pvt Shlok no- 212 page no-

730

65 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya Shlok no

1-2 page no- 309

66 Shree Yadunandanopadhyaya Madhavnidan with madhukosh

teekapublished by Chaukhamba Prakashana

67 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sutrasthan published by

Chaukhamba Orientalia Kiyantshirasiya Adhaya Shlok no 1713 page no-

258

68 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya Shlok no-

6 page no- 310

69 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005 Karnarogavigyniym Shlok no- 1725-26 Page no-

1003

70 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2140 page

no 131

71 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005 Adhyay 18 shlok 35

72 Acharya Trivedi Raguveer Prasad Ashtang sangrah uttartantra

published by Vaidyanath Ayurveda bhavan pvt

Karnarogapratishedhoadhya Shlok no-2211 Page no- 735

73 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Page | 152

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2141 page

no 131

74 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2142 page

no 131

75 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2144 page

no 131

76 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 34 page no- 649

77 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2145page

no 131

78 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 37 page no- 649

79 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2146page

no

80 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya page no-

316

81 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Page | 153

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2143page

no

82 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publication Krnarogadhikara adhaya page no-

318

83 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary

Madhyamkhand Vatkalpana shlok no- 782-83 page no- 137

84 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 72-77 page no- 651

85 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya page no-

316

86 Vd Shree Laxmipatishastri Yogratnakara

87 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

Karnarogadhikara Shlok no- 808182 page no- 652

88 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 83 page no- 652

89 (PDF) Otomycosis A Comprehensive Review (researchgatenet)

90 httpswwwncbinlmnihgovpubmed24948980

91 A Simon Carney Scott-Browns Otorhinolaryngology Head and Neck

Surgery CRC press 8th publication Otitis externa and otomycosis

92 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition Diseases of external ear

Chapter no Page no -

93 wwwguggulipidcomtradhtm

Page | 154

94 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

95 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 1 chapter no-28 page no-

43

96 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009Agaru page

no726-728

97 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishra chapter Karpuradi varga Shlok no-31-

43 Page no- 116

98 httpswwwthiemeinimagecatlogsample_chapter_GOMPpdf

99 (PDF) Chemical Constituents and Pharmacological Activity of Agarwood

and Aquilaria Plants (researchgatenet)

100 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 4 chapter no-2 page no-4

101 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 chapter no-152 Madanpage

no376-379

102 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

103 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 1 chapter no-54 page no-

84

104 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 page no697-699

patol-yawa

Page | 155

105 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

106 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

Dhoompanvidhi page no- 252-254

107 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012Chikitasasthan Shlok

no- 151page no-406

108 httpswwwmdpicom1420-3049232342pdf

109 httpswwwijamcoinindexphpijamarticledownload0610201530

0

Page | 156

BIBILOGRAPHY

Page | 157

1 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

2 Scott-Brown WG Diseases of the EarNose and Throat Landon

Botterworth and co(publishers) Ltd1952 Volume 2

3 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012

4 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009

5 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi commantry

Purvakhand and Madhyamkhand

6 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

7 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-Tatva-

Sandipika hindi commentary Published by Chaukhamba Sanskrit

SansthanVaranasi

8 The Ayurvedic Pharmacopeia of India Ministry of Health and family welfare

department of Ayush Part 1 and part 4

9 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005

10 Acharya Trivedi Raguveer Prasad Ashtang sangrah published by

Vaidyanath Ayurveda bhavan pvt

11 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition

12 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary published by Chaukhamba

Orientalia

Page | 158

ANNEXURE

Page | 159

ANNEXURE- 1

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

CASE RECORD FORM

RESEARCH PROFORMA FOR MS (AYU) DESSERTATION

DEPARTMENT OF SHALAKYATANTRA

NAME -

ADDRESS -

GENDER - AGE - OCCUPATION-

RELIGION - EDUCATION - MARITAL STATUS-

OPD IPD NO-

DATE OF ADMISSIONCOMMESEMENT-

DATE OF DISCHARGECOMPLITION-

DATE OF COUNSELLING-

TEL NO-

CHIEF COMPLAINTS-

PAST MEDICAL AND SURGICAL HISTORY-

TREATMENT HISTORY-

FAMILY HISTORY-

Page | 160

PERSONAL HISTORY-

a) Ahar(Diet)

b) Vihar

c) History of addiction

GENERAL EXAMINATION

PULSE - MIN BP - mm of hg

TEMP - 0F RR - MIN

ASHATAVIDHA PARIKSHANA

Nadi- Mutra- Mala-

Jivha- Shabda- Sparsha-

Drik- Aakruti-

SYSTEMIC EXAMINATION

RS ndash

CNS-

CVS ndash

Page | 161

LOCAL EXAMINATION (KARNA PARIKSHAN)

OBSERVATION TABLE FOR SUBJECTIVE CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching )

RIGHT EAR LEFT EAR

KARNASHASHUKULI

KARNAPUTRAK

KARNAPALI

KARNAKUHARA -

SRAVA

GANDH

VARNA

SWARUPA

KARNAPATALA (TM)

Page | 162

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

Hearing Test

1Renne Test ndash

2 Weber Test -

Examination of Ear-

Pathological Investigation-

Other Examination-

Nidan Panchak-

1Hetu-

2Purvarup-

3Rupa-

4Upashayanupashaya-

5Samprapti

Signature of Guide Signature of Doctor(Researcher)

Page | 163

ANNEXURE 12

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Dhoopana Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization were done as recommended in pharmacy procedure

The raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 were mixed together

in equal quantity to make Agaruwadi churn

STEP 4 - Agaruwadi churn were triturated with appropriate quantity of water

and prepared Varti in GMP Certified Ayurvedic pharmacy Standard aseptic

precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Dhoopana Varti was packed in sterile air packed

container

STEP 6 - Agaruwadi Dhoopan was given with the help of Dhoopan yantra

TREATMENT DETAIL-

Purvakarma -

1 The patient is asked to sit comfortably on chair having sufficient light and

less amount of dust

2 The EAC is cleaned thoroughly by Pichu Varti (cotton swab) to remove the

discharge and other debris

Pradhankarma -

1 The patient is asked to relax completely on the chair

Page | 164

2 Fumes are passed to the ear with Dhoopana Yantra

3 Dhoopana yantra is funnel shaped and its one end will keep the ear covered

for the passage of Dhooma into the ear canal and other end where Agaruwadi

Dhoopana Varti were placed which produces fumes

4 This Dhoopana was given for 5 min

Pashchat karma -

1 The patient were advised to avoid cold refrigerated food drinks cold water

bath cold wind fog and prevent water from entering the ear

(A) Agaruwadi Dhoopana Varti

B) Guggula Dhoopana Varti SOP of it is same as above Agaruwadi Dhoopana

Varti

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Page | 165

ANNEXURE 21

INFORMED CONSENT DOCUMENT

Study Title

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

Introduction

- You are invited to take part in a research study RANDOMSIED COMPARATIVE

CLINICAL TRIAL TO STUDY THE EFFECT OF AGARUWADI DHOOPANA AND

GUGGULA DHOOPANA IN KARNASRAVA

- Before you decide it is important for you to understand why the

research is being done and what it will involve

- Please take time to read the following information carefully and discuss

it with friends relatives and your doctor if you wish

- Ask us if there is anything that is not clear or if you would like more

information

Purpose amp Nature of Study

- In this research project by examine you and ldquoKarnasravardquo (Otomycosis)

disease were treated

- In the part of treatment Agaruwadi Dhoopana or Guggula Dhoopan were

given

- Dhoopana means medicated drug fumes were given in ear with the help of

Dhoopan Yantra

Page | 166

- Treatment was given for 7 days

Study Duration

7days

Participation

- Your participation is entirely voluntary

- If you do decide to take part you were given this information sheet to keep

and be asked to sign a informed consent form

- If you decide to take part you are still free to withdraw at any time and

without giving a reason This will not affect the standard of current or future

medical care you may receive

Confidentiality

- All information which is collected about you during the research were

kept strictly confidential

- Any information about you which is collected from the center will have

your identity in the form of a code number so that it will remain confidential

Benefits Of Study

- The results obtained from this study would be helpful for providing better

quality of treatment amp other essential facilities for Karnasrava (Discharge)

patients

- You will get clinical benefit from the study

Page | 167

Risks Of Study

- In this treatment there are few chances of Irritation of Ear Nose and

congestion at EAC if any of these happens then treatment were given

Results Of Study

- If the Results obtained are profitable then they may get published

without disclosing your details

Signature of patient

Date

Time

Phone no of Researcher

Page | 168

रण मादहती पतरक

सशोिनाच शीषवक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE

EFFECT OF AGARUWADI DHOOPANA AND GUGGULA DHOOPANA

IN KARNASRAVA

परसतताना

- आपणास या सशोिनातपमक अभयासात सहिागी होणय़ाच आाहन करणयात यत आह

- सशोिनातील सहिाग तननदशचत करणयापी सशोिनाच उददश समजन घया

- खालील मादहती काळजीपवक ाचा आणण आशयक ािलयास आपलया डॉकिराशी कका

दहतशरचतकाशी चचाव करा

- काही सददिता असलयास कका आणखी मादहती ही असलयास आमछयाशी चचाव करा

सशोिनाच उददीटि सतरप

- सदर सशोिन परकलपामरधय आपलयाला तपासणी करन कणवसरा या वयाशरिची शरचककतपसा दणयात

यणार आह

- सदर वयाशरिची शरचककतपसा महणन आपणास अगरादी िपन कका गगल िपन

दणयात यणार आह

- सदर औषि आपणास 7 ददस घयायाच आह

Page | 169

कालािी

- 7 ददस

सहिाग

- आपला सहिाग हा पणवपण ऎनदछिक आह

- आपला सहिाग तननदशचत असलयास आपणास ही मादहती पतरतरका दणयात यईल आपणास यातील

समती पतरकार सही कराी लागल

- सहिाग तननदशचत असनही आपण कोणतपयाही ळस कोणतही कारण न दता माघार घ शकता

याचा आपलया दयकीय सविर कोणताही पररणाम होणार नाही

गोपनीयता

- सशोिना दरमयान गोळा कलली आपलया वषयाची सव मादहती गोपनीय ठणयात यईल

- आपली यनदकतक मादहती साकततक सतरपात गोपनीय ठणयात यईल

सशोिनाच फ़ायद

- सशोिनाच तनटकषव कणवसरा बाशरित रणाछया दयकीय इतर सविाचा दजाव सिारणयास

फायदशीर ठरतील

सशोिनातील जोणखम

- य़ा शरचककतपसमरधय कान दखण डॊळय़ातन नाकातन पाणी य़ण नाकात जळजळण डोक जड

होण ही लिण ददस शकतात यापकी लिण तनमावण झालयास तपयाची शरचककतपसा कली जाईल

Page | 170

सशोिनाच तनटकषव

सशोिनाच तनटकषव फ़ायदशीर ठरलयास आपली मादहती गोपनीय ठन परकाशशत करणय़ात यईल

रण सतािरी-

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

Page | 171

ANNEXURE 31

INFORMED CONSENT FORM

Patient OPD no __________

Subjectrsquos Identifier

Date of Birth Age Gender

I _____________________________________ age___________ years

exercising my free power of choice hereby give my consent to be included

as a participant in the clinical study entitled

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

1 I confirm that I have read have been read and understood the information

sheet for the above study and can ask questions

2 I understand that my participation in the study is voluntary and that I am

free to withdraw at any time without giving any reason without affecting my

medical care or legal rights

3 I understand that the Ethics Committee members investigators and study

doctors will not need my permission to look at my health records both in

respect of the current study and any further research that may be conducted

in relation to it even if I withdraw from the trial I agree to his access

However I understand that my identity will not be revealed in information

released to third parties or published

4I agree not to restrict the use of any data or results that arisefrom this study

provided such a use only for scientific purpose

5 I agree to take part in the above study

Page | 172

signature with Date-

Left hand thumb impression

Name amp signature of the witness ndash

Name amp signature of the student ndash

Page | 173

ANNEXURE 32

समतीपतरक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

वयकतीच य

ददनाक जरमददनाक

1) मी ह तननदशचत कररत आह ककसदर सशोिन परकलपाबाबतची सपणव मदहती मी ाचली असनमला ती

समजली आहतपयाबददल मला परशन वचारणयाची पणव मिा आह सदर मादहतीन माझ समािान झाल

आह

2) मी सदर सशोिनातन माझया मजीनसार किीही बाहर पड शकतो या माझया अशरिकाराची मला कलपना

आह

3) माझी दयककय मादहती तपासणयाची कागदपतर कळ सशोिनाकररता ापरली जाणार आहत याची

मला मादहती आहसदर सशोिन परकलपातील सबशरित घिकाना माझी दयककय मादहती पाहणयाची मी

समती दत आहतरावप या सदिावतील माझी ओळख दशववणारी मादहती कोणासही ददली जाणार नाहीयाची

मला कलपना दणयात आली आह

4) सदर अभयासातन शमळणारी मादहती अरा तनटकषव कळ शासततरीय हतसाठी ापरल जाणयासाठी माझी

समती आह

5) रील अभयासात सहिागी होणयास माझी समती आह

रण सतािरी-

Page | 174

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

ASSESSMENT CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching)

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

a) कणवशल ( pain )- 0 - Absent

1 ndash Present

Page | 175

b) कणवकणड (Itching)- 0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

c) कणवसततरा ( Discharge )

0- Absent

1-Mild- Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाशरियव ( conductive Loss of hearing )

0 - Present

1 - Absent

Page | 176

Page | 177

Page | 178

Page | 179

Page | 180

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

Page | 181

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 182

AUTHENTIFICATION CERTIFICATE

Page | 7

PREVIOUS WORK DONE -

1 Anupama Patra B Effect Of Arka Taila In The Management Of

Karnasrava With Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching amp Research in Ayurveda

Gujarat Ayurved University Jamnagar 2007

2 Palmer Komalben K Further Study On Role Of Arka Taila In The

Management Of Karnasrava With Special Reference To

Otomycosis Shalakya Tantra Institute for Post Graduate Teaching amp

Research in Ayurveda Gujarat Ayurved University Jamnagar 2010

3 Sathisha Shankar B Management Of Karnasrava With Sthanika

Guggulu Dhoopana And Rasnaadi Guggulu-A Comparitive Study Shalakya

Tantra Government Ayurvedic Medical College Bangalore 2011

4 Shashikala DK Comparative Study On The Efficacy Of Vacha

Lashunaadi Taila Karna Pichu And Nimba Patraadi Dhoopana In The

Management Of Karna Srava Shalakya Tantra Government Ayurvedic

Medical College Bangalore 2014

5 Javale Anant A Clinical Study On The Efficacy Of Arka Taila In The

Management Of Karna-Srava Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching amp Research in Ayurveda

Gujarat Ayurved University Jamnagar 2005

6 Pournima V Koti Management Of Karnasrava With Priyangvadi Taila

Pichu With And Without Saarivadi Vati Shalakya Tantra Sri Jagadguru

Gavisiddeswar Ayurvedic Medical College Koppal 2015

7 Amisha Patel A Clinical Evaluation Of Honey In The Management Of

Karna Shoola With Special Reference To Otomycosis Shalakya

Tantra Institute for Post Graduate Teaching and Research in Ayurveda

Gujarat Ayurved University Jamnagar 2016

Page | 8

REVIEW OF LITRATURE

Page | 9

Ayurvedic literature Ayurveda is a science of life practice since

thousands of years The ancient Indian system of medicine and surgery is

commonly known as Ayurveda This was given the status of Upaveda or

fifth Veda in the next stage of growth Among the available literature three

Samhita that is Charaka Samhita Sushrut Samhita Ashtang Hrudayam and

Ashtang Samgraha are the chief source of knowledge of Ayurveda

Ayurveda consist of eight branches Shalakyatantra is one among them

Shalakyatantra is one of its specialized branch deals with science of

ophthalmology otorhinolaryngology Oro dental surgery and head Acharya

Sushruta himself a practical surgeon was the first to advocate dissection of

dead bodies is indispensable for a successful student of surgery He had

described gross anatomy in the first chapter of Uttartantra Shalakyatantra

define by different Acharys as follows

शालाकय नामोरधवजतरगताना रोगाणा शरणनयनदनघराणाददसशरशरताना वयाशरिनामपशमनारव

स स ११०

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत [13]

चस १७१२

Shalakya Tantra Nirukti and Parichaya

शलाकायााः कमव शालाकय ततपपरिान शलाकयम डलहण [14]

The term Shalakyatantra is derived from Shalakya and Tantra

The word Shalakya means A probe and Tantra denotes teaching and

practices found in scripturesThe compendium in which application of

Shalaka in various surgical procedures is principally described is called as

Shalakya tantra

दनदटिवशारदााः शालाककनाः डलहण ( सउ ११३)[15]

An eye specialist is termed as Shalaki by Dalhana

Page | 10

Synonyms of Shalakya Tantra

Uttamanga Chikitsa Jatrurdhwa Chikitsa Urdhwang Chikitsa Shalakya

Chikitsa

Importance of Shalakyatantra-

Life of living being and all the Indriyas are situated in the head hence it is

known as Uttamanga

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत

चस १७१२

The treatment given to this part of the body is described specially in

Shalakya tantra While describing the importance of Shiras Vagbhata

correlates it to the root of tree (Urdhwa Mula) and body to the trunk of tree

(Adha Shaka)

Sushruta has deal with Mukha Roga in Nidan Shan and its treatment in

Chikitsasthan The description regarding the disease of eye ear nose and

head are found only in UttaraSthan Sushruta specially describes the

disease of Shalakyatantra as told by Videha in the beginning of Uttartantra

itself[16]

Shalakyatantra Itihas-

India Exhibits traditional of more than thousands of years in art literature

language logic and philosophy etc The convention was in its sophisticated

and advanced attire throughout the Vedic period

Vedic period ndash

1 Natush was treated for deafness by Ashwinikumars (Rigveda)

2 Rujaswa and Kanva were treated for blindness by Ashwani Kumaras

(Rigvedas)

Page | 11

3 There are several prayers mentioned for normal functioning of sense

organs (Yajurveda)

4 Structures and functions of Mastishka are described (Atharveda)

5 Mantras having reference to disease of Eye Ear Oral cavity etc are

found (Atharvaveda)

Upanishada Period ndash

1 Samhita Period

a) Sushrut Samhita ndash

bull Explanation regarding Netra Nasa and Shirorogas (Uttartantra 1-

26th chapter)

bull Details regarding Mukha and Karna Roga Nidan and

Chikitsa(Nidansthan 16th and Chikitsasthan 22nd chapter)

bull Description regarding Karna Chedana Sandhana Nasa

Ostasandhana Sutra Sthan 16th chapter

b) Charaka Samhita -

bull Explanation regarding Shirorogas (Sutrasthan 17th chapter)

bull Explanation of Gala rogas like Upajivika Galshundi and Rohini

bull Nasa Shiro Mukha Karna and Netra Chikitsa (Chikitsa sthan 26th

chapter)

bull Description regarding Lakshana and Chikitsa of Shankhaka

Ardhavbhedaka Shirovirechana and Shiro basti (siddhi sthan 9th

chapter)

c)Ashtnga Sangraha ndash

bull Detailed description regarding Shalakyatantara (Uttartantra 11-28

chapter)

bull Description of Kriyakalpa (Sutrasthan 32nd and 33rd)

Page | 12

d)Ashtang Hrudayam

bull Detailed description on Shalakya Tantra (Uttar tantra 8-24 chapters)

bull Kriyakalpas (Sutrasthan 23rd and 24th chapter)

e) Bhela Samhita

bull Chakshushya Vaisheshik and Buddhi Vaisheshik Alochaka pitta

f) Harita Samhita- Branch of Medical science offering elaborating

information about the procedure like Nasya Anjan Gandusha etc

comprehended with their applications in disease of Head Eyes Ears

Eyebrows Throat Temporal region and cervical spine is known as

Shalakyatantara

शशरोरोगा नतररोगा कणवरोगा वशषताः भरकरठशङकमरयास य रोगा समिनदरत दह १३

तषा परततकारकम व नसतयतपयवणजनातन च अभयङगमखगणडषकियााः शालकयसशमतााः १४

इतत शालाकयनाम [17]

Documentation of different ancient literature gives various references

regarding all aspects of Karnasrava in various periods It is very much

important to know the history of Karnasrava from Vedic Pauranic Samhita

and Samgraha period

Vedic period ndash The Vedas being the oldest source of knowledge have no

direct mentioning of Karnasrava

Page | 13

Samhita and Samgraha period ndash

Aacharya Sushruta described about Karnaroga Karnasrava Nidan

Roopa and Chikitsa The detail description is available in Sushrut

Samhita Uttartantra 20 and 21st chapters

Aacharya Charaka did not specify Karnasrava but mentioned 4 types

of Karnarogas that is Vataj Pittaj Kaphaja and Sannipataja and their

treatment in 26th chapter of Chikitsasthan

In Ashtang Hrudaya karnasrava is not explained as a separate disease

but Chikitsa is mentioned in 18th chapter of Astanga Hrudaya

uttartantra

In Ashtang Samgraha Chikitsa is mentioned in 22nd chapter of Astang

Samgraha Uttartantra

The details about Karnasrava are explained in Bhavprakasha

Madhyamakhanda 64th chapter

Madhavakara has explained about Karnasrava in 57th chapter of

Madhymakhanda

Karnasrava is also explained in Sharangadara Samhita Uttarkhand 11th

chapter

The reference for treatment of Karnasrava is available in

Yogaratnakara

In Gadhnigraha Karnasrava and its treatment is mentioned in

Karnarogadhikara Adhaya

Vangasena had mentioned about the disease and treatment in 69th

chapter

Chakradatta explained Karnasrava in 57th chapter

Dalhana has given commentary on Sushrut Samhita Uttartantra 20th

and 21st chapter

Sankhya Samprapti of Karnasrava ndash

Aachary Sushruta explains 28 Karnaroga in Uttaratantra Karnaroga

Vigyniyam Aadhaya Aacharya charaka explain 4 Karnaroga in

Page | 14

Karnarohvigyniyam Adhaya based on doshas Acharya Vagabhata in

Ashtang Hrudaya explain 25 Karnaroga in Adhyaya

कणवशल परणादशरच बाशरियव कषड ए च

कणवसरााः कणवकणडाः कणव चवसतततर च

कशमकणवपरततनाहौ विशरिदवविसततरा

कणवपाकाः पततकणवसततराशवशरचतवविम

कणावबवद सपतवि शोफशरचावप चतवविाः

ऎत कणवगता रोगा अटिावशततरीररतााः

स उ २०- ३ त ५[18]

ातकणवरोग वपततकणवरोग कफकणवरोग

रकतकणवरोग सनदरनपातकणवरोग कणवनाद

बशरिरतप परततनाह कणडाः शोफ पततकणवक

किशमकणवक उियरपविरधयअशो अबवद

कशरचकणवक वपपपली वदाररका पाळीशोष

ततिका पररपोिो उतपपातो उरमरर दाःखिवन

शलहाखयााः परचवशनदरतकणवरोगा उकतााः

इदिीका अ स उ २१ [19]

चतपाराः कणवरोगााः

च स [20]

Page | 15

KARNA

Karna ndash करोतत शबद गरहण [21]

The organ of hearing

Karnasrava- कणवसतय कणवयोाव ससराा [22]

Discharge from the ear is referred as Karnasrava

KARNA SHAREERA

bull Nirukti

कणयवत अकणयवत अनन इती [23]

It means reception and conduction of sound waves

These are the functions of external and middle ear

bull Nirukti of Sravanam

शरयत अनन इती शरणम[24]

It means perception of sound

It can be attributed to the internal ear function

bull Karna Utpatti-

Karna is an organ formed by Akash Mahabhuta[25]

The fundamental characteristic is as follows

Indriya ndash Srotram [26]

Indriya Adhisthan ndash Karna [27]

Indriya Dravy ndash Akasha [28]

Indriya Arth ndashShabdha [29]

Indriya buddhi ndash Srotobyddhi

Page | 16

bull Paryaya of Karna- Shabdapatha Srotrapatha Sravanam shruti

Kuhuram Dwanigraham etc

bull Definition of Karna-

कणवशटकलयनदछिरनमिटिोपगरदहत शरोतरमछयत [30]

मा तन ५७१

The definition of Karna is stated in Madhav Nidanam Indriya which is not

seen with naked eye along with Shashkuli is called Shrotra that is Karna

Indriya is so minute that it is not perceived with any sense organ

In Charak Samhita the word Karna explain as the Indriya Adhisthan of

Shabdha Karna is described as one of the Prathyangas of the body He

emphasizes that all Indriyas manifest during the 3rd month of gestation

period

Acharya Sushruta while describing formation of Purusha from Prakriti or

Avyakta narrated that all Indriyas are developing from the Vikarika and

Taijas Ahankara Both Vagabhata and Sushruta stated that Karna as one of

the Bahirsrotas

शरण नयन दन घराण गदमढराणण न सततरोताशसराणा बदहमवखातन [31]

स शा ५-१०

In Ashtang Hradaya Vagbhata has states that all Indriyas are Atmaja

According to him lower lobule elevated helix projected posterior portion

fleshy and adherent ear are indications of long span of life[32]

ततरखातखातन दह अनदसतमन शरोतर शबद ववकतता [33]

ा शा ३-३

शबदाः शबदनदरिय सवनदछििसमहो ववकतता [34]

स शा १-२६

Page | 17

Ear has the prominence of Akash Mahabhuta The prominent dosha of ear

is Vata It is important seat of Vata The prominent Dhatus are Asthi and

Mamsa Karna is one of the Panchgnanendriyas and it meant for hearing

Sushruta narrated that Karnasthita Asthi and Sandhi

घराणकणवगरीाकषिकोषष तरणातन [35]

सशा ५-२२

शरोतरशरगािकष शखाताव [36]

सशा ५-३२

गडकणवशखटककम [37]

स शा ५-२२

One Sandhi and one Tarunasthi in ear

Sandhi ndash Karna contain two Sandhi one in each ear Type of Sandhi is

Shankhavartha which is present in Shringataka

Mansapeshi ndash 2[38]

Siras ndash 10 [39]

Vataj Sira - 4

Pittaj sira - 2

Kaphaj sira - 2

Raktaj Sira - 2

Avedhya sira-

कणवयोदवश तासा शबदादहनीनामकका पररहरत

सशा ७-२५[40]

Amongst above mentioned ten Siras each Karna lodges one Shabdavaha

Sira It is Avedhya

Page | 18

Dhamani -2

Length of ear is 4 Angula

Karna moola ndash 2 Angula

कणाविरतर चतदवशअगलम

स शा ३५-१४[41]

The distance between two ears through the back of the neck is 14 Angula

bull Marmas of Karna-

1 Vidhuras-

कणवपटठतो अिाःसशरशरत विर ततर बशरियवम

सशा ६-३७[42]

कणतपयादद सतनायममवणी ककनदचचनदरनममनाकर कलयकररणणच

डलहणाचयव[43]

अिसततात कणवयोतनवमन विर शरततहाररणण

ा शा ४-२९[44]

Sankhya-2

Vistara- frac12 Angula

Type- Snayumarma (Susha)

- Dhamanimarma(AH)

- Vaikalykar

Sthana- It is situated in the depressed portion in the back of the ear

Injury to them causes loss of hearing

Page | 19

2 Shringataka marma-

नदजवहाकषिनाशसकाशरोतरखचतटियसरमम

तालरयासतयातन चतपारर सरोतसा तष ममवस

वदि शरगातकाखयष सददसततपयजतत जीवतम

मा तन ५७१ [45]

Sankhya- 4

Type- Siramarma

Sthana- It is in head that is amidst Siras (blood vessels) nursing sense

organ

A palm size area near Talu

Injury to this Marma causes death

In modern anatomy ear divides into Bhayakarna or External ear Mdhyakarn

or Middle ear Antahkarna or Internal ear This is extremely appropriate

Even though the ear is divided into three divisions in the point of modern

anatomy Ayurveda denotes ear organ is one Ayurveda treats disease by

way of assessing Dosha and Dushya Here Dushya is one that is Karnendria

Dosha difference will call for different treatment for different disease Hence

treating the vitiated Dosha will cure the disease irrespective whether it is in

external middle or internal ear The thought is based on different

fundamental principle from Ayurveda

bull Parts of Karna

In Ayurveda classics detailed description about anatomy of ear is not

available But the various parts are mentioned as follows

Bhayakarna- External ear

Mdhyakarna ndash Middle ear

Antahkarna- Internal ear

Page | 20

द कणवशटकशलक दॊ कणवपतरकौ

च शा 7-11[46]

कणवशटकशलक कणवगतातवकौ कणवपतरकौ त बाहयकणा

चिदतत च शा 7-11[47]

शटकली बाहयपालयाशरिटिानम

डलहन- स शरच 25-1 12[48]

Karna Shashkulika ndash It is also called as Karna Shashakuli Charaka has

mentioned this term while describing different Pratyngas of the body

Acharaya Gananatha sen has given the clarification for it as a pinna or

auricle[49]

Karnapali ndash It is popularly known as lobule of the ear Daivakrita Chidra is

present in it

Karnaputrika- Ayurvedic scholars accepted two terms in this cortex They

are Karnaputrika and Karnaputrika The former is considered as Tragus and

antitragus[50]

Karna Prushtha- It can be taken as the cranial surface of mastoid or

auricle[51]

Karnapeetha- Aacharaya Sushruta firstly mention the term Karnapeetha

It is mentioned first by Sushruta while describing the procedure of

Karnavyadana Vagbhata has mentioned that it is Adhobhaga of Karna

Dalhana has clarified that it is the region above the Karnaputrika that is the

region which is at the bottom of the concha

Karnamoola ndash It can be considered as parotid region[52]

Karna lathika ndashAcharaya Dalhana mentioned lobule as a Karna Lathika

Page | 21

Karnaavatu ndashThis term is used by Sushruta while describing the

measurements of different Angapratyangas where he has mentioned that

the distance between the Karnaavatu is 14 Angul Dalhana has comments

that it can be taken as the distance between two ears from behind[53]

Shabdhavahasrotas ndash It also called as Shabdapatha or Srotapatha The

whole passage through which the sound waves pass can be taken as

Shabdavahasrotas[54]

Shrotashringataka ndash It can be taken as the labyrinth of ear[55]

bull Dosha in context to Karna-

Karna is principal location of Vayu

1 Prana Vayu- Prana Vayu circulating in oral cavity is responsible for

Dehadhruka that is keeping all body parts active Indriyadruka that is

keeping all Dnyanendriya healthy by proper nourishment (Purana) helps in

deglutition of food material and convey the stimulation of Indriyabuddhi

and atma

2 Udana Vayu- Bala(strength) Varna speech singing are its function It

is responsible for facial expressions due to pleasure sorrow anger love

frustration etc in general its circulation and actions are just opposite to

Pranavayu

3 Vyana Vayu- Its principal functions are circulation of Rasa and Rakta

through body and various movements Its main location is Hrudaya Five

types of movements for which it is responsible are expansion contraction

upward downward and oblique other activities are opening closure of

eyelid yawning perspiration During circulation if it gets obstructed due

to Srotodushti it generates disease of that Srotas Vyana Vayu gets vitiated

by disease of Rasa Rakta Oja and Chetanadhatu

Page | 22

4 Samana Vayu- It is circulating in the vicinity of stomach and intestine

and helps in keeping the Jatharagni (digestive juices and enzymes) in

equilibrium Disturbance in Jatharagni precipitates disease

5 Tarpaka Kapha- Entire body functions movements are controlled and

executed by various centers in the brain Sensation perceived by sense

organs is conveyed to Mann and Aatma residing in Hrudaya The motor

signals from them are then conveyed to the functioning

organsKarmendriya through Prana Vayu Shira head is therefore a

location of continuous activities motions of Vata All these centers are in

unctuous Majjadhatu in the Shira For stabilizing this ever-active Vata and

to nourish the Majja dhatu very unctuous Tarpaka Kapha situated in Shira

plays an important role

bull Ayurvedic aspect of sound perception [56]

According to Ayurveda Pratyaksha Dnyan or Perception of any sensation

including Shabda occurs due to interaction of the Karnendriya and the

Indriya- Arth -Karma resulting in Sravana

External Environmental acquaintance with living body is executed by five

sense organs namely Netra Karna Nasa Jivha and Twaka All

Dnyanendriya that is sense organ are Panchmahabhautic combination

Despite this fact every Indrya sense organ perceives object Tanmatra of

that Mahabhuta only from which it is originated from Akash Mahabhuta and

hence perceives Shabd only that is audio perception Shrotrendriya is one

of the principal locations of Vata and its function is to perceive Shabda that

is sound waves This sensation is conveyed through Shabdavahi Dhamanis

to Mana and Atma through Pranavayu and the sequence is responsible for

perception of sound in this way external sound is perceived and interpreted

when Atma is linked with Mann Mann is linked with Indriyabuddhi that is

minute virtual Dnyanendriya located in brain Indriyabuddhi is linked with

Adhishthana with prominent Mahabhuta and lastly with Indriya

ArthShabdatanmatra that is sense object Once this sequence is completed

Page | 23

the meaning of a particular sound is interpreted and understood In this

entire process of perception and interpretation of sound waves Pranavayu

and Tarpaka Kapha located in Shira play extremely important role Hence

the healthy status of all the sense organ depends upon the normal

physiologically homeostatic condition of Pranavayu and Tarpaka Kapha

MANAS

ATAMA

BUDDHI

AHANKARA

ARTHA

Page | 24

EAR ANATOMY

bull Embryology of the Ear [57]

1 The sound conducting apparatus develops from the branchial apparatus

whereas the sound perceptive apparatus from the ectodermal otocyst

2 The pinna develops from the six hillocks around the 1st branchial cleft

3 External auditory canal develops from 1st branchial cleft

4 The outpouching of the 1st pharyngeal pouch gives rise to a proximal

narrow part that forms the eustachian tube and distal dilated part that

forms the middle ear cavity

5 Prussakrsquos space is a potential space lateral to the Shrapnellrsquos membrane

and medically by the neck of malleus that can be involved during the

extension of cholesteatoma

6 Development starts in the 3rd week of the intrauterine life and is

completed by 16th week of intrauterine life Membranous and boney

labyrinth develops from the otic capsule

The Ear is divided into

1 External Ear

2 Middle Ear

3 Internal Ear or the labyrinth

Page | 25

Fig 1 Ear Anatomy

EXTERNAL EAR [58]

The outside ear contains pinna and lobule

Pinna is the noticeable piece of outer ear made from single sheet of yellow

flexible ligament covered by subcutaneous tissue and skin It has two

surfaces average and parallel It is intently disciple to perichondrium on its

sidelong surface while it is somewhat free on average surface Pinna

incorporates tragus helix against helix fossa three-sided scaphoid fossa

incisura terminalis

External auditory Canal ndash It extends from the bottom of the conchea to

the tympanic membrane and measures about 24 mm along its posterior

wallit is S shaped

Parts 1 Cartilaginous part

2 Bony part

Page | 26

Cartilaginous part ndash The outer one third is cartilaginous consist of fibro

cartilage is directed first inward backward and upward It has Fissure of

Santorium The skin of this part of the canal contains hair follicles

sebaceous gland and cruminous gland

Bony part ndash The inner two third part is boney It goes forward downward

and medially skin lined in this part is very thin Isthmus is the narrowest

part of the canal lying medial to junction of bony and cartilaginous part

nearly 5 mm lateral to tympanic membrane

The roof and posterior wall of the external auditory canal shorter than floor

and anterior wall The skin lining the tympanic membrane and boney canal

has a self-cleansing property due to migration of keratin layer of epithelium

from drum towards the cartilaginous portion

Relations- Anteriorly- Temporomandibular joint and parotid gland

Superiorly- Middle cranial fossa

Inferiorly- parotid gland

Posterior- Mastoid antrum mastoid air cells and facial nerve

Nerve supply ndashSensory nerve supply of the external ear The auricle

supplied by fibers of the great auricular nerve (C2 and C3) and lesser

occipital nerve (C2) Auriculo temporal branch of the 5th cranial nerve and

auricle branch of the vagus (Arnoldrsquos nerve) supply external canal Facial

nerve has small sensory contribution on posterior-inferior wall

Tympanic Membrane -It is the partition between EAC and middle ear It

is a thin semitranslucent membrane pearly white in colored lying obliquely

in the medial end of EAC with the angle of 55 It is forming major part of

lateral wall of middle ear Annulus tympanicus is attached at its

circumference to the sulcus The TM is oval shape It measures

approximately 10 mm in vertical diameter and 90 mm in horizontal

diameter

Page | 27

Layers ndash Tympanic membrane consist of three layers

1 Outer Epithelium or cuticular layer which is continuous with skin of

external ear

2 Middle fibrous layer has both circular and radial fibers middle layer

missing in upper part

3 Inner layer- Inner mucosal layer which is continuous with middle ear

mucosa

Parts ndash Tympanic membrane consist of two parts

1 Pars tensa -It is largest part below the malleolar folds The inner

surface at the center attached to the handle of malleus Angle of cone

is most illuminated part in the pars tensa at anteroinferior part of pars

tensa

2 Pars flaccida Sharpnells membrane -it is triangular area above the

malleolar folds which are thin and devoid of fibrous tissue and

annulus It fits into notch of Rivinous

Nerve supply 1 Anterior half of lateral surface Auriculotemporal V3

2 Posterior half of lateral surface Auricular branch of vagus cn 10

3 Medial Surface Tympanic branch of CN 9 (Jacobsons nerve)

Fig 2 Tympanic membrane of ear

Page | 28

MIDDLE EAR [59]

The middle ear or tympanic cavity is an irregular laterally compressed

space within the temporal bone It is filled with air that is supplied to you

from the nasal part of the throat through the ear canal It contains a chain

of mobile bones that connect its side with the medial wall and serve to

transmit vibrations transmitted to the eardrum through the cavity to the

inner ear Including the parapet the vertical and anteroposterior diameters

of the cavity are each approximately 15 mm The transverse diameter

measures about 6mm at the top and 4mm at the bottom Compared to the

eardrum it is only about 2mm The eardrum is limited laterally by the

eardrum medially by the lateral wall of the inner ear It communicates

behind with the tympanic antrum and through it with the air cells of the

mastoid and in front with the auditory canal The middle ear together with

the Eustachian tube aditus antral and mastoid air cells is called the

middle ear cleft It is lined by mucus membrane and filled with air

It is divided into 3 parts

1 Mesotympanum (located in front of the pars tensa)

2 Epitympanum or attic (located above the pars tensa but medial to

Sharpnells membrane and the lateral bony wall of the attic)

3 Hypotympanum (located under pars tensa) The middle ear is like a

hexagonal box with a roof

Carotid or Anterior wall- It separates middle ear cavity from internal

carotid artery The various structure passing through anterior wall of

tympanic cavity

bull Canal of chorda tympani nerve

bull Canal of tensor tympani muscle

bull Eustachian tube

bull Anterior malleolar ligament

bull Anterior tympanic artery

Page | 29

Posterior or mastoid wall ndash The upper part of the back wall shows the

opening of the auditorium Below the auditory is a triangular bony

projection known as the pyramidalis processors The stapedial tendon is

transmitted through the apex of the pyramidalis processes The vertical

portion of the facial nerve descends along the posterior wall until it opens

into the stylomastoid foramen

Roof or Tegmental wall (Pars terminalis)- It is formed by a thin bone

plate called the tegman tympanum that separates the skull and tympanic

cavities It is located on the anterior surface of the rocky part of the

temporal bone near the junction with the temporal shell it extends back to

the roof in the tympanic membrane and anteriorly to cover the half canal

of the tensor tympanic muscle The lateral border corresponds to the

remains of the Petro scaly suture

Floor ndash It is formed by a thin plate of bone which separate middle ear from

the bulb of the internal jugular vein lodged in the jugular fossa

Lateral wall ndash It is formed by tympanic membrane and partly by a portion

of squamous part of the temporal bone It separates the middle ear from

external ear

Medial wall- It separates the middle ear from the inner ear

bull The promontory is the most prominent and convex part formed by the

basal rotation of the cochlea

bull The bony lateral semicircular canal is postero-superior to the promontory

above the oval window

bull The oval window is located between the middle ear and the vestibular

slope of the cochlea It is closed by the stirrup footrest and the annular

ligament

Page | 30

bull The round window is located under and behind the cape The round

window recess is directed to the rear It is closed by the secondary eardrum

and separates the middle ear of the Scala tympani from the cochlea

bull The facial nerve passes through the bony fallopian tube above the oval

window

Mastoid Antrum ndash It is a large space with air in the upper part of the

mastoid and communicates with the attic through the aditus The roof is

formed by the antri tegmen which extends and separates the tympani

tegmen from the middle cranial fossa The lateral wall of the antrum is

formed by a bony plate that is on average 15 cm thick in adults It is

marked externally on the surface of the mastoid by the suprameatal triangle

(MacEwen)

Aditus and Antrum- Aditus is a gap through which the attic communicates

with the antrum The boney prominence of the horizontal canal lies on its

medial aspect even as the fossa incudes to thats attaches the quick system

of incus lies laterally Facial nerve publications simply underneath the

aditus

The mastoid and its air cell system-

The mastoid consists of bone cortex with a honeycomb of air cell

underneath Depending on development of air cell three types of mastoids

have been described

1Well-pneumatized or cellular- Mastoid cells are well developed and

intervening septa are thin

2Diploetic- Mastoid consist of marrow spaces and a few air cells

3Sclerotic or acellular ndash There are no cells or marrow spaces

With any type of mastoid pneumatization antrum is always present In

sclerotic mastoids antrum is usually small and the sigmoid sinus is

anteposed

Page | 31

Depending on the location mastoid air cells are divided into

1 Zygomatic cells (In the root of zygoma)

2 Tegman cell (Extending into tegmen tympani)

3 Perisinus cells (overlying the sinus plate)

4 Retrofecial cells (round the facial nerve)

5 Peri labyrinthine cells (located above below and behind the

labyrinthine some of them pass through the arch of superior

semicircular canal These cells may communicate with the petrous

apex)

6 Peritubal (around the Eustachian tube Along with hypotymoanic

cells they also communicate with the petrous apex)

7 Tip cells (which are quite large and lie medial and lateral to the

digastric ridge in the tip of mastoid)

8 Marginal cells (Lying behind the sinus plate and may extend into

the occipital bone)

9 Squamosal cells (Lying in the squamous part of temporal bone)

Development of Mastoid ndash

The mastoid develops from the scaly petrous bone The petrosquamosal

suture may persist in the form of a bone plate - Korners septum which

separates the superficial squamosal cells from the deep rock cells Korners

septum is surgically important because it can cause problems locating the

antrum and deeper cells and thus lead to incomplete removal of the disease

during mastoidectomy The mastoid antrum can only be reached if Korners

septum is removed

Page | 32

Fig 3 Cross section of Mastoid

Contents of the middle ear

Ossicles ndash Three tiny bones which conduct the sound from eardrum to oval

window

Malleus ndash It is the largest and most lateral ossicle measuring 8 mm in

length It has head neck handle anterior and lateral processes The head

is situated in the epitympanum A lateral process project laterally from the

neck while the handle is firmly fixed to the pars tensa of the ear drum

Incus- It has a body short process and long process The body short

process and long process The body articulate with the head of mallelus in

the attic and the short process project into the attic The long process

projects downwards behind the handle of malleus running parallel to it and

articulate with the head of the stapes via the lenticular process

Stapes ndash It is the smallest ossicle measuring about 35 mm and consist of

head neck footplate and anterior and posterior curcura The footplate of

stapes is held to the oval window by the annular ligament

Page | 33

Muscles ndash

1Tensor tympani ndash It is inserted is a branch of the facial nerve which carries

the sense of taste It is first arch muscle supplied by branch of mandibular

nerve V3

2 Stapedious muscles ndash It is inserted to the neck of stapes It is the second

arch muscle supplied by branch of facial nerve that is nerve to stapedius

Fig 4 Contents of the middle ear

Blood supply of Middle Ear

bull Anterior tympanic branch of maxillary artery which supplies tympanic

membrane

bull Stylomastoid branch of posterior auricular artery which supplies middle

ear and mastoid air cells

Page | 34

Four minor vessels are

bull Petrosal branch of middle meningeal artery runs along greater petrosal

nerve

bull Superior tympanic branch of middle meningeal srtery traversing along

the canal for tensor tympanic muscle

bull Branch of artery of pterygoid carotid

bull Tympanic branch of internal carotid

Lymphatic Drainage of Ear

Lymphatics from the middle ear drain into retropharyngeal and parotid

nodes while those of the Surgical Importance ndash Eustachian tube drain into

retropharyngeal group

1 The middle ear is part of contiguous organs including nose nasopharynx

Eustachian tube and mastoid bone lined by respiratory mucosa Any

respiratory infection or allergy is likely to pass to middle is likely to pass to

middle ear

2 Moreover middle ear suppurative disease may spread to adjacent organs

and produce complication eg Labyrinthitis meningitis facial nerve palsy

etc

3 Lenticular process is vulnerable in suppurative ear diseases and causes

ocular disruption

4 Prussac space is the site of primary acquired cholesteatoma

Page | 35

INNER EAR [60]

Inner ear is divided into two parts

1 Bony Labyrinth

2 Membranous labyrinth

Anatomy of bony labyrinth

It is divided into two parts

1 Vestibule

2 Cochlea

3 Semicircular canal

The vestibule is located between the medial wall of the middle ear and the

lateral to internal acoustic meatus anterior to the semicircular canal and

posterior to the cochlea The vestibule is the central part of the inner ear

On its side is the oval window opening which is closed by the bracket foot

plate The bony cochlea is located in front of the vestibule It has 275 turns

wound around a bony axis called a modiolus The cochlea is about 30 mm

long The hollow center of the modiolus is a spiral canal that contains the

fibers and ganglion cells of the cochlear nerve A thin bony sheet the bony

lamina winda around the modiolus This divides the cochlear duct into two

galleries the Scala vestibuli above and the scala tympani below

There are three semicircular canals superior posterior and lateral They

are semicircular in shape and open into the vestibule One end of the

semicircle is enlarged and is known as the sphere

The membranous labyrinth is in the bony labyrinth It is connected to the

bony labyrinth by fibrous trabeculae and is surrounded by perilymph The

endolymph is located in the membranous labyrinth

Page | 36

The utricle is in the upper part of the vestibule while the saccule is found

below Both the utricle and saccule contain a single sensory patch called

the macula Each macula is covered with a neuroepithelium made up of

neuroepithelium made up of sensory hair cells and support cells these cells

are separated by a basement membrane Fibers of the vestibulo-cochlear

nerve enter the macula and pierce the basement membrane to terminate

at the base of the hair cell or cell bodies The utricle and the saccule with

their macula are called otolith organs Membrane semicircular canals are

the membrane canals of the corresponding bony semicircular canals They

open into the utricle through five openings One end of the opening of each

channel is dilated called the sphere in which the sensory organ of each

channel is located The cross section of the Scala standard looks like a right

angle The base is formed by the basilar membrane Sensory cells are

arranged on the surface of the basilar membrane These sensory cells with

their supporting cells form a complex neuroepithelium called the basilar

papilla or the cortical organ named after an Italian microscopist The

organs of the corti have a gelatinous membrane called the tectorial

membrane and they are supported by the pillar of the corti The cortical

pillars enclose a space called the corti tunnel which contains a fluid called

cortical lymph Vestibule is lies between the medial wall of the middle ear

and lateral to internal acoustic meatus anterior to semicircular canal and

posterior to the cochlea Vestibule is the central part of the internal ear On

its lateral surface is the opening of oval window which is closed by the foot

plate of stapes Boney cochlea lies in front of the vestibule It has 275 turns

coiling around boney axis called modiolus Cochlea is approximately 30 mm

in length The hollow center of the modiolus is a spiral canal containing the

fibers and ganglion cells of cochlear nerve A thin boney sheet the osseous

lamina winda around the modiolus This divides the cochlear canal into two

galleries the Scala vestibuli above and the scala tympani below

Page | 37

Semicircular canals are three in number superior posterior and lateral

They are semicircular in shape and opens into the vestibule One of the

ends of the semicircular is enlarged and is known as ampulla

Membranous labyrinth is situated within the boney labyrinth It is connected

to the bony labyrinth by fibrous trabeculae and is surrounded by perilymph

Endolymph is situated within the membranous labyrinth

The utricle lies in the upper part of the vestibule while the saccule lies below

Utricle and saccule both contain single sensory patch called macula Each

macula is covered by neuroepithelium consist of Neuroepithelium consists

of sensory hair cells and supporting cells these cells are separated by

basement membrane Fibers from the vestibulo cochlear nerve enter the

macula and pierce the basement membrane to end either at the base of the

hair cell or cell bodies The utricle and saccule with their macula are referred

to as otolith organs Membranous semicircular ducts are the membranous

ducts in the corresponding bony semicircular canals They open into the

utricle by five openings One end of the opening of each canal is dilated

called ampulla in which the sensory organ of each canal is located The

cross section of Scala media resembles a right angle Its base is formed by

basilar membrane Upon the surface of the basilar membrane the sensory

cells are arranged These sensory cells with their supporting cells form a

complex neuroepithelium called the basilar papilla or Organ of corti named

after an Italian Microscopist Organ of corti has a gelatinous membrane

called tectorial membrane and they are supported by pillar of corti The

pillars of corti enclose a space called tunnel of corti which contains fluid

called corti lymph

Page | 38

Fig 5 Inner Ear

Blood supply of labyrinth

Labyrinthine artery

Common cochlear Anterior vestibular Artery

Vestibulocochlear artery Main cochlear artery

Cochlear branch posterior vestibular artery

Page | 39

PHYSIOLOGY OF HEARING [61]

A sound signal in the environment is collected by the pinna passes through

external auditory canal and strikes the tympanic membrane Vibrations of

the tympanic membrane are transmitted to stapes footplate through a chain

of ossicles coupled to the tympanic membrane Movements of stapes foot

plate cause pressure changes in labyrinthine fluids which move the basilar

membrane This stimulates the hair cells of the Organ of corti It is these

hair cells which act as transducers and convert mechanical energy to

electrical impulses which travel along the auditory nerve

Thus the mechanism of hearing can be broadly divided into

bull Mechanical conduction of sound (conductive apparatus)

bull Transduction of mechanical energy to electrical impulses (sensory

system of cochlea)

bull Conduction of electrical impulses to brain (neural

Fig 6 PHYSIOLOGY OF HEARING

Page | 40

Conduction of sound

Under the surface of water we cannot hear the sound made in air because

9995 of sound energy are reflected away from the surface of water because

of the impedance offered by it A similar situation exists in the ear when

air-conducted sound must travel to cochlear fluids Nature has

compensated for this loss of sound energy by interposing the middle ear

which converts sound of greater amplitude but lesser force to that of lesser

amplitude and greater force This function of middle ear is called impedance

matching mechanism or the transformer action It is accompanied by

a) Lever action of the ossicles

Handle of malleus is 13 times longer than long process of incus providing

a mechanical advantage of 13

b) Hydraulic action of tympanic membrane

The area of tympanic membrane is much larger than the area of stapes foot

plate the average ratio between the two beings 211 As the effective

vibratory area of the tympanic membrane is only two- thirds the effective

areal ratio is reduced to 141 and this is the mechanical advantage

provided by the tympanic membrane

c) curved membrane effect

Movements of tympanic membrane are more at the periphery than at the

center where handle of malleus is attached This too provides some

leverage

Transduction of mechanical energy to electrical impulses

Movements of stapes footplate transmitted to cochlear fluids move the

basilar membrane setting up shearing force between the tectorial

membrane and hair cells The distraction of hair cells gives rise to cochlear

microphonics which triggers the nerve impulse

Page | 41

Neural pathways

Hair cells get innervation from bipolar cells of spiral ganglion Central axons

of these cells collect to form cochlear nerve which goes to ventral and dorsal

cochlear nuclei From there both crossed and uncrossed fibers travel to

superior olivary nucleus lateral lemniscus inferior colliculus and medial

geniculate body and finally reach the auditory cortex of the temporal lobe

Page | 42

DISEASES REVIEW

करणसराव

Nirukti - करणसय कणवयोाव ससराा [62]

Nidana- Acharya Sushruta and Vagbhata describe the common etiological

factors for the Karnaroga

अशयाय जलिीडा कणवकणडयन मरत

शमथययोगन शसततरसतय कवपतो अरय च कोपन ||

सउ २० १२

1 Avashaya or Pratishaya

(Excessive exposure to cold)

2 Jalakrida

(Excessive swimming)

3 Karnakandunyanum

(Excessive scracing due to itching)

4 Mithyayogena Shatrasya

(Improper instrumentation during wax removal or foreign body removal)

5Shabdasya

(Louder sound for long durationperverted contact of sound)

6 Abhighata (Trauma)

7 Vitiation of Tridoshas

Page | 43

Samanya Nidana according to different Samhita

Vishesh Nidan of Karnasrava

Acharya Charaka has not mentioned any kind of Nidana regarding Karnaroga

but has described Utapati of Karnaroga from Siroroga in Karnasirasym

Adhyaya[67]

शशरोअशिघातादरा तनमजजतो जल परपकादरा अवप विि

सरतत पय शरणॊ अतनलात स कणवससरा इतत परककतीत

सउ २० १०

असस ३७२५ [68]

1 Shiroabhighatat - Head Injury-Fracture of middle cranial fossa

2 Jala nimajjana - CSF otorrhoea fracture of middle cranial fossa

3 Karnaprapaka

4 Karna Vidhradhi -Puyasrava

Sr

no

Samanya Nidana SU AH[63] AS[64] YR[65] MN[66]

1 Avashaya + + +

2 Pratishaya + +

3 Shabdha

mithyayoga

+

4 Shashtra

mithyayoga

+ + +

5 Karnakandooyan + + + + +

6 Jalkrida + + + + +

7 Abhighata + + +

Page | 44

Samanya samprapti

परापय शरोतरशसरा कयावत शल शरोतशस गान

त कणवगता रोगा अटिावशततरीता

सउ २० १२

Due to common and specific etiology factors the vitiated Doshas gets

Sthanasamshraya in Karna and causes Karnasrava It is the stages of

Samprapti were Doshas gets lodged in Srotas and start processes of Dosh

Dushya Sammurchsna Due to Shiroabhighata Jalanimmajana Karna Paka

Karna Vidhradi vitiated Vata Dosha and Karna becomes Avruta by Vata and

results in Karnasrava Normal physiology of Dosha Dhatus and Malas entirely

depends on the normality of Srotas Dosh Dushya Sammurchana or

manifestation of diseases will not take place if only vitiation of Doshas take

place without deformity of Srotas Here in Karnasrava vitiation of Srotas are

Atipravritti Sanga and Vimargagamana take place Atipravritti is being excess

production of fungus Sanga is obstruction in external acoustic canal

Vimargagamana is the propagation of discharge through ear

Vishesh Samprapti

Karnasrava occurs due to Nij nidana is Pratishaya while Agantuja nidanas are

Avashya Jalkrida and Karnakanduyan Due to etiological factors which are

Vata-Kapha provocative in nature gradual vitiation of Doshas will occur After

vitiation they get accumulated (Sthan samshraya) in external auditory canal

In other hand when patient does Sevana of Agantuj Nidan like water enter in

external ear scratching of ear unsterile instrumentation leads to Dosh

Prakopa These cause Twak and Mamsa Dhatu Dushti which leads to

discontinuity of epithelium of ear canal which creates suitable atmosphere for

fungal pathogen to grow The vitiated Vata will produce symptoms such as

Page | 45

pain hearing impairment and vitiated Kapha causes symptoms like itching

discharge ear blockage By assessing the symptoms it can be said that Kapha

Avrita Vata Dosha is responsible for the manifestation of clinical features like

pain itching discharge Which are seen in Karnasrava that is otomycosis

Acharya Charaka has mentioned while explaining Samanya Chikitsa of

Karnaroga that it should be treated like Vrana when Paka and Srava is present

as a symptom Fungal spores invade in the epithelial layer of EAC In response

to infection inflammatory process is start This is a Paka Avastha After

removing the fungal mass ulceration in external acoustic canal is commonly

seen As a result of infection process exudates was produced which will mix

up- with fungal colonies and appear as discharge As per Dosha involvement

in Vrana Shoola Srava can be differ According to Acharya Sushruta Ruk is

the Samanya Lakshana of Vrana and Vishesha Lakshana of Vrana includes

pain discharge discoloration itching etc according to Dosha involvement

which are also seen in otomycosis In otomycosis mainly watery and purulent

type of discharge is present which indicates Paka avastha If there is Dosha

involve in Vrana is called Dushta Vrana Acharya Sushruta and Acharya

Vagabhata have mentioned verity of Srava in Twak and Mamsa Vranavastu

which is found in otomycosis Based on this description otomycosis can be

correlated with Karnasrava

Page | 46

Representing the Samprapti of Karnasrava

Vishesh Nidana ndash Shiroabhighatat

Jala nimajjana

Prapaka Vidhradhi

Vitited vata

Avarana by kapha

Vimargagamana of Vata

Karnasrava

Samprapti Ghataka

Dosha ndash Kapha and Vata

Dushya ndash Rasa Rakta and Mansa

Strotodushti ndash Vimargagamana and Sang

Adhishthana ndash Karna (Bhayakarna)

Rogmarga ndash Madhyama

Page | 47

Purvarupa

The Purvarupa of Karnasrava are not mentioned separately in any ayurvedic

classics In routine practice cretin Purvarupa are noted

1 Karnakandu

2 Karnagurutwa

3 Alpa karnashoola

4 Discomfort in ear

Rupa

1 Karnashoola

2 Karnakandu

3 Karnasrava

4 karnabadhirya

5 Cotton wool like or wet newspaper like grayish brown or black colored mass

is seen

6 External auditory canal skin appears edematous and red

Upashaya and Anupashaya

Appropriate application of Aushadhi Ahara and Vihara when produces relief in

the symptom is called as Upashaya and when aggravates the symptoms is

called Anaupashaya There is not any reference available in the classics about

the Upashaya and Anupashaya of karnasrava

Sadhyasadhyata

Sushruta has not mentioned specially the Sadhyasadhyata of Karnarogas But

Vagbhata has mentioned Karnasrava as a Sadhyavyadhi[69]

Sadhysadhyatagives the clear picture of prognosis of the disease It depends

on many factors like nature of disease severity of disease Vaya Prakriti Bala

of the patient etc

Page | 48

Upadrava of Karnasrava

In Samhita there is no reference available regarding the Upadrava of

Karnasrava

Samanya Chikitsa ndash

The common treatment principle for all Karnaroga is Ghritapana Use of

Rasayana Bhrahmacharya Avyayama Shirasnana and Atibhashaya

सामरय कणवरोगष घतपान रसयनम

अवयायमो शशराःसतनान बरमहचयवम कतपरनम

स उ२१३

Ghratapana - Ghrita is a Yogavahi and follow Sanskara in addition to these

acquired properties and capable of retaining its own properties So Ghritapana

is effective in Karnasrava

Rasayana - Rasayana represent the basic approach of Ayurveda which

comprise preventive promotive and curative aspect of health

Brahmacharyaapalana -It is like Sadvrittapalana and is equals to Rasayana

effect

Vyayama - It leads to vitiation if Vatas a Karna is a Sthana of vata and

exercise causes Kshayaj Samprapti hence it is important to avoid exercise in

Karnasrava

Shirasnana- In Shirasnana water enters in external acoustic canal it changes

the PH of meatus skin from acid to alkali which favors the growth of pathogens

Atibhashya - Excessive speaking causes Vata Prakopa and Vatapraokopa is

basic Samprapti for Karnasrava as the preventive aspect avoidance of

excessive speaking is necessary

Page | 49

Ghritapana Rasayana and Brahmacharyapalana should be followed for

preservation of dhatu Samyata and restriction of vitiation of Vata Vayayama

Shirasnana and Atibhashaya should be avoided in Karnasrava to protect the

Siras from the affliction of Vata and Kapha

Vishesha Chikitsa ndash

The general treatment principle of Karnasrava described in classics is closely

related to Dushtavrana Chikitsa

शशरोवरचन च ए िपन परण तरा

परमाजवन िान च ीकषय ीकषय़ाचारत [70]

स उ २१४०

कणवसततरा ोददत कयावत पततकशमकणवयो [71]

ाउ १८३५

उपददि च सततरोत साय परात वपचततवशि परमजय

य अगर मदन सघत गगलना ा िपतयतपा मिना परयत [72]

असउ २२४२४३

In addition to that Shirovirechana Karnadhoopana Karnapurana

karnapramarjana Karnadhavana are also indicated

Page | 50

Treatment is also mentioned for Karnasrava

1 Karnaprakshalana Yoga - with Aargawadadi Gana Kashaya and Surasadi

Gana Kashaya [73]

2 Avachurnana Yoga ndash with Aargawadadi Gana Churna and Surasadi Gana

Churna[74]

3 Karnapoorna Yoga ndash

bull Rasanjana Laksha with Sarjachoorna[75]

bull Panchkashaya with Kapittha swarasa and Madhu[76]

bull Jambu AmrapallavShivalaKshuodra Mahavriksha and Madhuki all are

taken in equal quantity and Kalka is prepared and 4 times Taila is taken

and 16 parts of Kwatha is added and Taila Paka is done[77]

bull Sarjatwak Choorna with Karpashiphalarasa and Madhu[78]

bull Abhaya LodraTindukaSamanga(Manjista) Kwatha of this Dravyas mixed

with Madhu and Kapittha Rasa[79]

bull Yogratnakara mention the following drugs for Karnapoorana-

a Samudraphena Churna[80]

b Jambwambpatra Yoga

4 Karnadhoopana Yoga ndash

bull Dhoopana with Churna of Bilvapatra Haridra Palandu[81]

bull Vartak Dhoopana [82]

5 Internal Medications-

bull Rasnadi Guggula [83]

bull Triphala Guggula [84]

bull Sarivadi Vati [85]

bull Gandhaka Rasayana [86]

Page | 51

According to Vagbhata-

Ear should be cleaned with the Pichu and Varti followed by Guggula Dhoopana

and then Karnapoorana with Madhu Followed by Avachurnanana with

Sukshmachootana of Surasadigana

Pathyaapathya ndash Pathya and Apathy mentioned for Samanya Karnaroga is

recommended in Karnasrava also

पथय[87]

सतदो वरको मन नसतय िमाः शशरावयिाः

गोिमाः शालयो मदगााः याशच परतन हवाः 80

लाो मयरो हररणानदसततततरो नकककिाः

पिोल शशगर ातावक सतनषराण कदठललकम

रसायनातन सवणण बरमहचयवमिाषणाम |

उपयकत यरादोषशमद कणावमय दहतम ||81||

िापर २१

Aharaja Upacharaja

bull Godhuma bull Vamana

bull Shala bull Virechana

bull Mudga bull Nasya

bull Yava bull Dhoomapana

bull Puranagitra bull Kavala

bull Lava Harina Tittiramamsa

Page | 52

अपथय[88]

दरत काटठ शशरसतनान वययाम शलटमल गर

कणडयन तषारशच कणवरोगी पररतपयजत

िापर २१

Viharaja

bull Patola ShigruVartaka bull Bhramacharaya

bull Sunishannaka bull Avyayama

bull Katthlika bull Aakthanam

bull All types of Rasayana bull Upacharaja

bull Vamana

Apathyas

bull Abhishyandakara Aharas

bull Shirasnana

bull Karna kandooyana

bull Tushara sevana

bull Guru Kaphakaraka Aaharas

bull Dantdhavana

Page | 53

OTOMYCOSIS

Definition-

Otomycosis is a superficial acute sub-acute or chronic infection of external

ear canal It is mostly unilateral It is characterized by inflammation purities

and scaling Otomycosis is a common condition encountered in ENT practice

more in chronic and persistent ear infection

The Fungal infections are not communicable in the usual sense but the

humans become an accidental host by their introduction into tissue trauma

The virulence factors favoring colonization of fungus in human host are yet to

be identified Ability of the fungus to grow at 37 C and elaboration of a variety

of enzymes and toxins are speculated to contribute to virulence Only 100 to

150 species are generally recognized as a cause of disease in humans[89]

Prevalence-

Otomycosis is a word wide in distribution and in various record stated that 5

to 20 of all cases of infective otitis externa Otomycosis prevalent is more in

warm and humid climates It is one of the commonest manifestations in India

during rainy season It occurs mostly in humid atmosphere otitis externa due

to fungal infection may resembles the desquamative form of diffuse infective

otitis externa The incidence in temperature climates has increased in

proportion to the use of topical antibiotics which have a medium sterilized of

other organism in which the fungus may flourish

Page | 54

Predisposing factors- [90]

1 Environmental factors such as climate contagious and polluting hygiene

more frequently during rainy season as the humidity increases

2 Individual susceptibility ndashGeneral Immunological status of the Individual

eg HIV infection Radiotherapy chemotherapy Diabetes mellitus

3 Self-inflicted trauma that is use of pins to clean the itching ear or use of ear

bud to clean the wax

4 Wide spread of topical antibiotics steroid preparations which have medium

sterilized of other organism in which the fungus may grow

5 Failure of defense mechanism in External auditory canal

6 During swimming or head bath water enters in External acoustic canal

causes quantitative and qualitative change in ear wax It causes change in pH

7 Long term use of hearing aids

Pathophysiology ndash

The life cycle of the average mold encountered in the ear may be reckoned

as two weeks and flare ups may be anticipated at such intervals Swimming is

held responsible for infection in many cases The sequence sequence of

pathogenic changes produced by molds in the external ear is as follows ndash

1 Implantation of the organism in external ear

2 Growth of organism follows the rate depending on condition of temperature

moisture or preexisting irritation

3 Invasion of epithelium occurs with attendant itching and discomfort which

may be quite severe

Page | 55

4 Exfoliation of epithelium occurs as nature attempts to overcome the

infection by casting off upper most cells

5 Denudation occurs from exfoliation as the top layers of epithelium are cast

off and the canal becomes filled with debris

6 Superficial ulceration and lizematoid dermatitis results if the pathologic

process goes for enough The changes do not always proceed through the

entire sequence sometimes the molds produce changes of the mildest

imaginable character which may be overlooked[91]

Clinical features -

Symptoms-

1 Irritation and itching ndash Irritation is mostly found when the infective

organism is aspergillus niger There is sensation of discomfort which is more

diffuse in the ear canal then localized in the deeper part Candida infection

causes marked itching In external ear it is intense and worse at night

2 Discharge through ear- Intermittent scanty colorless discharge through

ear Mucus being a fungal metabolic product appears as discharge Excessive

discharge is associated with mixed infection

3 Pain and discomfort ndash Mild to severe pain in the ear occasionally Mostly

seen in cases where ear is infected with Aspergillus flavus mixed infection

with gram negative organism or mixed infection with candida and aspergillus

Headache is sometimes associated with pain

4 Deafness- Varying degree of mild to moderate conductive deafness

5 A sensation of fullness in ear

6 Tinnitus 7 Vertigo

Page | 56

Signs ndash

1 The external acoustic meatus may contain a mass formed of epithelial

debris exudates cerumen and fungus

2 Erythematous external canal

Fungal appearance

A Niger - The color of the mass which is usually grey or black is mainly

determined by the type of fungus concerned Its appearance is like wet

newspaper or blotting paper or a cotton wool It has a peculiar musty odor In

this infection fruiting heads may be seen as black specks in the debris

Occasionally as inactive form occurs in which the canal is lined by mold giving

a fluffy appearance due to the presence of tiny mycelia

Candida ndash Candida infections generally show as white deposits on magenta

colored skin when the debris is removed it rapidly recovers in 24 hrs

The underlying canal skin is often inflamed and granular due to invasion by

fungal mycelia and be seen in all cases In rare cases excoriation and

ulceration with marked extensive shedding of the epithelium and deep

ulceration can be seen usually associated with a flavus and with pathogenic

bacteria[92]

Otoscope Appearance

1 Aspergillus Niger ndash Black headed

2 Aspergillus Fumigators ndash pale blue or green

3 Candida Albicans ndash White- or cream-colored deposits

Page | 57

4 Auricle is normal in most cases In severe cases small ulceration with crust

formation may be present on lateral surface

5 Tympanic Membrane

In most cases it is normal with normal mobility and normal hearing In a few

cases the surface of the tympanic membrane is congested and scaly There is

erosion or ulceration of the external epithelial layer and the membrane itself

may be edematous

Diagnosis

1 Above mentioned symptoms and signs

2 In the stage at which patient with otitis externa usually first present

themselves mycelia threads conidiophors not visible to naked eye may

sometimes be identified with the microscope

3 Confirmed by culture

Page | 58

Fig7 Aspergillus Niger Fig8 Candida Albicans

Fig9 Aspergillus Fumigators Fig 10 Wet Paper like appearance

Page | 59

Treatment

1 Antibiotic or steroid drops should be discontinued if they are being instilled

since long time

2 Removal of fungal mass epithelial debris and discharge from the external

canal or mastoid cavity repeatedly and thoroughly by forcepa or suction or

syringing or cautiously blow a stream of air into the canal through a fine

cannula and dry thoroughly by swabbing liquid petroleum on swab used in

cleaning the ear lessens the burning sensation when metacresy acetate is to

be employed in the subsequent treatment

Furuncle is developed as a complication if there is no gentleness in cleaning

Cleansing may have to be delayed until local sensitiveness is lessened which

can usually be accomplished within twenty-four hours If there is excessive

epithelial debris along with otomycosis then metacresyl acetate which is a

keratolytic in introduction into the external auditory canal on cotton wick and

is allowed to remain for twenty-four hours After twenty-four hours the cotton

wick is removed at which time the canal can usually be cleansed with little

discomfort as the medication is also anesthetic The epithelium of the canal

was white from contact with the drug The top layer was detached and this

epithelial debris can be easily wiped away The wick is reinserted and wet with

metacresyl acetate

The treatment is employed for three to four days in succession and then a

bland application is substituted Icthyol iodine is of value at this stage Iodine

ointment 2 in combination with Tannic acid 2 is also an excellent local

application following cresatin treatment

Next one of the fungicides may be applied

Page | 60

1 Nystin Effective for candida infection but less active against aspergillus

group Nystatin in boric powder consisting of 100000units of nystatingm of

powder 3 times week for 3 weeks

2 Clotrimazole Available as 11 cream or drops or lotions Phenyl

(zchlorophenyl) 1 ndash imidazole ndash methane is a chlorinated trityl imidazol 1

effective against candida and dermatophytes and for aspergilli infection

3 Amphotericin B Available as cream and as 3 solution and 015 drops

for topical application Very effective for candida infection can be fungistatic

or fungicidal

4 Econazole Available as solution (Econazole nitrate) and as cream (1)

Broad spectrum ndash more effective for Aspergillus Also active against some

gram-positive bacteria (Staphylococci and Streptococci and Dermatophytes)

5 Miconazole Highly effective against dermatophytes and candida infections

used as a 21 cream applied once or twice a day for 10 days

6 Gentian violet 21 Available as drops (recently some evidence of

carcinogenicity) Discolors the ear canal and this interfere with clinical

examination

Other topical antifungal agents are ketoconazole Natamycin Tolciclat Bifonas

zole Fenticonzole Oxiconazole Tioconazole ciclopiroxolomine Tolnafate

Haloprogin Flucytosine Acetic acid Whit field ointment selenium sulfide

undcyclenic acid triacetin etc

Page | 61

Minimal length of treatment

A month of drug treatment is usually required because the antifungal agents

used are not sporicidal and it is necessary that the period of treatment covers

germination time It may be advisable to give short gaps in the period of

treatment to ensure all spores have germinated before deciding to terminate

therapy

Prevention

Accomplished by strict attention to the predisposing causes

1 Water should be prevented from entering the ear

2 Avoidance of external ear trauma

3 Use of alcohol medicated or plain in the ears after swimming mercuric

cyanide (15000) in ethyl alcohol (70) is a satisfactory liquid to use

Ear stoppers do no good unless their use is followed by some antiseptic in the

canal Divers exposed to water for long periods of time may also use acidic

alcohol

4 During Summer months with their high humidity special efforts are needed

to maintain ear dry 5 Indiscriminate use of topical antibiotics steroid

preparations should be avoided

Page | 62

DRUG REVIEW

1 GUGGULA

Fig11 - Guggula

Historical review of Guggula [93]

bull Atharvaveda one of the well-known Vedas of Hindus The earliest

reference given by Atharvaveda medicinal and therapeutic properties of

Guggula Guggula has long history of use in Ayurveda

bull Acharya Charaka Sushruta and Vagbhata describe detail regarding the

actions uses and indication as well as the variety of Guggula

Page | 63

bull Various Nighantus (Medical lexicons) were written between 12th and 14th

centuries AD was based on the Ayurvedic literature also describes

Guggula

bull The explanation of word Guggula is that Gunjo Vyadhegurdti Rakshati

which means to relief against different diseases

bull Guggula is the best medicine because it develops through the rays of

hot sun on specific circumstances

bull Guggula has an aromatic odor

गगलो कणवदौगवररधय िपन शरटठमछयत[94]

स उ २२११२

Latin name- Commiphora mukul

Family ndash Burseraceae

Rasa- Tikta Katu

Guna ndash Laghu Rukshasukshma vishada sara

Veerya ndash Ushna

Vipaka ndash Katu

Action- Rasayana Lekhana

Doshaghanta - Tridoshhara

Page | 64

Chemical composition [95]

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Oleoresin-Z-Guggulsterone E-Guggulsterone

Gum- guggulignans 1 and 2 guggula Tetrols mukulol allylcembrol c

27

Guggulusterol 1 2 ans 3 Z and E ndash guggulusterol

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Parts Used ndash Gum oleoresin

Guggula purity test

1 Yellowish brown emulsion is obtained when Guggula is triturated with

water

2 An ethereal solution of the drug attains reddish colour when treated

with br2 vapors and purple colour when moistened with nitric acid

Biochemical action ndash Antiseptic Anti-inflammatory Disinfectant Diuretic

Immunostimulant stimulating expectorant Ant suppurative Antipyretic

Enhance phagocytosis

Karma- Rasayana cardiovascular disease

Page | 65

2 AGARU-

Fig 12 Agaru

Historical review of Agaru [96]

bull The word Agaru literally means the one which is the heaviest and no

aromatic wood is heavier than it Since thousands of years Agaru lsquoThe

wood of Godrsquo has been used for multiple purpose like commercial

medicinal spiritual aromatic historical

bull The medicinal use of Agaru have been recorded in many pieces of India

Greek Roman Chinese Middle eastern and European since ancient times

bull Acharya Charaka used Agaru and pest of Rasna to counteract the effect of

cold in Agraya Dravyas

bull Acharya Sushruta used Agaru as a Dhoopana Dravya along with Guggula

Ral and Shoma in the treatment of Karnasweda and Vrana

Page | 66

Types-

bull Dhanwantsri Nighantu describes Kaleyaka as a type of Agaru

bull Sodhala Nighantu describes three types of Agaru ndash Agaru Krishna

Agaru Kakatunda Agaru

bull Raj Nighantu describes five types of Agaru ndash Krishna Agaru Kasht

Agaru Daha Agaru Mangalya Agaru and Agurusaar

bull Arthashasstra describes three Agaru wood product

1 Jongaka ndash Black or variegated black in colour and having variegated

spots

2 Dongaka ndash Black in color

3 Parasamudraka- Black in colour and smells like Navamallika

अगर उटण कि तपछय ततकत ततकषण च वपततलम

लघ कणाविरोगघन शीत ात कफपरणत

िापर २१ [97]

Family- Thymelaccensis

Latin name- Aquilaria agallocha

Guna- Laghu Ruksha Tikshan

Rasa- Katu Tikta

Vipaka ndash Katu

Virya ndash Ushna

Karma- Sheetaprasasmana Vranaorasadan Tvachya Pittavardhaka

Shirovirechana Mangalya Sugandhik and Rochaka in properties [100]

Krishna Agaru karma- Katu Tikta rasa Ushna Sheeta when applied externally

and Pittahara when taken orally

Page | 67

Chemical Constituents -

Agaru hardwood is rich in essential oil resins alkaloids saponins Steroids

terpenoids tannins flavonoids and phenolic compound Agaru wood

predominantly contains 2-[-2-phenylethy]-4H-chromen-4-one derivatives and

sesquiterpenes Agaru oil contains selinene dihydroselinene agarnol b-

agarofuran vetispira-2(11)valerianol dihydrokaranone and tetradecanoic

acids[99]

Part Used ndash

Heartwood- Dark resinous wood which is formed when the plant becomes

infected with a type of fungus (ascomycetous mold) Species of Aspergillus

fusarium and penicillium are reported to be associated with the development

of infection Prior to infection the heartwood is odorless relatively light and

pale colored however as the infection progresses the tree produces a dark

aromatic resin in the heartwood The infected resin in response to the attack

which results in accumulation of a very dense dark resin in the heartwood

The infected resin embedded wood is known as Agarwood Infection is more

common on the trunk roots and the area when branches divide The formation

of Agarwood starts when the tree attains the age of 20 years On an average

approximately 30 ml oil is extracted from 100 kg of infected Agarwood[98]

Qualities of best Agaru-

It should be black in color

It should be extremely heavy and aromatic

It should be oily in appearance and test

It should be sink in water

It should burn easily with bright flame with a bright flame giving off a pleasant

smell

Page | 68

3 MADANA

Fig 13 MADANA

Madana consist of dried fruit of Xeromphis spinosa It is a deciduous thorny

shrub or a small tree reaching a high up to 9 m and girth about a meter

branches numerous thick and horizontal found in sub-Himalayan tracts[101]

मदनो मिरनदसततकतो ीयोटणो लखनो लघ

ानदरतिदवििीहर परततशयायवरणारतक

रि कटठकफ़ानाहशोथगलमवरणापह[102]

िा पर १६० १६1

Page | 69

Latin name-Randia dumetorum

Familly ndash Rubiaceae

Rasa - Madhura Tikta

Guna-Laghu Ruksha

Virya- Ushna

Vipaka ndash Katu

Karma- Vamana and Lekhana

Chemical Composition-

Essential Oil Valerianic acid Saponin tannin resin [103]

Page | 70

YAWA [104]

Fig 14 Yawa

1 In Samhitakala Aacharya Charaka Acharya Sushruta explain detail about

medicinal properties of Yawa

2The use of Yawa in Aaharya Dravya mainly described by Dhanwantari

Nighantu Raj Nighantu Bhavprakash Nighantu[105]

Macroscopic Description-

Fruit a caryopsis elliptical oblong Ovoid and tapering at both ends smooth

about 1cm long and 02- 03cm wide dorsally compressed and flattened on

the sides with a shallow longitudinal furrow 3-5 ridges having shallow

depression between them grains tightly enclosed and adhering the lemma

and palea pale greenish yellow odor not distinct taste sweetish acrid

Page | 71

Latin Name ndash Hordenum vulgare

Family- Poaceae

Rasa- Kashaya Madhura

Virya- Sita

Vipaka- Katu

Karma- Vatakrt Pittahara Kaphahara Medahara Balya Visrya

SthairyakaraLekhana

Page | 72

PROCEDURE REVIEW [105]

In Ayurvedic classics there are many references regarding Dhoopana Dravya

Dhoopana is administering Dhuma with the help of Dhoopana Dravya

In Kashyapa Samhita there are 40 types of Dhoopana advised for children

Anesthesia (Mohajananam Dhoopa) is also mentioned For this Dhoopana the

drug used were herbs hairs of animals legs horns old cloths of Buddhist

monks

From the references available regarding Dhoopana we can understand that

Karna can be protected from maggots (krimi) Bactria (Rakshogna) lice etc

References clearly indicate the analgesic and disinfectant effect of Dhoopana

Karma Dhoopana is mentioned for Dushta Vrana Chikitsa It reduces Vedana

Srava Pootigandha of Dushtavrana It also helps in Vranaropana

Dushtavrana Chikitsa is mentioned in the treatment of Karnasrava[106]

Origin of Dhoopana-

In ancient period children of sages were constantly harassed by the

Rakshasas Hence the sages approached lord Agni for shelter Agni in turn

gave them Dhoopana Dravya and asked sages to use the Dhoopana for

protection against Rakshasas bhutas pishachas

Classification of Dhoopana

1 It is classified into Dhupa Anudhupa Pratidhupa

2 On the basis of Origin it is classified into Jangama and Sthavara

Selection of Guggula for Dhoopana

Page | 73

bull Guggul is a best Vatahara

bull It is Krimighana

bull It contains Oleoresin

bull In Ashtang Hrudaya Guggula Dhoopana mentioned for Karnasrava

Selection of Agaru for Dhoopana

bull Agaru is Laghu Ruksha Katu Tikshna

bull Vranaorasadan Tvachya

bull It should burn easily with bright flame with a bright flame giving off a

pleasant smell

Karna Dhoopana Indication

1 Karnaarava

2 Putikarna

3 Krimikarna

4Vataj Karnashula

Contraindications

Especially for Karnadhoopan contraindication is not mentioned in classic texts

But Dhoopana is contraindicated in Pittaj vaydhi Sharad and Grishma Rutu

Page | 74

MATERIAL AND METHOD

Page | 75

For randomize comparative clinical trial to study the effect of Agaruwadi

Karnadhoopana and Guggula Karnadhoopana in Karnasrava following material

and method were required

Source of data

Patient irrespective of gender occupation religion social economic status

signs and symptoms of classical features of Karnasrava (Otomycosis) selected

from the OPD of Shalakyatantra department

Materials ndash

1Patients

2 Drugs-Agaruwadi Dhoopana

Guggula Dhoopana

3Torch

4Otoscope

5 Tuning fork

6Jobson horn probe

7Cotton

8Case record form

DRUG

Group A Trial Group

1Churana of Agaru Yawa Madan

2Ghrita

3Jala

Group B Control Group

1Googula Churna

Page | 76

Properties of Drug

Table no 1 Properties of Drug

Drug

Family

Rasa Veerya Vipaka Effect

on

Dosha

Guna Karma

Agaru

(Aquilegria

Agallocha)

Thymelaca

ceae

Katu

Tikta

Ushna Katu KV Laghu

Ruksha

Tikshna

Shitaprashamana

Shothahara

Vedanasthapak

Durghandhihara

Madan

(Randia

spinosa)

Rubiaceace

Kashaya

Madhur

Tikat

Katu

Ushna Katu KV Ruksha

Laghu

Vatakaphaghana

Shothahara

Vedanasthapak

Vranashodhak

Yawa

Poaceae

Hordeum

Vulgare

Kashaya

Madhur

Sheeta Madhur KP Ruksha

Laghu

Vataghana

Vernashodhana

Raktshodhaka

Guggula

Commiphora

Mukul

Burseracea

e

Tikta

Kashaya

Anushna Katu VPK Laghu

Ruksha

Shothahara

Vedanasthapaka

Kandughna

Ghrita Madhura Sheet Madhur VK Snigdha Vataghana

Shothahara

Vedanasthapaka

Page | 77

METHODOLOGY

SELECTION CRITERIA

1)INCLUSION CRITERIA

1 Patients having signs and symptoms of Karnasrava (Otomycosis) ie करणशल

( pain ) करणकणड ( Itching ) करणसतराव ( Discharge )बाधिरण ( conductive Loss of

hearing )

2 Patient from age group 19 to 70 years

3 Any Gender

2)EXCLUSION CRITERIA

1 Patients suffering from any systemic disease like DM TB HTN

2 Chronic suppurative otitis media (CSOM)

3 Acute supportive otitis media (ASOM)

3 Perforation of Tympanic membrane

4 Chronic otitis media

3)WITHDRAWAL CRITERIA

1If patient develops any adverse effect such as irritation pain burning

sensation in ear loss of hearing and such patients was withdrawn from trial

and receive prompt appropriate medical attention

2If patient shows aggravation in symptoms

3If patient refuses to continue with the treatment

Page | 78

STUDY SETTING

Types of study - Randomized Clinical comparative Trial

Place of work - OPD of Shalakyatantra

Duration of study - 18 months

Study Population - Patients of Karnasrava in Shalakyatantra OPD

SAMPLE SIZE CALCULATION

Sampling Method ndash Purposive sampling followed by random allocation in two

groups

Sample size calculation-

n = z2 p (1-p)

d2

Were

n = sample size

P = prevalence of disease=10

z = standard normal variable ie 196

d = error ie005

desired Sample Size would be

n = Z2 P(1-P)d2

= (196)2x (0021) x(0979)(005)2

= 34

Visiting ENT OPD (ShalakyaTantra) and IPD (ShalakyaTantra) 21 = 34

n raquo34

So one group includes 34patients

Page | 79

Sampling Method

Total 68 patient of Karnasrava are selected by Purposive sampling followed by

random allocation in two groups Written informed consent is taken prior to

commencement of trial They are divided in 2 groups

Group A (Trial Group) 34 patients treated with Agaruwadi Dhoopana for 7

days

Dose 5 minutes twice in a day

Group B (Control Group) 34 patients treated with Guggula Dhoopana for 7

days

Dose 5 minutes twice in a day

STUDY DESIGN ndash

Open labeled Randomized Comparative Clinical trial

STUDY DESIGN

Screening of patient

Inclusion criteria satisfied Exclusion criteria

Initial assessment Excluded

Counseling of patient Treated accordingly

Patient selection by Simple Random Sampling Method

Page | 80

68 Patients were divided in two groups lsquoArsquo and lsquoBrsquo

Trial group A-34 patients were given

Agaruwadi Dhoopana

Control group B- 34 patients were

given Guggul Dhoopana

Informed written consent

Treatment was given for 7 days

Assessment on 1st 4th and 7th day

Post assessments follow up on 15th day

Observation

Data Collection

Statistical analysis of data

Conclusion

Page | 81

(A) Agaruwadi Varti for group A (Trial group)

Table no 2

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

B) Guggula Varti for group B (Control group)

SOP of it is same as above Agaruwadi Varti

Table no 3

Drug Guggula Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

FOLLOW UP

For both groups follow ups were done on 1st 4th and 7th and post

assessment follow up15th day

EXAMINATIONS

Torch for Local examination of ear

Otoscope examination

Tuning fork Test

Page | 82

OBSERVATION TABLE

Table no 4

Sr no Subjective criteria Day 1 Day 4 Day 7 Day 15

1 करणशल

(pain)

2 करणकणड

(Itching)

3 करणसतराव (Discharge )

4 बाधिरण (Conductive Deafness)

OBSERVATIONS

a) करणशल (Pain) -

0 - Absent

1 ndash Present

b) करणकणड (Itching) -

0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

Page | 83

c) करणसतराव (Discharge)

0- Absent

1- Mild -Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाधिरण (conductive Loss of hearing)

0 - Absent

1- Present

Observations were carried out before and after completion of treatment and

during each follow up After observations the data collected and presented in

the form of graphs charts and table

Page | 84

TRIAL DRUG

Authentication and standardization of raw drug material done After

authentication and standardizing of raw drug material Agaruwadi Varti was

prepared by Varti as explained in Ayurvedic classics

Method of Varti preparations

Panchavidh Kashaya Kalpana that is five method of pharmaceutical

preparation constitutes the fundamental process of Ayurvedic pharmaceutics

which is well explained in Sushrut Samhita Varti Kalpana is one among them

which can be included in Kalka Kalpana

तीररसतरपतपतीनामपरककव तीत [106]

स डलहण शरच 151

Medicines are powered triturated and given the Varti shape that is like wick

of lamp so it is called as Varti Kalpana

Drug content Agaru Madan Yawa

Route of Administration Local

Dose Two times a day

Duration 7 days

Page | 85

Methodology

Standard operating procedure (SOP) of Agaruwadi Varti

Agaruwadi Varti is prepared according to the classical text

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization was done as recommended in pharmacy procedure The

raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 mixed together in

equal quantity to make Agaruwadi churn

Quantity of each churn is 4 grams all are mixed when the Varti get dry total

weight of Varti was 10gram

STEP 4 - Agaruwadi churn triturated with appropriate quantity of water or

Ghrita and prepared Varti in GMP Certified Ayurvedic pharmacy Standard

aseptic precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Varti was packed in sterile air packed container

STEP 6 - Agaruwadi Dhoopana was given with the help of Dhoopana yantra

Authentication and Standardization of raw drug of Agaruwadi Varti was done

Sterilization was done as recommended in pharmacy procedure Sterile

preparation packed in sterile container of suitable size Under all aseptic

precaution Karnadhoopana given to infected ear

Page | 86

Containers for packaging and their sterilization-

Sterilization of the containers for storing Varties was done by Ethylene Oxide

(Eto) method

Ethylene Oxide (Eto) procedure-

It includes exposure of materials to ethylene oxide gas under vacuum in a

sealed chamber It consists of four primary variables

1Gas Concentration

2Humidity

3Temperature

4 Time

EtO gas is an alkylating agent which disturbs the DNA of microorganism

preventing them from reproducing It penetrates the breathable packaging

and sterilizes all the accessible surface of the product to render products

sterility by alkylation of essentials proteins for cell reproduction

Most Eto sterilization methods involves three different stages These can be

separated into three different on the size or number of devices to treat

1Preconditioning stage-

First products are passed through a preconditioning phase to make

microorganism grow The batch load goes through a well time under a

controlled environment of temperature and humidity

2Sterilizer stage-

Performed using process phase specially designed to provide the required level

of EtO exposure to assure sterility for a device or family of devices

3Degasser Aerration stage-

Finally products need to go through a degassing phase to remove any residual

particles of Eto The batch load goes over well time under a temperature-

controlled environment

The sterile containers were then used to store Agaruwadi Varti and handed to

patients included in the study

Page | 87

Packing of Agaruwadi Varti

The ETO sterilize plastic container were used for packing of Agaruwadi Varti

Varti was filled into these sterilize containers (7 in each) In an aseptic

environment plugging and capping was done under aseptic precautions In this

way packing of Agaruwadi Varti done These Varti were given to patient and

advise to take two times a day under all hygienic precautions

History and Examination

bull Proper history and presenting complains was recorded on case record form

bull Ear examination with otoscope was done during initial assessment and each

follow up

bull Otoscopic examination was done during initial assessment and each follow

up

bull Systemic Examination that is Blood Pressure Temperature Respiration

rate Pulse was recorded on case record form

Page | 88

Raw material

Fig14 यव चरण Fig15 मदनफळ चरण

Fig16 अगर चरण Fig17 गगगळ चरण

Page | 89

Preparation of Agaruwadi Varti

Fig18 Preparation of Agaruwadi Varti

Fig19 अगरवादी वरती

Page | 90

Fig20 Instruments used for examination of Karnasrava

Fig19 Karnadhoopana Yantra

Page | 91

Karnadhoopana Procedure

Fig 22 Karnadhoopana Procedure

Page | 92

OBSERVATIONS AND RESULTS

Page | 93

BASED ON DRUGS

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 94

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

AUTHENTICATION CERTIFICATE

Page | 95

BASED ON STASTICIAL ANALYSIS OF DEMOGRAPHIC DATA

68 patients of Karnasrava ndash Otomycosis

Table no 5

No of Patients Total

Group A Group B

Registered 38 37 75

Completed 34 34 68

Discontinue 04 03 07

Total 68 patients were enrolled in study 38 patients registered in group A

amongst them 34 patients completed the treatment and04 patients

discontinued the treatment However in group B 37 patients completed the

treatment and 03 patients discontinued the treatment out of 37 registered

patients

Hence the total number of patients registered in the present study was 75

and out of which 68 patients were discontinued the treatment So they

dropped out from the study While 68 patients were successfully completed

the treatment So observations and result of 68 patients were given below

Here we are going to discuss the statistical analysis of the data obtained in

the form of master chart that was prepared in accordance with the data

collected from the patients that had been included in the study The purpose

of statistical analysis was to analyzed the relation between age gender

occupation diet addiction and education

Page | 96

1 Age wise distribution of patients

Table no 6

In trial group 10 (29412) patients were from age group 18-25 years 14

(41176) patients were from age group 25-35 years 8 (23529) patients

were from age group 35-45 years and 2 (58824) patients were from age

group 45-60 yearsIn control group 6 (17647) patients were from age group

18-25 years 14 (41176) patients were from age group 25-35 years 7

(20588) patients were from age group 35-45 years and 7 (20588)

patients were from age group 45-60 years

Fig 23 Age wise distribution of patients

0

2

4

6

8

10

12

14

15 -25 25-35 35-45 45-60

10

14

8

2

6

14

7 7

Age Distribution

Trial Group N Control Group N

Age Distribution

Trial Group Control Group

N N

18 -25 10 29412 6 17647

25-35 14 41176 14 41176

35-45 8 23529 7 20588

45-60 2 58824 7 20588

Total 34 100 34 100

Page | 97

1 Gender wise distribution of patients

Table no 7

Sex

Trial Group Control Group

N N

Female 23 67647 15 44118

Male 11 32353 19 55882

Total 34 100 34 100

In trial group 23 (67647) patients were female and 11 (32353) patients

were male

In Control group 15 (44118) patients were female and 19 (55882)

patients were male

Fig 24 Gender wise distribution of patients

0

5

10

15

20

25

N N

TRIAL GROUP CONTROL GROUP

23

15

11

19

Gender

Female Male

Page | 98

2 Education wise distribution of patients

Table no 8

Education

Trial Group Control Group

N N

Illiterate 4 11765 3 88235

SSC 4 11765 3 88235

HSC 8 23529 9 26471

Graduation 16 47059 10 29412

Primary 1 29412 3 88235

Post-Graduation 1 29412 6 17647

Total 34 100 34 100

In trial group 4 (11765) patients were illiterate 4 (11765) patients were

SSC educated 8 (23529) patients were HSC educated 16 (47059)

patients were graduated 1 (29412) patients were primary educated and

1(29412) patients were post graduated

In control grou 3 (88235) patients were illiterate 3 (88235) patients

were SSC educated 9 (26471) patients were HSC educated 10 (29412)

patients were graduated 3 (88235) patients were primary educated and

6 (17647) patients were post graduated

Page | 99

Fig 25 Education wise distribution of patients

0

2

4

6

8

10

12

14

16

ILLITERATE SSC HSC GRADUATION PRIMARY POST GRADUATION

4 4

8

16

1 1

3 3

910

3

6

Education

Trial Group N Control Group N

Page | 100

3 Occupation wise distribution of patients

Table no 9

Occupation

Trial Group Control Group

N N

Accountant 1 294 2 588

Housewife 11 3235 8 2353

Engineer 1 294 1 294

Job 1 294 4 1176

Labor 1 294 3 882

Mess 1 294 0 000

Naturotherapyst 1 294 0 000

Pharma 1 294 0 000

Shopkeeper 4 1176 2 588

Singer 1 294 0 000

Student 8 2353 4 1176

Tailor 1 294 1 294

Teacher 1 294 1 294

Worker 1 294 3 882

Farmer 0 000 1 294

Lab Tech 0 000 1 294

Page | 101

Daily Collection 0 000 1 294

Fruit seller 0 000 1 294

Bus Driver 0 000 1 294

Total 34 10000 34 10000

In trial group 11 (3235 ) were housewife 8(2353) were students

4(1176) were shopkeeper 1(294) was accountant 1(294) was

engineer 1(294) was doing job 1(294)was labour 1(294) was

catering 1(294) was Naturotherapyst 1(294) was Pharma 1(294)

was Singer 1(294) was Tailor 1(294) was Teacher and 1(294) was

worker

In Control group 8 (2353)were housewife 4(1176) were students

2(588) were shopkeeper 2(588) was accountant 1(294) was

engineer 4( 1176) was doing job 3(882)was labor 1(294) was

Farmer 1(294) was Lab tech 1(294) was Daily collection 1(294)

was Tailor 1(294) was Teacher and 3(882) was worker 1(294) was

Fruit seller and 1(294) Bus driver

Fig 26 Education wise distribution of patients

0

2

4

6

8

10

12

1

11

1 1 1 1 1 1

4

1

8

1 1 10 0 0 0 0

2

8

1

43

0 0 02

0

4

1 13

1 1 1 1 1

Occupation

Trial Group N Control Group N

Page | 102

4 Religion wise distribution of patients

Table no 10

Religion

Trial Group Control Group

N N

Hindu 31 9118 33 9706

Muslim 3 882 1 294

Total 34 10000 34 10000

In trial group 31 (9118) patients were Hindu and 3 (882) patients were

Muslim

In control group 33 (9706) patients were Hindu and 1 (294) patient

were Muslim

Fig 27 Religion wise distribution of patients

0

5

10

15

20

25

30

35

N N

TRIAL GROUP CONTROL GROUP

3133

31

Religion

Hindu Muslim

Page | 103

5 Diet wise distribution of patients

Table no 11

Diet

Trial Group Control Group

N N

Veg 14 4118 20 5882

Non-Veg 20 5882 14 4118

Total 34 10000 34 10000

In trial group 14 (4118) patients were vegetarian and 20 (5882)

patients were Non vegetarian

In control group 20 (5882) patients were vegetarian and 14 (4118)

patients were Non-Veg

Fig 28 Diet wise distribution of patients

0

5

10

15

20

N N

TRIAL GROUP CONTROL GROUP

14

2020

14

Diet

Veg Non Veg

Page | 104

6 Addiction wise distribution of patients

Table no 12

Addiction

Trial Group Control Group

N N

None 30 8824 27 7941

Alcohol 2 588 0 000

Tobacco 1 294 2 588

Mishri 0 000 1 294

Smoking 1 294 4 1176

Total 34 10000 34 10000

In trial group 30 (8824) patients have no addiction 2 (588) patients

have addiction of alcohol 1 (294) patients have addiction of Tobacco 0

(0) patients have addiction of Mishri and 1 (294) patients have addiction

of smoking

In control group 27 (7941) patients have no addiction 0 (0) patients

have addiction of alcohol 2 (588) patients have addiction of Tobacco 1

(294) patients have addiction of Mishri and 11 (1176) patients have

addiction of smoking

Page | 105

Fig 29 Addiction wise distribution of patients

0

5

10

15

20

25

30

NONE ALCOHOL TOBACCO MISHRI SMOKING

30

21

01

27

0

21

4

Addiction

Trial Group N Control Group N

Page | 106

Statistical Analysis and Results

Effect of study on Karnashoola-

Table no 13

Karnashoola

Group A Group B

BT AT BT AT

N N N N

Grade 2 0 000 0 000 0 000 0 000

Grade 1 30 10000 7 2333 32 10667 5 1667

Grade 0 4 1333 27 9000 2 667 29 9667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 30 Effect of study on Karnashoola

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

30

7

32

54

27

2

29

Karnashoola

Grade 2 Grade 1 Grade 0

Page | 107

Table no 14

Karnashoola Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 088 100 033 006

969 2829E-

08 7667 HS

AT 021 000 041 007

Group

B

BT 094 100 024 004

1037 7103E-

11 8438 HS

AT 015 000 036 007

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 31

000010020030040050060070080090100

BT AT BT AT

GROUP A GROUP B

088

021

094

015

Karnashoola

Mean

Page | 108

Table no 15

Karnashoola

Mean SD Effect

Group

A

Group

B Trial Control Trial Control

Day 1 088 094 033 024 000 000

Day 3 065 071 049 046 2667 2500

Day 5 024 038 043 049 7333 5938

Day 14 021 015 041 036 7667 8438

000

010

020

030

040

050

060

070

080

090

100

Day 1 Day 3 Day 5 Day 14

Karnashoola

Mean Group A Mean Group B

Page | 109

Table no 16

Karnashoola N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3250 110500

510000 275 Control group 34 3650 124100

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 110

Effect of study on Karnakandu

Table no 17

Karnakandu

Group A Group B

BT AT BT AT

N N N N

Grade 3 7 2333 0 000 4 1333 0 000

Grade 2 18 6000 0 000 18 6000 0 000

Grade 1 7 2333 7 2333 10 3333 15 5000

Grade 0 2 667 27 9000 2 667 19 6333

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 32 Effect of study on Karnakandu

0

5

10

15

20

25

30

N N N N

BT AT BT AT

GROUP A GROUP B

7

0

4

0

18

0

18

0

7 7

10

15

2

27

2

19

karnakandu

Grade 3 Grade 2 Grade 1 Grade 0

Page | 111

Table no 18

Karnakandu Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 188 200 081 015

1091 3119E-

10 8906 HS

AT 021 000 041 007

Group

B

BT 171 200 076 014

1032 4746E-

09 7414 HS

AT 044 000 050 009

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Page | 112

Fig 33

Table no 19

Karnakandu

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 188 171 081 076 000 000

Day 3 126 118 057 058 3281 3103

Day 5 071 074 046 051 6250 5690

Day 14 021 044 041 050 8906 7414

000

020

040

060

080

100

120

140

160

180

200

BT AT BT AT

GROUP A GROUP B

188

021

171

044

Karnakandu

Mean

Page | 113

Table no 20

Karnakandu N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 4051 137750

373500 006 Control group 34 2849 96850

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is less than

005 Hence we conclude that there is significant difference between Trial

Group and Control Group

000

020

040

060

080

100

120

140

160

180

200

Day 1 Day 3 Day 5 Day 14

Karnakandu

Mean Group A Mean Group B

Page | 114

Effect of study on Karnasrava

Table no 21

Karnasrava

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 11 3667 0 000 8 2667 0 000

Grade 1 23 7667 3 1000 26 8667 2 667

Grade 0 0 000 31 10333 0 000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 34

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

11

0

8

0

23

3

26

20

31

0

32

Karnasrava

Grade 3 Grade 2 Grade 1 Grade 0

Page | 115

Table no 22

Karnasrava Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 132 100 047 009

1122 4356E-

13 9333 HS

AT 009 000 029 005

Group

B

BT 124 100 043 008

1130 9364E-

14 9524 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 35

000

020

040

060

080

100

120

140

BT AT BT AT

GROUP A GROUP B

132

009

124

006

Karnasrava

Mean

Page | 116

Table no 23

Karnasrava

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 132 124 047 043 000 000

Day 3 100 100 025 025 2444 1905

Day 5 047 038 051 049 6444 6905

Day 14 009 006 029 024 9333 9524

000

020

040

060

080

100

120

140

Day 1 Day 3 Day 5 Day 14

Karnasrava

Mean Group A Mean Group B

Page | 117

Table no 24

Karnasrava N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3535 120200

549000 655 Control

group 34 3365 114400

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 118

Effect of study on Karnabadhirya

Table no 25

Karn

Badhirya

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 0 000 0 000 0 000 0 000

Grade 1 13 4333 0 000 16 5333 2 667

Grade 0 21 7000 34 11333 18 6000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 36

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 00 0 0 0

13

0

16

2

21

34

18

32

Karnabadhirya

Grade 3 Grade 2 Grade 1 Grade 0

Page | 119

Table no 26

Karn

Badhirya Mean Median SD SE

Wilcoxon

W P-Value

Effect Result

Group

A

BT 038 000 049 009

799 7173E-

05 10000 HS

AT 000 000 000 000

Group

B

BT 047 000 051 009

816 0000138 8750 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 38

000

005

010

015

020

025

030

035

040

045

050

BT AT BT AT

GROUP A GROUP B

038

000

047

006

Karnbadhirya

Mean

Page | 120

Table no 27

Karn

Badhirya

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 038 047 049 051 000 000

Day 3 009 006 029 024 7692 8750

Day 5 003 006 017 024 9231 8750

Day 14 000 006 000 024 10000 8750

000

005

010

015

020

025

030

035

040

045

050

Day 1 Day 3 Day 5 Day 14

Karn Badhirya

Mean Group A Mean Group B

Page | 121

Table no 28

Karn

Badhirya N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3400 115600

561000 806 Control

group 34 3500 119000

Total 68

Page | 122

COMPARISION BETWEEN GROUP A AND GROUP B

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Table no 29

Overall Effect

Trial Group Control Group

N N

Marked Improvement 21 6176 16 4706

Moderate Improvement 8 2353 13 3824

Mild Improvement 4 1176 5 1471

No Change 1 2941 0 0

TOTAL 34 100 34 100

Fig 39

0

5

10

15

20

25

MARKED IMPROVEMENT

MODERATE IMPROVEMENT

MILD IMPROVEMENT NO CHANGE

21

8

41

1613

5

0

Overall Effect

Trial Group N Control Group N

Page | 123

DISCUSSION

Page | 124

Discussion is nothing but the logical reasoning of observations In

every research work discussion part is very important because it brings into

light about the logical analysis which are helpful in filling the research gap in

the scientific world

The discussion is categorized into following ways for the ease of

understanding

1 Discussion on selection of topic

2 Discussion on review of literature

3 Discussion on drugs their mode of action on the disease mode of action

of Karnadhoopana

4 Discussion on observation and results

1 Discussion on selection of topic

Otomycosis is commonly encountered in day-to-day practice Majority

of Indian people affected with this pathology This disease commonly

manifests in developing countries low socio-economic standard and lack

of hygiene Now a days due to busy lifestyle people are not able to follow

the proper instruction of care of ear which may be responsible for the

recurrent nature of disease So for the management of this we use

Karnadhoopana with the help of Agaruwadi Varti Dhoopana is simple

easy cost-effective procedure which can be done even at OPD levelso

for the disease Karnasrava we selected Karna Dhoopana as therapeutic

procedure Karnadhoopana was done with Agaruwadi Varti and Guggula

Varti which was very effective for treatment

Page | 125

2 Discussion on review of literature

Karnasrava is one such disease among 28 Karnarogas mentioned by

Acharya Sushruta in the chapter named Karna Roga Vigyana Acharya

Charaka included Karnasrava as symptom under the four types of

Karnarogas due to vitiation of different doshas Acharya Vagbhata has

not described Karnasrava separately It is a fact that systemic

description of Karnarogas is available in all the ancients of pus from a

Vata afflicted ear may results from head injury or immersion in water

Karnasrava is a clinical entity which can be correlated with Otomycosis

Karnasrava is explained as symptom as well as a disease in Ayurveda

Nidana- Karnasrava occur due to Samanya Nidana and Vishesh Nidana

Vishesh Nidana like Shirobhighata Nimmajato jale Mithyayoga of Shashtra

The exact pathology behind Karnasrava is not understood clearly

Purvarupa ndash No specific Purvarupa are found for Karnasrava in classical

literature Acharya Madhukara describe Purvarupa as expression of

Rupa(lakshana) with less intensity that is less intensity itching sound in ear

may considered as Purvarupa of Lakshana

Samprapti- Aacharya Sushruta not explained the Samprapti of Karnasrava

separately and we must consider the general Samprapti of Karnaroga Due to

various aetiologias as cited above ear afflicted by Vata dosha causes Twak

Rakta Mamsa dushti results in Karnasrava According to Acharya Sushruta

Vata-Kapha dose is dominance in Karnasrava

Page | 126

Nidan

Nija Agantuja

Vata ndash kapha prakopak nidana Shirobhighata Nimmajato-jale

Mithya yoga of Shastra

Vata- kapha Prakopaka(Chaya prakopak) Vata-kapha prakopaka

( Achay prakopak)

Twak Rakta Mamsa dushti

Karnasrava

Page | 127

Chikitsa

The curative aspect and this must be done simultaneously giving due

importance to Nidan Parivarjana that is preventive measures So Nidan

Parivarjana that is avoidance of causative factors like Jalkrida Mithyayogen

shashtrasya Karnakandu Shirasnan Pratishaya is the first step in combating

the disease and form the part of line of treatment

Above Samprapti helps us to proceed towards the treatment of Karnasrava

The main protocol of treatment is removal of fungus and wound management

which include various measures to keep area day clean clear of microbes and

providing ideal condition for healing

Samany Chikitsa- Acharya Sushruta described general treatment for

Karnaroga as Snehapana (Drinking ghee) Rasayana (Rejuvenation therapy)

Bhramacharya Avoid excessive speaking Avoidance of physical exercise and

head bath

Vishesha Chikitsa ndash Acharya Sushruta mentioned some procedures in the

treatment of Karnasrava which is Shirovirechana Karnadhoopana

Karnapurana Karanpramarjana Dhavan Avachurnana Karnapurana Above

various procedures described in Ayurveda for management of fungus growth

in ear discharging ear fulfill these requirements of wound management

Page | 128

Discussion on observation and Result

Out of 68 patients 34 patients included for the trial The incidence of

Karnasrava is observed in trial and control groups

The statistical analysis provided the following data

AGE

Trial group- Maximum no of patients that is 14 (41176) patients were from

age group 25-35 years followed by 29412 patients were from age group

18-25 years 23529patients were from age group 35-45 years and

58824 patients were from age group 45-60 years

Control group - Maximum no of patients that is 14 (41176) patients were

from age group 25-35 years followed by 20588 patients were from age

group 35-45 years and 20588 patients were from age group 45-60 years

17647 patients were from age group 15-25 years

The maximum no of cases of Karnasrava found in age group between 25 to

35 years The reason behind this is repeated use of ear bud or emersed water

in ear More use of earphone or working more in cold environment

GENDER

Trial group ndash A higher prevalence seen in females 6764 and 3235 in

males

Control group - A higher prevalence seen in males 5588 and 4411 in

females

Females and males both are prone to disease

Page | 129

EDUCATION

Trial group-It is observed that amongst 34 patients maximum ie16

(47059) patients were graduated 8 (23529) patients were HSC

educated 4 (11765) patients were SSC educated 4 (11765) patients

were illiterate 1 (29412) patient were primary educated and 1(29412)

patient were post graduated

Control group- It is observed that 10 (29412) patients were graduated 9

(26471) patients were HSC educated 6 (17647) patients were post

graduated 3 (88235) patients were SSC educated 3 (88235) patients

were primary educated3 (88235) patients were illiterate

There is no direct relation between education and Otomycosis

RELIGION

Trial group- The incidence of patients of Hindu religion are 9118 and Muslim

religion are 882

Control group- The incidence of patients of Hindu religion are 9706 and

Muslim religion are 294

There is no probable explanation for this maximum number of patients in

Hindu religion it depends upon the patients attend the hospital and

community residing there

Page | 130

DIET

Trial group It was found that maximum ie5882 patients were taking

mixed diet while 4118 were taking vegetarian diet

Control group It was found that maximum ie5882 were taking

vegetarian diet while 4118 patients were taking mixed diet

The dietary habit of person is based on choice availability and religious

customs of the person

ADDICTION-

Trial group- It was found that maximum ie 30 (8824) patients have no

addiction 2 (588) patients have addiction of alcohol 1 (294) patients

have addiction of Tobacco 1 (294) patients have addiction of smoking and

0 (0) patients have addiction of Mishri

Control group - It was found that maximum ie 27 (7941) patients have

no addiction 4(1176) patients have addiction of smoking 2 (588)

patients have addiction of Tobacco 1 (294) patients have addiction of

Mishri and 0 (0) patients have addiction of alcohol

Very few patients were addicted to Alcohol Smoking Tobacco and Mishri

These factors can be taken as provoking factors for Otomycosis

Page | 131

Discussion based on probable Mode of action of Karnadhoopana

In Ayurveda classics Karna Dhoopana is therapeutic procedure explain for

Karnasrava Dhoopana is administration of Dhooma (Fumes) with the help of

Dhoopan Dravya References indicates that analgesic and disinfectant effect

of Dhoopana karma and mention for Dushta Vrana Chikitsa It reduces

Vedana Srava amp also does Vrana Ropana action

Various Dhoopanas and Dhoopan Dravas for different element in various

Samhitas of Ayurveda but there is a lacuna of availability of reference

regarding how to do it and method of procedure Matra Kala Contraindication

etc

Currently simple modified way of Karnadhoopana according to Yukti Praman

and experience but there is lac of standardization

Karnadhoopana is one among the topical Bahiparimajan type of treatment

Karna Parmarjana is procedure of cleaning ear with the help of cotton or gauze

piece soaked in honey

Page | 132

Dhoopan

The fumes coming out on burning Agaruwadi Varti

Administrated directly into external ear canal

Causes vasodilation

Due to this increase blood supply in external ear canal

It helps in absorption of drug

Fumes dries up Srava and bring the analgesic effect

Karnagata Kapha amp Avrut Vata Dosha Shaman

Decrease in signs and symptoms like karnasrava Karnshool Karnabadhirya amp

Karnandu

Page | 133

3 Discussion based on probable mode of action of Agaruwadi

Dhoopana

Agaru ndash

I Agaru is a fragrant tree aroma is a result of fungal pathogenesis when the

wood of tree is contaminated by fungi at wounds it develops scrap filled

with resin and turn out to be aroma Medicinal use of Agaru have been

recorded in ancient medicinal science in in inflammatory disease and some

infective disease

II Acharya Charaka has referred to Agaru as an Ushna dravya despite having

Tikta Rasa Ashtang Samgraha used Agaru as Dhupana Dravya along with

Madan and Yawa in Karnasrava Nighantu recommended is use as a

Dhoopana

III In various Samhitas and Nighantus Agaru described as Tikta Snighdha

Sheetaprashamana Vranaprasadana Tvachya Due to these properties

Agaru is used in the treatment of Karna-Akashi Roga and Dushta Vrana

Shodhaka

IV Agaru is reported to have Antimicrobial Analgesic Antioxidants

Antihistaminic and anxiolytic properties Its Antihistaminic property gives

relief from itching which is cardinal feature of Otomycosis Due to Katu

Ushna Tikta Guna improves blood circulation Bheda stage develop It is

Niram Awastha of Dosha Karnagata kapha and vata get decrease and

symptoms like karnashoolakarnasrava get decrease Agaru also have a

Antioxidant properties

V Chemically Agaru Contain 2-(2-Phenylethyl) Chromones Terpenoids

Flavonoids

VI Natural Agarwood had inhibitive activities towards Staphylococcus Aures

The chloroform extract of Agarwood prolongs the pain threshold[108]

Page | 134

Madan

I Madanphala have therapeutic properties like Anti-inflammatory

Antiallergic Analgesic and Wound healing

II It is Useful in treatment of disease like Shotha (inflammation) Vidradhi

(Abscess) Pratishaya (Common cold) Kushta(Skin disease)

III Extract of Madanphala mainly contain Glcosides Tritorpenct

Glycosides Saponin

IV Saponin glycosides are act as fire extinguisher This property is helpful

for vartiIt also act as a detergent which clean the surface of fungus

V Tritorpenct act as a anti-inflammatory antimicrobial and

immunomodulator compound Interaction of glycosides with sterol

causes disturbance of selective permeability in plasmic membraneso

exudates and discharge get decrease

VI Pharmacological activity [109]

Antibacterial Activity The preliminary antibacterial activity of Methanolic

extract of Randia D lam was done on some standard and wild pathogenic

strains The inhibition of the bacterial growth was more pronounced on E coli

as compared to the other tested organism This shows the antibacterial action

of Randia D secondary infection can prevent

Anti-Allergic Activity In Ayurveda Randia D Extract and its fraction of milk

induced leukocytosis and eosinophilia in mice

Anti-Inflammatory Activity The crude methanol extract of fruit of Randia D

effectively reduced the carrageenin induced oedema in hind paw of the rats

significant reduction in granular tissue formation was recorded This activity

seems to be significant at various acute phases of inflammation and om

formation of granular tissue This proves action of Madanaphala in shopa

(inflammation)

Page | 135

Analgesic Activity Analgesic activity was tested in mice weighing between 20-

250 with six number of animals in each group Methanlic extract of fruit Randia

d give analgesic activity in both models This proves its Shoolanashaka (pain

killer) action

Immunomodulatory Activity Randia D has immunostimulant activity and

chloroform fraction which strongly affected immune system seems to be

bioactive fraction of this plant

The overall effect of Agaru Mandanphala Yawa having Anti-inflammatory

Antiseptic Antimicrobial Property Active ingredient shows these properties

Agaru Yawa Madanphala

Vatakaphaghna

Act as

Vranashodhak

Vedanasthapaka

Sheetaprashamana

Shothara

Avarana of Vata get decrease so helps to Shaman of Vata dosha

Karnakandu Karnashoola Karnasrava

Prashamana

Page | 136

This fact can be taken into consideration and probably acknowledge that

Karnadhoopana with Agaruwadi Varti had not leave any residue in the ear

Removal of fibrin keratinocyte migration and in growth of epithelial tissue

plays a major role in healing It is technique of fumigation of ear with the

smoke of anti-infective drug In Karnadhoopana Sthanik Swedana increase the

blood supply and helps in absorption of the drug reduce Karnakandu amp

Karnshoola associated with infection

Page | 137

SUMMARY AND CONCLUSION

Page | 138

The dissertation entitled randomize comparative clinical trial to study the

effect of Agaruwadi Karnadhoopan and Guggula Karnadhoopan In Karnasrava

wsr to Otomycosis

The dissertation is divided into fallowing parts

Introduction

Review of literature

Ayurvedic review

Modern Review

Drug review

Procedure review

Material and Method

Observation and result

Discussion

Summary and conclusion

bull INTRODUCTION

It includes importance of Shalakyatantra in Sushrut Samhita Charka

Samhita And Ashtang Samgraha

Common and specific causes of Karnasrava

Karnasrava is a clinical entity which can be corelate with Otomycosis

In Ashtang Samgraha stated the procedure like Karnadhoopana with

Agaru Yawa Madanphala in Karnasrava

Page | 139

bull REVIEW OF LITERATURE

1 Ayurvedic review

2 Modern review

3 Drug review

Ayurvedic review-

It includes Rachana-Sharir and Kriya-Sharir of Karna detail description of

Karnaroga and its types Karnaroga Samanya hetu Poorvaroopa Rupa

Samprapti Upadrava Pathya-Apathya of Karnasrava Vishesh Nidan and

Chikitsa of Karnasrava Detail description of Karnadhoopana according to

various Acharays have been mentioned

Modern review-

It includes anatomy and physiology of Ear brief anatomy of ear anatomy of

External middle and Internal ear Detail description of the disease

Otomycosis mechanism of fungal infection in external canal pathophysiology

investigations diagnosis and management

Drug review-

Detail description of Agaru Yawa Madan Guggula and its synonyms

Ayurvedic properties Karma uses Pharmacological action and their

pharmacodynamic properties

Page | 140

MATERIAL AND METHOD

It includes description regarding materials required for the study Preparation

of Agaruwadi Varti its Standardization Sterilization and packaging

Plan of study

1 Total 68 patients completed the treatment Age criteria was kept

between 18-60 years Patient selection was done by done by simple

random sampling method and divided into two groups A (Trial) and

Group B (Control) 34 patients in each group

2 Patients in Group A were treated with Karnadhoopana with Agaruwadi

Varti for 7 days two times in a day while patients in Group B were treated

with Karnadhoopana with Guggula for 7 days two times in a day

3 Clinical examination done during each follow up ie 0th 4rd 7th and

observation were recorded

Page | 141

OBSERVATIONS AND RESULTS

Page | 142

1 It was observed that higher incidence of disease Karnasrava ie

Otomycosis found in age group 25-35 years

2 Disease otomycosis was equal in both male and female

3 The trial group there was significant relief in Karnakandu (8906)

Karnasrava(9333) Karnashoola(7667) and karnabadhirya(100)

4 In control group there was significant relief in Karnakandu (7414)

Karnasrava(9524) Karnashoola(8438) and

karnabadhirya(8750)

Page | 143

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Tatva-Sandipika hindi commentary Nidansthan Published by Chaukhamba

Page | 150

Sanskrit SansthanVaranasi Vatvydhinidansa Adhaya Shlok no183 page

no- 304

55 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Chaukhamba Sanskrit SansthanVaranasi Sharirsankhyavaykaransharir

Adhaya Shlok no-532 page no61

56 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sutrasthan published by

Chaukhamba Orientalia Tristaisniya adhaya Shlok no 1120 page no-

163

57 P Hazarika Dr Nayaka R Balkrishnan Textbook of EarNoseThroat and

Head-Neck Surgery CBS Publication Anatomy of Ear

58 DrKB Bhargava DrSKBhargava DrTMShaha A short book of ENT

Diseases Published by Usha Publication 10th edition page no10

59 MrSalah Mansour MrJacques MagnanMr Hassan Haidar MrKaren

Nicolas MRStephan Louryan Comprehensive and clinical anatomy of the

Middle Ear Published by Springer publication Chapter -Middle Ear cavity

Page no 19 to 121

60 DrPLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition Diseases of external ear

Chapter no 7

61 James OPickles An introduction to Physiology of Hearing Published by

Emerald publication 4th edition page no- 1 to 265

62 Raja Radhakantadeva Shabdakalpadruma Naga PublicationsDelhi 3rd

edition -2006 Volume 2 Page no 42

63 VdBramhand Tripathi Ashtanghradaya Uttarsthan Published by

Chaukhamba prakashana 2005 Karnaroga vigyniyam adhaya Shlok

no1713 page no- 998

Page | 151

64 Acharya Trivedi Raguveer Prasad Ashtang sangrah uttartantra

published by Vaidyanath Ayurveda bhavan pvt Shlok no- 212 page no-

730

65 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya Shlok no

1-2 page no- 309

66 Shree Yadunandanopadhyaya Madhavnidan with madhukosh

teekapublished by Chaukhamba Prakashana

67 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sutrasthan published by

Chaukhamba Orientalia Kiyantshirasiya Adhaya Shlok no 1713 page no-

258

68 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya Shlok no-

6 page no- 310

69 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005 Karnarogavigyniym Shlok no- 1725-26 Page no-

1003

70 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2140 page

no 131

71 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005 Adhyay 18 shlok 35

72 Acharya Trivedi Raguveer Prasad Ashtang sangrah uttartantra

published by Vaidyanath Ayurveda bhavan pvt

Karnarogapratishedhoadhya Shlok no-2211 Page no- 735

73 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Page | 152

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2141 page

no 131

74 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2142 page

no 131

75 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2144 page

no 131

76 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 34 page no- 649

77 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2145page

no 131

78 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 37 page no- 649

79 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2146page

no

80 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya page no-

316

81 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Page | 153

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2143page

no

82 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publication Krnarogadhikara adhaya page no-

318

83 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary

Madhyamkhand Vatkalpana shlok no- 782-83 page no- 137

84 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 72-77 page no- 651

85 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya page no-

316

86 Vd Shree Laxmipatishastri Yogratnakara

87 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

Karnarogadhikara Shlok no- 808182 page no- 652

88 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 83 page no- 652

89 (PDF) Otomycosis A Comprehensive Review (researchgatenet)

90 httpswwwncbinlmnihgovpubmed24948980

91 A Simon Carney Scott-Browns Otorhinolaryngology Head and Neck

Surgery CRC press 8th publication Otitis externa and otomycosis

92 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition Diseases of external ear

Chapter no Page no -

93 wwwguggulipidcomtradhtm

Page | 154

94 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

95 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 1 chapter no-28 page no-

43

96 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009Agaru page

no726-728

97 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishra chapter Karpuradi varga Shlok no-31-

43 Page no- 116

98 httpswwwthiemeinimagecatlogsample_chapter_GOMPpdf

99 (PDF) Chemical Constituents and Pharmacological Activity of Agarwood

and Aquilaria Plants (researchgatenet)

100 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 4 chapter no-2 page no-4

101 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 chapter no-152 Madanpage

no376-379

102 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

103 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 1 chapter no-54 page no-

84

104 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 page no697-699

patol-yawa

Page | 155

105 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

106 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

Dhoompanvidhi page no- 252-254

107 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012Chikitasasthan Shlok

no- 151page no-406

108 httpswwwmdpicom1420-3049232342pdf

109 httpswwwijamcoinindexphpijamarticledownload0610201530

0

Page | 156

BIBILOGRAPHY

Page | 157

1 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

2 Scott-Brown WG Diseases of the EarNose and Throat Landon

Botterworth and co(publishers) Ltd1952 Volume 2

3 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012

4 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009

5 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi commantry

Purvakhand and Madhyamkhand

6 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

7 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-Tatva-

Sandipika hindi commentary Published by Chaukhamba Sanskrit

SansthanVaranasi

8 The Ayurvedic Pharmacopeia of India Ministry of Health and family welfare

department of Ayush Part 1 and part 4

9 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005

10 Acharya Trivedi Raguveer Prasad Ashtang sangrah published by

Vaidyanath Ayurveda bhavan pvt

11 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition

12 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary published by Chaukhamba

Orientalia

Page | 158

ANNEXURE

Page | 159

ANNEXURE- 1

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

CASE RECORD FORM

RESEARCH PROFORMA FOR MS (AYU) DESSERTATION

DEPARTMENT OF SHALAKYATANTRA

NAME -

ADDRESS -

GENDER - AGE - OCCUPATION-

RELIGION - EDUCATION - MARITAL STATUS-

OPD IPD NO-

DATE OF ADMISSIONCOMMESEMENT-

DATE OF DISCHARGECOMPLITION-

DATE OF COUNSELLING-

TEL NO-

CHIEF COMPLAINTS-

PAST MEDICAL AND SURGICAL HISTORY-

TREATMENT HISTORY-

FAMILY HISTORY-

Page | 160

PERSONAL HISTORY-

a) Ahar(Diet)

b) Vihar

c) History of addiction

GENERAL EXAMINATION

PULSE - MIN BP - mm of hg

TEMP - 0F RR - MIN

ASHATAVIDHA PARIKSHANA

Nadi- Mutra- Mala-

Jivha- Shabda- Sparsha-

Drik- Aakruti-

SYSTEMIC EXAMINATION

RS ndash

CNS-

CVS ndash

Page | 161

LOCAL EXAMINATION (KARNA PARIKSHAN)

OBSERVATION TABLE FOR SUBJECTIVE CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching )

RIGHT EAR LEFT EAR

KARNASHASHUKULI

KARNAPUTRAK

KARNAPALI

KARNAKUHARA -

SRAVA

GANDH

VARNA

SWARUPA

KARNAPATALA (TM)

Page | 162

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

Hearing Test

1Renne Test ndash

2 Weber Test -

Examination of Ear-

Pathological Investigation-

Other Examination-

Nidan Panchak-

1Hetu-

2Purvarup-

3Rupa-

4Upashayanupashaya-

5Samprapti

Signature of Guide Signature of Doctor(Researcher)

Page | 163

ANNEXURE 12

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Dhoopana Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization were done as recommended in pharmacy procedure

The raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 were mixed together

in equal quantity to make Agaruwadi churn

STEP 4 - Agaruwadi churn were triturated with appropriate quantity of water

and prepared Varti in GMP Certified Ayurvedic pharmacy Standard aseptic

precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Dhoopana Varti was packed in sterile air packed

container

STEP 6 - Agaruwadi Dhoopan was given with the help of Dhoopan yantra

TREATMENT DETAIL-

Purvakarma -

1 The patient is asked to sit comfortably on chair having sufficient light and

less amount of dust

2 The EAC is cleaned thoroughly by Pichu Varti (cotton swab) to remove the

discharge and other debris

Pradhankarma -

1 The patient is asked to relax completely on the chair

Page | 164

2 Fumes are passed to the ear with Dhoopana Yantra

3 Dhoopana yantra is funnel shaped and its one end will keep the ear covered

for the passage of Dhooma into the ear canal and other end where Agaruwadi

Dhoopana Varti were placed which produces fumes

4 This Dhoopana was given for 5 min

Pashchat karma -

1 The patient were advised to avoid cold refrigerated food drinks cold water

bath cold wind fog and prevent water from entering the ear

(A) Agaruwadi Dhoopana Varti

B) Guggula Dhoopana Varti SOP of it is same as above Agaruwadi Dhoopana

Varti

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Page | 165

ANNEXURE 21

INFORMED CONSENT DOCUMENT

Study Title

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

Introduction

- You are invited to take part in a research study RANDOMSIED COMPARATIVE

CLINICAL TRIAL TO STUDY THE EFFECT OF AGARUWADI DHOOPANA AND

GUGGULA DHOOPANA IN KARNASRAVA

- Before you decide it is important for you to understand why the

research is being done and what it will involve

- Please take time to read the following information carefully and discuss

it with friends relatives and your doctor if you wish

- Ask us if there is anything that is not clear or if you would like more

information

Purpose amp Nature of Study

- In this research project by examine you and ldquoKarnasravardquo (Otomycosis)

disease were treated

- In the part of treatment Agaruwadi Dhoopana or Guggula Dhoopan were

given

- Dhoopana means medicated drug fumes were given in ear with the help of

Dhoopan Yantra

Page | 166

- Treatment was given for 7 days

Study Duration

7days

Participation

- Your participation is entirely voluntary

- If you do decide to take part you were given this information sheet to keep

and be asked to sign a informed consent form

- If you decide to take part you are still free to withdraw at any time and

without giving a reason This will not affect the standard of current or future

medical care you may receive

Confidentiality

- All information which is collected about you during the research were

kept strictly confidential

- Any information about you which is collected from the center will have

your identity in the form of a code number so that it will remain confidential

Benefits Of Study

- The results obtained from this study would be helpful for providing better

quality of treatment amp other essential facilities for Karnasrava (Discharge)

patients

- You will get clinical benefit from the study

Page | 167

Risks Of Study

- In this treatment there are few chances of Irritation of Ear Nose and

congestion at EAC if any of these happens then treatment were given

Results Of Study

- If the Results obtained are profitable then they may get published

without disclosing your details

Signature of patient

Date

Time

Phone no of Researcher

Page | 168

रण मादहती पतरक

सशोिनाच शीषवक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE

EFFECT OF AGARUWADI DHOOPANA AND GUGGULA DHOOPANA

IN KARNASRAVA

परसतताना

- आपणास या सशोिनातपमक अभयासात सहिागी होणय़ाच आाहन करणयात यत आह

- सशोिनातील सहिाग तननदशचत करणयापी सशोिनाच उददश समजन घया

- खालील मादहती काळजीपवक ाचा आणण आशयक ािलयास आपलया डॉकिराशी कका

दहतशरचतकाशी चचाव करा

- काही सददिता असलयास कका आणखी मादहती ही असलयास आमछयाशी चचाव करा

सशोिनाच उददीटि सतरप

- सदर सशोिन परकलपामरधय आपलयाला तपासणी करन कणवसरा या वयाशरिची शरचककतपसा दणयात

यणार आह

- सदर वयाशरिची शरचककतपसा महणन आपणास अगरादी िपन कका गगल िपन

दणयात यणार आह

- सदर औषि आपणास 7 ददस घयायाच आह

Page | 169

कालािी

- 7 ददस

सहिाग

- आपला सहिाग हा पणवपण ऎनदछिक आह

- आपला सहिाग तननदशचत असलयास आपणास ही मादहती पतरतरका दणयात यईल आपणास यातील

समती पतरकार सही कराी लागल

- सहिाग तननदशचत असनही आपण कोणतपयाही ळस कोणतही कारण न दता माघार घ शकता

याचा आपलया दयकीय सविर कोणताही पररणाम होणार नाही

गोपनीयता

- सशोिना दरमयान गोळा कलली आपलया वषयाची सव मादहती गोपनीय ठणयात यईल

- आपली यनदकतक मादहती साकततक सतरपात गोपनीय ठणयात यईल

सशोिनाच फ़ायद

- सशोिनाच तनटकषव कणवसरा बाशरित रणाछया दयकीय इतर सविाचा दजाव सिारणयास

फायदशीर ठरतील

सशोिनातील जोणखम

- य़ा शरचककतपसमरधय कान दखण डॊळय़ातन नाकातन पाणी य़ण नाकात जळजळण डोक जड

होण ही लिण ददस शकतात यापकी लिण तनमावण झालयास तपयाची शरचककतपसा कली जाईल

Page | 170

सशोिनाच तनटकषव

सशोिनाच तनटकषव फ़ायदशीर ठरलयास आपली मादहती गोपनीय ठन परकाशशत करणय़ात यईल

रण सतािरी-

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

Page | 171

ANNEXURE 31

INFORMED CONSENT FORM

Patient OPD no __________

Subjectrsquos Identifier

Date of Birth Age Gender

I _____________________________________ age___________ years

exercising my free power of choice hereby give my consent to be included

as a participant in the clinical study entitled

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

1 I confirm that I have read have been read and understood the information

sheet for the above study and can ask questions

2 I understand that my participation in the study is voluntary and that I am

free to withdraw at any time without giving any reason without affecting my

medical care or legal rights

3 I understand that the Ethics Committee members investigators and study

doctors will not need my permission to look at my health records both in

respect of the current study and any further research that may be conducted

in relation to it even if I withdraw from the trial I agree to his access

However I understand that my identity will not be revealed in information

released to third parties or published

4I agree not to restrict the use of any data or results that arisefrom this study

provided such a use only for scientific purpose

5 I agree to take part in the above study

Page | 172

signature with Date-

Left hand thumb impression

Name amp signature of the witness ndash

Name amp signature of the student ndash

Page | 173

ANNEXURE 32

समतीपतरक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

वयकतीच य

ददनाक जरमददनाक

1) मी ह तननदशचत कररत आह ककसदर सशोिन परकलपाबाबतची सपणव मदहती मी ाचली असनमला ती

समजली आहतपयाबददल मला परशन वचारणयाची पणव मिा आह सदर मादहतीन माझ समािान झाल

आह

2) मी सदर सशोिनातन माझया मजीनसार किीही बाहर पड शकतो या माझया अशरिकाराची मला कलपना

आह

3) माझी दयककय मादहती तपासणयाची कागदपतर कळ सशोिनाकररता ापरली जाणार आहत याची

मला मादहती आहसदर सशोिन परकलपातील सबशरित घिकाना माझी दयककय मादहती पाहणयाची मी

समती दत आहतरावप या सदिावतील माझी ओळख दशववणारी मादहती कोणासही ददली जाणार नाहीयाची

मला कलपना दणयात आली आह

4) सदर अभयासातन शमळणारी मादहती अरा तनटकषव कळ शासततरीय हतसाठी ापरल जाणयासाठी माझी

समती आह

5) रील अभयासात सहिागी होणयास माझी समती आह

रण सतािरी-

Page | 174

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

ASSESSMENT CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching)

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

a) कणवशल ( pain )- 0 - Absent

1 ndash Present

Page | 175

b) कणवकणड (Itching)- 0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

c) कणवसततरा ( Discharge )

0- Absent

1-Mild- Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाशरियव ( conductive Loss of hearing )

0 - Present

1 - Absent

Page | 176

Page | 177

Page | 178

Page | 179

Page | 180

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

Page | 181

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 182

AUTHENTIFICATION CERTIFICATE

Page | 8

REVIEW OF LITRATURE

Page | 9

Ayurvedic literature Ayurveda is a science of life practice since

thousands of years The ancient Indian system of medicine and surgery is

commonly known as Ayurveda This was given the status of Upaveda or

fifth Veda in the next stage of growth Among the available literature three

Samhita that is Charaka Samhita Sushrut Samhita Ashtang Hrudayam and

Ashtang Samgraha are the chief source of knowledge of Ayurveda

Ayurveda consist of eight branches Shalakyatantra is one among them

Shalakyatantra is one of its specialized branch deals with science of

ophthalmology otorhinolaryngology Oro dental surgery and head Acharya

Sushruta himself a practical surgeon was the first to advocate dissection of

dead bodies is indispensable for a successful student of surgery He had

described gross anatomy in the first chapter of Uttartantra Shalakyatantra

define by different Acharys as follows

शालाकय नामोरधवजतरगताना रोगाणा शरणनयनदनघराणाददसशरशरताना वयाशरिनामपशमनारव

स स ११०

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत [13]

चस १७१२

Shalakya Tantra Nirukti and Parichaya

शलाकायााः कमव शालाकय ततपपरिान शलाकयम डलहण [14]

The term Shalakyatantra is derived from Shalakya and Tantra

The word Shalakya means A probe and Tantra denotes teaching and

practices found in scripturesThe compendium in which application of

Shalaka in various surgical procedures is principally described is called as

Shalakya tantra

दनदटिवशारदााः शालाककनाः डलहण ( सउ ११३)[15]

An eye specialist is termed as Shalaki by Dalhana

Page | 10

Synonyms of Shalakya Tantra

Uttamanga Chikitsa Jatrurdhwa Chikitsa Urdhwang Chikitsa Shalakya

Chikitsa

Importance of Shalakyatantra-

Life of living being and all the Indriyas are situated in the head hence it is

known as Uttamanga

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत

चस १७१२

The treatment given to this part of the body is described specially in

Shalakya tantra While describing the importance of Shiras Vagbhata

correlates it to the root of tree (Urdhwa Mula) and body to the trunk of tree

(Adha Shaka)

Sushruta has deal with Mukha Roga in Nidan Shan and its treatment in

Chikitsasthan The description regarding the disease of eye ear nose and

head are found only in UttaraSthan Sushruta specially describes the

disease of Shalakyatantra as told by Videha in the beginning of Uttartantra

itself[16]

Shalakyatantra Itihas-

India Exhibits traditional of more than thousands of years in art literature

language logic and philosophy etc The convention was in its sophisticated

and advanced attire throughout the Vedic period

Vedic period ndash

1 Natush was treated for deafness by Ashwinikumars (Rigveda)

2 Rujaswa and Kanva were treated for blindness by Ashwani Kumaras

(Rigvedas)

Page | 11

3 There are several prayers mentioned for normal functioning of sense

organs (Yajurveda)

4 Structures and functions of Mastishka are described (Atharveda)

5 Mantras having reference to disease of Eye Ear Oral cavity etc are

found (Atharvaveda)

Upanishada Period ndash

1 Samhita Period

a) Sushrut Samhita ndash

bull Explanation regarding Netra Nasa and Shirorogas (Uttartantra 1-

26th chapter)

bull Details regarding Mukha and Karna Roga Nidan and

Chikitsa(Nidansthan 16th and Chikitsasthan 22nd chapter)

bull Description regarding Karna Chedana Sandhana Nasa

Ostasandhana Sutra Sthan 16th chapter

b) Charaka Samhita -

bull Explanation regarding Shirorogas (Sutrasthan 17th chapter)

bull Explanation of Gala rogas like Upajivika Galshundi and Rohini

bull Nasa Shiro Mukha Karna and Netra Chikitsa (Chikitsa sthan 26th

chapter)

bull Description regarding Lakshana and Chikitsa of Shankhaka

Ardhavbhedaka Shirovirechana and Shiro basti (siddhi sthan 9th

chapter)

c)Ashtnga Sangraha ndash

bull Detailed description regarding Shalakyatantara (Uttartantra 11-28

chapter)

bull Description of Kriyakalpa (Sutrasthan 32nd and 33rd)

Page | 12

d)Ashtang Hrudayam

bull Detailed description on Shalakya Tantra (Uttar tantra 8-24 chapters)

bull Kriyakalpas (Sutrasthan 23rd and 24th chapter)

e) Bhela Samhita

bull Chakshushya Vaisheshik and Buddhi Vaisheshik Alochaka pitta

f) Harita Samhita- Branch of Medical science offering elaborating

information about the procedure like Nasya Anjan Gandusha etc

comprehended with their applications in disease of Head Eyes Ears

Eyebrows Throat Temporal region and cervical spine is known as

Shalakyatantara

शशरोरोगा नतररोगा कणवरोगा वशषताः भरकरठशङकमरयास य रोगा समिनदरत दह १३

तषा परततकारकम व नसतयतपयवणजनातन च अभयङगमखगणडषकियााः शालकयसशमतााः १४

इतत शालाकयनाम [17]

Documentation of different ancient literature gives various references

regarding all aspects of Karnasrava in various periods It is very much

important to know the history of Karnasrava from Vedic Pauranic Samhita

and Samgraha period

Vedic period ndash The Vedas being the oldest source of knowledge have no

direct mentioning of Karnasrava

Page | 13

Samhita and Samgraha period ndash

Aacharya Sushruta described about Karnaroga Karnasrava Nidan

Roopa and Chikitsa The detail description is available in Sushrut

Samhita Uttartantra 20 and 21st chapters

Aacharya Charaka did not specify Karnasrava but mentioned 4 types

of Karnarogas that is Vataj Pittaj Kaphaja and Sannipataja and their

treatment in 26th chapter of Chikitsasthan

In Ashtang Hrudaya karnasrava is not explained as a separate disease

but Chikitsa is mentioned in 18th chapter of Astanga Hrudaya

uttartantra

In Ashtang Samgraha Chikitsa is mentioned in 22nd chapter of Astang

Samgraha Uttartantra

The details about Karnasrava are explained in Bhavprakasha

Madhyamakhanda 64th chapter

Madhavakara has explained about Karnasrava in 57th chapter of

Madhymakhanda

Karnasrava is also explained in Sharangadara Samhita Uttarkhand 11th

chapter

The reference for treatment of Karnasrava is available in

Yogaratnakara

In Gadhnigraha Karnasrava and its treatment is mentioned in

Karnarogadhikara Adhaya

Vangasena had mentioned about the disease and treatment in 69th

chapter

Chakradatta explained Karnasrava in 57th chapter

Dalhana has given commentary on Sushrut Samhita Uttartantra 20th

and 21st chapter

Sankhya Samprapti of Karnasrava ndash

Aachary Sushruta explains 28 Karnaroga in Uttaratantra Karnaroga

Vigyniyam Aadhaya Aacharya charaka explain 4 Karnaroga in

Page | 14

Karnarohvigyniyam Adhaya based on doshas Acharya Vagabhata in

Ashtang Hrudaya explain 25 Karnaroga in Adhyaya

कणवशल परणादशरच बाशरियव कषड ए च

कणवसरााः कणवकणडाः कणव चवसतततर च

कशमकणवपरततनाहौ विशरिदवविसततरा

कणवपाकाः पततकणवसततराशवशरचतवविम

कणावबवद सपतवि शोफशरचावप चतवविाः

ऎत कणवगता रोगा अटिावशततरीररतााः

स उ २०- ३ त ५[18]

ातकणवरोग वपततकणवरोग कफकणवरोग

रकतकणवरोग सनदरनपातकणवरोग कणवनाद

बशरिरतप परततनाह कणडाः शोफ पततकणवक

किशमकणवक उियरपविरधयअशो अबवद

कशरचकणवक वपपपली वदाररका पाळीशोष

ततिका पररपोिो उतपपातो उरमरर दाःखिवन

शलहाखयााः परचवशनदरतकणवरोगा उकतााः

इदिीका अ स उ २१ [19]

चतपाराः कणवरोगााः

च स [20]

Page | 15

KARNA

Karna ndash करोतत शबद गरहण [21]

The organ of hearing

Karnasrava- कणवसतय कणवयोाव ससराा [22]

Discharge from the ear is referred as Karnasrava

KARNA SHAREERA

bull Nirukti

कणयवत अकणयवत अनन इती [23]

It means reception and conduction of sound waves

These are the functions of external and middle ear

bull Nirukti of Sravanam

शरयत अनन इती शरणम[24]

It means perception of sound

It can be attributed to the internal ear function

bull Karna Utpatti-

Karna is an organ formed by Akash Mahabhuta[25]

The fundamental characteristic is as follows

Indriya ndash Srotram [26]

Indriya Adhisthan ndash Karna [27]

Indriya Dravy ndash Akasha [28]

Indriya Arth ndashShabdha [29]

Indriya buddhi ndash Srotobyddhi

Page | 16

bull Paryaya of Karna- Shabdapatha Srotrapatha Sravanam shruti

Kuhuram Dwanigraham etc

bull Definition of Karna-

कणवशटकलयनदछिरनमिटिोपगरदहत शरोतरमछयत [30]

मा तन ५७१

The definition of Karna is stated in Madhav Nidanam Indriya which is not

seen with naked eye along with Shashkuli is called Shrotra that is Karna

Indriya is so minute that it is not perceived with any sense organ

In Charak Samhita the word Karna explain as the Indriya Adhisthan of

Shabdha Karna is described as one of the Prathyangas of the body He

emphasizes that all Indriyas manifest during the 3rd month of gestation

period

Acharya Sushruta while describing formation of Purusha from Prakriti or

Avyakta narrated that all Indriyas are developing from the Vikarika and

Taijas Ahankara Both Vagabhata and Sushruta stated that Karna as one of

the Bahirsrotas

शरण नयन दन घराण गदमढराणण न सततरोताशसराणा बदहमवखातन [31]

स शा ५-१०

In Ashtang Hradaya Vagbhata has states that all Indriyas are Atmaja

According to him lower lobule elevated helix projected posterior portion

fleshy and adherent ear are indications of long span of life[32]

ततरखातखातन दह अनदसतमन शरोतर शबद ववकतता [33]

ा शा ३-३

शबदाः शबदनदरिय सवनदछििसमहो ववकतता [34]

स शा १-२६

Page | 17

Ear has the prominence of Akash Mahabhuta The prominent dosha of ear

is Vata It is important seat of Vata The prominent Dhatus are Asthi and

Mamsa Karna is one of the Panchgnanendriyas and it meant for hearing

Sushruta narrated that Karnasthita Asthi and Sandhi

घराणकणवगरीाकषिकोषष तरणातन [35]

सशा ५-२२

शरोतरशरगािकष शखाताव [36]

सशा ५-३२

गडकणवशखटककम [37]

स शा ५-२२

One Sandhi and one Tarunasthi in ear

Sandhi ndash Karna contain two Sandhi one in each ear Type of Sandhi is

Shankhavartha which is present in Shringataka

Mansapeshi ndash 2[38]

Siras ndash 10 [39]

Vataj Sira - 4

Pittaj sira - 2

Kaphaj sira - 2

Raktaj Sira - 2

Avedhya sira-

कणवयोदवश तासा शबदादहनीनामकका पररहरत

सशा ७-२५[40]

Amongst above mentioned ten Siras each Karna lodges one Shabdavaha

Sira It is Avedhya

Page | 18

Dhamani -2

Length of ear is 4 Angula

Karna moola ndash 2 Angula

कणाविरतर चतदवशअगलम

स शा ३५-१४[41]

The distance between two ears through the back of the neck is 14 Angula

bull Marmas of Karna-

1 Vidhuras-

कणवपटठतो अिाःसशरशरत विर ततर बशरियवम

सशा ६-३७[42]

कणतपयादद सतनायममवणी ककनदचचनदरनममनाकर कलयकररणणच

डलहणाचयव[43]

अिसततात कणवयोतनवमन विर शरततहाररणण

ा शा ४-२९[44]

Sankhya-2

Vistara- frac12 Angula

Type- Snayumarma (Susha)

- Dhamanimarma(AH)

- Vaikalykar

Sthana- It is situated in the depressed portion in the back of the ear

Injury to them causes loss of hearing

Page | 19

2 Shringataka marma-

नदजवहाकषिनाशसकाशरोतरखचतटियसरमम

तालरयासतयातन चतपारर सरोतसा तष ममवस

वदि शरगातकाखयष सददसततपयजतत जीवतम

मा तन ५७१ [45]

Sankhya- 4

Type- Siramarma

Sthana- It is in head that is amidst Siras (blood vessels) nursing sense

organ

A palm size area near Talu

Injury to this Marma causes death

In modern anatomy ear divides into Bhayakarna or External ear Mdhyakarn

or Middle ear Antahkarna or Internal ear This is extremely appropriate

Even though the ear is divided into three divisions in the point of modern

anatomy Ayurveda denotes ear organ is one Ayurveda treats disease by

way of assessing Dosha and Dushya Here Dushya is one that is Karnendria

Dosha difference will call for different treatment for different disease Hence

treating the vitiated Dosha will cure the disease irrespective whether it is in

external middle or internal ear The thought is based on different

fundamental principle from Ayurveda

bull Parts of Karna

In Ayurveda classics detailed description about anatomy of ear is not

available But the various parts are mentioned as follows

Bhayakarna- External ear

Mdhyakarna ndash Middle ear

Antahkarna- Internal ear

Page | 20

द कणवशटकशलक दॊ कणवपतरकौ

च शा 7-11[46]

कणवशटकशलक कणवगतातवकौ कणवपतरकौ त बाहयकणा

चिदतत च शा 7-11[47]

शटकली बाहयपालयाशरिटिानम

डलहन- स शरच 25-1 12[48]

Karna Shashkulika ndash It is also called as Karna Shashakuli Charaka has

mentioned this term while describing different Pratyngas of the body

Acharaya Gananatha sen has given the clarification for it as a pinna or

auricle[49]

Karnapali ndash It is popularly known as lobule of the ear Daivakrita Chidra is

present in it

Karnaputrika- Ayurvedic scholars accepted two terms in this cortex They

are Karnaputrika and Karnaputrika The former is considered as Tragus and

antitragus[50]

Karna Prushtha- It can be taken as the cranial surface of mastoid or

auricle[51]

Karnapeetha- Aacharaya Sushruta firstly mention the term Karnapeetha

It is mentioned first by Sushruta while describing the procedure of

Karnavyadana Vagbhata has mentioned that it is Adhobhaga of Karna

Dalhana has clarified that it is the region above the Karnaputrika that is the

region which is at the bottom of the concha

Karnamoola ndash It can be considered as parotid region[52]

Karna lathika ndashAcharaya Dalhana mentioned lobule as a Karna Lathika

Page | 21

Karnaavatu ndashThis term is used by Sushruta while describing the

measurements of different Angapratyangas where he has mentioned that

the distance between the Karnaavatu is 14 Angul Dalhana has comments

that it can be taken as the distance between two ears from behind[53]

Shabdhavahasrotas ndash It also called as Shabdapatha or Srotapatha The

whole passage through which the sound waves pass can be taken as

Shabdavahasrotas[54]

Shrotashringataka ndash It can be taken as the labyrinth of ear[55]

bull Dosha in context to Karna-

Karna is principal location of Vayu

1 Prana Vayu- Prana Vayu circulating in oral cavity is responsible for

Dehadhruka that is keeping all body parts active Indriyadruka that is

keeping all Dnyanendriya healthy by proper nourishment (Purana) helps in

deglutition of food material and convey the stimulation of Indriyabuddhi

and atma

2 Udana Vayu- Bala(strength) Varna speech singing are its function It

is responsible for facial expressions due to pleasure sorrow anger love

frustration etc in general its circulation and actions are just opposite to

Pranavayu

3 Vyana Vayu- Its principal functions are circulation of Rasa and Rakta

through body and various movements Its main location is Hrudaya Five

types of movements for which it is responsible are expansion contraction

upward downward and oblique other activities are opening closure of

eyelid yawning perspiration During circulation if it gets obstructed due

to Srotodushti it generates disease of that Srotas Vyana Vayu gets vitiated

by disease of Rasa Rakta Oja and Chetanadhatu

Page | 22

4 Samana Vayu- It is circulating in the vicinity of stomach and intestine

and helps in keeping the Jatharagni (digestive juices and enzymes) in

equilibrium Disturbance in Jatharagni precipitates disease

5 Tarpaka Kapha- Entire body functions movements are controlled and

executed by various centers in the brain Sensation perceived by sense

organs is conveyed to Mann and Aatma residing in Hrudaya The motor

signals from them are then conveyed to the functioning

organsKarmendriya through Prana Vayu Shira head is therefore a

location of continuous activities motions of Vata All these centers are in

unctuous Majjadhatu in the Shira For stabilizing this ever-active Vata and

to nourish the Majja dhatu very unctuous Tarpaka Kapha situated in Shira

plays an important role

bull Ayurvedic aspect of sound perception [56]

According to Ayurveda Pratyaksha Dnyan or Perception of any sensation

including Shabda occurs due to interaction of the Karnendriya and the

Indriya- Arth -Karma resulting in Sravana

External Environmental acquaintance with living body is executed by five

sense organs namely Netra Karna Nasa Jivha and Twaka All

Dnyanendriya that is sense organ are Panchmahabhautic combination

Despite this fact every Indrya sense organ perceives object Tanmatra of

that Mahabhuta only from which it is originated from Akash Mahabhuta and

hence perceives Shabd only that is audio perception Shrotrendriya is one

of the principal locations of Vata and its function is to perceive Shabda that

is sound waves This sensation is conveyed through Shabdavahi Dhamanis

to Mana and Atma through Pranavayu and the sequence is responsible for

perception of sound in this way external sound is perceived and interpreted

when Atma is linked with Mann Mann is linked with Indriyabuddhi that is

minute virtual Dnyanendriya located in brain Indriyabuddhi is linked with

Adhishthana with prominent Mahabhuta and lastly with Indriya

ArthShabdatanmatra that is sense object Once this sequence is completed

Page | 23

the meaning of a particular sound is interpreted and understood In this

entire process of perception and interpretation of sound waves Pranavayu

and Tarpaka Kapha located in Shira play extremely important role Hence

the healthy status of all the sense organ depends upon the normal

physiologically homeostatic condition of Pranavayu and Tarpaka Kapha

MANAS

ATAMA

BUDDHI

AHANKARA

ARTHA

Page | 24

EAR ANATOMY

bull Embryology of the Ear [57]

1 The sound conducting apparatus develops from the branchial apparatus

whereas the sound perceptive apparatus from the ectodermal otocyst

2 The pinna develops from the six hillocks around the 1st branchial cleft

3 External auditory canal develops from 1st branchial cleft

4 The outpouching of the 1st pharyngeal pouch gives rise to a proximal

narrow part that forms the eustachian tube and distal dilated part that

forms the middle ear cavity

5 Prussakrsquos space is a potential space lateral to the Shrapnellrsquos membrane

and medically by the neck of malleus that can be involved during the

extension of cholesteatoma

6 Development starts in the 3rd week of the intrauterine life and is

completed by 16th week of intrauterine life Membranous and boney

labyrinth develops from the otic capsule

The Ear is divided into

1 External Ear

2 Middle Ear

3 Internal Ear or the labyrinth

Page | 25

Fig 1 Ear Anatomy

EXTERNAL EAR [58]

The outside ear contains pinna and lobule

Pinna is the noticeable piece of outer ear made from single sheet of yellow

flexible ligament covered by subcutaneous tissue and skin It has two

surfaces average and parallel It is intently disciple to perichondrium on its

sidelong surface while it is somewhat free on average surface Pinna

incorporates tragus helix against helix fossa three-sided scaphoid fossa

incisura terminalis

External auditory Canal ndash It extends from the bottom of the conchea to

the tympanic membrane and measures about 24 mm along its posterior

wallit is S shaped

Parts 1 Cartilaginous part

2 Bony part

Page | 26

Cartilaginous part ndash The outer one third is cartilaginous consist of fibro

cartilage is directed first inward backward and upward It has Fissure of

Santorium The skin of this part of the canal contains hair follicles

sebaceous gland and cruminous gland

Bony part ndash The inner two third part is boney It goes forward downward

and medially skin lined in this part is very thin Isthmus is the narrowest

part of the canal lying medial to junction of bony and cartilaginous part

nearly 5 mm lateral to tympanic membrane

The roof and posterior wall of the external auditory canal shorter than floor

and anterior wall The skin lining the tympanic membrane and boney canal

has a self-cleansing property due to migration of keratin layer of epithelium

from drum towards the cartilaginous portion

Relations- Anteriorly- Temporomandibular joint and parotid gland

Superiorly- Middle cranial fossa

Inferiorly- parotid gland

Posterior- Mastoid antrum mastoid air cells and facial nerve

Nerve supply ndashSensory nerve supply of the external ear The auricle

supplied by fibers of the great auricular nerve (C2 and C3) and lesser

occipital nerve (C2) Auriculo temporal branch of the 5th cranial nerve and

auricle branch of the vagus (Arnoldrsquos nerve) supply external canal Facial

nerve has small sensory contribution on posterior-inferior wall

Tympanic Membrane -It is the partition between EAC and middle ear It

is a thin semitranslucent membrane pearly white in colored lying obliquely

in the medial end of EAC with the angle of 55 It is forming major part of

lateral wall of middle ear Annulus tympanicus is attached at its

circumference to the sulcus The TM is oval shape It measures

approximately 10 mm in vertical diameter and 90 mm in horizontal

diameter

Page | 27

Layers ndash Tympanic membrane consist of three layers

1 Outer Epithelium or cuticular layer which is continuous with skin of

external ear

2 Middle fibrous layer has both circular and radial fibers middle layer

missing in upper part

3 Inner layer- Inner mucosal layer which is continuous with middle ear

mucosa

Parts ndash Tympanic membrane consist of two parts

1 Pars tensa -It is largest part below the malleolar folds The inner

surface at the center attached to the handle of malleus Angle of cone

is most illuminated part in the pars tensa at anteroinferior part of pars

tensa

2 Pars flaccida Sharpnells membrane -it is triangular area above the

malleolar folds which are thin and devoid of fibrous tissue and

annulus It fits into notch of Rivinous

Nerve supply 1 Anterior half of lateral surface Auriculotemporal V3

2 Posterior half of lateral surface Auricular branch of vagus cn 10

3 Medial Surface Tympanic branch of CN 9 (Jacobsons nerve)

Fig 2 Tympanic membrane of ear

Page | 28

MIDDLE EAR [59]

The middle ear or tympanic cavity is an irregular laterally compressed

space within the temporal bone It is filled with air that is supplied to you

from the nasal part of the throat through the ear canal It contains a chain

of mobile bones that connect its side with the medial wall and serve to

transmit vibrations transmitted to the eardrum through the cavity to the

inner ear Including the parapet the vertical and anteroposterior diameters

of the cavity are each approximately 15 mm The transverse diameter

measures about 6mm at the top and 4mm at the bottom Compared to the

eardrum it is only about 2mm The eardrum is limited laterally by the

eardrum medially by the lateral wall of the inner ear It communicates

behind with the tympanic antrum and through it with the air cells of the

mastoid and in front with the auditory canal The middle ear together with

the Eustachian tube aditus antral and mastoid air cells is called the

middle ear cleft It is lined by mucus membrane and filled with air

It is divided into 3 parts

1 Mesotympanum (located in front of the pars tensa)

2 Epitympanum or attic (located above the pars tensa but medial to

Sharpnells membrane and the lateral bony wall of the attic)

3 Hypotympanum (located under pars tensa) The middle ear is like a

hexagonal box with a roof

Carotid or Anterior wall- It separates middle ear cavity from internal

carotid artery The various structure passing through anterior wall of

tympanic cavity

bull Canal of chorda tympani nerve

bull Canal of tensor tympani muscle

bull Eustachian tube

bull Anterior malleolar ligament

bull Anterior tympanic artery

Page | 29

Posterior or mastoid wall ndash The upper part of the back wall shows the

opening of the auditorium Below the auditory is a triangular bony

projection known as the pyramidalis processors The stapedial tendon is

transmitted through the apex of the pyramidalis processes The vertical

portion of the facial nerve descends along the posterior wall until it opens

into the stylomastoid foramen

Roof or Tegmental wall (Pars terminalis)- It is formed by a thin bone

plate called the tegman tympanum that separates the skull and tympanic

cavities It is located on the anterior surface of the rocky part of the

temporal bone near the junction with the temporal shell it extends back to

the roof in the tympanic membrane and anteriorly to cover the half canal

of the tensor tympanic muscle The lateral border corresponds to the

remains of the Petro scaly suture

Floor ndash It is formed by a thin plate of bone which separate middle ear from

the bulb of the internal jugular vein lodged in the jugular fossa

Lateral wall ndash It is formed by tympanic membrane and partly by a portion

of squamous part of the temporal bone It separates the middle ear from

external ear

Medial wall- It separates the middle ear from the inner ear

bull The promontory is the most prominent and convex part formed by the

basal rotation of the cochlea

bull The bony lateral semicircular canal is postero-superior to the promontory

above the oval window

bull The oval window is located between the middle ear and the vestibular

slope of the cochlea It is closed by the stirrup footrest and the annular

ligament

Page | 30

bull The round window is located under and behind the cape The round

window recess is directed to the rear It is closed by the secondary eardrum

and separates the middle ear of the Scala tympani from the cochlea

bull The facial nerve passes through the bony fallopian tube above the oval

window

Mastoid Antrum ndash It is a large space with air in the upper part of the

mastoid and communicates with the attic through the aditus The roof is

formed by the antri tegmen which extends and separates the tympani

tegmen from the middle cranial fossa The lateral wall of the antrum is

formed by a bony plate that is on average 15 cm thick in adults It is

marked externally on the surface of the mastoid by the suprameatal triangle

(MacEwen)

Aditus and Antrum- Aditus is a gap through which the attic communicates

with the antrum The boney prominence of the horizontal canal lies on its

medial aspect even as the fossa incudes to thats attaches the quick system

of incus lies laterally Facial nerve publications simply underneath the

aditus

The mastoid and its air cell system-

The mastoid consists of bone cortex with a honeycomb of air cell

underneath Depending on development of air cell three types of mastoids

have been described

1Well-pneumatized or cellular- Mastoid cells are well developed and

intervening septa are thin

2Diploetic- Mastoid consist of marrow spaces and a few air cells

3Sclerotic or acellular ndash There are no cells or marrow spaces

With any type of mastoid pneumatization antrum is always present In

sclerotic mastoids antrum is usually small and the sigmoid sinus is

anteposed

Page | 31

Depending on the location mastoid air cells are divided into

1 Zygomatic cells (In the root of zygoma)

2 Tegman cell (Extending into tegmen tympani)

3 Perisinus cells (overlying the sinus plate)

4 Retrofecial cells (round the facial nerve)

5 Peri labyrinthine cells (located above below and behind the

labyrinthine some of them pass through the arch of superior

semicircular canal These cells may communicate with the petrous

apex)

6 Peritubal (around the Eustachian tube Along with hypotymoanic

cells they also communicate with the petrous apex)

7 Tip cells (which are quite large and lie medial and lateral to the

digastric ridge in the tip of mastoid)

8 Marginal cells (Lying behind the sinus plate and may extend into

the occipital bone)

9 Squamosal cells (Lying in the squamous part of temporal bone)

Development of Mastoid ndash

The mastoid develops from the scaly petrous bone The petrosquamosal

suture may persist in the form of a bone plate - Korners septum which

separates the superficial squamosal cells from the deep rock cells Korners

septum is surgically important because it can cause problems locating the

antrum and deeper cells and thus lead to incomplete removal of the disease

during mastoidectomy The mastoid antrum can only be reached if Korners

septum is removed

Page | 32

Fig 3 Cross section of Mastoid

Contents of the middle ear

Ossicles ndash Three tiny bones which conduct the sound from eardrum to oval

window

Malleus ndash It is the largest and most lateral ossicle measuring 8 mm in

length It has head neck handle anterior and lateral processes The head

is situated in the epitympanum A lateral process project laterally from the

neck while the handle is firmly fixed to the pars tensa of the ear drum

Incus- It has a body short process and long process The body short

process and long process The body articulate with the head of mallelus in

the attic and the short process project into the attic The long process

projects downwards behind the handle of malleus running parallel to it and

articulate with the head of the stapes via the lenticular process

Stapes ndash It is the smallest ossicle measuring about 35 mm and consist of

head neck footplate and anterior and posterior curcura The footplate of

stapes is held to the oval window by the annular ligament

Page | 33

Muscles ndash

1Tensor tympani ndash It is inserted is a branch of the facial nerve which carries

the sense of taste It is first arch muscle supplied by branch of mandibular

nerve V3

2 Stapedious muscles ndash It is inserted to the neck of stapes It is the second

arch muscle supplied by branch of facial nerve that is nerve to stapedius

Fig 4 Contents of the middle ear

Blood supply of Middle Ear

bull Anterior tympanic branch of maxillary artery which supplies tympanic

membrane

bull Stylomastoid branch of posterior auricular artery which supplies middle

ear and mastoid air cells

Page | 34

Four minor vessels are

bull Petrosal branch of middle meningeal artery runs along greater petrosal

nerve

bull Superior tympanic branch of middle meningeal srtery traversing along

the canal for tensor tympanic muscle

bull Branch of artery of pterygoid carotid

bull Tympanic branch of internal carotid

Lymphatic Drainage of Ear

Lymphatics from the middle ear drain into retropharyngeal and parotid

nodes while those of the Surgical Importance ndash Eustachian tube drain into

retropharyngeal group

1 The middle ear is part of contiguous organs including nose nasopharynx

Eustachian tube and mastoid bone lined by respiratory mucosa Any

respiratory infection or allergy is likely to pass to middle is likely to pass to

middle ear

2 Moreover middle ear suppurative disease may spread to adjacent organs

and produce complication eg Labyrinthitis meningitis facial nerve palsy

etc

3 Lenticular process is vulnerable in suppurative ear diseases and causes

ocular disruption

4 Prussac space is the site of primary acquired cholesteatoma

Page | 35

INNER EAR [60]

Inner ear is divided into two parts

1 Bony Labyrinth

2 Membranous labyrinth

Anatomy of bony labyrinth

It is divided into two parts

1 Vestibule

2 Cochlea

3 Semicircular canal

The vestibule is located between the medial wall of the middle ear and the

lateral to internal acoustic meatus anterior to the semicircular canal and

posterior to the cochlea The vestibule is the central part of the inner ear

On its side is the oval window opening which is closed by the bracket foot

plate The bony cochlea is located in front of the vestibule It has 275 turns

wound around a bony axis called a modiolus The cochlea is about 30 mm

long The hollow center of the modiolus is a spiral canal that contains the

fibers and ganglion cells of the cochlear nerve A thin bony sheet the bony

lamina winda around the modiolus This divides the cochlear duct into two

galleries the Scala vestibuli above and the scala tympani below

There are three semicircular canals superior posterior and lateral They

are semicircular in shape and open into the vestibule One end of the

semicircle is enlarged and is known as the sphere

The membranous labyrinth is in the bony labyrinth It is connected to the

bony labyrinth by fibrous trabeculae and is surrounded by perilymph The

endolymph is located in the membranous labyrinth

Page | 36

The utricle is in the upper part of the vestibule while the saccule is found

below Both the utricle and saccule contain a single sensory patch called

the macula Each macula is covered with a neuroepithelium made up of

neuroepithelium made up of sensory hair cells and support cells these cells

are separated by a basement membrane Fibers of the vestibulo-cochlear

nerve enter the macula and pierce the basement membrane to terminate

at the base of the hair cell or cell bodies The utricle and the saccule with

their macula are called otolith organs Membrane semicircular canals are

the membrane canals of the corresponding bony semicircular canals They

open into the utricle through five openings One end of the opening of each

channel is dilated called the sphere in which the sensory organ of each

channel is located The cross section of the Scala standard looks like a right

angle The base is formed by the basilar membrane Sensory cells are

arranged on the surface of the basilar membrane These sensory cells with

their supporting cells form a complex neuroepithelium called the basilar

papilla or the cortical organ named after an Italian microscopist The

organs of the corti have a gelatinous membrane called the tectorial

membrane and they are supported by the pillar of the corti The cortical

pillars enclose a space called the corti tunnel which contains a fluid called

cortical lymph Vestibule is lies between the medial wall of the middle ear

and lateral to internal acoustic meatus anterior to semicircular canal and

posterior to the cochlea Vestibule is the central part of the internal ear On

its lateral surface is the opening of oval window which is closed by the foot

plate of stapes Boney cochlea lies in front of the vestibule It has 275 turns

coiling around boney axis called modiolus Cochlea is approximately 30 mm

in length The hollow center of the modiolus is a spiral canal containing the

fibers and ganglion cells of cochlear nerve A thin boney sheet the osseous

lamina winda around the modiolus This divides the cochlear canal into two

galleries the Scala vestibuli above and the scala tympani below

Page | 37

Semicircular canals are three in number superior posterior and lateral

They are semicircular in shape and opens into the vestibule One of the

ends of the semicircular is enlarged and is known as ampulla

Membranous labyrinth is situated within the boney labyrinth It is connected

to the bony labyrinth by fibrous trabeculae and is surrounded by perilymph

Endolymph is situated within the membranous labyrinth

The utricle lies in the upper part of the vestibule while the saccule lies below

Utricle and saccule both contain single sensory patch called macula Each

macula is covered by neuroepithelium consist of Neuroepithelium consists

of sensory hair cells and supporting cells these cells are separated by

basement membrane Fibers from the vestibulo cochlear nerve enter the

macula and pierce the basement membrane to end either at the base of the

hair cell or cell bodies The utricle and saccule with their macula are referred

to as otolith organs Membranous semicircular ducts are the membranous

ducts in the corresponding bony semicircular canals They open into the

utricle by five openings One end of the opening of each canal is dilated

called ampulla in which the sensory organ of each canal is located The

cross section of Scala media resembles a right angle Its base is formed by

basilar membrane Upon the surface of the basilar membrane the sensory

cells are arranged These sensory cells with their supporting cells form a

complex neuroepithelium called the basilar papilla or Organ of corti named

after an Italian Microscopist Organ of corti has a gelatinous membrane

called tectorial membrane and they are supported by pillar of corti The

pillars of corti enclose a space called tunnel of corti which contains fluid

called corti lymph

Page | 38

Fig 5 Inner Ear

Blood supply of labyrinth

Labyrinthine artery

Common cochlear Anterior vestibular Artery

Vestibulocochlear artery Main cochlear artery

Cochlear branch posterior vestibular artery

Page | 39

PHYSIOLOGY OF HEARING [61]

A sound signal in the environment is collected by the pinna passes through

external auditory canal and strikes the tympanic membrane Vibrations of

the tympanic membrane are transmitted to stapes footplate through a chain

of ossicles coupled to the tympanic membrane Movements of stapes foot

plate cause pressure changes in labyrinthine fluids which move the basilar

membrane This stimulates the hair cells of the Organ of corti It is these

hair cells which act as transducers and convert mechanical energy to

electrical impulses which travel along the auditory nerve

Thus the mechanism of hearing can be broadly divided into

bull Mechanical conduction of sound (conductive apparatus)

bull Transduction of mechanical energy to electrical impulses (sensory

system of cochlea)

bull Conduction of electrical impulses to brain (neural

Fig 6 PHYSIOLOGY OF HEARING

Page | 40

Conduction of sound

Under the surface of water we cannot hear the sound made in air because

9995 of sound energy are reflected away from the surface of water because

of the impedance offered by it A similar situation exists in the ear when

air-conducted sound must travel to cochlear fluids Nature has

compensated for this loss of sound energy by interposing the middle ear

which converts sound of greater amplitude but lesser force to that of lesser

amplitude and greater force This function of middle ear is called impedance

matching mechanism or the transformer action It is accompanied by

a) Lever action of the ossicles

Handle of malleus is 13 times longer than long process of incus providing

a mechanical advantage of 13

b) Hydraulic action of tympanic membrane

The area of tympanic membrane is much larger than the area of stapes foot

plate the average ratio between the two beings 211 As the effective

vibratory area of the tympanic membrane is only two- thirds the effective

areal ratio is reduced to 141 and this is the mechanical advantage

provided by the tympanic membrane

c) curved membrane effect

Movements of tympanic membrane are more at the periphery than at the

center where handle of malleus is attached This too provides some

leverage

Transduction of mechanical energy to electrical impulses

Movements of stapes footplate transmitted to cochlear fluids move the

basilar membrane setting up shearing force between the tectorial

membrane and hair cells The distraction of hair cells gives rise to cochlear

microphonics which triggers the nerve impulse

Page | 41

Neural pathways

Hair cells get innervation from bipolar cells of spiral ganglion Central axons

of these cells collect to form cochlear nerve which goes to ventral and dorsal

cochlear nuclei From there both crossed and uncrossed fibers travel to

superior olivary nucleus lateral lemniscus inferior colliculus and medial

geniculate body and finally reach the auditory cortex of the temporal lobe

Page | 42

DISEASES REVIEW

करणसराव

Nirukti - करणसय कणवयोाव ससराा [62]

Nidana- Acharya Sushruta and Vagbhata describe the common etiological

factors for the Karnaroga

अशयाय जलिीडा कणवकणडयन मरत

शमथययोगन शसततरसतय कवपतो अरय च कोपन ||

सउ २० १२

1 Avashaya or Pratishaya

(Excessive exposure to cold)

2 Jalakrida

(Excessive swimming)

3 Karnakandunyanum

(Excessive scracing due to itching)

4 Mithyayogena Shatrasya

(Improper instrumentation during wax removal or foreign body removal)

5Shabdasya

(Louder sound for long durationperverted contact of sound)

6 Abhighata (Trauma)

7 Vitiation of Tridoshas

Page | 43

Samanya Nidana according to different Samhita

Vishesh Nidan of Karnasrava

Acharya Charaka has not mentioned any kind of Nidana regarding Karnaroga

but has described Utapati of Karnaroga from Siroroga in Karnasirasym

Adhyaya[67]

शशरोअशिघातादरा तनमजजतो जल परपकादरा अवप विि

सरतत पय शरणॊ अतनलात स कणवससरा इतत परककतीत

सउ २० १०

असस ३७२५ [68]

1 Shiroabhighatat - Head Injury-Fracture of middle cranial fossa

2 Jala nimajjana - CSF otorrhoea fracture of middle cranial fossa

3 Karnaprapaka

4 Karna Vidhradhi -Puyasrava

Sr

no

Samanya Nidana SU AH[63] AS[64] YR[65] MN[66]

1 Avashaya + + +

2 Pratishaya + +

3 Shabdha

mithyayoga

+

4 Shashtra

mithyayoga

+ + +

5 Karnakandooyan + + + + +

6 Jalkrida + + + + +

7 Abhighata + + +

Page | 44

Samanya samprapti

परापय शरोतरशसरा कयावत शल शरोतशस गान

त कणवगता रोगा अटिावशततरीता

सउ २० १२

Due to common and specific etiology factors the vitiated Doshas gets

Sthanasamshraya in Karna and causes Karnasrava It is the stages of

Samprapti were Doshas gets lodged in Srotas and start processes of Dosh

Dushya Sammurchsna Due to Shiroabhighata Jalanimmajana Karna Paka

Karna Vidhradi vitiated Vata Dosha and Karna becomes Avruta by Vata and

results in Karnasrava Normal physiology of Dosha Dhatus and Malas entirely

depends on the normality of Srotas Dosh Dushya Sammurchana or

manifestation of diseases will not take place if only vitiation of Doshas take

place without deformity of Srotas Here in Karnasrava vitiation of Srotas are

Atipravritti Sanga and Vimargagamana take place Atipravritti is being excess

production of fungus Sanga is obstruction in external acoustic canal

Vimargagamana is the propagation of discharge through ear

Vishesh Samprapti

Karnasrava occurs due to Nij nidana is Pratishaya while Agantuja nidanas are

Avashya Jalkrida and Karnakanduyan Due to etiological factors which are

Vata-Kapha provocative in nature gradual vitiation of Doshas will occur After

vitiation they get accumulated (Sthan samshraya) in external auditory canal

In other hand when patient does Sevana of Agantuj Nidan like water enter in

external ear scratching of ear unsterile instrumentation leads to Dosh

Prakopa These cause Twak and Mamsa Dhatu Dushti which leads to

discontinuity of epithelium of ear canal which creates suitable atmosphere for

fungal pathogen to grow The vitiated Vata will produce symptoms such as

Page | 45

pain hearing impairment and vitiated Kapha causes symptoms like itching

discharge ear blockage By assessing the symptoms it can be said that Kapha

Avrita Vata Dosha is responsible for the manifestation of clinical features like

pain itching discharge Which are seen in Karnasrava that is otomycosis

Acharya Charaka has mentioned while explaining Samanya Chikitsa of

Karnaroga that it should be treated like Vrana when Paka and Srava is present

as a symptom Fungal spores invade in the epithelial layer of EAC In response

to infection inflammatory process is start This is a Paka Avastha After

removing the fungal mass ulceration in external acoustic canal is commonly

seen As a result of infection process exudates was produced which will mix

up- with fungal colonies and appear as discharge As per Dosha involvement

in Vrana Shoola Srava can be differ According to Acharya Sushruta Ruk is

the Samanya Lakshana of Vrana and Vishesha Lakshana of Vrana includes

pain discharge discoloration itching etc according to Dosha involvement

which are also seen in otomycosis In otomycosis mainly watery and purulent

type of discharge is present which indicates Paka avastha If there is Dosha

involve in Vrana is called Dushta Vrana Acharya Sushruta and Acharya

Vagabhata have mentioned verity of Srava in Twak and Mamsa Vranavastu

which is found in otomycosis Based on this description otomycosis can be

correlated with Karnasrava

Page | 46

Representing the Samprapti of Karnasrava

Vishesh Nidana ndash Shiroabhighatat

Jala nimajjana

Prapaka Vidhradhi

Vitited vata

Avarana by kapha

Vimargagamana of Vata

Karnasrava

Samprapti Ghataka

Dosha ndash Kapha and Vata

Dushya ndash Rasa Rakta and Mansa

Strotodushti ndash Vimargagamana and Sang

Adhishthana ndash Karna (Bhayakarna)

Rogmarga ndash Madhyama

Page | 47

Purvarupa

The Purvarupa of Karnasrava are not mentioned separately in any ayurvedic

classics In routine practice cretin Purvarupa are noted

1 Karnakandu

2 Karnagurutwa

3 Alpa karnashoola

4 Discomfort in ear

Rupa

1 Karnashoola

2 Karnakandu

3 Karnasrava

4 karnabadhirya

5 Cotton wool like or wet newspaper like grayish brown or black colored mass

is seen

6 External auditory canal skin appears edematous and red

Upashaya and Anupashaya

Appropriate application of Aushadhi Ahara and Vihara when produces relief in

the symptom is called as Upashaya and when aggravates the symptoms is

called Anaupashaya There is not any reference available in the classics about

the Upashaya and Anupashaya of karnasrava

Sadhyasadhyata

Sushruta has not mentioned specially the Sadhyasadhyata of Karnarogas But

Vagbhata has mentioned Karnasrava as a Sadhyavyadhi[69]

Sadhysadhyatagives the clear picture of prognosis of the disease It depends

on many factors like nature of disease severity of disease Vaya Prakriti Bala

of the patient etc

Page | 48

Upadrava of Karnasrava

In Samhita there is no reference available regarding the Upadrava of

Karnasrava

Samanya Chikitsa ndash

The common treatment principle for all Karnaroga is Ghritapana Use of

Rasayana Bhrahmacharya Avyayama Shirasnana and Atibhashaya

सामरय कणवरोगष घतपान रसयनम

अवयायमो शशराःसतनान बरमहचयवम कतपरनम

स उ२१३

Ghratapana - Ghrita is a Yogavahi and follow Sanskara in addition to these

acquired properties and capable of retaining its own properties So Ghritapana

is effective in Karnasrava

Rasayana - Rasayana represent the basic approach of Ayurveda which

comprise preventive promotive and curative aspect of health

Brahmacharyaapalana -It is like Sadvrittapalana and is equals to Rasayana

effect

Vyayama - It leads to vitiation if Vatas a Karna is a Sthana of vata and

exercise causes Kshayaj Samprapti hence it is important to avoid exercise in

Karnasrava

Shirasnana- In Shirasnana water enters in external acoustic canal it changes

the PH of meatus skin from acid to alkali which favors the growth of pathogens

Atibhashya - Excessive speaking causes Vata Prakopa and Vatapraokopa is

basic Samprapti for Karnasrava as the preventive aspect avoidance of

excessive speaking is necessary

Page | 49

Ghritapana Rasayana and Brahmacharyapalana should be followed for

preservation of dhatu Samyata and restriction of vitiation of Vata Vayayama

Shirasnana and Atibhashaya should be avoided in Karnasrava to protect the

Siras from the affliction of Vata and Kapha

Vishesha Chikitsa ndash

The general treatment principle of Karnasrava described in classics is closely

related to Dushtavrana Chikitsa

शशरोवरचन च ए िपन परण तरा

परमाजवन िान च ीकषय ीकषय़ाचारत [70]

स उ २१४०

कणवसततरा ोददत कयावत पततकशमकणवयो [71]

ाउ १८३५

उपददि च सततरोत साय परात वपचततवशि परमजय

य अगर मदन सघत गगलना ा िपतयतपा मिना परयत [72]

असउ २२४२४३

In addition to that Shirovirechana Karnadhoopana Karnapurana

karnapramarjana Karnadhavana are also indicated

Page | 50

Treatment is also mentioned for Karnasrava

1 Karnaprakshalana Yoga - with Aargawadadi Gana Kashaya and Surasadi

Gana Kashaya [73]

2 Avachurnana Yoga ndash with Aargawadadi Gana Churna and Surasadi Gana

Churna[74]

3 Karnapoorna Yoga ndash

bull Rasanjana Laksha with Sarjachoorna[75]

bull Panchkashaya with Kapittha swarasa and Madhu[76]

bull Jambu AmrapallavShivalaKshuodra Mahavriksha and Madhuki all are

taken in equal quantity and Kalka is prepared and 4 times Taila is taken

and 16 parts of Kwatha is added and Taila Paka is done[77]

bull Sarjatwak Choorna with Karpashiphalarasa and Madhu[78]

bull Abhaya LodraTindukaSamanga(Manjista) Kwatha of this Dravyas mixed

with Madhu and Kapittha Rasa[79]

bull Yogratnakara mention the following drugs for Karnapoorana-

a Samudraphena Churna[80]

b Jambwambpatra Yoga

4 Karnadhoopana Yoga ndash

bull Dhoopana with Churna of Bilvapatra Haridra Palandu[81]

bull Vartak Dhoopana [82]

5 Internal Medications-

bull Rasnadi Guggula [83]

bull Triphala Guggula [84]

bull Sarivadi Vati [85]

bull Gandhaka Rasayana [86]

Page | 51

According to Vagbhata-

Ear should be cleaned with the Pichu and Varti followed by Guggula Dhoopana

and then Karnapoorana with Madhu Followed by Avachurnanana with

Sukshmachootana of Surasadigana

Pathyaapathya ndash Pathya and Apathy mentioned for Samanya Karnaroga is

recommended in Karnasrava also

पथय[87]

सतदो वरको मन नसतय िमाः शशरावयिाः

गोिमाः शालयो मदगााः याशच परतन हवाः 80

लाो मयरो हररणानदसततततरो नकककिाः

पिोल शशगर ातावक सतनषराण कदठललकम

रसायनातन सवणण बरमहचयवमिाषणाम |

उपयकत यरादोषशमद कणावमय दहतम ||81||

िापर २१

Aharaja Upacharaja

bull Godhuma bull Vamana

bull Shala bull Virechana

bull Mudga bull Nasya

bull Yava bull Dhoomapana

bull Puranagitra bull Kavala

bull Lava Harina Tittiramamsa

Page | 52

अपथय[88]

दरत काटठ शशरसतनान वययाम शलटमल गर

कणडयन तषारशच कणवरोगी पररतपयजत

िापर २१

Viharaja

bull Patola ShigruVartaka bull Bhramacharaya

bull Sunishannaka bull Avyayama

bull Katthlika bull Aakthanam

bull All types of Rasayana bull Upacharaja

bull Vamana

Apathyas

bull Abhishyandakara Aharas

bull Shirasnana

bull Karna kandooyana

bull Tushara sevana

bull Guru Kaphakaraka Aaharas

bull Dantdhavana

Page | 53

OTOMYCOSIS

Definition-

Otomycosis is a superficial acute sub-acute or chronic infection of external

ear canal It is mostly unilateral It is characterized by inflammation purities

and scaling Otomycosis is a common condition encountered in ENT practice

more in chronic and persistent ear infection

The Fungal infections are not communicable in the usual sense but the

humans become an accidental host by their introduction into tissue trauma

The virulence factors favoring colonization of fungus in human host are yet to

be identified Ability of the fungus to grow at 37 C and elaboration of a variety

of enzymes and toxins are speculated to contribute to virulence Only 100 to

150 species are generally recognized as a cause of disease in humans[89]

Prevalence-

Otomycosis is a word wide in distribution and in various record stated that 5

to 20 of all cases of infective otitis externa Otomycosis prevalent is more in

warm and humid climates It is one of the commonest manifestations in India

during rainy season It occurs mostly in humid atmosphere otitis externa due

to fungal infection may resembles the desquamative form of diffuse infective

otitis externa The incidence in temperature climates has increased in

proportion to the use of topical antibiotics which have a medium sterilized of

other organism in which the fungus may flourish

Page | 54

Predisposing factors- [90]

1 Environmental factors such as climate contagious and polluting hygiene

more frequently during rainy season as the humidity increases

2 Individual susceptibility ndashGeneral Immunological status of the Individual

eg HIV infection Radiotherapy chemotherapy Diabetes mellitus

3 Self-inflicted trauma that is use of pins to clean the itching ear or use of ear

bud to clean the wax

4 Wide spread of topical antibiotics steroid preparations which have medium

sterilized of other organism in which the fungus may grow

5 Failure of defense mechanism in External auditory canal

6 During swimming or head bath water enters in External acoustic canal

causes quantitative and qualitative change in ear wax It causes change in pH

7 Long term use of hearing aids

Pathophysiology ndash

The life cycle of the average mold encountered in the ear may be reckoned

as two weeks and flare ups may be anticipated at such intervals Swimming is

held responsible for infection in many cases The sequence sequence of

pathogenic changes produced by molds in the external ear is as follows ndash

1 Implantation of the organism in external ear

2 Growth of organism follows the rate depending on condition of temperature

moisture or preexisting irritation

3 Invasion of epithelium occurs with attendant itching and discomfort which

may be quite severe

Page | 55

4 Exfoliation of epithelium occurs as nature attempts to overcome the

infection by casting off upper most cells

5 Denudation occurs from exfoliation as the top layers of epithelium are cast

off and the canal becomes filled with debris

6 Superficial ulceration and lizematoid dermatitis results if the pathologic

process goes for enough The changes do not always proceed through the

entire sequence sometimes the molds produce changes of the mildest

imaginable character which may be overlooked[91]

Clinical features -

Symptoms-

1 Irritation and itching ndash Irritation is mostly found when the infective

organism is aspergillus niger There is sensation of discomfort which is more

diffuse in the ear canal then localized in the deeper part Candida infection

causes marked itching In external ear it is intense and worse at night

2 Discharge through ear- Intermittent scanty colorless discharge through

ear Mucus being a fungal metabolic product appears as discharge Excessive

discharge is associated with mixed infection

3 Pain and discomfort ndash Mild to severe pain in the ear occasionally Mostly

seen in cases where ear is infected with Aspergillus flavus mixed infection

with gram negative organism or mixed infection with candida and aspergillus

Headache is sometimes associated with pain

4 Deafness- Varying degree of mild to moderate conductive deafness

5 A sensation of fullness in ear

6 Tinnitus 7 Vertigo

Page | 56

Signs ndash

1 The external acoustic meatus may contain a mass formed of epithelial

debris exudates cerumen and fungus

2 Erythematous external canal

Fungal appearance

A Niger - The color of the mass which is usually grey or black is mainly

determined by the type of fungus concerned Its appearance is like wet

newspaper or blotting paper or a cotton wool It has a peculiar musty odor In

this infection fruiting heads may be seen as black specks in the debris

Occasionally as inactive form occurs in which the canal is lined by mold giving

a fluffy appearance due to the presence of tiny mycelia

Candida ndash Candida infections generally show as white deposits on magenta

colored skin when the debris is removed it rapidly recovers in 24 hrs

The underlying canal skin is often inflamed and granular due to invasion by

fungal mycelia and be seen in all cases In rare cases excoriation and

ulceration with marked extensive shedding of the epithelium and deep

ulceration can be seen usually associated with a flavus and with pathogenic

bacteria[92]

Otoscope Appearance

1 Aspergillus Niger ndash Black headed

2 Aspergillus Fumigators ndash pale blue or green

3 Candida Albicans ndash White- or cream-colored deposits

Page | 57

4 Auricle is normal in most cases In severe cases small ulceration with crust

formation may be present on lateral surface

5 Tympanic Membrane

In most cases it is normal with normal mobility and normal hearing In a few

cases the surface of the tympanic membrane is congested and scaly There is

erosion or ulceration of the external epithelial layer and the membrane itself

may be edematous

Diagnosis

1 Above mentioned symptoms and signs

2 In the stage at which patient with otitis externa usually first present

themselves mycelia threads conidiophors not visible to naked eye may

sometimes be identified with the microscope

3 Confirmed by culture

Page | 58

Fig7 Aspergillus Niger Fig8 Candida Albicans

Fig9 Aspergillus Fumigators Fig 10 Wet Paper like appearance

Page | 59

Treatment

1 Antibiotic or steroid drops should be discontinued if they are being instilled

since long time

2 Removal of fungal mass epithelial debris and discharge from the external

canal or mastoid cavity repeatedly and thoroughly by forcepa or suction or

syringing or cautiously blow a stream of air into the canal through a fine

cannula and dry thoroughly by swabbing liquid petroleum on swab used in

cleaning the ear lessens the burning sensation when metacresy acetate is to

be employed in the subsequent treatment

Furuncle is developed as a complication if there is no gentleness in cleaning

Cleansing may have to be delayed until local sensitiveness is lessened which

can usually be accomplished within twenty-four hours If there is excessive

epithelial debris along with otomycosis then metacresyl acetate which is a

keratolytic in introduction into the external auditory canal on cotton wick and

is allowed to remain for twenty-four hours After twenty-four hours the cotton

wick is removed at which time the canal can usually be cleansed with little

discomfort as the medication is also anesthetic The epithelium of the canal

was white from contact with the drug The top layer was detached and this

epithelial debris can be easily wiped away The wick is reinserted and wet with

metacresyl acetate

The treatment is employed for three to four days in succession and then a

bland application is substituted Icthyol iodine is of value at this stage Iodine

ointment 2 in combination with Tannic acid 2 is also an excellent local

application following cresatin treatment

Next one of the fungicides may be applied

Page | 60

1 Nystin Effective for candida infection but less active against aspergillus

group Nystatin in boric powder consisting of 100000units of nystatingm of

powder 3 times week for 3 weeks

2 Clotrimazole Available as 11 cream or drops or lotions Phenyl

(zchlorophenyl) 1 ndash imidazole ndash methane is a chlorinated trityl imidazol 1

effective against candida and dermatophytes and for aspergilli infection

3 Amphotericin B Available as cream and as 3 solution and 015 drops

for topical application Very effective for candida infection can be fungistatic

or fungicidal

4 Econazole Available as solution (Econazole nitrate) and as cream (1)

Broad spectrum ndash more effective for Aspergillus Also active against some

gram-positive bacteria (Staphylococci and Streptococci and Dermatophytes)

5 Miconazole Highly effective against dermatophytes and candida infections

used as a 21 cream applied once or twice a day for 10 days

6 Gentian violet 21 Available as drops (recently some evidence of

carcinogenicity) Discolors the ear canal and this interfere with clinical

examination

Other topical antifungal agents are ketoconazole Natamycin Tolciclat Bifonas

zole Fenticonzole Oxiconazole Tioconazole ciclopiroxolomine Tolnafate

Haloprogin Flucytosine Acetic acid Whit field ointment selenium sulfide

undcyclenic acid triacetin etc

Page | 61

Minimal length of treatment

A month of drug treatment is usually required because the antifungal agents

used are not sporicidal and it is necessary that the period of treatment covers

germination time It may be advisable to give short gaps in the period of

treatment to ensure all spores have germinated before deciding to terminate

therapy

Prevention

Accomplished by strict attention to the predisposing causes

1 Water should be prevented from entering the ear

2 Avoidance of external ear trauma

3 Use of alcohol medicated or plain in the ears after swimming mercuric

cyanide (15000) in ethyl alcohol (70) is a satisfactory liquid to use

Ear stoppers do no good unless their use is followed by some antiseptic in the

canal Divers exposed to water for long periods of time may also use acidic

alcohol

4 During Summer months with their high humidity special efforts are needed

to maintain ear dry 5 Indiscriminate use of topical antibiotics steroid

preparations should be avoided

Page | 62

DRUG REVIEW

1 GUGGULA

Fig11 - Guggula

Historical review of Guggula [93]

bull Atharvaveda one of the well-known Vedas of Hindus The earliest

reference given by Atharvaveda medicinal and therapeutic properties of

Guggula Guggula has long history of use in Ayurveda

bull Acharya Charaka Sushruta and Vagbhata describe detail regarding the

actions uses and indication as well as the variety of Guggula

Page | 63

bull Various Nighantus (Medical lexicons) were written between 12th and 14th

centuries AD was based on the Ayurvedic literature also describes

Guggula

bull The explanation of word Guggula is that Gunjo Vyadhegurdti Rakshati

which means to relief against different diseases

bull Guggula is the best medicine because it develops through the rays of

hot sun on specific circumstances

bull Guggula has an aromatic odor

गगलो कणवदौगवररधय िपन शरटठमछयत[94]

स उ २२११२

Latin name- Commiphora mukul

Family ndash Burseraceae

Rasa- Tikta Katu

Guna ndash Laghu Rukshasukshma vishada sara

Veerya ndash Ushna

Vipaka ndash Katu

Action- Rasayana Lekhana

Doshaghanta - Tridoshhara

Page | 64

Chemical composition [95]

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Oleoresin-Z-Guggulsterone E-Guggulsterone

Gum- guggulignans 1 and 2 guggula Tetrols mukulol allylcembrol c

27

Guggulusterol 1 2 ans 3 Z and E ndash guggulusterol

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Parts Used ndash Gum oleoresin

Guggula purity test

1 Yellowish brown emulsion is obtained when Guggula is triturated with

water

2 An ethereal solution of the drug attains reddish colour when treated

with br2 vapors and purple colour when moistened with nitric acid

Biochemical action ndash Antiseptic Anti-inflammatory Disinfectant Diuretic

Immunostimulant stimulating expectorant Ant suppurative Antipyretic

Enhance phagocytosis

Karma- Rasayana cardiovascular disease

Page | 65

2 AGARU-

Fig 12 Agaru

Historical review of Agaru [96]

bull The word Agaru literally means the one which is the heaviest and no

aromatic wood is heavier than it Since thousands of years Agaru lsquoThe

wood of Godrsquo has been used for multiple purpose like commercial

medicinal spiritual aromatic historical

bull The medicinal use of Agaru have been recorded in many pieces of India

Greek Roman Chinese Middle eastern and European since ancient times

bull Acharya Charaka used Agaru and pest of Rasna to counteract the effect of

cold in Agraya Dravyas

bull Acharya Sushruta used Agaru as a Dhoopana Dravya along with Guggula

Ral and Shoma in the treatment of Karnasweda and Vrana

Page | 66

Types-

bull Dhanwantsri Nighantu describes Kaleyaka as a type of Agaru

bull Sodhala Nighantu describes three types of Agaru ndash Agaru Krishna

Agaru Kakatunda Agaru

bull Raj Nighantu describes five types of Agaru ndash Krishna Agaru Kasht

Agaru Daha Agaru Mangalya Agaru and Agurusaar

bull Arthashasstra describes three Agaru wood product

1 Jongaka ndash Black or variegated black in colour and having variegated

spots

2 Dongaka ndash Black in color

3 Parasamudraka- Black in colour and smells like Navamallika

अगर उटण कि तपछय ततकत ततकषण च वपततलम

लघ कणाविरोगघन शीत ात कफपरणत

िापर २१ [97]

Family- Thymelaccensis

Latin name- Aquilaria agallocha

Guna- Laghu Ruksha Tikshan

Rasa- Katu Tikta

Vipaka ndash Katu

Virya ndash Ushna

Karma- Sheetaprasasmana Vranaorasadan Tvachya Pittavardhaka

Shirovirechana Mangalya Sugandhik and Rochaka in properties [100]

Krishna Agaru karma- Katu Tikta rasa Ushna Sheeta when applied externally

and Pittahara when taken orally

Page | 67

Chemical Constituents -

Agaru hardwood is rich in essential oil resins alkaloids saponins Steroids

terpenoids tannins flavonoids and phenolic compound Agaru wood

predominantly contains 2-[-2-phenylethy]-4H-chromen-4-one derivatives and

sesquiterpenes Agaru oil contains selinene dihydroselinene agarnol b-

agarofuran vetispira-2(11)valerianol dihydrokaranone and tetradecanoic

acids[99]

Part Used ndash

Heartwood- Dark resinous wood which is formed when the plant becomes

infected with a type of fungus (ascomycetous mold) Species of Aspergillus

fusarium and penicillium are reported to be associated with the development

of infection Prior to infection the heartwood is odorless relatively light and

pale colored however as the infection progresses the tree produces a dark

aromatic resin in the heartwood The infected resin in response to the attack

which results in accumulation of a very dense dark resin in the heartwood

The infected resin embedded wood is known as Agarwood Infection is more

common on the trunk roots and the area when branches divide The formation

of Agarwood starts when the tree attains the age of 20 years On an average

approximately 30 ml oil is extracted from 100 kg of infected Agarwood[98]

Qualities of best Agaru-

It should be black in color

It should be extremely heavy and aromatic

It should be oily in appearance and test

It should be sink in water

It should burn easily with bright flame with a bright flame giving off a pleasant

smell

Page | 68

3 MADANA

Fig 13 MADANA

Madana consist of dried fruit of Xeromphis spinosa It is a deciduous thorny

shrub or a small tree reaching a high up to 9 m and girth about a meter

branches numerous thick and horizontal found in sub-Himalayan tracts[101]

मदनो मिरनदसततकतो ीयोटणो लखनो लघ

ानदरतिदवििीहर परततशयायवरणारतक

रि कटठकफ़ानाहशोथगलमवरणापह[102]

िा पर १६० १६1

Page | 69

Latin name-Randia dumetorum

Familly ndash Rubiaceae

Rasa - Madhura Tikta

Guna-Laghu Ruksha

Virya- Ushna

Vipaka ndash Katu

Karma- Vamana and Lekhana

Chemical Composition-

Essential Oil Valerianic acid Saponin tannin resin [103]

Page | 70

YAWA [104]

Fig 14 Yawa

1 In Samhitakala Aacharya Charaka Acharya Sushruta explain detail about

medicinal properties of Yawa

2The use of Yawa in Aaharya Dravya mainly described by Dhanwantari

Nighantu Raj Nighantu Bhavprakash Nighantu[105]

Macroscopic Description-

Fruit a caryopsis elliptical oblong Ovoid and tapering at both ends smooth

about 1cm long and 02- 03cm wide dorsally compressed and flattened on

the sides with a shallow longitudinal furrow 3-5 ridges having shallow

depression between them grains tightly enclosed and adhering the lemma

and palea pale greenish yellow odor not distinct taste sweetish acrid

Page | 71

Latin Name ndash Hordenum vulgare

Family- Poaceae

Rasa- Kashaya Madhura

Virya- Sita

Vipaka- Katu

Karma- Vatakrt Pittahara Kaphahara Medahara Balya Visrya

SthairyakaraLekhana

Page | 72

PROCEDURE REVIEW [105]

In Ayurvedic classics there are many references regarding Dhoopana Dravya

Dhoopana is administering Dhuma with the help of Dhoopana Dravya

In Kashyapa Samhita there are 40 types of Dhoopana advised for children

Anesthesia (Mohajananam Dhoopa) is also mentioned For this Dhoopana the

drug used were herbs hairs of animals legs horns old cloths of Buddhist

monks

From the references available regarding Dhoopana we can understand that

Karna can be protected from maggots (krimi) Bactria (Rakshogna) lice etc

References clearly indicate the analgesic and disinfectant effect of Dhoopana

Karma Dhoopana is mentioned for Dushta Vrana Chikitsa It reduces Vedana

Srava Pootigandha of Dushtavrana It also helps in Vranaropana

Dushtavrana Chikitsa is mentioned in the treatment of Karnasrava[106]

Origin of Dhoopana-

In ancient period children of sages were constantly harassed by the

Rakshasas Hence the sages approached lord Agni for shelter Agni in turn

gave them Dhoopana Dravya and asked sages to use the Dhoopana for

protection against Rakshasas bhutas pishachas

Classification of Dhoopana

1 It is classified into Dhupa Anudhupa Pratidhupa

2 On the basis of Origin it is classified into Jangama and Sthavara

Selection of Guggula for Dhoopana

Page | 73

bull Guggul is a best Vatahara

bull It is Krimighana

bull It contains Oleoresin

bull In Ashtang Hrudaya Guggula Dhoopana mentioned for Karnasrava

Selection of Agaru for Dhoopana

bull Agaru is Laghu Ruksha Katu Tikshna

bull Vranaorasadan Tvachya

bull It should burn easily with bright flame with a bright flame giving off a

pleasant smell

Karna Dhoopana Indication

1 Karnaarava

2 Putikarna

3 Krimikarna

4Vataj Karnashula

Contraindications

Especially for Karnadhoopan contraindication is not mentioned in classic texts

But Dhoopana is contraindicated in Pittaj vaydhi Sharad and Grishma Rutu

Page | 74

MATERIAL AND METHOD

Page | 75

For randomize comparative clinical trial to study the effect of Agaruwadi

Karnadhoopana and Guggula Karnadhoopana in Karnasrava following material

and method were required

Source of data

Patient irrespective of gender occupation religion social economic status

signs and symptoms of classical features of Karnasrava (Otomycosis) selected

from the OPD of Shalakyatantra department

Materials ndash

1Patients

2 Drugs-Agaruwadi Dhoopana

Guggula Dhoopana

3Torch

4Otoscope

5 Tuning fork

6Jobson horn probe

7Cotton

8Case record form

DRUG

Group A Trial Group

1Churana of Agaru Yawa Madan

2Ghrita

3Jala

Group B Control Group

1Googula Churna

Page | 76

Properties of Drug

Table no 1 Properties of Drug

Drug

Family

Rasa Veerya Vipaka Effect

on

Dosha

Guna Karma

Agaru

(Aquilegria

Agallocha)

Thymelaca

ceae

Katu

Tikta

Ushna Katu KV Laghu

Ruksha

Tikshna

Shitaprashamana

Shothahara

Vedanasthapak

Durghandhihara

Madan

(Randia

spinosa)

Rubiaceace

Kashaya

Madhur

Tikat

Katu

Ushna Katu KV Ruksha

Laghu

Vatakaphaghana

Shothahara

Vedanasthapak

Vranashodhak

Yawa

Poaceae

Hordeum

Vulgare

Kashaya

Madhur

Sheeta Madhur KP Ruksha

Laghu

Vataghana

Vernashodhana

Raktshodhaka

Guggula

Commiphora

Mukul

Burseracea

e

Tikta

Kashaya

Anushna Katu VPK Laghu

Ruksha

Shothahara

Vedanasthapaka

Kandughna

Ghrita Madhura Sheet Madhur VK Snigdha Vataghana

Shothahara

Vedanasthapaka

Page | 77

METHODOLOGY

SELECTION CRITERIA

1)INCLUSION CRITERIA

1 Patients having signs and symptoms of Karnasrava (Otomycosis) ie करणशल

( pain ) करणकणड ( Itching ) करणसतराव ( Discharge )बाधिरण ( conductive Loss of

hearing )

2 Patient from age group 19 to 70 years

3 Any Gender

2)EXCLUSION CRITERIA

1 Patients suffering from any systemic disease like DM TB HTN

2 Chronic suppurative otitis media (CSOM)

3 Acute supportive otitis media (ASOM)

3 Perforation of Tympanic membrane

4 Chronic otitis media

3)WITHDRAWAL CRITERIA

1If patient develops any adverse effect such as irritation pain burning

sensation in ear loss of hearing and such patients was withdrawn from trial

and receive prompt appropriate medical attention

2If patient shows aggravation in symptoms

3If patient refuses to continue with the treatment

Page | 78

STUDY SETTING

Types of study - Randomized Clinical comparative Trial

Place of work - OPD of Shalakyatantra

Duration of study - 18 months

Study Population - Patients of Karnasrava in Shalakyatantra OPD

SAMPLE SIZE CALCULATION

Sampling Method ndash Purposive sampling followed by random allocation in two

groups

Sample size calculation-

n = z2 p (1-p)

d2

Were

n = sample size

P = prevalence of disease=10

z = standard normal variable ie 196

d = error ie005

desired Sample Size would be

n = Z2 P(1-P)d2

= (196)2x (0021) x(0979)(005)2

= 34

Visiting ENT OPD (ShalakyaTantra) and IPD (ShalakyaTantra) 21 = 34

n raquo34

So one group includes 34patients

Page | 79

Sampling Method

Total 68 patient of Karnasrava are selected by Purposive sampling followed by

random allocation in two groups Written informed consent is taken prior to

commencement of trial They are divided in 2 groups

Group A (Trial Group) 34 patients treated with Agaruwadi Dhoopana for 7

days

Dose 5 minutes twice in a day

Group B (Control Group) 34 patients treated with Guggula Dhoopana for 7

days

Dose 5 minutes twice in a day

STUDY DESIGN ndash

Open labeled Randomized Comparative Clinical trial

STUDY DESIGN

Screening of patient

Inclusion criteria satisfied Exclusion criteria

Initial assessment Excluded

Counseling of patient Treated accordingly

Patient selection by Simple Random Sampling Method

Page | 80

68 Patients were divided in two groups lsquoArsquo and lsquoBrsquo

Trial group A-34 patients were given

Agaruwadi Dhoopana

Control group B- 34 patients were

given Guggul Dhoopana

Informed written consent

Treatment was given for 7 days

Assessment on 1st 4th and 7th day

Post assessments follow up on 15th day

Observation

Data Collection

Statistical analysis of data

Conclusion

Page | 81

(A) Agaruwadi Varti for group A (Trial group)

Table no 2

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

B) Guggula Varti for group B (Control group)

SOP of it is same as above Agaruwadi Varti

Table no 3

Drug Guggula Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

FOLLOW UP

For both groups follow ups were done on 1st 4th and 7th and post

assessment follow up15th day

EXAMINATIONS

Torch for Local examination of ear

Otoscope examination

Tuning fork Test

Page | 82

OBSERVATION TABLE

Table no 4

Sr no Subjective criteria Day 1 Day 4 Day 7 Day 15

1 करणशल

(pain)

2 करणकणड

(Itching)

3 करणसतराव (Discharge )

4 बाधिरण (Conductive Deafness)

OBSERVATIONS

a) करणशल (Pain) -

0 - Absent

1 ndash Present

b) करणकणड (Itching) -

0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

Page | 83

c) करणसतराव (Discharge)

0- Absent

1- Mild -Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाधिरण (conductive Loss of hearing)

0 - Absent

1- Present

Observations were carried out before and after completion of treatment and

during each follow up After observations the data collected and presented in

the form of graphs charts and table

Page | 84

TRIAL DRUG

Authentication and standardization of raw drug material done After

authentication and standardizing of raw drug material Agaruwadi Varti was

prepared by Varti as explained in Ayurvedic classics

Method of Varti preparations

Panchavidh Kashaya Kalpana that is five method of pharmaceutical

preparation constitutes the fundamental process of Ayurvedic pharmaceutics

which is well explained in Sushrut Samhita Varti Kalpana is one among them

which can be included in Kalka Kalpana

तीररसतरपतपतीनामपरककव तीत [106]

स डलहण शरच 151

Medicines are powered triturated and given the Varti shape that is like wick

of lamp so it is called as Varti Kalpana

Drug content Agaru Madan Yawa

Route of Administration Local

Dose Two times a day

Duration 7 days

Page | 85

Methodology

Standard operating procedure (SOP) of Agaruwadi Varti

Agaruwadi Varti is prepared according to the classical text

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization was done as recommended in pharmacy procedure The

raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 mixed together in

equal quantity to make Agaruwadi churn

Quantity of each churn is 4 grams all are mixed when the Varti get dry total

weight of Varti was 10gram

STEP 4 - Agaruwadi churn triturated with appropriate quantity of water or

Ghrita and prepared Varti in GMP Certified Ayurvedic pharmacy Standard

aseptic precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Varti was packed in sterile air packed container

STEP 6 - Agaruwadi Dhoopana was given with the help of Dhoopana yantra

Authentication and Standardization of raw drug of Agaruwadi Varti was done

Sterilization was done as recommended in pharmacy procedure Sterile

preparation packed in sterile container of suitable size Under all aseptic

precaution Karnadhoopana given to infected ear

Page | 86

Containers for packaging and their sterilization-

Sterilization of the containers for storing Varties was done by Ethylene Oxide

(Eto) method

Ethylene Oxide (Eto) procedure-

It includes exposure of materials to ethylene oxide gas under vacuum in a

sealed chamber It consists of four primary variables

1Gas Concentration

2Humidity

3Temperature

4 Time

EtO gas is an alkylating agent which disturbs the DNA of microorganism

preventing them from reproducing It penetrates the breathable packaging

and sterilizes all the accessible surface of the product to render products

sterility by alkylation of essentials proteins for cell reproduction

Most Eto sterilization methods involves three different stages These can be

separated into three different on the size or number of devices to treat

1Preconditioning stage-

First products are passed through a preconditioning phase to make

microorganism grow The batch load goes through a well time under a

controlled environment of temperature and humidity

2Sterilizer stage-

Performed using process phase specially designed to provide the required level

of EtO exposure to assure sterility for a device or family of devices

3Degasser Aerration stage-

Finally products need to go through a degassing phase to remove any residual

particles of Eto The batch load goes over well time under a temperature-

controlled environment

The sterile containers were then used to store Agaruwadi Varti and handed to

patients included in the study

Page | 87

Packing of Agaruwadi Varti

The ETO sterilize plastic container were used for packing of Agaruwadi Varti

Varti was filled into these sterilize containers (7 in each) In an aseptic

environment plugging and capping was done under aseptic precautions In this

way packing of Agaruwadi Varti done These Varti were given to patient and

advise to take two times a day under all hygienic precautions

History and Examination

bull Proper history and presenting complains was recorded on case record form

bull Ear examination with otoscope was done during initial assessment and each

follow up

bull Otoscopic examination was done during initial assessment and each follow

up

bull Systemic Examination that is Blood Pressure Temperature Respiration

rate Pulse was recorded on case record form

Page | 88

Raw material

Fig14 यव चरण Fig15 मदनफळ चरण

Fig16 अगर चरण Fig17 गगगळ चरण

Page | 89

Preparation of Agaruwadi Varti

Fig18 Preparation of Agaruwadi Varti

Fig19 अगरवादी वरती

Page | 90

Fig20 Instruments used for examination of Karnasrava

Fig19 Karnadhoopana Yantra

Page | 91

Karnadhoopana Procedure

Fig 22 Karnadhoopana Procedure

Page | 92

OBSERVATIONS AND RESULTS

Page | 93

BASED ON DRUGS

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 94

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

AUTHENTICATION CERTIFICATE

Page | 95

BASED ON STASTICIAL ANALYSIS OF DEMOGRAPHIC DATA

68 patients of Karnasrava ndash Otomycosis

Table no 5

No of Patients Total

Group A Group B

Registered 38 37 75

Completed 34 34 68

Discontinue 04 03 07

Total 68 patients were enrolled in study 38 patients registered in group A

amongst them 34 patients completed the treatment and04 patients

discontinued the treatment However in group B 37 patients completed the

treatment and 03 patients discontinued the treatment out of 37 registered

patients

Hence the total number of patients registered in the present study was 75

and out of which 68 patients were discontinued the treatment So they

dropped out from the study While 68 patients were successfully completed

the treatment So observations and result of 68 patients were given below

Here we are going to discuss the statistical analysis of the data obtained in

the form of master chart that was prepared in accordance with the data

collected from the patients that had been included in the study The purpose

of statistical analysis was to analyzed the relation between age gender

occupation diet addiction and education

Page | 96

1 Age wise distribution of patients

Table no 6

In trial group 10 (29412) patients were from age group 18-25 years 14

(41176) patients were from age group 25-35 years 8 (23529) patients

were from age group 35-45 years and 2 (58824) patients were from age

group 45-60 yearsIn control group 6 (17647) patients were from age group

18-25 years 14 (41176) patients were from age group 25-35 years 7

(20588) patients were from age group 35-45 years and 7 (20588)

patients were from age group 45-60 years

Fig 23 Age wise distribution of patients

0

2

4

6

8

10

12

14

15 -25 25-35 35-45 45-60

10

14

8

2

6

14

7 7

Age Distribution

Trial Group N Control Group N

Age Distribution

Trial Group Control Group

N N

18 -25 10 29412 6 17647

25-35 14 41176 14 41176

35-45 8 23529 7 20588

45-60 2 58824 7 20588

Total 34 100 34 100

Page | 97

1 Gender wise distribution of patients

Table no 7

Sex

Trial Group Control Group

N N

Female 23 67647 15 44118

Male 11 32353 19 55882

Total 34 100 34 100

In trial group 23 (67647) patients were female and 11 (32353) patients

were male

In Control group 15 (44118) patients were female and 19 (55882)

patients were male

Fig 24 Gender wise distribution of patients

0

5

10

15

20

25

N N

TRIAL GROUP CONTROL GROUP

23

15

11

19

Gender

Female Male

Page | 98

2 Education wise distribution of patients

Table no 8

Education

Trial Group Control Group

N N

Illiterate 4 11765 3 88235

SSC 4 11765 3 88235

HSC 8 23529 9 26471

Graduation 16 47059 10 29412

Primary 1 29412 3 88235

Post-Graduation 1 29412 6 17647

Total 34 100 34 100

In trial group 4 (11765) patients were illiterate 4 (11765) patients were

SSC educated 8 (23529) patients were HSC educated 16 (47059)

patients were graduated 1 (29412) patients were primary educated and

1(29412) patients were post graduated

In control grou 3 (88235) patients were illiterate 3 (88235) patients

were SSC educated 9 (26471) patients were HSC educated 10 (29412)

patients were graduated 3 (88235) patients were primary educated and

6 (17647) patients were post graduated

Page | 99

Fig 25 Education wise distribution of patients

0

2

4

6

8

10

12

14

16

ILLITERATE SSC HSC GRADUATION PRIMARY POST GRADUATION

4 4

8

16

1 1

3 3

910

3

6

Education

Trial Group N Control Group N

Page | 100

3 Occupation wise distribution of patients

Table no 9

Occupation

Trial Group Control Group

N N

Accountant 1 294 2 588

Housewife 11 3235 8 2353

Engineer 1 294 1 294

Job 1 294 4 1176

Labor 1 294 3 882

Mess 1 294 0 000

Naturotherapyst 1 294 0 000

Pharma 1 294 0 000

Shopkeeper 4 1176 2 588

Singer 1 294 0 000

Student 8 2353 4 1176

Tailor 1 294 1 294

Teacher 1 294 1 294

Worker 1 294 3 882

Farmer 0 000 1 294

Lab Tech 0 000 1 294

Page | 101

Daily Collection 0 000 1 294

Fruit seller 0 000 1 294

Bus Driver 0 000 1 294

Total 34 10000 34 10000

In trial group 11 (3235 ) were housewife 8(2353) were students

4(1176) were shopkeeper 1(294) was accountant 1(294) was

engineer 1(294) was doing job 1(294)was labour 1(294) was

catering 1(294) was Naturotherapyst 1(294) was Pharma 1(294)

was Singer 1(294) was Tailor 1(294) was Teacher and 1(294) was

worker

In Control group 8 (2353)were housewife 4(1176) were students

2(588) were shopkeeper 2(588) was accountant 1(294) was

engineer 4( 1176) was doing job 3(882)was labor 1(294) was

Farmer 1(294) was Lab tech 1(294) was Daily collection 1(294)

was Tailor 1(294) was Teacher and 3(882) was worker 1(294) was

Fruit seller and 1(294) Bus driver

Fig 26 Education wise distribution of patients

0

2

4

6

8

10

12

1

11

1 1 1 1 1 1

4

1

8

1 1 10 0 0 0 0

2

8

1

43

0 0 02

0

4

1 13

1 1 1 1 1

Occupation

Trial Group N Control Group N

Page | 102

4 Religion wise distribution of patients

Table no 10

Religion

Trial Group Control Group

N N

Hindu 31 9118 33 9706

Muslim 3 882 1 294

Total 34 10000 34 10000

In trial group 31 (9118) patients were Hindu and 3 (882) patients were

Muslim

In control group 33 (9706) patients were Hindu and 1 (294) patient

were Muslim

Fig 27 Religion wise distribution of patients

0

5

10

15

20

25

30

35

N N

TRIAL GROUP CONTROL GROUP

3133

31

Religion

Hindu Muslim

Page | 103

5 Diet wise distribution of patients

Table no 11

Diet

Trial Group Control Group

N N

Veg 14 4118 20 5882

Non-Veg 20 5882 14 4118

Total 34 10000 34 10000

In trial group 14 (4118) patients were vegetarian and 20 (5882)

patients were Non vegetarian

In control group 20 (5882) patients were vegetarian and 14 (4118)

patients were Non-Veg

Fig 28 Diet wise distribution of patients

0

5

10

15

20

N N

TRIAL GROUP CONTROL GROUP

14

2020

14

Diet

Veg Non Veg

Page | 104

6 Addiction wise distribution of patients

Table no 12

Addiction

Trial Group Control Group

N N

None 30 8824 27 7941

Alcohol 2 588 0 000

Tobacco 1 294 2 588

Mishri 0 000 1 294

Smoking 1 294 4 1176

Total 34 10000 34 10000

In trial group 30 (8824) patients have no addiction 2 (588) patients

have addiction of alcohol 1 (294) patients have addiction of Tobacco 0

(0) patients have addiction of Mishri and 1 (294) patients have addiction

of smoking

In control group 27 (7941) patients have no addiction 0 (0) patients

have addiction of alcohol 2 (588) patients have addiction of Tobacco 1

(294) patients have addiction of Mishri and 11 (1176) patients have

addiction of smoking

Page | 105

Fig 29 Addiction wise distribution of patients

0

5

10

15

20

25

30

NONE ALCOHOL TOBACCO MISHRI SMOKING

30

21

01

27

0

21

4

Addiction

Trial Group N Control Group N

Page | 106

Statistical Analysis and Results

Effect of study on Karnashoola-

Table no 13

Karnashoola

Group A Group B

BT AT BT AT

N N N N

Grade 2 0 000 0 000 0 000 0 000

Grade 1 30 10000 7 2333 32 10667 5 1667

Grade 0 4 1333 27 9000 2 667 29 9667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 30 Effect of study on Karnashoola

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

30

7

32

54

27

2

29

Karnashoola

Grade 2 Grade 1 Grade 0

Page | 107

Table no 14

Karnashoola Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 088 100 033 006

969 2829E-

08 7667 HS

AT 021 000 041 007

Group

B

BT 094 100 024 004

1037 7103E-

11 8438 HS

AT 015 000 036 007

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 31

000010020030040050060070080090100

BT AT BT AT

GROUP A GROUP B

088

021

094

015

Karnashoola

Mean

Page | 108

Table no 15

Karnashoola

Mean SD Effect

Group

A

Group

B Trial Control Trial Control

Day 1 088 094 033 024 000 000

Day 3 065 071 049 046 2667 2500

Day 5 024 038 043 049 7333 5938

Day 14 021 015 041 036 7667 8438

000

010

020

030

040

050

060

070

080

090

100

Day 1 Day 3 Day 5 Day 14

Karnashoola

Mean Group A Mean Group B

Page | 109

Table no 16

Karnashoola N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3250 110500

510000 275 Control group 34 3650 124100

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 110

Effect of study on Karnakandu

Table no 17

Karnakandu

Group A Group B

BT AT BT AT

N N N N

Grade 3 7 2333 0 000 4 1333 0 000

Grade 2 18 6000 0 000 18 6000 0 000

Grade 1 7 2333 7 2333 10 3333 15 5000

Grade 0 2 667 27 9000 2 667 19 6333

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 32 Effect of study on Karnakandu

0

5

10

15

20

25

30

N N N N

BT AT BT AT

GROUP A GROUP B

7

0

4

0

18

0

18

0

7 7

10

15

2

27

2

19

karnakandu

Grade 3 Grade 2 Grade 1 Grade 0

Page | 111

Table no 18

Karnakandu Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 188 200 081 015

1091 3119E-

10 8906 HS

AT 021 000 041 007

Group

B

BT 171 200 076 014

1032 4746E-

09 7414 HS

AT 044 000 050 009

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Page | 112

Fig 33

Table no 19

Karnakandu

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 188 171 081 076 000 000

Day 3 126 118 057 058 3281 3103

Day 5 071 074 046 051 6250 5690

Day 14 021 044 041 050 8906 7414

000

020

040

060

080

100

120

140

160

180

200

BT AT BT AT

GROUP A GROUP B

188

021

171

044

Karnakandu

Mean

Page | 113

Table no 20

Karnakandu N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 4051 137750

373500 006 Control group 34 2849 96850

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is less than

005 Hence we conclude that there is significant difference between Trial

Group and Control Group

000

020

040

060

080

100

120

140

160

180

200

Day 1 Day 3 Day 5 Day 14

Karnakandu

Mean Group A Mean Group B

Page | 114

Effect of study on Karnasrava

Table no 21

Karnasrava

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 11 3667 0 000 8 2667 0 000

Grade 1 23 7667 3 1000 26 8667 2 667

Grade 0 0 000 31 10333 0 000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 34

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

11

0

8

0

23

3

26

20

31

0

32

Karnasrava

Grade 3 Grade 2 Grade 1 Grade 0

Page | 115

Table no 22

Karnasrava Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 132 100 047 009

1122 4356E-

13 9333 HS

AT 009 000 029 005

Group

B

BT 124 100 043 008

1130 9364E-

14 9524 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 35

000

020

040

060

080

100

120

140

BT AT BT AT

GROUP A GROUP B

132

009

124

006

Karnasrava

Mean

Page | 116

Table no 23

Karnasrava

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 132 124 047 043 000 000

Day 3 100 100 025 025 2444 1905

Day 5 047 038 051 049 6444 6905

Day 14 009 006 029 024 9333 9524

000

020

040

060

080

100

120

140

Day 1 Day 3 Day 5 Day 14

Karnasrava

Mean Group A Mean Group B

Page | 117

Table no 24

Karnasrava N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3535 120200

549000 655 Control

group 34 3365 114400

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 118

Effect of study on Karnabadhirya

Table no 25

Karn

Badhirya

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 0 000 0 000 0 000 0 000

Grade 1 13 4333 0 000 16 5333 2 667

Grade 0 21 7000 34 11333 18 6000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 36

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 00 0 0 0

13

0

16

2

21

34

18

32

Karnabadhirya

Grade 3 Grade 2 Grade 1 Grade 0

Page | 119

Table no 26

Karn

Badhirya Mean Median SD SE

Wilcoxon

W P-Value

Effect Result

Group

A

BT 038 000 049 009

799 7173E-

05 10000 HS

AT 000 000 000 000

Group

B

BT 047 000 051 009

816 0000138 8750 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 38

000

005

010

015

020

025

030

035

040

045

050

BT AT BT AT

GROUP A GROUP B

038

000

047

006

Karnbadhirya

Mean

Page | 120

Table no 27

Karn

Badhirya

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 038 047 049 051 000 000

Day 3 009 006 029 024 7692 8750

Day 5 003 006 017 024 9231 8750

Day 14 000 006 000 024 10000 8750

000

005

010

015

020

025

030

035

040

045

050

Day 1 Day 3 Day 5 Day 14

Karn Badhirya

Mean Group A Mean Group B

Page | 121

Table no 28

Karn

Badhirya N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3400 115600

561000 806 Control

group 34 3500 119000

Total 68

Page | 122

COMPARISION BETWEEN GROUP A AND GROUP B

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Table no 29

Overall Effect

Trial Group Control Group

N N

Marked Improvement 21 6176 16 4706

Moderate Improvement 8 2353 13 3824

Mild Improvement 4 1176 5 1471

No Change 1 2941 0 0

TOTAL 34 100 34 100

Fig 39

0

5

10

15

20

25

MARKED IMPROVEMENT

MODERATE IMPROVEMENT

MILD IMPROVEMENT NO CHANGE

21

8

41

1613

5

0

Overall Effect

Trial Group N Control Group N

Page | 123

DISCUSSION

Page | 124

Discussion is nothing but the logical reasoning of observations In

every research work discussion part is very important because it brings into

light about the logical analysis which are helpful in filling the research gap in

the scientific world

The discussion is categorized into following ways for the ease of

understanding

1 Discussion on selection of topic

2 Discussion on review of literature

3 Discussion on drugs their mode of action on the disease mode of action

of Karnadhoopana

4 Discussion on observation and results

1 Discussion on selection of topic

Otomycosis is commonly encountered in day-to-day practice Majority

of Indian people affected with this pathology This disease commonly

manifests in developing countries low socio-economic standard and lack

of hygiene Now a days due to busy lifestyle people are not able to follow

the proper instruction of care of ear which may be responsible for the

recurrent nature of disease So for the management of this we use

Karnadhoopana with the help of Agaruwadi Varti Dhoopana is simple

easy cost-effective procedure which can be done even at OPD levelso

for the disease Karnasrava we selected Karna Dhoopana as therapeutic

procedure Karnadhoopana was done with Agaruwadi Varti and Guggula

Varti which was very effective for treatment

Page | 125

2 Discussion on review of literature

Karnasrava is one such disease among 28 Karnarogas mentioned by

Acharya Sushruta in the chapter named Karna Roga Vigyana Acharya

Charaka included Karnasrava as symptom under the four types of

Karnarogas due to vitiation of different doshas Acharya Vagbhata has

not described Karnasrava separately It is a fact that systemic

description of Karnarogas is available in all the ancients of pus from a

Vata afflicted ear may results from head injury or immersion in water

Karnasrava is a clinical entity which can be correlated with Otomycosis

Karnasrava is explained as symptom as well as a disease in Ayurveda

Nidana- Karnasrava occur due to Samanya Nidana and Vishesh Nidana

Vishesh Nidana like Shirobhighata Nimmajato jale Mithyayoga of Shashtra

The exact pathology behind Karnasrava is not understood clearly

Purvarupa ndash No specific Purvarupa are found for Karnasrava in classical

literature Acharya Madhukara describe Purvarupa as expression of

Rupa(lakshana) with less intensity that is less intensity itching sound in ear

may considered as Purvarupa of Lakshana

Samprapti- Aacharya Sushruta not explained the Samprapti of Karnasrava

separately and we must consider the general Samprapti of Karnaroga Due to

various aetiologias as cited above ear afflicted by Vata dosha causes Twak

Rakta Mamsa dushti results in Karnasrava According to Acharya Sushruta

Vata-Kapha dose is dominance in Karnasrava

Page | 126

Nidan

Nija Agantuja

Vata ndash kapha prakopak nidana Shirobhighata Nimmajato-jale

Mithya yoga of Shastra

Vata- kapha Prakopaka(Chaya prakopak) Vata-kapha prakopaka

( Achay prakopak)

Twak Rakta Mamsa dushti

Karnasrava

Page | 127

Chikitsa

The curative aspect and this must be done simultaneously giving due

importance to Nidan Parivarjana that is preventive measures So Nidan

Parivarjana that is avoidance of causative factors like Jalkrida Mithyayogen

shashtrasya Karnakandu Shirasnan Pratishaya is the first step in combating

the disease and form the part of line of treatment

Above Samprapti helps us to proceed towards the treatment of Karnasrava

The main protocol of treatment is removal of fungus and wound management

which include various measures to keep area day clean clear of microbes and

providing ideal condition for healing

Samany Chikitsa- Acharya Sushruta described general treatment for

Karnaroga as Snehapana (Drinking ghee) Rasayana (Rejuvenation therapy)

Bhramacharya Avoid excessive speaking Avoidance of physical exercise and

head bath

Vishesha Chikitsa ndash Acharya Sushruta mentioned some procedures in the

treatment of Karnasrava which is Shirovirechana Karnadhoopana

Karnapurana Karanpramarjana Dhavan Avachurnana Karnapurana Above

various procedures described in Ayurveda for management of fungus growth

in ear discharging ear fulfill these requirements of wound management

Page | 128

Discussion on observation and Result

Out of 68 patients 34 patients included for the trial The incidence of

Karnasrava is observed in trial and control groups

The statistical analysis provided the following data

AGE

Trial group- Maximum no of patients that is 14 (41176) patients were from

age group 25-35 years followed by 29412 patients were from age group

18-25 years 23529patients were from age group 35-45 years and

58824 patients were from age group 45-60 years

Control group - Maximum no of patients that is 14 (41176) patients were

from age group 25-35 years followed by 20588 patients were from age

group 35-45 years and 20588 patients were from age group 45-60 years

17647 patients were from age group 15-25 years

The maximum no of cases of Karnasrava found in age group between 25 to

35 years The reason behind this is repeated use of ear bud or emersed water

in ear More use of earphone or working more in cold environment

GENDER

Trial group ndash A higher prevalence seen in females 6764 and 3235 in

males

Control group - A higher prevalence seen in males 5588 and 4411 in

females

Females and males both are prone to disease

Page | 129

EDUCATION

Trial group-It is observed that amongst 34 patients maximum ie16

(47059) patients were graduated 8 (23529) patients were HSC

educated 4 (11765) patients were SSC educated 4 (11765) patients

were illiterate 1 (29412) patient were primary educated and 1(29412)

patient were post graduated

Control group- It is observed that 10 (29412) patients were graduated 9

(26471) patients were HSC educated 6 (17647) patients were post

graduated 3 (88235) patients were SSC educated 3 (88235) patients

were primary educated3 (88235) patients were illiterate

There is no direct relation between education and Otomycosis

RELIGION

Trial group- The incidence of patients of Hindu religion are 9118 and Muslim

religion are 882

Control group- The incidence of patients of Hindu religion are 9706 and

Muslim religion are 294

There is no probable explanation for this maximum number of patients in

Hindu religion it depends upon the patients attend the hospital and

community residing there

Page | 130

DIET

Trial group It was found that maximum ie5882 patients were taking

mixed diet while 4118 were taking vegetarian diet

Control group It was found that maximum ie5882 were taking

vegetarian diet while 4118 patients were taking mixed diet

The dietary habit of person is based on choice availability and religious

customs of the person

ADDICTION-

Trial group- It was found that maximum ie 30 (8824) patients have no

addiction 2 (588) patients have addiction of alcohol 1 (294) patients

have addiction of Tobacco 1 (294) patients have addiction of smoking and

0 (0) patients have addiction of Mishri

Control group - It was found that maximum ie 27 (7941) patients have

no addiction 4(1176) patients have addiction of smoking 2 (588)

patients have addiction of Tobacco 1 (294) patients have addiction of

Mishri and 0 (0) patients have addiction of alcohol

Very few patients were addicted to Alcohol Smoking Tobacco and Mishri

These factors can be taken as provoking factors for Otomycosis

Page | 131

Discussion based on probable Mode of action of Karnadhoopana

In Ayurveda classics Karna Dhoopana is therapeutic procedure explain for

Karnasrava Dhoopana is administration of Dhooma (Fumes) with the help of

Dhoopan Dravya References indicates that analgesic and disinfectant effect

of Dhoopana karma and mention for Dushta Vrana Chikitsa It reduces

Vedana Srava amp also does Vrana Ropana action

Various Dhoopanas and Dhoopan Dravas for different element in various

Samhitas of Ayurveda but there is a lacuna of availability of reference

regarding how to do it and method of procedure Matra Kala Contraindication

etc

Currently simple modified way of Karnadhoopana according to Yukti Praman

and experience but there is lac of standardization

Karnadhoopana is one among the topical Bahiparimajan type of treatment

Karna Parmarjana is procedure of cleaning ear with the help of cotton or gauze

piece soaked in honey

Page | 132

Dhoopan

The fumes coming out on burning Agaruwadi Varti

Administrated directly into external ear canal

Causes vasodilation

Due to this increase blood supply in external ear canal

It helps in absorption of drug

Fumes dries up Srava and bring the analgesic effect

Karnagata Kapha amp Avrut Vata Dosha Shaman

Decrease in signs and symptoms like karnasrava Karnshool Karnabadhirya amp

Karnandu

Page | 133

3 Discussion based on probable mode of action of Agaruwadi

Dhoopana

Agaru ndash

I Agaru is a fragrant tree aroma is a result of fungal pathogenesis when the

wood of tree is contaminated by fungi at wounds it develops scrap filled

with resin and turn out to be aroma Medicinal use of Agaru have been

recorded in ancient medicinal science in in inflammatory disease and some

infective disease

II Acharya Charaka has referred to Agaru as an Ushna dravya despite having

Tikta Rasa Ashtang Samgraha used Agaru as Dhupana Dravya along with

Madan and Yawa in Karnasrava Nighantu recommended is use as a

Dhoopana

III In various Samhitas and Nighantus Agaru described as Tikta Snighdha

Sheetaprashamana Vranaprasadana Tvachya Due to these properties

Agaru is used in the treatment of Karna-Akashi Roga and Dushta Vrana

Shodhaka

IV Agaru is reported to have Antimicrobial Analgesic Antioxidants

Antihistaminic and anxiolytic properties Its Antihistaminic property gives

relief from itching which is cardinal feature of Otomycosis Due to Katu

Ushna Tikta Guna improves blood circulation Bheda stage develop It is

Niram Awastha of Dosha Karnagata kapha and vata get decrease and

symptoms like karnashoolakarnasrava get decrease Agaru also have a

Antioxidant properties

V Chemically Agaru Contain 2-(2-Phenylethyl) Chromones Terpenoids

Flavonoids

VI Natural Agarwood had inhibitive activities towards Staphylococcus Aures

The chloroform extract of Agarwood prolongs the pain threshold[108]

Page | 134

Madan

I Madanphala have therapeutic properties like Anti-inflammatory

Antiallergic Analgesic and Wound healing

II It is Useful in treatment of disease like Shotha (inflammation) Vidradhi

(Abscess) Pratishaya (Common cold) Kushta(Skin disease)

III Extract of Madanphala mainly contain Glcosides Tritorpenct

Glycosides Saponin

IV Saponin glycosides are act as fire extinguisher This property is helpful

for vartiIt also act as a detergent which clean the surface of fungus

V Tritorpenct act as a anti-inflammatory antimicrobial and

immunomodulator compound Interaction of glycosides with sterol

causes disturbance of selective permeability in plasmic membraneso

exudates and discharge get decrease

VI Pharmacological activity [109]

Antibacterial Activity The preliminary antibacterial activity of Methanolic

extract of Randia D lam was done on some standard and wild pathogenic

strains The inhibition of the bacterial growth was more pronounced on E coli

as compared to the other tested organism This shows the antibacterial action

of Randia D secondary infection can prevent

Anti-Allergic Activity In Ayurveda Randia D Extract and its fraction of milk

induced leukocytosis and eosinophilia in mice

Anti-Inflammatory Activity The crude methanol extract of fruit of Randia D

effectively reduced the carrageenin induced oedema in hind paw of the rats

significant reduction in granular tissue formation was recorded This activity

seems to be significant at various acute phases of inflammation and om

formation of granular tissue This proves action of Madanaphala in shopa

(inflammation)

Page | 135

Analgesic Activity Analgesic activity was tested in mice weighing between 20-

250 with six number of animals in each group Methanlic extract of fruit Randia

d give analgesic activity in both models This proves its Shoolanashaka (pain

killer) action

Immunomodulatory Activity Randia D has immunostimulant activity and

chloroform fraction which strongly affected immune system seems to be

bioactive fraction of this plant

The overall effect of Agaru Mandanphala Yawa having Anti-inflammatory

Antiseptic Antimicrobial Property Active ingredient shows these properties

Agaru Yawa Madanphala

Vatakaphaghna

Act as

Vranashodhak

Vedanasthapaka

Sheetaprashamana

Shothara

Avarana of Vata get decrease so helps to Shaman of Vata dosha

Karnakandu Karnashoola Karnasrava

Prashamana

Page | 136

This fact can be taken into consideration and probably acknowledge that

Karnadhoopana with Agaruwadi Varti had not leave any residue in the ear

Removal of fibrin keratinocyte migration and in growth of epithelial tissue

plays a major role in healing It is technique of fumigation of ear with the

smoke of anti-infective drug In Karnadhoopana Sthanik Swedana increase the

blood supply and helps in absorption of the drug reduce Karnakandu amp

Karnshoola associated with infection

Page | 137

SUMMARY AND CONCLUSION

Page | 138

The dissertation entitled randomize comparative clinical trial to study the

effect of Agaruwadi Karnadhoopan and Guggula Karnadhoopan In Karnasrava

wsr to Otomycosis

The dissertation is divided into fallowing parts

Introduction

Review of literature

Ayurvedic review

Modern Review

Drug review

Procedure review

Material and Method

Observation and result

Discussion

Summary and conclusion

bull INTRODUCTION

It includes importance of Shalakyatantra in Sushrut Samhita Charka

Samhita And Ashtang Samgraha

Common and specific causes of Karnasrava

Karnasrava is a clinical entity which can be corelate with Otomycosis

In Ashtang Samgraha stated the procedure like Karnadhoopana with

Agaru Yawa Madanphala in Karnasrava

Page | 139

bull REVIEW OF LITERATURE

1 Ayurvedic review

2 Modern review

3 Drug review

Ayurvedic review-

It includes Rachana-Sharir and Kriya-Sharir of Karna detail description of

Karnaroga and its types Karnaroga Samanya hetu Poorvaroopa Rupa

Samprapti Upadrava Pathya-Apathya of Karnasrava Vishesh Nidan and

Chikitsa of Karnasrava Detail description of Karnadhoopana according to

various Acharays have been mentioned

Modern review-

It includes anatomy and physiology of Ear brief anatomy of ear anatomy of

External middle and Internal ear Detail description of the disease

Otomycosis mechanism of fungal infection in external canal pathophysiology

investigations diagnosis and management

Drug review-

Detail description of Agaru Yawa Madan Guggula and its synonyms

Ayurvedic properties Karma uses Pharmacological action and their

pharmacodynamic properties

Page | 140

MATERIAL AND METHOD

It includes description regarding materials required for the study Preparation

of Agaruwadi Varti its Standardization Sterilization and packaging

Plan of study

1 Total 68 patients completed the treatment Age criteria was kept

between 18-60 years Patient selection was done by done by simple

random sampling method and divided into two groups A (Trial) and

Group B (Control) 34 patients in each group

2 Patients in Group A were treated with Karnadhoopana with Agaruwadi

Varti for 7 days two times in a day while patients in Group B were treated

with Karnadhoopana with Guggula for 7 days two times in a day

3 Clinical examination done during each follow up ie 0th 4rd 7th and

observation were recorded

Page | 141

OBSERVATIONS AND RESULTS

Page | 142

1 It was observed that higher incidence of disease Karnasrava ie

Otomycosis found in age group 25-35 years

2 Disease otomycosis was equal in both male and female

3 The trial group there was significant relief in Karnakandu (8906)

Karnasrava(9333) Karnashoola(7667) and karnabadhirya(100)

4 In control group there was significant relief in Karnakandu (7414)

Karnasrava(9524) Karnashoola(8438) and

karnabadhirya(8750)

Page | 143

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and Aquilaria Plants (researchgatenet)

100 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 4 chapter no-2 page no-4

101 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 chapter no-152 Madanpage

no376-379

102 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

103 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 1 chapter no-54 page no-

84

104 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 page no697-699

patol-yawa

Page | 155

105 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

106 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

Dhoompanvidhi page no- 252-254

107 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012Chikitasasthan Shlok

no- 151page no-406

108 httpswwwmdpicom1420-3049232342pdf

109 httpswwwijamcoinindexphpijamarticledownload0610201530

0

Page | 156

BIBILOGRAPHY

Page | 157

1 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

2 Scott-Brown WG Diseases of the EarNose and Throat Landon

Botterworth and co(publishers) Ltd1952 Volume 2

3 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012

4 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009

5 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi commantry

Purvakhand and Madhyamkhand

6 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

7 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-Tatva-

Sandipika hindi commentary Published by Chaukhamba Sanskrit

SansthanVaranasi

8 The Ayurvedic Pharmacopeia of India Ministry of Health and family welfare

department of Ayush Part 1 and part 4

9 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005

10 Acharya Trivedi Raguveer Prasad Ashtang sangrah published by

Vaidyanath Ayurveda bhavan pvt

11 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition

12 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary published by Chaukhamba

Orientalia

Page | 158

ANNEXURE

Page | 159

ANNEXURE- 1

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

CASE RECORD FORM

RESEARCH PROFORMA FOR MS (AYU) DESSERTATION

DEPARTMENT OF SHALAKYATANTRA

NAME -

ADDRESS -

GENDER - AGE - OCCUPATION-

RELIGION - EDUCATION - MARITAL STATUS-

OPD IPD NO-

DATE OF ADMISSIONCOMMESEMENT-

DATE OF DISCHARGECOMPLITION-

DATE OF COUNSELLING-

TEL NO-

CHIEF COMPLAINTS-

PAST MEDICAL AND SURGICAL HISTORY-

TREATMENT HISTORY-

FAMILY HISTORY-

Page | 160

PERSONAL HISTORY-

a) Ahar(Diet)

b) Vihar

c) History of addiction

GENERAL EXAMINATION

PULSE - MIN BP - mm of hg

TEMP - 0F RR - MIN

ASHATAVIDHA PARIKSHANA

Nadi- Mutra- Mala-

Jivha- Shabda- Sparsha-

Drik- Aakruti-

SYSTEMIC EXAMINATION

RS ndash

CNS-

CVS ndash

Page | 161

LOCAL EXAMINATION (KARNA PARIKSHAN)

OBSERVATION TABLE FOR SUBJECTIVE CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching )

RIGHT EAR LEFT EAR

KARNASHASHUKULI

KARNAPUTRAK

KARNAPALI

KARNAKUHARA -

SRAVA

GANDH

VARNA

SWARUPA

KARNAPATALA (TM)

Page | 162

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

Hearing Test

1Renne Test ndash

2 Weber Test -

Examination of Ear-

Pathological Investigation-

Other Examination-

Nidan Panchak-

1Hetu-

2Purvarup-

3Rupa-

4Upashayanupashaya-

5Samprapti

Signature of Guide Signature of Doctor(Researcher)

Page | 163

ANNEXURE 12

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Dhoopana Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization were done as recommended in pharmacy procedure

The raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 were mixed together

in equal quantity to make Agaruwadi churn

STEP 4 - Agaruwadi churn were triturated with appropriate quantity of water

and prepared Varti in GMP Certified Ayurvedic pharmacy Standard aseptic

precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Dhoopana Varti was packed in sterile air packed

container

STEP 6 - Agaruwadi Dhoopan was given with the help of Dhoopan yantra

TREATMENT DETAIL-

Purvakarma -

1 The patient is asked to sit comfortably on chair having sufficient light and

less amount of dust

2 The EAC is cleaned thoroughly by Pichu Varti (cotton swab) to remove the

discharge and other debris

Pradhankarma -

1 The patient is asked to relax completely on the chair

Page | 164

2 Fumes are passed to the ear with Dhoopana Yantra

3 Dhoopana yantra is funnel shaped and its one end will keep the ear covered

for the passage of Dhooma into the ear canal and other end where Agaruwadi

Dhoopana Varti were placed which produces fumes

4 This Dhoopana was given for 5 min

Pashchat karma -

1 The patient were advised to avoid cold refrigerated food drinks cold water

bath cold wind fog and prevent water from entering the ear

(A) Agaruwadi Dhoopana Varti

B) Guggula Dhoopana Varti SOP of it is same as above Agaruwadi Dhoopana

Varti

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Page | 165

ANNEXURE 21

INFORMED CONSENT DOCUMENT

Study Title

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

Introduction

- You are invited to take part in a research study RANDOMSIED COMPARATIVE

CLINICAL TRIAL TO STUDY THE EFFECT OF AGARUWADI DHOOPANA AND

GUGGULA DHOOPANA IN KARNASRAVA

- Before you decide it is important for you to understand why the

research is being done and what it will involve

- Please take time to read the following information carefully and discuss

it with friends relatives and your doctor if you wish

- Ask us if there is anything that is not clear or if you would like more

information

Purpose amp Nature of Study

- In this research project by examine you and ldquoKarnasravardquo (Otomycosis)

disease were treated

- In the part of treatment Agaruwadi Dhoopana or Guggula Dhoopan were

given

- Dhoopana means medicated drug fumes were given in ear with the help of

Dhoopan Yantra

Page | 166

- Treatment was given for 7 days

Study Duration

7days

Participation

- Your participation is entirely voluntary

- If you do decide to take part you were given this information sheet to keep

and be asked to sign a informed consent form

- If you decide to take part you are still free to withdraw at any time and

without giving a reason This will not affect the standard of current or future

medical care you may receive

Confidentiality

- All information which is collected about you during the research were

kept strictly confidential

- Any information about you which is collected from the center will have

your identity in the form of a code number so that it will remain confidential

Benefits Of Study

- The results obtained from this study would be helpful for providing better

quality of treatment amp other essential facilities for Karnasrava (Discharge)

patients

- You will get clinical benefit from the study

Page | 167

Risks Of Study

- In this treatment there are few chances of Irritation of Ear Nose and

congestion at EAC if any of these happens then treatment were given

Results Of Study

- If the Results obtained are profitable then they may get published

without disclosing your details

Signature of patient

Date

Time

Phone no of Researcher

Page | 168

रण मादहती पतरक

सशोिनाच शीषवक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE

EFFECT OF AGARUWADI DHOOPANA AND GUGGULA DHOOPANA

IN KARNASRAVA

परसतताना

- आपणास या सशोिनातपमक अभयासात सहिागी होणय़ाच आाहन करणयात यत आह

- सशोिनातील सहिाग तननदशचत करणयापी सशोिनाच उददश समजन घया

- खालील मादहती काळजीपवक ाचा आणण आशयक ािलयास आपलया डॉकिराशी कका

दहतशरचतकाशी चचाव करा

- काही सददिता असलयास कका आणखी मादहती ही असलयास आमछयाशी चचाव करा

सशोिनाच उददीटि सतरप

- सदर सशोिन परकलपामरधय आपलयाला तपासणी करन कणवसरा या वयाशरिची शरचककतपसा दणयात

यणार आह

- सदर वयाशरिची शरचककतपसा महणन आपणास अगरादी िपन कका गगल िपन

दणयात यणार आह

- सदर औषि आपणास 7 ददस घयायाच आह

Page | 169

कालािी

- 7 ददस

सहिाग

- आपला सहिाग हा पणवपण ऎनदछिक आह

- आपला सहिाग तननदशचत असलयास आपणास ही मादहती पतरतरका दणयात यईल आपणास यातील

समती पतरकार सही कराी लागल

- सहिाग तननदशचत असनही आपण कोणतपयाही ळस कोणतही कारण न दता माघार घ शकता

याचा आपलया दयकीय सविर कोणताही पररणाम होणार नाही

गोपनीयता

- सशोिना दरमयान गोळा कलली आपलया वषयाची सव मादहती गोपनीय ठणयात यईल

- आपली यनदकतक मादहती साकततक सतरपात गोपनीय ठणयात यईल

सशोिनाच फ़ायद

- सशोिनाच तनटकषव कणवसरा बाशरित रणाछया दयकीय इतर सविाचा दजाव सिारणयास

फायदशीर ठरतील

सशोिनातील जोणखम

- य़ा शरचककतपसमरधय कान दखण डॊळय़ातन नाकातन पाणी य़ण नाकात जळजळण डोक जड

होण ही लिण ददस शकतात यापकी लिण तनमावण झालयास तपयाची शरचककतपसा कली जाईल

Page | 170

सशोिनाच तनटकषव

सशोिनाच तनटकषव फ़ायदशीर ठरलयास आपली मादहती गोपनीय ठन परकाशशत करणय़ात यईल

रण सतािरी-

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

Page | 171

ANNEXURE 31

INFORMED CONSENT FORM

Patient OPD no __________

Subjectrsquos Identifier

Date of Birth Age Gender

I _____________________________________ age___________ years

exercising my free power of choice hereby give my consent to be included

as a participant in the clinical study entitled

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

1 I confirm that I have read have been read and understood the information

sheet for the above study and can ask questions

2 I understand that my participation in the study is voluntary and that I am

free to withdraw at any time without giving any reason without affecting my

medical care or legal rights

3 I understand that the Ethics Committee members investigators and study

doctors will not need my permission to look at my health records both in

respect of the current study and any further research that may be conducted

in relation to it even if I withdraw from the trial I agree to his access

However I understand that my identity will not be revealed in information

released to third parties or published

4I agree not to restrict the use of any data or results that arisefrom this study

provided such a use only for scientific purpose

5 I agree to take part in the above study

Page | 172

signature with Date-

Left hand thumb impression

Name amp signature of the witness ndash

Name amp signature of the student ndash

Page | 173

ANNEXURE 32

समतीपतरक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

वयकतीच य

ददनाक जरमददनाक

1) मी ह तननदशचत कररत आह ककसदर सशोिन परकलपाबाबतची सपणव मदहती मी ाचली असनमला ती

समजली आहतपयाबददल मला परशन वचारणयाची पणव मिा आह सदर मादहतीन माझ समािान झाल

आह

2) मी सदर सशोिनातन माझया मजीनसार किीही बाहर पड शकतो या माझया अशरिकाराची मला कलपना

आह

3) माझी दयककय मादहती तपासणयाची कागदपतर कळ सशोिनाकररता ापरली जाणार आहत याची

मला मादहती आहसदर सशोिन परकलपातील सबशरित घिकाना माझी दयककय मादहती पाहणयाची मी

समती दत आहतरावप या सदिावतील माझी ओळख दशववणारी मादहती कोणासही ददली जाणार नाहीयाची

मला कलपना दणयात आली आह

4) सदर अभयासातन शमळणारी मादहती अरा तनटकषव कळ शासततरीय हतसाठी ापरल जाणयासाठी माझी

समती आह

5) रील अभयासात सहिागी होणयास माझी समती आह

रण सतािरी-

Page | 174

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

ASSESSMENT CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching)

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

a) कणवशल ( pain )- 0 - Absent

1 ndash Present

Page | 175

b) कणवकणड (Itching)- 0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

c) कणवसततरा ( Discharge )

0- Absent

1-Mild- Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाशरियव ( conductive Loss of hearing )

0 - Present

1 - Absent

Page | 176

Page | 177

Page | 178

Page | 179

Page | 180

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

Page | 181

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 182

AUTHENTIFICATION CERTIFICATE

Page | 9

Ayurvedic literature Ayurveda is a science of life practice since

thousands of years The ancient Indian system of medicine and surgery is

commonly known as Ayurveda This was given the status of Upaveda or

fifth Veda in the next stage of growth Among the available literature three

Samhita that is Charaka Samhita Sushrut Samhita Ashtang Hrudayam and

Ashtang Samgraha are the chief source of knowledge of Ayurveda

Ayurveda consist of eight branches Shalakyatantra is one among them

Shalakyatantra is one of its specialized branch deals with science of

ophthalmology otorhinolaryngology Oro dental surgery and head Acharya

Sushruta himself a practical surgeon was the first to advocate dissection of

dead bodies is indispensable for a successful student of surgery He had

described gross anatomy in the first chapter of Uttartantra Shalakyatantra

define by different Acharys as follows

शालाकय नामोरधवजतरगताना रोगाणा शरणनयनदनघराणाददसशरशरताना वयाशरिनामपशमनारव

स स ११०

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत [13]

चस १७१२

Shalakya Tantra Nirukti and Parichaya

शलाकायााः कमव शालाकय ततपपरिान शलाकयम डलहण [14]

The term Shalakyatantra is derived from Shalakya and Tantra

The word Shalakya means A probe and Tantra denotes teaching and

practices found in scripturesThe compendium in which application of

Shalaka in various surgical procedures is principally described is called as

Shalakya tantra

दनदटिवशारदााः शालाककनाः डलहण ( सउ ११३)[15]

An eye specialist is termed as Shalaki by Dalhana

Page | 10

Synonyms of Shalakya Tantra

Uttamanga Chikitsa Jatrurdhwa Chikitsa Urdhwang Chikitsa Shalakya

Chikitsa

Importance of Shalakyatantra-

Life of living being and all the Indriyas are situated in the head hence it is

known as Uttamanga

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत

चस १७१२

The treatment given to this part of the body is described specially in

Shalakya tantra While describing the importance of Shiras Vagbhata

correlates it to the root of tree (Urdhwa Mula) and body to the trunk of tree

(Adha Shaka)

Sushruta has deal with Mukha Roga in Nidan Shan and its treatment in

Chikitsasthan The description regarding the disease of eye ear nose and

head are found only in UttaraSthan Sushruta specially describes the

disease of Shalakyatantra as told by Videha in the beginning of Uttartantra

itself[16]

Shalakyatantra Itihas-

India Exhibits traditional of more than thousands of years in art literature

language logic and philosophy etc The convention was in its sophisticated

and advanced attire throughout the Vedic period

Vedic period ndash

1 Natush was treated for deafness by Ashwinikumars (Rigveda)

2 Rujaswa and Kanva were treated for blindness by Ashwani Kumaras

(Rigvedas)

Page | 11

3 There are several prayers mentioned for normal functioning of sense

organs (Yajurveda)

4 Structures and functions of Mastishka are described (Atharveda)

5 Mantras having reference to disease of Eye Ear Oral cavity etc are

found (Atharvaveda)

Upanishada Period ndash

1 Samhita Period

a) Sushrut Samhita ndash

bull Explanation regarding Netra Nasa and Shirorogas (Uttartantra 1-

26th chapter)

bull Details regarding Mukha and Karna Roga Nidan and

Chikitsa(Nidansthan 16th and Chikitsasthan 22nd chapter)

bull Description regarding Karna Chedana Sandhana Nasa

Ostasandhana Sutra Sthan 16th chapter

b) Charaka Samhita -

bull Explanation regarding Shirorogas (Sutrasthan 17th chapter)

bull Explanation of Gala rogas like Upajivika Galshundi and Rohini

bull Nasa Shiro Mukha Karna and Netra Chikitsa (Chikitsa sthan 26th

chapter)

bull Description regarding Lakshana and Chikitsa of Shankhaka

Ardhavbhedaka Shirovirechana and Shiro basti (siddhi sthan 9th

chapter)

c)Ashtnga Sangraha ndash

bull Detailed description regarding Shalakyatantara (Uttartantra 11-28

chapter)

bull Description of Kriyakalpa (Sutrasthan 32nd and 33rd)

Page | 12

d)Ashtang Hrudayam

bull Detailed description on Shalakya Tantra (Uttar tantra 8-24 chapters)

bull Kriyakalpas (Sutrasthan 23rd and 24th chapter)

e) Bhela Samhita

bull Chakshushya Vaisheshik and Buddhi Vaisheshik Alochaka pitta

f) Harita Samhita- Branch of Medical science offering elaborating

information about the procedure like Nasya Anjan Gandusha etc

comprehended with their applications in disease of Head Eyes Ears

Eyebrows Throat Temporal region and cervical spine is known as

Shalakyatantara

शशरोरोगा नतररोगा कणवरोगा वशषताः भरकरठशङकमरयास य रोगा समिनदरत दह १३

तषा परततकारकम व नसतयतपयवणजनातन च अभयङगमखगणडषकियााः शालकयसशमतााः १४

इतत शालाकयनाम [17]

Documentation of different ancient literature gives various references

regarding all aspects of Karnasrava in various periods It is very much

important to know the history of Karnasrava from Vedic Pauranic Samhita

and Samgraha period

Vedic period ndash The Vedas being the oldest source of knowledge have no

direct mentioning of Karnasrava

Page | 13

Samhita and Samgraha period ndash

Aacharya Sushruta described about Karnaroga Karnasrava Nidan

Roopa and Chikitsa The detail description is available in Sushrut

Samhita Uttartantra 20 and 21st chapters

Aacharya Charaka did not specify Karnasrava but mentioned 4 types

of Karnarogas that is Vataj Pittaj Kaphaja and Sannipataja and their

treatment in 26th chapter of Chikitsasthan

In Ashtang Hrudaya karnasrava is not explained as a separate disease

but Chikitsa is mentioned in 18th chapter of Astanga Hrudaya

uttartantra

In Ashtang Samgraha Chikitsa is mentioned in 22nd chapter of Astang

Samgraha Uttartantra

The details about Karnasrava are explained in Bhavprakasha

Madhyamakhanda 64th chapter

Madhavakara has explained about Karnasrava in 57th chapter of

Madhymakhanda

Karnasrava is also explained in Sharangadara Samhita Uttarkhand 11th

chapter

The reference for treatment of Karnasrava is available in

Yogaratnakara

In Gadhnigraha Karnasrava and its treatment is mentioned in

Karnarogadhikara Adhaya

Vangasena had mentioned about the disease and treatment in 69th

chapter

Chakradatta explained Karnasrava in 57th chapter

Dalhana has given commentary on Sushrut Samhita Uttartantra 20th

and 21st chapter

Sankhya Samprapti of Karnasrava ndash

Aachary Sushruta explains 28 Karnaroga in Uttaratantra Karnaroga

Vigyniyam Aadhaya Aacharya charaka explain 4 Karnaroga in

Page | 14

Karnarohvigyniyam Adhaya based on doshas Acharya Vagabhata in

Ashtang Hrudaya explain 25 Karnaroga in Adhyaya

कणवशल परणादशरच बाशरियव कषड ए च

कणवसरााः कणवकणडाः कणव चवसतततर च

कशमकणवपरततनाहौ विशरिदवविसततरा

कणवपाकाः पततकणवसततराशवशरचतवविम

कणावबवद सपतवि शोफशरचावप चतवविाः

ऎत कणवगता रोगा अटिावशततरीररतााः

स उ २०- ३ त ५[18]

ातकणवरोग वपततकणवरोग कफकणवरोग

रकतकणवरोग सनदरनपातकणवरोग कणवनाद

बशरिरतप परततनाह कणडाः शोफ पततकणवक

किशमकणवक उियरपविरधयअशो अबवद

कशरचकणवक वपपपली वदाररका पाळीशोष

ततिका पररपोिो उतपपातो उरमरर दाःखिवन

शलहाखयााः परचवशनदरतकणवरोगा उकतााः

इदिीका अ स उ २१ [19]

चतपाराः कणवरोगााः

च स [20]

Page | 15

KARNA

Karna ndash करोतत शबद गरहण [21]

The organ of hearing

Karnasrava- कणवसतय कणवयोाव ससराा [22]

Discharge from the ear is referred as Karnasrava

KARNA SHAREERA

bull Nirukti

कणयवत अकणयवत अनन इती [23]

It means reception and conduction of sound waves

These are the functions of external and middle ear

bull Nirukti of Sravanam

शरयत अनन इती शरणम[24]

It means perception of sound

It can be attributed to the internal ear function

bull Karna Utpatti-

Karna is an organ formed by Akash Mahabhuta[25]

The fundamental characteristic is as follows

Indriya ndash Srotram [26]

Indriya Adhisthan ndash Karna [27]

Indriya Dravy ndash Akasha [28]

Indriya Arth ndashShabdha [29]

Indriya buddhi ndash Srotobyddhi

Page | 16

bull Paryaya of Karna- Shabdapatha Srotrapatha Sravanam shruti

Kuhuram Dwanigraham etc

bull Definition of Karna-

कणवशटकलयनदछिरनमिटिोपगरदहत शरोतरमछयत [30]

मा तन ५७१

The definition of Karna is stated in Madhav Nidanam Indriya which is not

seen with naked eye along with Shashkuli is called Shrotra that is Karna

Indriya is so minute that it is not perceived with any sense organ

In Charak Samhita the word Karna explain as the Indriya Adhisthan of

Shabdha Karna is described as one of the Prathyangas of the body He

emphasizes that all Indriyas manifest during the 3rd month of gestation

period

Acharya Sushruta while describing formation of Purusha from Prakriti or

Avyakta narrated that all Indriyas are developing from the Vikarika and

Taijas Ahankara Both Vagabhata and Sushruta stated that Karna as one of

the Bahirsrotas

शरण नयन दन घराण गदमढराणण न सततरोताशसराणा बदहमवखातन [31]

स शा ५-१०

In Ashtang Hradaya Vagbhata has states that all Indriyas are Atmaja

According to him lower lobule elevated helix projected posterior portion

fleshy and adherent ear are indications of long span of life[32]

ततरखातखातन दह अनदसतमन शरोतर शबद ववकतता [33]

ा शा ३-३

शबदाः शबदनदरिय सवनदछििसमहो ववकतता [34]

स शा १-२६

Page | 17

Ear has the prominence of Akash Mahabhuta The prominent dosha of ear

is Vata It is important seat of Vata The prominent Dhatus are Asthi and

Mamsa Karna is one of the Panchgnanendriyas and it meant for hearing

Sushruta narrated that Karnasthita Asthi and Sandhi

घराणकणवगरीाकषिकोषष तरणातन [35]

सशा ५-२२

शरोतरशरगािकष शखाताव [36]

सशा ५-३२

गडकणवशखटककम [37]

स शा ५-२२

One Sandhi and one Tarunasthi in ear

Sandhi ndash Karna contain two Sandhi one in each ear Type of Sandhi is

Shankhavartha which is present in Shringataka

Mansapeshi ndash 2[38]

Siras ndash 10 [39]

Vataj Sira - 4

Pittaj sira - 2

Kaphaj sira - 2

Raktaj Sira - 2

Avedhya sira-

कणवयोदवश तासा शबदादहनीनामकका पररहरत

सशा ७-२५[40]

Amongst above mentioned ten Siras each Karna lodges one Shabdavaha

Sira It is Avedhya

Page | 18

Dhamani -2

Length of ear is 4 Angula

Karna moola ndash 2 Angula

कणाविरतर चतदवशअगलम

स शा ३५-१४[41]

The distance between two ears through the back of the neck is 14 Angula

bull Marmas of Karna-

1 Vidhuras-

कणवपटठतो अिाःसशरशरत विर ततर बशरियवम

सशा ६-३७[42]

कणतपयादद सतनायममवणी ककनदचचनदरनममनाकर कलयकररणणच

डलहणाचयव[43]

अिसततात कणवयोतनवमन विर शरततहाररणण

ा शा ४-२९[44]

Sankhya-2

Vistara- frac12 Angula

Type- Snayumarma (Susha)

- Dhamanimarma(AH)

- Vaikalykar

Sthana- It is situated in the depressed portion in the back of the ear

Injury to them causes loss of hearing

Page | 19

2 Shringataka marma-

नदजवहाकषिनाशसकाशरोतरखचतटियसरमम

तालरयासतयातन चतपारर सरोतसा तष ममवस

वदि शरगातकाखयष सददसततपयजतत जीवतम

मा तन ५७१ [45]

Sankhya- 4

Type- Siramarma

Sthana- It is in head that is amidst Siras (blood vessels) nursing sense

organ

A palm size area near Talu

Injury to this Marma causes death

In modern anatomy ear divides into Bhayakarna or External ear Mdhyakarn

or Middle ear Antahkarna or Internal ear This is extremely appropriate

Even though the ear is divided into three divisions in the point of modern

anatomy Ayurveda denotes ear organ is one Ayurveda treats disease by

way of assessing Dosha and Dushya Here Dushya is one that is Karnendria

Dosha difference will call for different treatment for different disease Hence

treating the vitiated Dosha will cure the disease irrespective whether it is in

external middle or internal ear The thought is based on different

fundamental principle from Ayurveda

bull Parts of Karna

In Ayurveda classics detailed description about anatomy of ear is not

available But the various parts are mentioned as follows

Bhayakarna- External ear

Mdhyakarna ndash Middle ear

Antahkarna- Internal ear

Page | 20

द कणवशटकशलक दॊ कणवपतरकौ

च शा 7-11[46]

कणवशटकशलक कणवगतातवकौ कणवपतरकौ त बाहयकणा

चिदतत च शा 7-11[47]

शटकली बाहयपालयाशरिटिानम

डलहन- स शरच 25-1 12[48]

Karna Shashkulika ndash It is also called as Karna Shashakuli Charaka has

mentioned this term while describing different Pratyngas of the body

Acharaya Gananatha sen has given the clarification for it as a pinna or

auricle[49]

Karnapali ndash It is popularly known as lobule of the ear Daivakrita Chidra is

present in it

Karnaputrika- Ayurvedic scholars accepted two terms in this cortex They

are Karnaputrika and Karnaputrika The former is considered as Tragus and

antitragus[50]

Karna Prushtha- It can be taken as the cranial surface of mastoid or

auricle[51]

Karnapeetha- Aacharaya Sushruta firstly mention the term Karnapeetha

It is mentioned first by Sushruta while describing the procedure of

Karnavyadana Vagbhata has mentioned that it is Adhobhaga of Karna

Dalhana has clarified that it is the region above the Karnaputrika that is the

region which is at the bottom of the concha

Karnamoola ndash It can be considered as parotid region[52]

Karna lathika ndashAcharaya Dalhana mentioned lobule as a Karna Lathika

Page | 21

Karnaavatu ndashThis term is used by Sushruta while describing the

measurements of different Angapratyangas where he has mentioned that

the distance between the Karnaavatu is 14 Angul Dalhana has comments

that it can be taken as the distance between two ears from behind[53]

Shabdhavahasrotas ndash It also called as Shabdapatha or Srotapatha The

whole passage through which the sound waves pass can be taken as

Shabdavahasrotas[54]

Shrotashringataka ndash It can be taken as the labyrinth of ear[55]

bull Dosha in context to Karna-

Karna is principal location of Vayu

1 Prana Vayu- Prana Vayu circulating in oral cavity is responsible for

Dehadhruka that is keeping all body parts active Indriyadruka that is

keeping all Dnyanendriya healthy by proper nourishment (Purana) helps in

deglutition of food material and convey the stimulation of Indriyabuddhi

and atma

2 Udana Vayu- Bala(strength) Varna speech singing are its function It

is responsible for facial expressions due to pleasure sorrow anger love

frustration etc in general its circulation and actions are just opposite to

Pranavayu

3 Vyana Vayu- Its principal functions are circulation of Rasa and Rakta

through body and various movements Its main location is Hrudaya Five

types of movements for which it is responsible are expansion contraction

upward downward and oblique other activities are opening closure of

eyelid yawning perspiration During circulation if it gets obstructed due

to Srotodushti it generates disease of that Srotas Vyana Vayu gets vitiated

by disease of Rasa Rakta Oja and Chetanadhatu

Page | 22

4 Samana Vayu- It is circulating in the vicinity of stomach and intestine

and helps in keeping the Jatharagni (digestive juices and enzymes) in

equilibrium Disturbance in Jatharagni precipitates disease

5 Tarpaka Kapha- Entire body functions movements are controlled and

executed by various centers in the brain Sensation perceived by sense

organs is conveyed to Mann and Aatma residing in Hrudaya The motor

signals from them are then conveyed to the functioning

organsKarmendriya through Prana Vayu Shira head is therefore a

location of continuous activities motions of Vata All these centers are in

unctuous Majjadhatu in the Shira For stabilizing this ever-active Vata and

to nourish the Majja dhatu very unctuous Tarpaka Kapha situated in Shira

plays an important role

bull Ayurvedic aspect of sound perception [56]

According to Ayurveda Pratyaksha Dnyan or Perception of any sensation

including Shabda occurs due to interaction of the Karnendriya and the

Indriya- Arth -Karma resulting in Sravana

External Environmental acquaintance with living body is executed by five

sense organs namely Netra Karna Nasa Jivha and Twaka All

Dnyanendriya that is sense organ are Panchmahabhautic combination

Despite this fact every Indrya sense organ perceives object Tanmatra of

that Mahabhuta only from which it is originated from Akash Mahabhuta and

hence perceives Shabd only that is audio perception Shrotrendriya is one

of the principal locations of Vata and its function is to perceive Shabda that

is sound waves This sensation is conveyed through Shabdavahi Dhamanis

to Mana and Atma through Pranavayu and the sequence is responsible for

perception of sound in this way external sound is perceived and interpreted

when Atma is linked with Mann Mann is linked with Indriyabuddhi that is

minute virtual Dnyanendriya located in brain Indriyabuddhi is linked with

Adhishthana with prominent Mahabhuta and lastly with Indriya

ArthShabdatanmatra that is sense object Once this sequence is completed

Page | 23

the meaning of a particular sound is interpreted and understood In this

entire process of perception and interpretation of sound waves Pranavayu

and Tarpaka Kapha located in Shira play extremely important role Hence

the healthy status of all the sense organ depends upon the normal

physiologically homeostatic condition of Pranavayu and Tarpaka Kapha

MANAS

ATAMA

BUDDHI

AHANKARA

ARTHA

Page | 24

EAR ANATOMY

bull Embryology of the Ear [57]

1 The sound conducting apparatus develops from the branchial apparatus

whereas the sound perceptive apparatus from the ectodermal otocyst

2 The pinna develops from the six hillocks around the 1st branchial cleft

3 External auditory canal develops from 1st branchial cleft

4 The outpouching of the 1st pharyngeal pouch gives rise to a proximal

narrow part that forms the eustachian tube and distal dilated part that

forms the middle ear cavity

5 Prussakrsquos space is a potential space lateral to the Shrapnellrsquos membrane

and medically by the neck of malleus that can be involved during the

extension of cholesteatoma

6 Development starts in the 3rd week of the intrauterine life and is

completed by 16th week of intrauterine life Membranous and boney

labyrinth develops from the otic capsule

The Ear is divided into

1 External Ear

2 Middle Ear

3 Internal Ear or the labyrinth

Page | 25

Fig 1 Ear Anatomy

EXTERNAL EAR [58]

The outside ear contains pinna and lobule

Pinna is the noticeable piece of outer ear made from single sheet of yellow

flexible ligament covered by subcutaneous tissue and skin It has two

surfaces average and parallel It is intently disciple to perichondrium on its

sidelong surface while it is somewhat free on average surface Pinna

incorporates tragus helix against helix fossa three-sided scaphoid fossa

incisura terminalis

External auditory Canal ndash It extends from the bottom of the conchea to

the tympanic membrane and measures about 24 mm along its posterior

wallit is S shaped

Parts 1 Cartilaginous part

2 Bony part

Page | 26

Cartilaginous part ndash The outer one third is cartilaginous consist of fibro

cartilage is directed first inward backward and upward It has Fissure of

Santorium The skin of this part of the canal contains hair follicles

sebaceous gland and cruminous gland

Bony part ndash The inner two third part is boney It goes forward downward

and medially skin lined in this part is very thin Isthmus is the narrowest

part of the canal lying medial to junction of bony and cartilaginous part

nearly 5 mm lateral to tympanic membrane

The roof and posterior wall of the external auditory canal shorter than floor

and anterior wall The skin lining the tympanic membrane and boney canal

has a self-cleansing property due to migration of keratin layer of epithelium

from drum towards the cartilaginous portion

Relations- Anteriorly- Temporomandibular joint and parotid gland

Superiorly- Middle cranial fossa

Inferiorly- parotid gland

Posterior- Mastoid antrum mastoid air cells and facial nerve

Nerve supply ndashSensory nerve supply of the external ear The auricle

supplied by fibers of the great auricular nerve (C2 and C3) and lesser

occipital nerve (C2) Auriculo temporal branch of the 5th cranial nerve and

auricle branch of the vagus (Arnoldrsquos nerve) supply external canal Facial

nerve has small sensory contribution on posterior-inferior wall

Tympanic Membrane -It is the partition between EAC and middle ear It

is a thin semitranslucent membrane pearly white in colored lying obliquely

in the medial end of EAC with the angle of 55 It is forming major part of

lateral wall of middle ear Annulus tympanicus is attached at its

circumference to the sulcus The TM is oval shape It measures

approximately 10 mm in vertical diameter and 90 mm in horizontal

diameter

Page | 27

Layers ndash Tympanic membrane consist of three layers

1 Outer Epithelium or cuticular layer which is continuous with skin of

external ear

2 Middle fibrous layer has both circular and radial fibers middle layer

missing in upper part

3 Inner layer- Inner mucosal layer which is continuous with middle ear

mucosa

Parts ndash Tympanic membrane consist of two parts

1 Pars tensa -It is largest part below the malleolar folds The inner

surface at the center attached to the handle of malleus Angle of cone

is most illuminated part in the pars tensa at anteroinferior part of pars

tensa

2 Pars flaccida Sharpnells membrane -it is triangular area above the

malleolar folds which are thin and devoid of fibrous tissue and

annulus It fits into notch of Rivinous

Nerve supply 1 Anterior half of lateral surface Auriculotemporal V3

2 Posterior half of lateral surface Auricular branch of vagus cn 10

3 Medial Surface Tympanic branch of CN 9 (Jacobsons nerve)

Fig 2 Tympanic membrane of ear

Page | 28

MIDDLE EAR [59]

The middle ear or tympanic cavity is an irregular laterally compressed

space within the temporal bone It is filled with air that is supplied to you

from the nasal part of the throat through the ear canal It contains a chain

of mobile bones that connect its side with the medial wall and serve to

transmit vibrations transmitted to the eardrum through the cavity to the

inner ear Including the parapet the vertical and anteroposterior diameters

of the cavity are each approximately 15 mm The transverse diameter

measures about 6mm at the top and 4mm at the bottom Compared to the

eardrum it is only about 2mm The eardrum is limited laterally by the

eardrum medially by the lateral wall of the inner ear It communicates

behind with the tympanic antrum and through it with the air cells of the

mastoid and in front with the auditory canal The middle ear together with

the Eustachian tube aditus antral and mastoid air cells is called the

middle ear cleft It is lined by mucus membrane and filled with air

It is divided into 3 parts

1 Mesotympanum (located in front of the pars tensa)

2 Epitympanum or attic (located above the pars tensa but medial to

Sharpnells membrane and the lateral bony wall of the attic)

3 Hypotympanum (located under pars tensa) The middle ear is like a

hexagonal box with a roof

Carotid or Anterior wall- It separates middle ear cavity from internal

carotid artery The various structure passing through anterior wall of

tympanic cavity

bull Canal of chorda tympani nerve

bull Canal of tensor tympani muscle

bull Eustachian tube

bull Anterior malleolar ligament

bull Anterior tympanic artery

Page | 29

Posterior or mastoid wall ndash The upper part of the back wall shows the

opening of the auditorium Below the auditory is a triangular bony

projection known as the pyramidalis processors The stapedial tendon is

transmitted through the apex of the pyramidalis processes The vertical

portion of the facial nerve descends along the posterior wall until it opens

into the stylomastoid foramen

Roof or Tegmental wall (Pars terminalis)- It is formed by a thin bone

plate called the tegman tympanum that separates the skull and tympanic

cavities It is located on the anterior surface of the rocky part of the

temporal bone near the junction with the temporal shell it extends back to

the roof in the tympanic membrane and anteriorly to cover the half canal

of the tensor tympanic muscle The lateral border corresponds to the

remains of the Petro scaly suture

Floor ndash It is formed by a thin plate of bone which separate middle ear from

the bulb of the internal jugular vein lodged in the jugular fossa

Lateral wall ndash It is formed by tympanic membrane and partly by a portion

of squamous part of the temporal bone It separates the middle ear from

external ear

Medial wall- It separates the middle ear from the inner ear

bull The promontory is the most prominent and convex part formed by the

basal rotation of the cochlea

bull The bony lateral semicircular canal is postero-superior to the promontory

above the oval window

bull The oval window is located between the middle ear and the vestibular

slope of the cochlea It is closed by the stirrup footrest and the annular

ligament

Page | 30

bull The round window is located under and behind the cape The round

window recess is directed to the rear It is closed by the secondary eardrum

and separates the middle ear of the Scala tympani from the cochlea

bull The facial nerve passes through the bony fallopian tube above the oval

window

Mastoid Antrum ndash It is a large space with air in the upper part of the

mastoid and communicates with the attic through the aditus The roof is

formed by the antri tegmen which extends and separates the tympani

tegmen from the middle cranial fossa The lateral wall of the antrum is

formed by a bony plate that is on average 15 cm thick in adults It is

marked externally on the surface of the mastoid by the suprameatal triangle

(MacEwen)

Aditus and Antrum- Aditus is a gap through which the attic communicates

with the antrum The boney prominence of the horizontal canal lies on its

medial aspect even as the fossa incudes to thats attaches the quick system

of incus lies laterally Facial nerve publications simply underneath the

aditus

The mastoid and its air cell system-

The mastoid consists of bone cortex with a honeycomb of air cell

underneath Depending on development of air cell three types of mastoids

have been described

1Well-pneumatized or cellular- Mastoid cells are well developed and

intervening septa are thin

2Diploetic- Mastoid consist of marrow spaces and a few air cells

3Sclerotic or acellular ndash There are no cells or marrow spaces

With any type of mastoid pneumatization antrum is always present In

sclerotic mastoids antrum is usually small and the sigmoid sinus is

anteposed

Page | 31

Depending on the location mastoid air cells are divided into

1 Zygomatic cells (In the root of zygoma)

2 Tegman cell (Extending into tegmen tympani)

3 Perisinus cells (overlying the sinus plate)

4 Retrofecial cells (round the facial nerve)

5 Peri labyrinthine cells (located above below and behind the

labyrinthine some of them pass through the arch of superior

semicircular canal These cells may communicate with the petrous

apex)

6 Peritubal (around the Eustachian tube Along with hypotymoanic

cells they also communicate with the petrous apex)

7 Tip cells (which are quite large and lie medial and lateral to the

digastric ridge in the tip of mastoid)

8 Marginal cells (Lying behind the sinus plate and may extend into

the occipital bone)

9 Squamosal cells (Lying in the squamous part of temporal bone)

Development of Mastoid ndash

The mastoid develops from the scaly petrous bone The petrosquamosal

suture may persist in the form of a bone plate - Korners septum which

separates the superficial squamosal cells from the deep rock cells Korners

septum is surgically important because it can cause problems locating the

antrum and deeper cells and thus lead to incomplete removal of the disease

during mastoidectomy The mastoid antrum can only be reached if Korners

septum is removed

Page | 32

Fig 3 Cross section of Mastoid

Contents of the middle ear

Ossicles ndash Three tiny bones which conduct the sound from eardrum to oval

window

Malleus ndash It is the largest and most lateral ossicle measuring 8 mm in

length It has head neck handle anterior and lateral processes The head

is situated in the epitympanum A lateral process project laterally from the

neck while the handle is firmly fixed to the pars tensa of the ear drum

Incus- It has a body short process and long process The body short

process and long process The body articulate with the head of mallelus in

the attic and the short process project into the attic The long process

projects downwards behind the handle of malleus running parallel to it and

articulate with the head of the stapes via the lenticular process

Stapes ndash It is the smallest ossicle measuring about 35 mm and consist of

head neck footplate and anterior and posterior curcura The footplate of

stapes is held to the oval window by the annular ligament

Page | 33

Muscles ndash

1Tensor tympani ndash It is inserted is a branch of the facial nerve which carries

the sense of taste It is first arch muscle supplied by branch of mandibular

nerve V3

2 Stapedious muscles ndash It is inserted to the neck of stapes It is the second

arch muscle supplied by branch of facial nerve that is nerve to stapedius

Fig 4 Contents of the middle ear

Blood supply of Middle Ear

bull Anterior tympanic branch of maxillary artery which supplies tympanic

membrane

bull Stylomastoid branch of posterior auricular artery which supplies middle

ear and mastoid air cells

Page | 34

Four minor vessels are

bull Petrosal branch of middle meningeal artery runs along greater petrosal

nerve

bull Superior tympanic branch of middle meningeal srtery traversing along

the canal for tensor tympanic muscle

bull Branch of artery of pterygoid carotid

bull Tympanic branch of internal carotid

Lymphatic Drainage of Ear

Lymphatics from the middle ear drain into retropharyngeal and parotid

nodes while those of the Surgical Importance ndash Eustachian tube drain into

retropharyngeal group

1 The middle ear is part of contiguous organs including nose nasopharynx

Eustachian tube and mastoid bone lined by respiratory mucosa Any

respiratory infection or allergy is likely to pass to middle is likely to pass to

middle ear

2 Moreover middle ear suppurative disease may spread to adjacent organs

and produce complication eg Labyrinthitis meningitis facial nerve palsy

etc

3 Lenticular process is vulnerable in suppurative ear diseases and causes

ocular disruption

4 Prussac space is the site of primary acquired cholesteatoma

Page | 35

INNER EAR [60]

Inner ear is divided into two parts

1 Bony Labyrinth

2 Membranous labyrinth

Anatomy of bony labyrinth

It is divided into two parts

1 Vestibule

2 Cochlea

3 Semicircular canal

The vestibule is located between the medial wall of the middle ear and the

lateral to internal acoustic meatus anterior to the semicircular canal and

posterior to the cochlea The vestibule is the central part of the inner ear

On its side is the oval window opening which is closed by the bracket foot

plate The bony cochlea is located in front of the vestibule It has 275 turns

wound around a bony axis called a modiolus The cochlea is about 30 mm

long The hollow center of the modiolus is a spiral canal that contains the

fibers and ganglion cells of the cochlear nerve A thin bony sheet the bony

lamina winda around the modiolus This divides the cochlear duct into two

galleries the Scala vestibuli above and the scala tympani below

There are three semicircular canals superior posterior and lateral They

are semicircular in shape and open into the vestibule One end of the

semicircle is enlarged and is known as the sphere

The membranous labyrinth is in the bony labyrinth It is connected to the

bony labyrinth by fibrous trabeculae and is surrounded by perilymph The

endolymph is located in the membranous labyrinth

Page | 36

The utricle is in the upper part of the vestibule while the saccule is found

below Both the utricle and saccule contain a single sensory patch called

the macula Each macula is covered with a neuroepithelium made up of

neuroepithelium made up of sensory hair cells and support cells these cells

are separated by a basement membrane Fibers of the vestibulo-cochlear

nerve enter the macula and pierce the basement membrane to terminate

at the base of the hair cell or cell bodies The utricle and the saccule with

their macula are called otolith organs Membrane semicircular canals are

the membrane canals of the corresponding bony semicircular canals They

open into the utricle through five openings One end of the opening of each

channel is dilated called the sphere in which the sensory organ of each

channel is located The cross section of the Scala standard looks like a right

angle The base is formed by the basilar membrane Sensory cells are

arranged on the surface of the basilar membrane These sensory cells with

their supporting cells form a complex neuroepithelium called the basilar

papilla or the cortical organ named after an Italian microscopist The

organs of the corti have a gelatinous membrane called the tectorial

membrane and they are supported by the pillar of the corti The cortical

pillars enclose a space called the corti tunnel which contains a fluid called

cortical lymph Vestibule is lies between the medial wall of the middle ear

and lateral to internal acoustic meatus anterior to semicircular canal and

posterior to the cochlea Vestibule is the central part of the internal ear On

its lateral surface is the opening of oval window which is closed by the foot

plate of stapes Boney cochlea lies in front of the vestibule It has 275 turns

coiling around boney axis called modiolus Cochlea is approximately 30 mm

in length The hollow center of the modiolus is a spiral canal containing the

fibers and ganglion cells of cochlear nerve A thin boney sheet the osseous

lamina winda around the modiolus This divides the cochlear canal into two

galleries the Scala vestibuli above and the scala tympani below

Page | 37

Semicircular canals are three in number superior posterior and lateral

They are semicircular in shape and opens into the vestibule One of the

ends of the semicircular is enlarged and is known as ampulla

Membranous labyrinth is situated within the boney labyrinth It is connected

to the bony labyrinth by fibrous trabeculae and is surrounded by perilymph

Endolymph is situated within the membranous labyrinth

The utricle lies in the upper part of the vestibule while the saccule lies below

Utricle and saccule both contain single sensory patch called macula Each

macula is covered by neuroepithelium consist of Neuroepithelium consists

of sensory hair cells and supporting cells these cells are separated by

basement membrane Fibers from the vestibulo cochlear nerve enter the

macula and pierce the basement membrane to end either at the base of the

hair cell or cell bodies The utricle and saccule with their macula are referred

to as otolith organs Membranous semicircular ducts are the membranous

ducts in the corresponding bony semicircular canals They open into the

utricle by five openings One end of the opening of each canal is dilated

called ampulla in which the sensory organ of each canal is located The

cross section of Scala media resembles a right angle Its base is formed by

basilar membrane Upon the surface of the basilar membrane the sensory

cells are arranged These sensory cells with their supporting cells form a

complex neuroepithelium called the basilar papilla or Organ of corti named

after an Italian Microscopist Organ of corti has a gelatinous membrane

called tectorial membrane and they are supported by pillar of corti The

pillars of corti enclose a space called tunnel of corti which contains fluid

called corti lymph

Page | 38

Fig 5 Inner Ear

Blood supply of labyrinth

Labyrinthine artery

Common cochlear Anterior vestibular Artery

Vestibulocochlear artery Main cochlear artery

Cochlear branch posterior vestibular artery

Page | 39

PHYSIOLOGY OF HEARING [61]

A sound signal in the environment is collected by the pinna passes through

external auditory canal and strikes the tympanic membrane Vibrations of

the tympanic membrane are transmitted to stapes footplate through a chain

of ossicles coupled to the tympanic membrane Movements of stapes foot

plate cause pressure changes in labyrinthine fluids which move the basilar

membrane This stimulates the hair cells of the Organ of corti It is these

hair cells which act as transducers and convert mechanical energy to

electrical impulses which travel along the auditory nerve

Thus the mechanism of hearing can be broadly divided into

bull Mechanical conduction of sound (conductive apparatus)

bull Transduction of mechanical energy to electrical impulses (sensory

system of cochlea)

bull Conduction of electrical impulses to brain (neural

Fig 6 PHYSIOLOGY OF HEARING

Page | 40

Conduction of sound

Under the surface of water we cannot hear the sound made in air because

9995 of sound energy are reflected away from the surface of water because

of the impedance offered by it A similar situation exists in the ear when

air-conducted sound must travel to cochlear fluids Nature has

compensated for this loss of sound energy by interposing the middle ear

which converts sound of greater amplitude but lesser force to that of lesser

amplitude and greater force This function of middle ear is called impedance

matching mechanism or the transformer action It is accompanied by

a) Lever action of the ossicles

Handle of malleus is 13 times longer than long process of incus providing

a mechanical advantage of 13

b) Hydraulic action of tympanic membrane

The area of tympanic membrane is much larger than the area of stapes foot

plate the average ratio between the two beings 211 As the effective

vibratory area of the tympanic membrane is only two- thirds the effective

areal ratio is reduced to 141 and this is the mechanical advantage

provided by the tympanic membrane

c) curved membrane effect

Movements of tympanic membrane are more at the periphery than at the

center where handle of malleus is attached This too provides some

leverage

Transduction of mechanical energy to electrical impulses

Movements of stapes footplate transmitted to cochlear fluids move the

basilar membrane setting up shearing force between the tectorial

membrane and hair cells The distraction of hair cells gives rise to cochlear

microphonics which triggers the nerve impulse

Page | 41

Neural pathways

Hair cells get innervation from bipolar cells of spiral ganglion Central axons

of these cells collect to form cochlear nerve which goes to ventral and dorsal

cochlear nuclei From there both crossed and uncrossed fibers travel to

superior olivary nucleus lateral lemniscus inferior colliculus and medial

geniculate body and finally reach the auditory cortex of the temporal lobe

Page | 42

DISEASES REVIEW

करणसराव

Nirukti - करणसय कणवयोाव ससराा [62]

Nidana- Acharya Sushruta and Vagbhata describe the common etiological

factors for the Karnaroga

अशयाय जलिीडा कणवकणडयन मरत

शमथययोगन शसततरसतय कवपतो अरय च कोपन ||

सउ २० १२

1 Avashaya or Pratishaya

(Excessive exposure to cold)

2 Jalakrida

(Excessive swimming)

3 Karnakandunyanum

(Excessive scracing due to itching)

4 Mithyayogena Shatrasya

(Improper instrumentation during wax removal or foreign body removal)

5Shabdasya

(Louder sound for long durationperverted contact of sound)

6 Abhighata (Trauma)

7 Vitiation of Tridoshas

Page | 43

Samanya Nidana according to different Samhita

Vishesh Nidan of Karnasrava

Acharya Charaka has not mentioned any kind of Nidana regarding Karnaroga

but has described Utapati of Karnaroga from Siroroga in Karnasirasym

Adhyaya[67]

शशरोअशिघातादरा तनमजजतो जल परपकादरा अवप विि

सरतत पय शरणॊ अतनलात स कणवससरा इतत परककतीत

सउ २० १०

असस ३७२५ [68]

1 Shiroabhighatat - Head Injury-Fracture of middle cranial fossa

2 Jala nimajjana - CSF otorrhoea fracture of middle cranial fossa

3 Karnaprapaka

4 Karna Vidhradhi -Puyasrava

Sr

no

Samanya Nidana SU AH[63] AS[64] YR[65] MN[66]

1 Avashaya + + +

2 Pratishaya + +

3 Shabdha

mithyayoga

+

4 Shashtra

mithyayoga

+ + +

5 Karnakandooyan + + + + +

6 Jalkrida + + + + +

7 Abhighata + + +

Page | 44

Samanya samprapti

परापय शरोतरशसरा कयावत शल शरोतशस गान

त कणवगता रोगा अटिावशततरीता

सउ २० १२

Due to common and specific etiology factors the vitiated Doshas gets

Sthanasamshraya in Karna and causes Karnasrava It is the stages of

Samprapti were Doshas gets lodged in Srotas and start processes of Dosh

Dushya Sammurchsna Due to Shiroabhighata Jalanimmajana Karna Paka

Karna Vidhradi vitiated Vata Dosha and Karna becomes Avruta by Vata and

results in Karnasrava Normal physiology of Dosha Dhatus and Malas entirely

depends on the normality of Srotas Dosh Dushya Sammurchana or

manifestation of diseases will not take place if only vitiation of Doshas take

place without deformity of Srotas Here in Karnasrava vitiation of Srotas are

Atipravritti Sanga and Vimargagamana take place Atipravritti is being excess

production of fungus Sanga is obstruction in external acoustic canal

Vimargagamana is the propagation of discharge through ear

Vishesh Samprapti

Karnasrava occurs due to Nij nidana is Pratishaya while Agantuja nidanas are

Avashya Jalkrida and Karnakanduyan Due to etiological factors which are

Vata-Kapha provocative in nature gradual vitiation of Doshas will occur After

vitiation they get accumulated (Sthan samshraya) in external auditory canal

In other hand when patient does Sevana of Agantuj Nidan like water enter in

external ear scratching of ear unsterile instrumentation leads to Dosh

Prakopa These cause Twak and Mamsa Dhatu Dushti which leads to

discontinuity of epithelium of ear canal which creates suitable atmosphere for

fungal pathogen to grow The vitiated Vata will produce symptoms such as

Page | 45

pain hearing impairment and vitiated Kapha causes symptoms like itching

discharge ear blockage By assessing the symptoms it can be said that Kapha

Avrita Vata Dosha is responsible for the manifestation of clinical features like

pain itching discharge Which are seen in Karnasrava that is otomycosis

Acharya Charaka has mentioned while explaining Samanya Chikitsa of

Karnaroga that it should be treated like Vrana when Paka and Srava is present

as a symptom Fungal spores invade in the epithelial layer of EAC In response

to infection inflammatory process is start This is a Paka Avastha After

removing the fungal mass ulceration in external acoustic canal is commonly

seen As a result of infection process exudates was produced which will mix

up- with fungal colonies and appear as discharge As per Dosha involvement

in Vrana Shoola Srava can be differ According to Acharya Sushruta Ruk is

the Samanya Lakshana of Vrana and Vishesha Lakshana of Vrana includes

pain discharge discoloration itching etc according to Dosha involvement

which are also seen in otomycosis In otomycosis mainly watery and purulent

type of discharge is present which indicates Paka avastha If there is Dosha

involve in Vrana is called Dushta Vrana Acharya Sushruta and Acharya

Vagabhata have mentioned verity of Srava in Twak and Mamsa Vranavastu

which is found in otomycosis Based on this description otomycosis can be

correlated with Karnasrava

Page | 46

Representing the Samprapti of Karnasrava

Vishesh Nidana ndash Shiroabhighatat

Jala nimajjana

Prapaka Vidhradhi

Vitited vata

Avarana by kapha

Vimargagamana of Vata

Karnasrava

Samprapti Ghataka

Dosha ndash Kapha and Vata

Dushya ndash Rasa Rakta and Mansa

Strotodushti ndash Vimargagamana and Sang

Adhishthana ndash Karna (Bhayakarna)

Rogmarga ndash Madhyama

Page | 47

Purvarupa

The Purvarupa of Karnasrava are not mentioned separately in any ayurvedic

classics In routine practice cretin Purvarupa are noted

1 Karnakandu

2 Karnagurutwa

3 Alpa karnashoola

4 Discomfort in ear

Rupa

1 Karnashoola

2 Karnakandu

3 Karnasrava

4 karnabadhirya

5 Cotton wool like or wet newspaper like grayish brown or black colored mass

is seen

6 External auditory canal skin appears edematous and red

Upashaya and Anupashaya

Appropriate application of Aushadhi Ahara and Vihara when produces relief in

the symptom is called as Upashaya and when aggravates the symptoms is

called Anaupashaya There is not any reference available in the classics about

the Upashaya and Anupashaya of karnasrava

Sadhyasadhyata

Sushruta has not mentioned specially the Sadhyasadhyata of Karnarogas But

Vagbhata has mentioned Karnasrava as a Sadhyavyadhi[69]

Sadhysadhyatagives the clear picture of prognosis of the disease It depends

on many factors like nature of disease severity of disease Vaya Prakriti Bala

of the patient etc

Page | 48

Upadrava of Karnasrava

In Samhita there is no reference available regarding the Upadrava of

Karnasrava

Samanya Chikitsa ndash

The common treatment principle for all Karnaroga is Ghritapana Use of

Rasayana Bhrahmacharya Avyayama Shirasnana and Atibhashaya

सामरय कणवरोगष घतपान रसयनम

अवयायमो शशराःसतनान बरमहचयवम कतपरनम

स उ२१३

Ghratapana - Ghrita is a Yogavahi and follow Sanskara in addition to these

acquired properties and capable of retaining its own properties So Ghritapana

is effective in Karnasrava

Rasayana - Rasayana represent the basic approach of Ayurveda which

comprise preventive promotive and curative aspect of health

Brahmacharyaapalana -It is like Sadvrittapalana and is equals to Rasayana

effect

Vyayama - It leads to vitiation if Vatas a Karna is a Sthana of vata and

exercise causes Kshayaj Samprapti hence it is important to avoid exercise in

Karnasrava

Shirasnana- In Shirasnana water enters in external acoustic canal it changes

the PH of meatus skin from acid to alkali which favors the growth of pathogens

Atibhashya - Excessive speaking causes Vata Prakopa and Vatapraokopa is

basic Samprapti for Karnasrava as the preventive aspect avoidance of

excessive speaking is necessary

Page | 49

Ghritapana Rasayana and Brahmacharyapalana should be followed for

preservation of dhatu Samyata and restriction of vitiation of Vata Vayayama

Shirasnana and Atibhashaya should be avoided in Karnasrava to protect the

Siras from the affliction of Vata and Kapha

Vishesha Chikitsa ndash

The general treatment principle of Karnasrava described in classics is closely

related to Dushtavrana Chikitsa

शशरोवरचन च ए िपन परण तरा

परमाजवन िान च ीकषय ीकषय़ाचारत [70]

स उ २१४०

कणवसततरा ोददत कयावत पततकशमकणवयो [71]

ाउ १८३५

उपददि च सततरोत साय परात वपचततवशि परमजय

य अगर मदन सघत गगलना ा िपतयतपा मिना परयत [72]

असउ २२४२४३

In addition to that Shirovirechana Karnadhoopana Karnapurana

karnapramarjana Karnadhavana are also indicated

Page | 50

Treatment is also mentioned for Karnasrava

1 Karnaprakshalana Yoga - with Aargawadadi Gana Kashaya and Surasadi

Gana Kashaya [73]

2 Avachurnana Yoga ndash with Aargawadadi Gana Churna and Surasadi Gana

Churna[74]

3 Karnapoorna Yoga ndash

bull Rasanjana Laksha with Sarjachoorna[75]

bull Panchkashaya with Kapittha swarasa and Madhu[76]

bull Jambu AmrapallavShivalaKshuodra Mahavriksha and Madhuki all are

taken in equal quantity and Kalka is prepared and 4 times Taila is taken

and 16 parts of Kwatha is added and Taila Paka is done[77]

bull Sarjatwak Choorna with Karpashiphalarasa and Madhu[78]

bull Abhaya LodraTindukaSamanga(Manjista) Kwatha of this Dravyas mixed

with Madhu and Kapittha Rasa[79]

bull Yogratnakara mention the following drugs for Karnapoorana-

a Samudraphena Churna[80]

b Jambwambpatra Yoga

4 Karnadhoopana Yoga ndash

bull Dhoopana with Churna of Bilvapatra Haridra Palandu[81]

bull Vartak Dhoopana [82]

5 Internal Medications-

bull Rasnadi Guggula [83]

bull Triphala Guggula [84]

bull Sarivadi Vati [85]

bull Gandhaka Rasayana [86]

Page | 51

According to Vagbhata-

Ear should be cleaned with the Pichu and Varti followed by Guggula Dhoopana

and then Karnapoorana with Madhu Followed by Avachurnanana with

Sukshmachootana of Surasadigana

Pathyaapathya ndash Pathya and Apathy mentioned for Samanya Karnaroga is

recommended in Karnasrava also

पथय[87]

सतदो वरको मन नसतय िमाः शशरावयिाः

गोिमाः शालयो मदगााः याशच परतन हवाः 80

लाो मयरो हररणानदसततततरो नकककिाः

पिोल शशगर ातावक सतनषराण कदठललकम

रसायनातन सवणण बरमहचयवमिाषणाम |

उपयकत यरादोषशमद कणावमय दहतम ||81||

िापर २१

Aharaja Upacharaja

bull Godhuma bull Vamana

bull Shala bull Virechana

bull Mudga bull Nasya

bull Yava bull Dhoomapana

bull Puranagitra bull Kavala

bull Lava Harina Tittiramamsa

Page | 52

अपथय[88]

दरत काटठ शशरसतनान वययाम शलटमल गर

कणडयन तषारशच कणवरोगी पररतपयजत

िापर २१

Viharaja

bull Patola ShigruVartaka bull Bhramacharaya

bull Sunishannaka bull Avyayama

bull Katthlika bull Aakthanam

bull All types of Rasayana bull Upacharaja

bull Vamana

Apathyas

bull Abhishyandakara Aharas

bull Shirasnana

bull Karna kandooyana

bull Tushara sevana

bull Guru Kaphakaraka Aaharas

bull Dantdhavana

Page | 53

OTOMYCOSIS

Definition-

Otomycosis is a superficial acute sub-acute or chronic infection of external

ear canal It is mostly unilateral It is characterized by inflammation purities

and scaling Otomycosis is a common condition encountered in ENT practice

more in chronic and persistent ear infection

The Fungal infections are not communicable in the usual sense but the

humans become an accidental host by their introduction into tissue trauma

The virulence factors favoring colonization of fungus in human host are yet to

be identified Ability of the fungus to grow at 37 C and elaboration of a variety

of enzymes and toxins are speculated to contribute to virulence Only 100 to

150 species are generally recognized as a cause of disease in humans[89]

Prevalence-

Otomycosis is a word wide in distribution and in various record stated that 5

to 20 of all cases of infective otitis externa Otomycosis prevalent is more in

warm and humid climates It is one of the commonest manifestations in India

during rainy season It occurs mostly in humid atmosphere otitis externa due

to fungal infection may resembles the desquamative form of diffuse infective

otitis externa The incidence in temperature climates has increased in

proportion to the use of topical antibiotics which have a medium sterilized of

other organism in which the fungus may flourish

Page | 54

Predisposing factors- [90]

1 Environmental factors such as climate contagious and polluting hygiene

more frequently during rainy season as the humidity increases

2 Individual susceptibility ndashGeneral Immunological status of the Individual

eg HIV infection Radiotherapy chemotherapy Diabetes mellitus

3 Self-inflicted trauma that is use of pins to clean the itching ear or use of ear

bud to clean the wax

4 Wide spread of topical antibiotics steroid preparations which have medium

sterilized of other organism in which the fungus may grow

5 Failure of defense mechanism in External auditory canal

6 During swimming or head bath water enters in External acoustic canal

causes quantitative and qualitative change in ear wax It causes change in pH

7 Long term use of hearing aids

Pathophysiology ndash

The life cycle of the average mold encountered in the ear may be reckoned

as two weeks and flare ups may be anticipated at such intervals Swimming is

held responsible for infection in many cases The sequence sequence of

pathogenic changes produced by molds in the external ear is as follows ndash

1 Implantation of the organism in external ear

2 Growth of organism follows the rate depending on condition of temperature

moisture or preexisting irritation

3 Invasion of epithelium occurs with attendant itching and discomfort which

may be quite severe

Page | 55

4 Exfoliation of epithelium occurs as nature attempts to overcome the

infection by casting off upper most cells

5 Denudation occurs from exfoliation as the top layers of epithelium are cast

off and the canal becomes filled with debris

6 Superficial ulceration and lizematoid dermatitis results if the pathologic

process goes for enough The changes do not always proceed through the

entire sequence sometimes the molds produce changes of the mildest

imaginable character which may be overlooked[91]

Clinical features -

Symptoms-

1 Irritation and itching ndash Irritation is mostly found when the infective

organism is aspergillus niger There is sensation of discomfort which is more

diffuse in the ear canal then localized in the deeper part Candida infection

causes marked itching In external ear it is intense and worse at night

2 Discharge through ear- Intermittent scanty colorless discharge through

ear Mucus being a fungal metabolic product appears as discharge Excessive

discharge is associated with mixed infection

3 Pain and discomfort ndash Mild to severe pain in the ear occasionally Mostly

seen in cases where ear is infected with Aspergillus flavus mixed infection

with gram negative organism or mixed infection with candida and aspergillus

Headache is sometimes associated with pain

4 Deafness- Varying degree of mild to moderate conductive deafness

5 A sensation of fullness in ear

6 Tinnitus 7 Vertigo

Page | 56

Signs ndash

1 The external acoustic meatus may contain a mass formed of epithelial

debris exudates cerumen and fungus

2 Erythematous external canal

Fungal appearance

A Niger - The color of the mass which is usually grey or black is mainly

determined by the type of fungus concerned Its appearance is like wet

newspaper or blotting paper or a cotton wool It has a peculiar musty odor In

this infection fruiting heads may be seen as black specks in the debris

Occasionally as inactive form occurs in which the canal is lined by mold giving

a fluffy appearance due to the presence of tiny mycelia

Candida ndash Candida infections generally show as white deposits on magenta

colored skin when the debris is removed it rapidly recovers in 24 hrs

The underlying canal skin is often inflamed and granular due to invasion by

fungal mycelia and be seen in all cases In rare cases excoriation and

ulceration with marked extensive shedding of the epithelium and deep

ulceration can be seen usually associated with a flavus and with pathogenic

bacteria[92]

Otoscope Appearance

1 Aspergillus Niger ndash Black headed

2 Aspergillus Fumigators ndash pale blue or green

3 Candida Albicans ndash White- or cream-colored deposits

Page | 57

4 Auricle is normal in most cases In severe cases small ulceration with crust

formation may be present on lateral surface

5 Tympanic Membrane

In most cases it is normal with normal mobility and normal hearing In a few

cases the surface of the tympanic membrane is congested and scaly There is

erosion or ulceration of the external epithelial layer and the membrane itself

may be edematous

Diagnosis

1 Above mentioned symptoms and signs

2 In the stage at which patient with otitis externa usually first present

themselves mycelia threads conidiophors not visible to naked eye may

sometimes be identified with the microscope

3 Confirmed by culture

Page | 58

Fig7 Aspergillus Niger Fig8 Candida Albicans

Fig9 Aspergillus Fumigators Fig 10 Wet Paper like appearance

Page | 59

Treatment

1 Antibiotic or steroid drops should be discontinued if they are being instilled

since long time

2 Removal of fungal mass epithelial debris and discharge from the external

canal or mastoid cavity repeatedly and thoroughly by forcepa or suction or

syringing or cautiously blow a stream of air into the canal through a fine

cannula and dry thoroughly by swabbing liquid petroleum on swab used in

cleaning the ear lessens the burning sensation when metacresy acetate is to

be employed in the subsequent treatment

Furuncle is developed as a complication if there is no gentleness in cleaning

Cleansing may have to be delayed until local sensitiveness is lessened which

can usually be accomplished within twenty-four hours If there is excessive

epithelial debris along with otomycosis then metacresyl acetate which is a

keratolytic in introduction into the external auditory canal on cotton wick and

is allowed to remain for twenty-four hours After twenty-four hours the cotton

wick is removed at which time the canal can usually be cleansed with little

discomfort as the medication is also anesthetic The epithelium of the canal

was white from contact with the drug The top layer was detached and this

epithelial debris can be easily wiped away The wick is reinserted and wet with

metacresyl acetate

The treatment is employed for three to four days in succession and then a

bland application is substituted Icthyol iodine is of value at this stage Iodine

ointment 2 in combination with Tannic acid 2 is also an excellent local

application following cresatin treatment

Next one of the fungicides may be applied

Page | 60

1 Nystin Effective for candida infection but less active against aspergillus

group Nystatin in boric powder consisting of 100000units of nystatingm of

powder 3 times week for 3 weeks

2 Clotrimazole Available as 11 cream or drops or lotions Phenyl

(zchlorophenyl) 1 ndash imidazole ndash methane is a chlorinated trityl imidazol 1

effective against candida and dermatophytes and for aspergilli infection

3 Amphotericin B Available as cream and as 3 solution and 015 drops

for topical application Very effective for candida infection can be fungistatic

or fungicidal

4 Econazole Available as solution (Econazole nitrate) and as cream (1)

Broad spectrum ndash more effective for Aspergillus Also active against some

gram-positive bacteria (Staphylococci and Streptococci and Dermatophytes)

5 Miconazole Highly effective against dermatophytes and candida infections

used as a 21 cream applied once or twice a day for 10 days

6 Gentian violet 21 Available as drops (recently some evidence of

carcinogenicity) Discolors the ear canal and this interfere with clinical

examination

Other topical antifungal agents are ketoconazole Natamycin Tolciclat Bifonas

zole Fenticonzole Oxiconazole Tioconazole ciclopiroxolomine Tolnafate

Haloprogin Flucytosine Acetic acid Whit field ointment selenium sulfide

undcyclenic acid triacetin etc

Page | 61

Minimal length of treatment

A month of drug treatment is usually required because the antifungal agents

used are not sporicidal and it is necessary that the period of treatment covers

germination time It may be advisable to give short gaps in the period of

treatment to ensure all spores have germinated before deciding to terminate

therapy

Prevention

Accomplished by strict attention to the predisposing causes

1 Water should be prevented from entering the ear

2 Avoidance of external ear trauma

3 Use of alcohol medicated or plain in the ears after swimming mercuric

cyanide (15000) in ethyl alcohol (70) is a satisfactory liquid to use

Ear stoppers do no good unless their use is followed by some antiseptic in the

canal Divers exposed to water for long periods of time may also use acidic

alcohol

4 During Summer months with their high humidity special efforts are needed

to maintain ear dry 5 Indiscriminate use of topical antibiotics steroid

preparations should be avoided

Page | 62

DRUG REVIEW

1 GUGGULA

Fig11 - Guggula

Historical review of Guggula [93]

bull Atharvaveda one of the well-known Vedas of Hindus The earliest

reference given by Atharvaveda medicinal and therapeutic properties of

Guggula Guggula has long history of use in Ayurveda

bull Acharya Charaka Sushruta and Vagbhata describe detail regarding the

actions uses and indication as well as the variety of Guggula

Page | 63

bull Various Nighantus (Medical lexicons) were written between 12th and 14th

centuries AD was based on the Ayurvedic literature also describes

Guggula

bull The explanation of word Guggula is that Gunjo Vyadhegurdti Rakshati

which means to relief against different diseases

bull Guggula is the best medicine because it develops through the rays of

hot sun on specific circumstances

bull Guggula has an aromatic odor

गगलो कणवदौगवररधय िपन शरटठमछयत[94]

स उ २२११२

Latin name- Commiphora mukul

Family ndash Burseraceae

Rasa- Tikta Katu

Guna ndash Laghu Rukshasukshma vishada sara

Veerya ndash Ushna

Vipaka ndash Katu

Action- Rasayana Lekhana

Doshaghanta - Tridoshhara

Page | 64

Chemical composition [95]

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Oleoresin-Z-Guggulsterone E-Guggulsterone

Gum- guggulignans 1 and 2 guggula Tetrols mukulol allylcembrol c

27

Guggulusterol 1 2 ans 3 Z and E ndash guggulusterol

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Parts Used ndash Gum oleoresin

Guggula purity test

1 Yellowish brown emulsion is obtained when Guggula is triturated with

water

2 An ethereal solution of the drug attains reddish colour when treated

with br2 vapors and purple colour when moistened with nitric acid

Biochemical action ndash Antiseptic Anti-inflammatory Disinfectant Diuretic

Immunostimulant stimulating expectorant Ant suppurative Antipyretic

Enhance phagocytosis

Karma- Rasayana cardiovascular disease

Page | 65

2 AGARU-

Fig 12 Agaru

Historical review of Agaru [96]

bull The word Agaru literally means the one which is the heaviest and no

aromatic wood is heavier than it Since thousands of years Agaru lsquoThe

wood of Godrsquo has been used for multiple purpose like commercial

medicinal spiritual aromatic historical

bull The medicinal use of Agaru have been recorded in many pieces of India

Greek Roman Chinese Middle eastern and European since ancient times

bull Acharya Charaka used Agaru and pest of Rasna to counteract the effect of

cold in Agraya Dravyas

bull Acharya Sushruta used Agaru as a Dhoopana Dravya along with Guggula

Ral and Shoma in the treatment of Karnasweda and Vrana

Page | 66

Types-

bull Dhanwantsri Nighantu describes Kaleyaka as a type of Agaru

bull Sodhala Nighantu describes three types of Agaru ndash Agaru Krishna

Agaru Kakatunda Agaru

bull Raj Nighantu describes five types of Agaru ndash Krishna Agaru Kasht

Agaru Daha Agaru Mangalya Agaru and Agurusaar

bull Arthashasstra describes three Agaru wood product

1 Jongaka ndash Black or variegated black in colour and having variegated

spots

2 Dongaka ndash Black in color

3 Parasamudraka- Black in colour and smells like Navamallika

अगर उटण कि तपछय ततकत ततकषण च वपततलम

लघ कणाविरोगघन शीत ात कफपरणत

िापर २१ [97]

Family- Thymelaccensis

Latin name- Aquilaria agallocha

Guna- Laghu Ruksha Tikshan

Rasa- Katu Tikta

Vipaka ndash Katu

Virya ndash Ushna

Karma- Sheetaprasasmana Vranaorasadan Tvachya Pittavardhaka

Shirovirechana Mangalya Sugandhik and Rochaka in properties [100]

Krishna Agaru karma- Katu Tikta rasa Ushna Sheeta when applied externally

and Pittahara when taken orally

Page | 67

Chemical Constituents -

Agaru hardwood is rich in essential oil resins alkaloids saponins Steroids

terpenoids tannins flavonoids and phenolic compound Agaru wood

predominantly contains 2-[-2-phenylethy]-4H-chromen-4-one derivatives and

sesquiterpenes Agaru oil contains selinene dihydroselinene agarnol b-

agarofuran vetispira-2(11)valerianol dihydrokaranone and tetradecanoic

acids[99]

Part Used ndash

Heartwood- Dark resinous wood which is formed when the plant becomes

infected with a type of fungus (ascomycetous mold) Species of Aspergillus

fusarium and penicillium are reported to be associated with the development

of infection Prior to infection the heartwood is odorless relatively light and

pale colored however as the infection progresses the tree produces a dark

aromatic resin in the heartwood The infected resin in response to the attack

which results in accumulation of a very dense dark resin in the heartwood

The infected resin embedded wood is known as Agarwood Infection is more

common on the trunk roots and the area when branches divide The formation

of Agarwood starts when the tree attains the age of 20 years On an average

approximately 30 ml oil is extracted from 100 kg of infected Agarwood[98]

Qualities of best Agaru-

It should be black in color

It should be extremely heavy and aromatic

It should be oily in appearance and test

It should be sink in water

It should burn easily with bright flame with a bright flame giving off a pleasant

smell

Page | 68

3 MADANA

Fig 13 MADANA

Madana consist of dried fruit of Xeromphis spinosa It is a deciduous thorny

shrub or a small tree reaching a high up to 9 m and girth about a meter

branches numerous thick and horizontal found in sub-Himalayan tracts[101]

मदनो मिरनदसततकतो ीयोटणो लखनो लघ

ानदरतिदवििीहर परततशयायवरणारतक

रि कटठकफ़ानाहशोथगलमवरणापह[102]

िा पर १६० १६1

Page | 69

Latin name-Randia dumetorum

Familly ndash Rubiaceae

Rasa - Madhura Tikta

Guna-Laghu Ruksha

Virya- Ushna

Vipaka ndash Katu

Karma- Vamana and Lekhana

Chemical Composition-

Essential Oil Valerianic acid Saponin tannin resin [103]

Page | 70

YAWA [104]

Fig 14 Yawa

1 In Samhitakala Aacharya Charaka Acharya Sushruta explain detail about

medicinal properties of Yawa

2The use of Yawa in Aaharya Dravya mainly described by Dhanwantari

Nighantu Raj Nighantu Bhavprakash Nighantu[105]

Macroscopic Description-

Fruit a caryopsis elliptical oblong Ovoid and tapering at both ends smooth

about 1cm long and 02- 03cm wide dorsally compressed and flattened on

the sides with a shallow longitudinal furrow 3-5 ridges having shallow

depression between them grains tightly enclosed and adhering the lemma

and palea pale greenish yellow odor not distinct taste sweetish acrid

Page | 71

Latin Name ndash Hordenum vulgare

Family- Poaceae

Rasa- Kashaya Madhura

Virya- Sita

Vipaka- Katu

Karma- Vatakrt Pittahara Kaphahara Medahara Balya Visrya

SthairyakaraLekhana

Page | 72

PROCEDURE REVIEW [105]

In Ayurvedic classics there are many references regarding Dhoopana Dravya

Dhoopana is administering Dhuma with the help of Dhoopana Dravya

In Kashyapa Samhita there are 40 types of Dhoopana advised for children

Anesthesia (Mohajananam Dhoopa) is also mentioned For this Dhoopana the

drug used were herbs hairs of animals legs horns old cloths of Buddhist

monks

From the references available regarding Dhoopana we can understand that

Karna can be protected from maggots (krimi) Bactria (Rakshogna) lice etc

References clearly indicate the analgesic and disinfectant effect of Dhoopana

Karma Dhoopana is mentioned for Dushta Vrana Chikitsa It reduces Vedana

Srava Pootigandha of Dushtavrana It also helps in Vranaropana

Dushtavrana Chikitsa is mentioned in the treatment of Karnasrava[106]

Origin of Dhoopana-

In ancient period children of sages were constantly harassed by the

Rakshasas Hence the sages approached lord Agni for shelter Agni in turn

gave them Dhoopana Dravya and asked sages to use the Dhoopana for

protection against Rakshasas bhutas pishachas

Classification of Dhoopana

1 It is classified into Dhupa Anudhupa Pratidhupa

2 On the basis of Origin it is classified into Jangama and Sthavara

Selection of Guggula for Dhoopana

Page | 73

bull Guggul is a best Vatahara

bull It is Krimighana

bull It contains Oleoresin

bull In Ashtang Hrudaya Guggula Dhoopana mentioned for Karnasrava

Selection of Agaru for Dhoopana

bull Agaru is Laghu Ruksha Katu Tikshna

bull Vranaorasadan Tvachya

bull It should burn easily with bright flame with a bright flame giving off a

pleasant smell

Karna Dhoopana Indication

1 Karnaarava

2 Putikarna

3 Krimikarna

4Vataj Karnashula

Contraindications

Especially for Karnadhoopan contraindication is not mentioned in classic texts

But Dhoopana is contraindicated in Pittaj vaydhi Sharad and Grishma Rutu

Page | 74

MATERIAL AND METHOD

Page | 75

For randomize comparative clinical trial to study the effect of Agaruwadi

Karnadhoopana and Guggula Karnadhoopana in Karnasrava following material

and method were required

Source of data

Patient irrespective of gender occupation religion social economic status

signs and symptoms of classical features of Karnasrava (Otomycosis) selected

from the OPD of Shalakyatantra department

Materials ndash

1Patients

2 Drugs-Agaruwadi Dhoopana

Guggula Dhoopana

3Torch

4Otoscope

5 Tuning fork

6Jobson horn probe

7Cotton

8Case record form

DRUG

Group A Trial Group

1Churana of Agaru Yawa Madan

2Ghrita

3Jala

Group B Control Group

1Googula Churna

Page | 76

Properties of Drug

Table no 1 Properties of Drug

Drug

Family

Rasa Veerya Vipaka Effect

on

Dosha

Guna Karma

Agaru

(Aquilegria

Agallocha)

Thymelaca

ceae

Katu

Tikta

Ushna Katu KV Laghu

Ruksha

Tikshna

Shitaprashamana

Shothahara

Vedanasthapak

Durghandhihara

Madan

(Randia

spinosa)

Rubiaceace

Kashaya

Madhur

Tikat

Katu

Ushna Katu KV Ruksha

Laghu

Vatakaphaghana

Shothahara

Vedanasthapak

Vranashodhak

Yawa

Poaceae

Hordeum

Vulgare

Kashaya

Madhur

Sheeta Madhur KP Ruksha

Laghu

Vataghana

Vernashodhana

Raktshodhaka

Guggula

Commiphora

Mukul

Burseracea

e

Tikta

Kashaya

Anushna Katu VPK Laghu

Ruksha

Shothahara

Vedanasthapaka

Kandughna

Ghrita Madhura Sheet Madhur VK Snigdha Vataghana

Shothahara

Vedanasthapaka

Page | 77

METHODOLOGY

SELECTION CRITERIA

1)INCLUSION CRITERIA

1 Patients having signs and symptoms of Karnasrava (Otomycosis) ie करणशल

( pain ) करणकणड ( Itching ) करणसतराव ( Discharge )बाधिरण ( conductive Loss of

hearing )

2 Patient from age group 19 to 70 years

3 Any Gender

2)EXCLUSION CRITERIA

1 Patients suffering from any systemic disease like DM TB HTN

2 Chronic suppurative otitis media (CSOM)

3 Acute supportive otitis media (ASOM)

3 Perforation of Tympanic membrane

4 Chronic otitis media

3)WITHDRAWAL CRITERIA

1If patient develops any adverse effect such as irritation pain burning

sensation in ear loss of hearing and such patients was withdrawn from trial

and receive prompt appropriate medical attention

2If patient shows aggravation in symptoms

3If patient refuses to continue with the treatment

Page | 78

STUDY SETTING

Types of study - Randomized Clinical comparative Trial

Place of work - OPD of Shalakyatantra

Duration of study - 18 months

Study Population - Patients of Karnasrava in Shalakyatantra OPD

SAMPLE SIZE CALCULATION

Sampling Method ndash Purposive sampling followed by random allocation in two

groups

Sample size calculation-

n = z2 p (1-p)

d2

Were

n = sample size

P = prevalence of disease=10

z = standard normal variable ie 196

d = error ie005

desired Sample Size would be

n = Z2 P(1-P)d2

= (196)2x (0021) x(0979)(005)2

= 34

Visiting ENT OPD (ShalakyaTantra) and IPD (ShalakyaTantra) 21 = 34

n raquo34

So one group includes 34patients

Page | 79

Sampling Method

Total 68 patient of Karnasrava are selected by Purposive sampling followed by

random allocation in two groups Written informed consent is taken prior to

commencement of trial They are divided in 2 groups

Group A (Trial Group) 34 patients treated with Agaruwadi Dhoopana for 7

days

Dose 5 minutes twice in a day

Group B (Control Group) 34 patients treated with Guggula Dhoopana for 7

days

Dose 5 minutes twice in a day

STUDY DESIGN ndash

Open labeled Randomized Comparative Clinical trial

STUDY DESIGN

Screening of patient

Inclusion criteria satisfied Exclusion criteria

Initial assessment Excluded

Counseling of patient Treated accordingly

Patient selection by Simple Random Sampling Method

Page | 80

68 Patients were divided in two groups lsquoArsquo and lsquoBrsquo

Trial group A-34 patients were given

Agaruwadi Dhoopana

Control group B- 34 patients were

given Guggul Dhoopana

Informed written consent

Treatment was given for 7 days

Assessment on 1st 4th and 7th day

Post assessments follow up on 15th day

Observation

Data Collection

Statistical analysis of data

Conclusion

Page | 81

(A) Agaruwadi Varti for group A (Trial group)

Table no 2

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

B) Guggula Varti for group B (Control group)

SOP of it is same as above Agaruwadi Varti

Table no 3

Drug Guggula Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

FOLLOW UP

For both groups follow ups were done on 1st 4th and 7th and post

assessment follow up15th day

EXAMINATIONS

Torch for Local examination of ear

Otoscope examination

Tuning fork Test

Page | 82

OBSERVATION TABLE

Table no 4

Sr no Subjective criteria Day 1 Day 4 Day 7 Day 15

1 करणशल

(pain)

2 करणकणड

(Itching)

3 करणसतराव (Discharge )

4 बाधिरण (Conductive Deafness)

OBSERVATIONS

a) करणशल (Pain) -

0 - Absent

1 ndash Present

b) करणकणड (Itching) -

0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

Page | 83

c) करणसतराव (Discharge)

0- Absent

1- Mild -Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाधिरण (conductive Loss of hearing)

0 - Absent

1- Present

Observations were carried out before and after completion of treatment and

during each follow up After observations the data collected and presented in

the form of graphs charts and table

Page | 84

TRIAL DRUG

Authentication and standardization of raw drug material done After

authentication and standardizing of raw drug material Agaruwadi Varti was

prepared by Varti as explained in Ayurvedic classics

Method of Varti preparations

Panchavidh Kashaya Kalpana that is five method of pharmaceutical

preparation constitutes the fundamental process of Ayurvedic pharmaceutics

which is well explained in Sushrut Samhita Varti Kalpana is one among them

which can be included in Kalka Kalpana

तीररसतरपतपतीनामपरककव तीत [106]

स डलहण शरच 151

Medicines are powered triturated and given the Varti shape that is like wick

of lamp so it is called as Varti Kalpana

Drug content Agaru Madan Yawa

Route of Administration Local

Dose Two times a day

Duration 7 days

Page | 85

Methodology

Standard operating procedure (SOP) of Agaruwadi Varti

Agaruwadi Varti is prepared according to the classical text

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization was done as recommended in pharmacy procedure The

raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 mixed together in

equal quantity to make Agaruwadi churn

Quantity of each churn is 4 grams all are mixed when the Varti get dry total

weight of Varti was 10gram

STEP 4 - Agaruwadi churn triturated with appropriate quantity of water or

Ghrita and prepared Varti in GMP Certified Ayurvedic pharmacy Standard

aseptic precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Varti was packed in sterile air packed container

STEP 6 - Agaruwadi Dhoopana was given with the help of Dhoopana yantra

Authentication and Standardization of raw drug of Agaruwadi Varti was done

Sterilization was done as recommended in pharmacy procedure Sterile

preparation packed in sterile container of suitable size Under all aseptic

precaution Karnadhoopana given to infected ear

Page | 86

Containers for packaging and their sterilization-

Sterilization of the containers for storing Varties was done by Ethylene Oxide

(Eto) method

Ethylene Oxide (Eto) procedure-

It includes exposure of materials to ethylene oxide gas under vacuum in a

sealed chamber It consists of four primary variables

1Gas Concentration

2Humidity

3Temperature

4 Time

EtO gas is an alkylating agent which disturbs the DNA of microorganism

preventing them from reproducing It penetrates the breathable packaging

and sterilizes all the accessible surface of the product to render products

sterility by alkylation of essentials proteins for cell reproduction

Most Eto sterilization methods involves three different stages These can be

separated into three different on the size or number of devices to treat

1Preconditioning stage-

First products are passed through a preconditioning phase to make

microorganism grow The batch load goes through a well time under a

controlled environment of temperature and humidity

2Sterilizer stage-

Performed using process phase specially designed to provide the required level

of EtO exposure to assure sterility for a device or family of devices

3Degasser Aerration stage-

Finally products need to go through a degassing phase to remove any residual

particles of Eto The batch load goes over well time under a temperature-

controlled environment

The sterile containers were then used to store Agaruwadi Varti and handed to

patients included in the study

Page | 87

Packing of Agaruwadi Varti

The ETO sterilize plastic container were used for packing of Agaruwadi Varti

Varti was filled into these sterilize containers (7 in each) In an aseptic

environment plugging and capping was done under aseptic precautions In this

way packing of Agaruwadi Varti done These Varti were given to patient and

advise to take two times a day under all hygienic precautions

History and Examination

bull Proper history and presenting complains was recorded on case record form

bull Ear examination with otoscope was done during initial assessment and each

follow up

bull Otoscopic examination was done during initial assessment and each follow

up

bull Systemic Examination that is Blood Pressure Temperature Respiration

rate Pulse was recorded on case record form

Page | 88

Raw material

Fig14 यव चरण Fig15 मदनफळ चरण

Fig16 अगर चरण Fig17 गगगळ चरण

Page | 89

Preparation of Agaruwadi Varti

Fig18 Preparation of Agaruwadi Varti

Fig19 अगरवादी वरती

Page | 90

Fig20 Instruments used for examination of Karnasrava

Fig19 Karnadhoopana Yantra

Page | 91

Karnadhoopana Procedure

Fig 22 Karnadhoopana Procedure

Page | 92

OBSERVATIONS AND RESULTS

Page | 93

BASED ON DRUGS

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 94

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

AUTHENTICATION CERTIFICATE

Page | 95

BASED ON STASTICIAL ANALYSIS OF DEMOGRAPHIC DATA

68 patients of Karnasrava ndash Otomycosis

Table no 5

No of Patients Total

Group A Group B

Registered 38 37 75

Completed 34 34 68

Discontinue 04 03 07

Total 68 patients were enrolled in study 38 patients registered in group A

amongst them 34 patients completed the treatment and04 patients

discontinued the treatment However in group B 37 patients completed the

treatment and 03 patients discontinued the treatment out of 37 registered

patients

Hence the total number of patients registered in the present study was 75

and out of which 68 patients were discontinued the treatment So they

dropped out from the study While 68 patients were successfully completed

the treatment So observations and result of 68 patients were given below

Here we are going to discuss the statistical analysis of the data obtained in

the form of master chart that was prepared in accordance with the data

collected from the patients that had been included in the study The purpose

of statistical analysis was to analyzed the relation between age gender

occupation diet addiction and education

Page | 96

1 Age wise distribution of patients

Table no 6

In trial group 10 (29412) patients were from age group 18-25 years 14

(41176) patients were from age group 25-35 years 8 (23529) patients

were from age group 35-45 years and 2 (58824) patients were from age

group 45-60 yearsIn control group 6 (17647) patients were from age group

18-25 years 14 (41176) patients were from age group 25-35 years 7

(20588) patients were from age group 35-45 years and 7 (20588)

patients were from age group 45-60 years

Fig 23 Age wise distribution of patients

0

2

4

6

8

10

12

14

15 -25 25-35 35-45 45-60

10

14

8

2

6

14

7 7

Age Distribution

Trial Group N Control Group N

Age Distribution

Trial Group Control Group

N N

18 -25 10 29412 6 17647

25-35 14 41176 14 41176

35-45 8 23529 7 20588

45-60 2 58824 7 20588

Total 34 100 34 100

Page | 97

1 Gender wise distribution of patients

Table no 7

Sex

Trial Group Control Group

N N

Female 23 67647 15 44118

Male 11 32353 19 55882

Total 34 100 34 100

In trial group 23 (67647) patients were female and 11 (32353) patients

were male

In Control group 15 (44118) patients were female and 19 (55882)

patients were male

Fig 24 Gender wise distribution of patients

0

5

10

15

20

25

N N

TRIAL GROUP CONTROL GROUP

23

15

11

19

Gender

Female Male

Page | 98

2 Education wise distribution of patients

Table no 8

Education

Trial Group Control Group

N N

Illiterate 4 11765 3 88235

SSC 4 11765 3 88235

HSC 8 23529 9 26471

Graduation 16 47059 10 29412

Primary 1 29412 3 88235

Post-Graduation 1 29412 6 17647

Total 34 100 34 100

In trial group 4 (11765) patients were illiterate 4 (11765) patients were

SSC educated 8 (23529) patients were HSC educated 16 (47059)

patients were graduated 1 (29412) patients were primary educated and

1(29412) patients were post graduated

In control grou 3 (88235) patients were illiterate 3 (88235) patients

were SSC educated 9 (26471) patients were HSC educated 10 (29412)

patients were graduated 3 (88235) patients were primary educated and

6 (17647) patients were post graduated

Page | 99

Fig 25 Education wise distribution of patients

0

2

4

6

8

10

12

14

16

ILLITERATE SSC HSC GRADUATION PRIMARY POST GRADUATION

4 4

8

16

1 1

3 3

910

3

6

Education

Trial Group N Control Group N

Page | 100

3 Occupation wise distribution of patients

Table no 9

Occupation

Trial Group Control Group

N N

Accountant 1 294 2 588

Housewife 11 3235 8 2353

Engineer 1 294 1 294

Job 1 294 4 1176

Labor 1 294 3 882

Mess 1 294 0 000

Naturotherapyst 1 294 0 000

Pharma 1 294 0 000

Shopkeeper 4 1176 2 588

Singer 1 294 0 000

Student 8 2353 4 1176

Tailor 1 294 1 294

Teacher 1 294 1 294

Worker 1 294 3 882

Farmer 0 000 1 294

Lab Tech 0 000 1 294

Page | 101

Daily Collection 0 000 1 294

Fruit seller 0 000 1 294

Bus Driver 0 000 1 294

Total 34 10000 34 10000

In trial group 11 (3235 ) were housewife 8(2353) were students

4(1176) were shopkeeper 1(294) was accountant 1(294) was

engineer 1(294) was doing job 1(294)was labour 1(294) was

catering 1(294) was Naturotherapyst 1(294) was Pharma 1(294)

was Singer 1(294) was Tailor 1(294) was Teacher and 1(294) was

worker

In Control group 8 (2353)were housewife 4(1176) were students

2(588) were shopkeeper 2(588) was accountant 1(294) was

engineer 4( 1176) was doing job 3(882)was labor 1(294) was

Farmer 1(294) was Lab tech 1(294) was Daily collection 1(294)

was Tailor 1(294) was Teacher and 3(882) was worker 1(294) was

Fruit seller and 1(294) Bus driver

Fig 26 Education wise distribution of patients

0

2

4

6

8

10

12

1

11

1 1 1 1 1 1

4

1

8

1 1 10 0 0 0 0

2

8

1

43

0 0 02

0

4

1 13

1 1 1 1 1

Occupation

Trial Group N Control Group N

Page | 102

4 Religion wise distribution of patients

Table no 10

Religion

Trial Group Control Group

N N

Hindu 31 9118 33 9706

Muslim 3 882 1 294

Total 34 10000 34 10000

In trial group 31 (9118) patients were Hindu and 3 (882) patients were

Muslim

In control group 33 (9706) patients were Hindu and 1 (294) patient

were Muslim

Fig 27 Religion wise distribution of patients

0

5

10

15

20

25

30

35

N N

TRIAL GROUP CONTROL GROUP

3133

31

Religion

Hindu Muslim

Page | 103

5 Diet wise distribution of patients

Table no 11

Diet

Trial Group Control Group

N N

Veg 14 4118 20 5882

Non-Veg 20 5882 14 4118

Total 34 10000 34 10000

In trial group 14 (4118) patients were vegetarian and 20 (5882)

patients were Non vegetarian

In control group 20 (5882) patients were vegetarian and 14 (4118)

patients were Non-Veg

Fig 28 Diet wise distribution of patients

0

5

10

15

20

N N

TRIAL GROUP CONTROL GROUP

14

2020

14

Diet

Veg Non Veg

Page | 104

6 Addiction wise distribution of patients

Table no 12

Addiction

Trial Group Control Group

N N

None 30 8824 27 7941

Alcohol 2 588 0 000

Tobacco 1 294 2 588

Mishri 0 000 1 294

Smoking 1 294 4 1176

Total 34 10000 34 10000

In trial group 30 (8824) patients have no addiction 2 (588) patients

have addiction of alcohol 1 (294) patients have addiction of Tobacco 0

(0) patients have addiction of Mishri and 1 (294) patients have addiction

of smoking

In control group 27 (7941) patients have no addiction 0 (0) patients

have addiction of alcohol 2 (588) patients have addiction of Tobacco 1

(294) patients have addiction of Mishri and 11 (1176) patients have

addiction of smoking

Page | 105

Fig 29 Addiction wise distribution of patients

0

5

10

15

20

25

30

NONE ALCOHOL TOBACCO MISHRI SMOKING

30

21

01

27

0

21

4

Addiction

Trial Group N Control Group N

Page | 106

Statistical Analysis and Results

Effect of study on Karnashoola-

Table no 13

Karnashoola

Group A Group B

BT AT BT AT

N N N N

Grade 2 0 000 0 000 0 000 0 000

Grade 1 30 10000 7 2333 32 10667 5 1667

Grade 0 4 1333 27 9000 2 667 29 9667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 30 Effect of study on Karnashoola

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

30

7

32

54

27

2

29

Karnashoola

Grade 2 Grade 1 Grade 0

Page | 107

Table no 14

Karnashoola Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 088 100 033 006

969 2829E-

08 7667 HS

AT 021 000 041 007

Group

B

BT 094 100 024 004

1037 7103E-

11 8438 HS

AT 015 000 036 007

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 31

000010020030040050060070080090100

BT AT BT AT

GROUP A GROUP B

088

021

094

015

Karnashoola

Mean

Page | 108

Table no 15

Karnashoola

Mean SD Effect

Group

A

Group

B Trial Control Trial Control

Day 1 088 094 033 024 000 000

Day 3 065 071 049 046 2667 2500

Day 5 024 038 043 049 7333 5938

Day 14 021 015 041 036 7667 8438

000

010

020

030

040

050

060

070

080

090

100

Day 1 Day 3 Day 5 Day 14

Karnashoola

Mean Group A Mean Group B

Page | 109

Table no 16

Karnashoola N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3250 110500

510000 275 Control group 34 3650 124100

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 110

Effect of study on Karnakandu

Table no 17

Karnakandu

Group A Group B

BT AT BT AT

N N N N

Grade 3 7 2333 0 000 4 1333 0 000

Grade 2 18 6000 0 000 18 6000 0 000

Grade 1 7 2333 7 2333 10 3333 15 5000

Grade 0 2 667 27 9000 2 667 19 6333

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 32 Effect of study on Karnakandu

0

5

10

15

20

25

30

N N N N

BT AT BT AT

GROUP A GROUP B

7

0

4

0

18

0

18

0

7 7

10

15

2

27

2

19

karnakandu

Grade 3 Grade 2 Grade 1 Grade 0

Page | 111

Table no 18

Karnakandu Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 188 200 081 015

1091 3119E-

10 8906 HS

AT 021 000 041 007

Group

B

BT 171 200 076 014

1032 4746E-

09 7414 HS

AT 044 000 050 009

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Page | 112

Fig 33

Table no 19

Karnakandu

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 188 171 081 076 000 000

Day 3 126 118 057 058 3281 3103

Day 5 071 074 046 051 6250 5690

Day 14 021 044 041 050 8906 7414

000

020

040

060

080

100

120

140

160

180

200

BT AT BT AT

GROUP A GROUP B

188

021

171

044

Karnakandu

Mean

Page | 113

Table no 20

Karnakandu N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 4051 137750

373500 006 Control group 34 2849 96850

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is less than

005 Hence we conclude that there is significant difference between Trial

Group and Control Group

000

020

040

060

080

100

120

140

160

180

200

Day 1 Day 3 Day 5 Day 14

Karnakandu

Mean Group A Mean Group B

Page | 114

Effect of study on Karnasrava

Table no 21

Karnasrava

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 11 3667 0 000 8 2667 0 000

Grade 1 23 7667 3 1000 26 8667 2 667

Grade 0 0 000 31 10333 0 000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 34

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

11

0

8

0

23

3

26

20

31

0

32

Karnasrava

Grade 3 Grade 2 Grade 1 Grade 0

Page | 115

Table no 22

Karnasrava Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 132 100 047 009

1122 4356E-

13 9333 HS

AT 009 000 029 005

Group

B

BT 124 100 043 008

1130 9364E-

14 9524 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 35

000

020

040

060

080

100

120

140

BT AT BT AT

GROUP A GROUP B

132

009

124

006

Karnasrava

Mean

Page | 116

Table no 23

Karnasrava

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 132 124 047 043 000 000

Day 3 100 100 025 025 2444 1905

Day 5 047 038 051 049 6444 6905

Day 14 009 006 029 024 9333 9524

000

020

040

060

080

100

120

140

Day 1 Day 3 Day 5 Day 14

Karnasrava

Mean Group A Mean Group B

Page | 117

Table no 24

Karnasrava N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3535 120200

549000 655 Control

group 34 3365 114400

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 118

Effect of study on Karnabadhirya

Table no 25

Karn

Badhirya

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 0 000 0 000 0 000 0 000

Grade 1 13 4333 0 000 16 5333 2 667

Grade 0 21 7000 34 11333 18 6000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 36

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 00 0 0 0

13

0

16

2

21

34

18

32

Karnabadhirya

Grade 3 Grade 2 Grade 1 Grade 0

Page | 119

Table no 26

Karn

Badhirya Mean Median SD SE

Wilcoxon

W P-Value

Effect Result

Group

A

BT 038 000 049 009

799 7173E-

05 10000 HS

AT 000 000 000 000

Group

B

BT 047 000 051 009

816 0000138 8750 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 38

000

005

010

015

020

025

030

035

040

045

050

BT AT BT AT

GROUP A GROUP B

038

000

047

006

Karnbadhirya

Mean

Page | 120

Table no 27

Karn

Badhirya

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 038 047 049 051 000 000

Day 3 009 006 029 024 7692 8750

Day 5 003 006 017 024 9231 8750

Day 14 000 006 000 024 10000 8750

000

005

010

015

020

025

030

035

040

045

050

Day 1 Day 3 Day 5 Day 14

Karn Badhirya

Mean Group A Mean Group B

Page | 121

Table no 28

Karn

Badhirya N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3400 115600

561000 806 Control

group 34 3500 119000

Total 68

Page | 122

COMPARISION BETWEEN GROUP A AND GROUP B

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Table no 29

Overall Effect

Trial Group Control Group

N N

Marked Improvement 21 6176 16 4706

Moderate Improvement 8 2353 13 3824

Mild Improvement 4 1176 5 1471

No Change 1 2941 0 0

TOTAL 34 100 34 100

Fig 39

0

5

10

15

20

25

MARKED IMPROVEMENT

MODERATE IMPROVEMENT

MILD IMPROVEMENT NO CHANGE

21

8

41

1613

5

0

Overall Effect

Trial Group N Control Group N

Page | 123

DISCUSSION

Page | 124

Discussion is nothing but the logical reasoning of observations In

every research work discussion part is very important because it brings into

light about the logical analysis which are helpful in filling the research gap in

the scientific world

The discussion is categorized into following ways for the ease of

understanding

1 Discussion on selection of topic

2 Discussion on review of literature

3 Discussion on drugs their mode of action on the disease mode of action

of Karnadhoopana

4 Discussion on observation and results

1 Discussion on selection of topic

Otomycosis is commonly encountered in day-to-day practice Majority

of Indian people affected with this pathology This disease commonly

manifests in developing countries low socio-economic standard and lack

of hygiene Now a days due to busy lifestyle people are not able to follow

the proper instruction of care of ear which may be responsible for the

recurrent nature of disease So for the management of this we use

Karnadhoopana with the help of Agaruwadi Varti Dhoopana is simple

easy cost-effective procedure which can be done even at OPD levelso

for the disease Karnasrava we selected Karna Dhoopana as therapeutic

procedure Karnadhoopana was done with Agaruwadi Varti and Guggula

Varti which was very effective for treatment

Page | 125

2 Discussion on review of literature

Karnasrava is one such disease among 28 Karnarogas mentioned by

Acharya Sushruta in the chapter named Karna Roga Vigyana Acharya

Charaka included Karnasrava as symptom under the four types of

Karnarogas due to vitiation of different doshas Acharya Vagbhata has

not described Karnasrava separately It is a fact that systemic

description of Karnarogas is available in all the ancients of pus from a

Vata afflicted ear may results from head injury or immersion in water

Karnasrava is a clinical entity which can be correlated with Otomycosis

Karnasrava is explained as symptom as well as a disease in Ayurveda

Nidana- Karnasrava occur due to Samanya Nidana and Vishesh Nidana

Vishesh Nidana like Shirobhighata Nimmajato jale Mithyayoga of Shashtra

The exact pathology behind Karnasrava is not understood clearly

Purvarupa ndash No specific Purvarupa are found for Karnasrava in classical

literature Acharya Madhukara describe Purvarupa as expression of

Rupa(lakshana) with less intensity that is less intensity itching sound in ear

may considered as Purvarupa of Lakshana

Samprapti- Aacharya Sushruta not explained the Samprapti of Karnasrava

separately and we must consider the general Samprapti of Karnaroga Due to

various aetiologias as cited above ear afflicted by Vata dosha causes Twak

Rakta Mamsa dushti results in Karnasrava According to Acharya Sushruta

Vata-Kapha dose is dominance in Karnasrava

Page | 126

Nidan

Nija Agantuja

Vata ndash kapha prakopak nidana Shirobhighata Nimmajato-jale

Mithya yoga of Shastra

Vata- kapha Prakopaka(Chaya prakopak) Vata-kapha prakopaka

( Achay prakopak)

Twak Rakta Mamsa dushti

Karnasrava

Page | 127

Chikitsa

The curative aspect and this must be done simultaneously giving due

importance to Nidan Parivarjana that is preventive measures So Nidan

Parivarjana that is avoidance of causative factors like Jalkrida Mithyayogen

shashtrasya Karnakandu Shirasnan Pratishaya is the first step in combating

the disease and form the part of line of treatment

Above Samprapti helps us to proceed towards the treatment of Karnasrava

The main protocol of treatment is removal of fungus and wound management

which include various measures to keep area day clean clear of microbes and

providing ideal condition for healing

Samany Chikitsa- Acharya Sushruta described general treatment for

Karnaroga as Snehapana (Drinking ghee) Rasayana (Rejuvenation therapy)

Bhramacharya Avoid excessive speaking Avoidance of physical exercise and

head bath

Vishesha Chikitsa ndash Acharya Sushruta mentioned some procedures in the

treatment of Karnasrava which is Shirovirechana Karnadhoopana

Karnapurana Karanpramarjana Dhavan Avachurnana Karnapurana Above

various procedures described in Ayurveda for management of fungus growth

in ear discharging ear fulfill these requirements of wound management

Page | 128

Discussion on observation and Result

Out of 68 patients 34 patients included for the trial The incidence of

Karnasrava is observed in trial and control groups

The statistical analysis provided the following data

AGE

Trial group- Maximum no of patients that is 14 (41176) patients were from

age group 25-35 years followed by 29412 patients were from age group

18-25 years 23529patients were from age group 35-45 years and

58824 patients were from age group 45-60 years

Control group - Maximum no of patients that is 14 (41176) patients were

from age group 25-35 years followed by 20588 patients were from age

group 35-45 years and 20588 patients were from age group 45-60 years

17647 patients were from age group 15-25 years

The maximum no of cases of Karnasrava found in age group between 25 to

35 years The reason behind this is repeated use of ear bud or emersed water

in ear More use of earphone or working more in cold environment

GENDER

Trial group ndash A higher prevalence seen in females 6764 and 3235 in

males

Control group - A higher prevalence seen in males 5588 and 4411 in

females

Females and males both are prone to disease

Page | 129

EDUCATION

Trial group-It is observed that amongst 34 patients maximum ie16

(47059) patients were graduated 8 (23529) patients were HSC

educated 4 (11765) patients were SSC educated 4 (11765) patients

were illiterate 1 (29412) patient were primary educated and 1(29412)

patient were post graduated

Control group- It is observed that 10 (29412) patients were graduated 9

(26471) patients were HSC educated 6 (17647) patients were post

graduated 3 (88235) patients were SSC educated 3 (88235) patients

were primary educated3 (88235) patients were illiterate

There is no direct relation between education and Otomycosis

RELIGION

Trial group- The incidence of patients of Hindu religion are 9118 and Muslim

religion are 882

Control group- The incidence of patients of Hindu religion are 9706 and

Muslim religion are 294

There is no probable explanation for this maximum number of patients in

Hindu religion it depends upon the patients attend the hospital and

community residing there

Page | 130

DIET

Trial group It was found that maximum ie5882 patients were taking

mixed diet while 4118 were taking vegetarian diet

Control group It was found that maximum ie5882 were taking

vegetarian diet while 4118 patients were taking mixed diet

The dietary habit of person is based on choice availability and religious

customs of the person

ADDICTION-

Trial group- It was found that maximum ie 30 (8824) patients have no

addiction 2 (588) patients have addiction of alcohol 1 (294) patients

have addiction of Tobacco 1 (294) patients have addiction of smoking and

0 (0) patients have addiction of Mishri

Control group - It was found that maximum ie 27 (7941) patients have

no addiction 4(1176) patients have addiction of smoking 2 (588)

patients have addiction of Tobacco 1 (294) patients have addiction of

Mishri and 0 (0) patients have addiction of alcohol

Very few patients were addicted to Alcohol Smoking Tobacco and Mishri

These factors can be taken as provoking factors for Otomycosis

Page | 131

Discussion based on probable Mode of action of Karnadhoopana

In Ayurveda classics Karna Dhoopana is therapeutic procedure explain for

Karnasrava Dhoopana is administration of Dhooma (Fumes) with the help of

Dhoopan Dravya References indicates that analgesic and disinfectant effect

of Dhoopana karma and mention for Dushta Vrana Chikitsa It reduces

Vedana Srava amp also does Vrana Ropana action

Various Dhoopanas and Dhoopan Dravas for different element in various

Samhitas of Ayurveda but there is a lacuna of availability of reference

regarding how to do it and method of procedure Matra Kala Contraindication

etc

Currently simple modified way of Karnadhoopana according to Yukti Praman

and experience but there is lac of standardization

Karnadhoopana is one among the topical Bahiparimajan type of treatment

Karna Parmarjana is procedure of cleaning ear with the help of cotton or gauze

piece soaked in honey

Page | 132

Dhoopan

The fumes coming out on burning Agaruwadi Varti

Administrated directly into external ear canal

Causes vasodilation

Due to this increase blood supply in external ear canal

It helps in absorption of drug

Fumes dries up Srava and bring the analgesic effect

Karnagata Kapha amp Avrut Vata Dosha Shaman

Decrease in signs and symptoms like karnasrava Karnshool Karnabadhirya amp

Karnandu

Page | 133

3 Discussion based on probable mode of action of Agaruwadi

Dhoopana

Agaru ndash

I Agaru is a fragrant tree aroma is a result of fungal pathogenesis when the

wood of tree is contaminated by fungi at wounds it develops scrap filled

with resin and turn out to be aroma Medicinal use of Agaru have been

recorded in ancient medicinal science in in inflammatory disease and some

infective disease

II Acharya Charaka has referred to Agaru as an Ushna dravya despite having

Tikta Rasa Ashtang Samgraha used Agaru as Dhupana Dravya along with

Madan and Yawa in Karnasrava Nighantu recommended is use as a

Dhoopana

III In various Samhitas and Nighantus Agaru described as Tikta Snighdha

Sheetaprashamana Vranaprasadana Tvachya Due to these properties

Agaru is used in the treatment of Karna-Akashi Roga and Dushta Vrana

Shodhaka

IV Agaru is reported to have Antimicrobial Analgesic Antioxidants

Antihistaminic and anxiolytic properties Its Antihistaminic property gives

relief from itching which is cardinal feature of Otomycosis Due to Katu

Ushna Tikta Guna improves blood circulation Bheda stage develop It is

Niram Awastha of Dosha Karnagata kapha and vata get decrease and

symptoms like karnashoolakarnasrava get decrease Agaru also have a

Antioxidant properties

V Chemically Agaru Contain 2-(2-Phenylethyl) Chromones Terpenoids

Flavonoids

VI Natural Agarwood had inhibitive activities towards Staphylococcus Aures

The chloroform extract of Agarwood prolongs the pain threshold[108]

Page | 134

Madan

I Madanphala have therapeutic properties like Anti-inflammatory

Antiallergic Analgesic and Wound healing

II It is Useful in treatment of disease like Shotha (inflammation) Vidradhi

(Abscess) Pratishaya (Common cold) Kushta(Skin disease)

III Extract of Madanphala mainly contain Glcosides Tritorpenct

Glycosides Saponin

IV Saponin glycosides are act as fire extinguisher This property is helpful

for vartiIt also act as a detergent which clean the surface of fungus

V Tritorpenct act as a anti-inflammatory antimicrobial and

immunomodulator compound Interaction of glycosides with sterol

causes disturbance of selective permeability in plasmic membraneso

exudates and discharge get decrease

VI Pharmacological activity [109]

Antibacterial Activity The preliminary antibacterial activity of Methanolic

extract of Randia D lam was done on some standard and wild pathogenic

strains The inhibition of the bacterial growth was more pronounced on E coli

as compared to the other tested organism This shows the antibacterial action

of Randia D secondary infection can prevent

Anti-Allergic Activity In Ayurveda Randia D Extract and its fraction of milk

induced leukocytosis and eosinophilia in mice

Anti-Inflammatory Activity The crude methanol extract of fruit of Randia D

effectively reduced the carrageenin induced oedema in hind paw of the rats

significant reduction in granular tissue formation was recorded This activity

seems to be significant at various acute phases of inflammation and om

formation of granular tissue This proves action of Madanaphala in shopa

(inflammation)

Page | 135

Analgesic Activity Analgesic activity was tested in mice weighing between 20-

250 with six number of animals in each group Methanlic extract of fruit Randia

d give analgesic activity in both models This proves its Shoolanashaka (pain

killer) action

Immunomodulatory Activity Randia D has immunostimulant activity and

chloroform fraction which strongly affected immune system seems to be

bioactive fraction of this plant

The overall effect of Agaru Mandanphala Yawa having Anti-inflammatory

Antiseptic Antimicrobial Property Active ingredient shows these properties

Agaru Yawa Madanphala

Vatakaphaghna

Act as

Vranashodhak

Vedanasthapaka

Sheetaprashamana

Shothara

Avarana of Vata get decrease so helps to Shaman of Vata dosha

Karnakandu Karnashoola Karnasrava

Prashamana

Page | 136

This fact can be taken into consideration and probably acknowledge that

Karnadhoopana with Agaruwadi Varti had not leave any residue in the ear

Removal of fibrin keratinocyte migration and in growth of epithelial tissue

plays a major role in healing It is technique of fumigation of ear with the

smoke of anti-infective drug In Karnadhoopana Sthanik Swedana increase the

blood supply and helps in absorption of the drug reduce Karnakandu amp

Karnshoola associated with infection

Page | 137

SUMMARY AND CONCLUSION

Page | 138

The dissertation entitled randomize comparative clinical trial to study the

effect of Agaruwadi Karnadhoopan and Guggula Karnadhoopan In Karnasrava

wsr to Otomycosis

The dissertation is divided into fallowing parts

Introduction

Review of literature

Ayurvedic review

Modern Review

Drug review

Procedure review

Material and Method

Observation and result

Discussion

Summary and conclusion

bull INTRODUCTION

It includes importance of Shalakyatantra in Sushrut Samhita Charka

Samhita And Ashtang Samgraha

Common and specific causes of Karnasrava

Karnasrava is a clinical entity which can be corelate with Otomycosis

In Ashtang Samgraha stated the procedure like Karnadhoopana with

Agaru Yawa Madanphala in Karnasrava

Page | 139

bull REVIEW OF LITERATURE

1 Ayurvedic review

2 Modern review

3 Drug review

Ayurvedic review-

It includes Rachana-Sharir and Kriya-Sharir of Karna detail description of

Karnaroga and its types Karnaroga Samanya hetu Poorvaroopa Rupa

Samprapti Upadrava Pathya-Apathya of Karnasrava Vishesh Nidan and

Chikitsa of Karnasrava Detail description of Karnadhoopana according to

various Acharays have been mentioned

Modern review-

It includes anatomy and physiology of Ear brief anatomy of ear anatomy of

External middle and Internal ear Detail description of the disease

Otomycosis mechanism of fungal infection in external canal pathophysiology

investigations diagnosis and management

Drug review-

Detail description of Agaru Yawa Madan Guggula and its synonyms

Ayurvedic properties Karma uses Pharmacological action and their

pharmacodynamic properties

Page | 140

MATERIAL AND METHOD

It includes description regarding materials required for the study Preparation

of Agaruwadi Varti its Standardization Sterilization and packaging

Plan of study

1 Total 68 patients completed the treatment Age criteria was kept

between 18-60 years Patient selection was done by done by simple

random sampling method and divided into two groups A (Trial) and

Group B (Control) 34 patients in each group

2 Patients in Group A were treated with Karnadhoopana with Agaruwadi

Varti for 7 days two times in a day while patients in Group B were treated

with Karnadhoopana with Guggula for 7 days two times in a day

3 Clinical examination done during each follow up ie 0th 4rd 7th and

observation were recorded

Page | 141

OBSERVATIONS AND RESULTS

Page | 142

1 It was observed that higher incidence of disease Karnasrava ie

Otomycosis found in age group 25-35 years

2 Disease otomycosis was equal in both male and female

3 The trial group there was significant relief in Karnakandu (8906)

Karnasrava(9333) Karnashoola(7667) and karnabadhirya(100)

4 In control group there was significant relief in Karnakandu (7414)

Karnasrava(9524) Karnashoola(8438) and

karnabadhirya(8750)

Page | 143

REFERANCES

Page | 144

1 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-Tatva-

Sandipika hindi commentary Sutrasthan Published byChaukhamba

Sanskrit SansthanVaranasi Vedotaptti Adhaya Shlok no- 17 page no

5

2 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-Tatva-

Sandipika hindi commentary Sutrasthan Published by Chaukhamba

Sanskrit SansthanVaranasi Vedotaptti Adhaya Shlok no- 19 page no

6

3 DRNarayan Vidwas Shero-Karna-Nasa and MukhrogaAnand publication

edition 4th 2014 Page no-52

4 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-Tatva-

Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogvigyniya Adhaya Shlok no-205

page no 111

5 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-Tatva-

Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogvigyniya Adhaya Shlok no-203

page no 111

6 VdBramhand Tripathi Ashtanghradaya Sutrasthan Published by

Chaukhamba prakashana 2005 Shlok no2012

7 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-Tatva-

Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogvigyniya Adhaya Shlok no-203

page no 112

8 Dr KBBhargavaDr SK BhargavaDr TMShahaA Short book of ENT

diseases Usha publication edition 10th

9 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition Diseases of external ear

Chapter no 8 Page no -52

Page | 145

10 Research and Review Journal of Ayurvedic science yoga and

Naturopathy 2017 4(3) 1-5 pA Critical review of Otomycosis in cortex to

Karnaroga described in Ayurvedic classic by amisha patel D B Vaghala

Chandani goswami Vol4 no3 (2017)

11 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogpratished Adhaya Shlok no-213

page no127

12 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedh Adhaya Shlok no-

2140 page no 131

13 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sutrasthan published by

Chaukhamba Orientalia Kiyant shirasiya adhaya Shlok no 1712 page no-

258

14 Vaidya Yadavaji trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri Dalhanacharya Published by-

Chaukhamba Sanskrit sansthanEdition reprinted 2012

15 Vaidya Yadavaji trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri Dalhanacharya Published by-

Chaukhamba Sanskrit sansthanEdition reprinted 2012

16 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Aupadravik Adhaya Shlok no-15 page no

2

17 Vaidya Jaymini panday Harit Samhita hindi commentaryChaukhamba

vidhyabhartiVaranasiedition 2010 Shlok no- 13-14page no-10

18 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Page | 146

Sanskrit SansthanVaranasi Karnarogvigyniya Adhaya Shlok no-20345

page no 112

19 Acharya Trivedi Raguveer Prasad Ashtang sangrah uttartantra

published by Vaidyanath Ayurveda bhavan pvt Karnarogavigyniyam Shlok

no 21 Page no-731

20 Charak

21 Pandit Harigovind Shashtri Namalinganusasana Amarkosha of

Amarsimha hindi commentary published by Chaukhamba Sanskrit

Sansthan page no- 463

22 Raja Radhakantadeva Shabdakalpadruma Naga PublicationsDelhi 3rd

edition -2006 Volume 2 Page no 42

23 Raja Radhakantadeva Shabdakalpadruma Naga PublicationsDelhi 3rd

edition -2006 Volume 2 Page no 37

24 Shree Taranath-Trkavachspati-Bhattacharyen Vchaspatym published

by Rashtriya Samskrit Sansthandelhi Volume 4 page no- 5149

25 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sharirsthan published by

Chaukhamba Orientalia Sharirsankhyasharir Adhaya Shlok no 716 page

no- 850

26 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sharirsthan published by

Chaukhamba Orientalia Sharirsankhyasharir Adhaya Shlok no 77 page

no- 847

27 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sharirsthan published by

Chaukhamba Orientalia Sharirsankhyasharir Adhaya Shlok no 77 page

no- 847

28 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sharirsthan published by

Page | 147

Chaukhamba Orientalia Sharirsankhyasharir Adhaya Shlok no 716 page

no- 850

29 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sutrasthan published by

Chaukhamba Orientalia Indriyaopakramaniya Adhaya Shlok no 811

page no- 125

30 Shree Yadunandanopadhyaya Madhavnidan with madhukosh

teekapublished by Chaukhamba Prakashana571 page no- 243

31 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Chaukhamba Sanskrit SansthanVaranasi Sharirsankhyavykaransharir

Adhaya Shlok no-510 page no56

32 VdBramhand Tripathi Ashtanghradaya Sharirsthan Published by

Chaukhamba prakashana 2005 Shlok no3108 page no- 385

33 VdBramhand Tripathi Ashtanghradaya Sharirsthan Published by

Chaukhamba prakashana 2005 Shlok no33 page no- 366

34 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Chaukhamba Sanskrit SansthanVaranasi Sarvabhutachintasharir Adhaya

Shlok no-126 page no9

35 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Chaukhamba Sanskrit SansthanVaranasi Sharirsankhyavykaransharir

Adhaya Shlok no-522 page no60

36 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Chaukhamba Sanskrit SansthanVaranasi Sharirsankhyavykaransharir

Adhaya Shlok no-532 page no61

37 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Page | 148

Chaukhamba Sanskrit SansthanVaranasi Sharirsankhyavykaransharir

Adhaya Shlok no-521page no58

38 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Chaukhamba Sanskrit SansthanVaranasi Sharirsankhyavykaransharir

Adhaya Shlok no-527 page no61

39 VdBramhand Tripathi Ashtanghradaya Sharirsthansthan Published by

Chaukhamba prakashana 2005 Shlok no331 page no-372

40 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Chaukhamba Sanskrit SansthanVaranasi Siravarnavibhaktisharir Adhaya

Shlok no-725 page no83

41 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sutrasthan Published by Chaukhamba

Sanskrit SansthanVaranasi Sharirsankhyavykaransharir Adhaya Shlok

no-512

42 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Chaukhamba Sanskrit SansthanVaranasi Pratekmarmanirdeshsharir

Adhaya Shlok no-628 page no75

43 Vaidya Yadavaji trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri Dalhanacharya Published by-

Chaukhamba Sanskrit sansthanEdition reprinted 2012

44 VdBramhand Tripathi Ashtanghradaya Sharirsthan Published by

Chaukhamba prakashana 2005 Marmasharirsthan Shlok no429 page

no- 393

45 Shree Yadunandanopadhyaya Madhavnidan with madhukosh

teekapublished by Chaukhamba Prakashana571 page no- 243244

Page | 149

46 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sharirsthan published by

Chaukhamba Orientalia Sharirsankhyasharir Adhaya Shlok no 711 page

no- 847

47 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sharirsthan pu blished by

Chaukhamba Orientalia Sharirsankhyasharir Adhaya Shlok no 711

48 Vaidya Yadavaji trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri Dalhanacharya Published by-

Chaukhamba Sanskrit sansthanEdition reprinted 2012

49 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sharirsthan published by

Chaukhamba Orientalia Sharirsankhyasharir Adhaya Shlok no 711 page

no- 847

50 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sutrasthan published by

Chaukhamba Orientalia Shlok no 711 page no- 847

51 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sutrasthan Published by Chaukhamba

Sanskrit SansthanVaranasi Adhaya Shlok no-628 page no- 75

52 VdBramhand Tripathi Ashtanghradaya Sutrasthan Published by

Chaukhamba prakashana 2005 Gandushavidhiadhaya Shlok no2232

page no- 261

53 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sutrasthan Published by Chaukhamba

Sanskrit SansthanVaranasi Karnavydhbandhvidhi Adhaya Shlok no-

1611 page no- 86

54 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Nidansthan Published by Chaukhamba

Page | 150

Sanskrit SansthanVaranasi Vatvydhinidansa Adhaya Shlok no183 page

no- 304

55 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Chaukhamba Sanskrit SansthanVaranasi Sharirsankhyavaykaransharir

Adhaya Shlok no-532 page no61

56 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sutrasthan published by

Chaukhamba Orientalia Tristaisniya adhaya Shlok no 1120 page no-

163

57 P Hazarika Dr Nayaka R Balkrishnan Textbook of EarNoseThroat and

Head-Neck Surgery CBS Publication Anatomy of Ear

58 DrKB Bhargava DrSKBhargava DrTMShaha A short book of ENT

Diseases Published by Usha Publication 10th edition page no10

59 MrSalah Mansour MrJacques MagnanMr Hassan Haidar MrKaren

Nicolas MRStephan Louryan Comprehensive and clinical anatomy of the

Middle Ear Published by Springer publication Chapter -Middle Ear cavity

Page no 19 to 121

60 DrPLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition Diseases of external ear

Chapter no 7

61 James OPickles An introduction to Physiology of Hearing Published by

Emerald publication 4th edition page no- 1 to 265

62 Raja Radhakantadeva Shabdakalpadruma Naga PublicationsDelhi 3rd

edition -2006 Volume 2 Page no 42

63 VdBramhand Tripathi Ashtanghradaya Uttarsthan Published by

Chaukhamba prakashana 2005 Karnaroga vigyniyam adhaya Shlok

no1713 page no- 998

Page | 151

64 Acharya Trivedi Raguveer Prasad Ashtang sangrah uttartantra

published by Vaidyanath Ayurveda bhavan pvt Shlok no- 212 page no-

730

65 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya Shlok no

1-2 page no- 309

66 Shree Yadunandanopadhyaya Madhavnidan with madhukosh

teekapublished by Chaukhamba Prakashana

67 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sutrasthan published by

Chaukhamba Orientalia Kiyantshirasiya Adhaya Shlok no 1713 page no-

258

68 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya Shlok no-

6 page no- 310

69 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005 Karnarogavigyniym Shlok no- 1725-26 Page no-

1003

70 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2140 page

no 131

71 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005 Adhyay 18 shlok 35

72 Acharya Trivedi Raguveer Prasad Ashtang sangrah uttartantra

published by Vaidyanath Ayurveda bhavan pvt

Karnarogapratishedhoadhya Shlok no-2211 Page no- 735

73 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Page | 152

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2141 page

no 131

74 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2142 page

no 131

75 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2144 page

no 131

76 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 34 page no- 649

77 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2145page

no 131

78 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 37 page no- 649

79 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2146page

no

80 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya page no-

316

81 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Page | 153

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2143page

no

82 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publication Krnarogadhikara adhaya page no-

318

83 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary

Madhyamkhand Vatkalpana shlok no- 782-83 page no- 137

84 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 72-77 page no- 651

85 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya page no-

316

86 Vd Shree Laxmipatishastri Yogratnakara

87 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

Karnarogadhikara Shlok no- 808182 page no- 652

88 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 83 page no- 652

89 (PDF) Otomycosis A Comprehensive Review (researchgatenet)

90 httpswwwncbinlmnihgovpubmed24948980

91 A Simon Carney Scott-Browns Otorhinolaryngology Head and Neck

Surgery CRC press 8th publication Otitis externa and otomycosis

92 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition Diseases of external ear

Chapter no Page no -

93 wwwguggulipidcomtradhtm

Page | 154

94 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

95 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 1 chapter no-28 page no-

43

96 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009Agaru page

no726-728

97 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishra chapter Karpuradi varga Shlok no-31-

43 Page no- 116

98 httpswwwthiemeinimagecatlogsample_chapter_GOMPpdf

99 (PDF) Chemical Constituents and Pharmacological Activity of Agarwood

and Aquilaria Plants (researchgatenet)

100 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 4 chapter no-2 page no-4

101 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 chapter no-152 Madanpage

no376-379

102 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

103 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 1 chapter no-54 page no-

84

104 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 page no697-699

patol-yawa

Page | 155

105 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

106 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

Dhoompanvidhi page no- 252-254

107 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012Chikitasasthan Shlok

no- 151page no-406

108 httpswwwmdpicom1420-3049232342pdf

109 httpswwwijamcoinindexphpijamarticledownload0610201530

0

Page | 156

BIBILOGRAPHY

Page | 157

1 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

2 Scott-Brown WG Diseases of the EarNose and Throat Landon

Botterworth and co(publishers) Ltd1952 Volume 2

3 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012

4 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009

5 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi commantry

Purvakhand and Madhyamkhand

6 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

7 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-Tatva-

Sandipika hindi commentary Published by Chaukhamba Sanskrit

SansthanVaranasi

8 The Ayurvedic Pharmacopeia of India Ministry of Health and family welfare

department of Ayush Part 1 and part 4

9 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005

10 Acharya Trivedi Raguveer Prasad Ashtang sangrah published by

Vaidyanath Ayurveda bhavan pvt

11 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition

12 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary published by Chaukhamba

Orientalia

Page | 158

ANNEXURE

Page | 159

ANNEXURE- 1

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

CASE RECORD FORM

RESEARCH PROFORMA FOR MS (AYU) DESSERTATION

DEPARTMENT OF SHALAKYATANTRA

NAME -

ADDRESS -

GENDER - AGE - OCCUPATION-

RELIGION - EDUCATION - MARITAL STATUS-

OPD IPD NO-

DATE OF ADMISSIONCOMMESEMENT-

DATE OF DISCHARGECOMPLITION-

DATE OF COUNSELLING-

TEL NO-

CHIEF COMPLAINTS-

PAST MEDICAL AND SURGICAL HISTORY-

TREATMENT HISTORY-

FAMILY HISTORY-

Page | 160

PERSONAL HISTORY-

a) Ahar(Diet)

b) Vihar

c) History of addiction

GENERAL EXAMINATION

PULSE - MIN BP - mm of hg

TEMP - 0F RR - MIN

ASHATAVIDHA PARIKSHANA

Nadi- Mutra- Mala-

Jivha- Shabda- Sparsha-

Drik- Aakruti-

SYSTEMIC EXAMINATION

RS ndash

CNS-

CVS ndash

Page | 161

LOCAL EXAMINATION (KARNA PARIKSHAN)

OBSERVATION TABLE FOR SUBJECTIVE CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching )

RIGHT EAR LEFT EAR

KARNASHASHUKULI

KARNAPUTRAK

KARNAPALI

KARNAKUHARA -

SRAVA

GANDH

VARNA

SWARUPA

KARNAPATALA (TM)

Page | 162

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

Hearing Test

1Renne Test ndash

2 Weber Test -

Examination of Ear-

Pathological Investigation-

Other Examination-

Nidan Panchak-

1Hetu-

2Purvarup-

3Rupa-

4Upashayanupashaya-

5Samprapti

Signature of Guide Signature of Doctor(Researcher)

Page | 163

ANNEXURE 12

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Dhoopana Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization were done as recommended in pharmacy procedure

The raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 were mixed together

in equal quantity to make Agaruwadi churn

STEP 4 - Agaruwadi churn were triturated with appropriate quantity of water

and prepared Varti in GMP Certified Ayurvedic pharmacy Standard aseptic

precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Dhoopana Varti was packed in sterile air packed

container

STEP 6 - Agaruwadi Dhoopan was given with the help of Dhoopan yantra

TREATMENT DETAIL-

Purvakarma -

1 The patient is asked to sit comfortably on chair having sufficient light and

less amount of dust

2 The EAC is cleaned thoroughly by Pichu Varti (cotton swab) to remove the

discharge and other debris

Pradhankarma -

1 The patient is asked to relax completely on the chair

Page | 164

2 Fumes are passed to the ear with Dhoopana Yantra

3 Dhoopana yantra is funnel shaped and its one end will keep the ear covered

for the passage of Dhooma into the ear canal and other end where Agaruwadi

Dhoopana Varti were placed which produces fumes

4 This Dhoopana was given for 5 min

Pashchat karma -

1 The patient were advised to avoid cold refrigerated food drinks cold water

bath cold wind fog and prevent water from entering the ear

(A) Agaruwadi Dhoopana Varti

B) Guggula Dhoopana Varti SOP of it is same as above Agaruwadi Dhoopana

Varti

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Page | 165

ANNEXURE 21

INFORMED CONSENT DOCUMENT

Study Title

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

Introduction

- You are invited to take part in a research study RANDOMSIED COMPARATIVE

CLINICAL TRIAL TO STUDY THE EFFECT OF AGARUWADI DHOOPANA AND

GUGGULA DHOOPANA IN KARNASRAVA

- Before you decide it is important for you to understand why the

research is being done and what it will involve

- Please take time to read the following information carefully and discuss

it with friends relatives and your doctor if you wish

- Ask us if there is anything that is not clear or if you would like more

information

Purpose amp Nature of Study

- In this research project by examine you and ldquoKarnasravardquo (Otomycosis)

disease were treated

- In the part of treatment Agaruwadi Dhoopana or Guggula Dhoopan were

given

- Dhoopana means medicated drug fumes were given in ear with the help of

Dhoopan Yantra

Page | 166

- Treatment was given for 7 days

Study Duration

7days

Participation

- Your participation is entirely voluntary

- If you do decide to take part you were given this information sheet to keep

and be asked to sign a informed consent form

- If you decide to take part you are still free to withdraw at any time and

without giving a reason This will not affect the standard of current or future

medical care you may receive

Confidentiality

- All information which is collected about you during the research were

kept strictly confidential

- Any information about you which is collected from the center will have

your identity in the form of a code number so that it will remain confidential

Benefits Of Study

- The results obtained from this study would be helpful for providing better

quality of treatment amp other essential facilities for Karnasrava (Discharge)

patients

- You will get clinical benefit from the study

Page | 167

Risks Of Study

- In this treatment there are few chances of Irritation of Ear Nose and

congestion at EAC if any of these happens then treatment were given

Results Of Study

- If the Results obtained are profitable then they may get published

without disclosing your details

Signature of patient

Date

Time

Phone no of Researcher

Page | 168

रण मादहती पतरक

सशोिनाच शीषवक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE

EFFECT OF AGARUWADI DHOOPANA AND GUGGULA DHOOPANA

IN KARNASRAVA

परसतताना

- आपणास या सशोिनातपमक अभयासात सहिागी होणय़ाच आाहन करणयात यत आह

- सशोिनातील सहिाग तननदशचत करणयापी सशोिनाच उददश समजन घया

- खालील मादहती काळजीपवक ाचा आणण आशयक ािलयास आपलया डॉकिराशी कका

दहतशरचतकाशी चचाव करा

- काही सददिता असलयास कका आणखी मादहती ही असलयास आमछयाशी चचाव करा

सशोिनाच उददीटि सतरप

- सदर सशोिन परकलपामरधय आपलयाला तपासणी करन कणवसरा या वयाशरिची शरचककतपसा दणयात

यणार आह

- सदर वयाशरिची शरचककतपसा महणन आपणास अगरादी िपन कका गगल िपन

दणयात यणार आह

- सदर औषि आपणास 7 ददस घयायाच आह

Page | 169

कालािी

- 7 ददस

सहिाग

- आपला सहिाग हा पणवपण ऎनदछिक आह

- आपला सहिाग तननदशचत असलयास आपणास ही मादहती पतरतरका दणयात यईल आपणास यातील

समती पतरकार सही कराी लागल

- सहिाग तननदशचत असनही आपण कोणतपयाही ळस कोणतही कारण न दता माघार घ शकता

याचा आपलया दयकीय सविर कोणताही पररणाम होणार नाही

गोपनीयता

- सशोिना दरमयान गोळा कलली आपलया वषयाची सव मादहती गोपनीय ठणयात यईल

- आपली यनदकतक मादहती साकततक सतरपात गोपनीय ठणयात यईल

सशोिनाच फ़ायद

- सशोिनाच तनटकषव कणवसरा बाशरित रणाछया दयकीय इतर सविाचा दजाव सिारणयास

फायदशीर ठरतील

सशोिनातील जोणखम

- य़ा शरचककतपसमरधय कान दखण डॊळय़ातन नाकातन पाणी य़ण नाकात जळजळण डोक जड

होण ही लिण ददस शकतात यापकी लिण तनमावण झालयास तपयाची शरचककतपसा कली जाईल

Page | 170

सशोिनाच तनटकषव

सशोिनाच तनटकषव फ़ायदशीर ठरलयास आपली मादहती गोपनीय ठन परकाशशत करणय़ात यईल

रण सतािरी-

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

Page | 171

ANNEXURE 31

INFORMED CONSENT FORM

Patient OPD no __________

Subjectrsquos Identifier

Date of Birth Age Gender

I _____________________________________ age___________ years

exercising my free power of choice hereby give my consent to be included

as a participant in the clinical study entitled

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

1 I confirm that I have read have been read and understood the information

sheet for the above study and can ask questions

2 I understand that my participation in the study is voluntary and that I am

free to withdraw at any time without giving any reason without affecting my

medical care or legal rights

3 I understand that the Ethics Committee members investigators and study

doctors will not need my permission to look at my health records both in

respect of the current study and any further research that may be conducted

in relation to it even if I withdraw from the trial I agree to his access

However I understand that my identity will not be revealed in information

released to third parties or published

4I agree not to restrict the use of any data or results that arisefrom this study

provided such a use only for scientific purpose

5 I agree to take part in the above study

Page | 172

signature with Date-

Left hand thumb impression

Name amp signature of the witness ndash

Name amp signature of the student ndash

Page | 173

ANNEXURE 32

समतीपतरक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

वयकतीच य

ददनाक जरमददनाक

1) मी ह तननदशचत कररत आह ककसदर सशोिन परकलपाबाबतची सपणव मदहती मी ाचली असनमला ती

समजली आहतपयाबददल मला परशन वचारणयाची पणव मिा आह सदर मादहतीन माझ समािान झाल

आह

2) मी सदर सशोिनातन माझया मजीनसार किीही बाहर पड शकतो या माझया अशरिकाराची मला कलपना

आह

3) माझी दयककय मादहती तपासणयाची कागदपतर कळ सशोिनाकररता ापरली जाणार आहत याची

मला मादहती आहसदर सशोिन परकलपातील सबशरित घिकाना माझी दयककय मादहती पाहणयाची मी

समती दत आहतरावप या सदिावतील माझी ओळख दशववणारी मादहती कोणासही ददली जाणार नाहीयाची

मला कलपना दणयात आली आह

4) सदर अभयासातन शमळणारी मादहती अरा तनटकषव कळ शासततरीय हतसाठी ापरल जाणयासाठी माझी

समती आह

5) रील अभयासात सहिागी होणयास माझी समती आह

रण सतािरी-

Page | 174

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

ASSESSMENT CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching)

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

a) कणवशल ( pain )- 0 - Absent

1 ndash Present

Page | 175

b) कणवकणड (Itching)- 0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

c) कणवसततरा ( Discharge )

0- Absent

1-Mild- Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाशरियव ( conductive Loss of hearing )

0 - Present

1 - Absent

Page | 176

Page | 177

Page | 178

Page | 179

Page | 180

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

Page | 181

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 182

AUTHENTIFICATION CERTIFICATE

Page | 10

Synonyms of Shalakya Tantra

Uttamanga Chikitsa Jatrurdhwa Chikitsa Urdhwang Chikitsa Shalakya

Chikitsa

Importance of Shalakyatantra-

Life of living being and all the Indriyas are situated in the head hence it is

known as Uttamanga

पराणभरता यतराशरशरतााः सइनदरियणण च यदततमागाना शशरसतततदशिशरियत

चस १७१२

The treatment given to this part of the body is described specially in

Shalakya tantra While describing the importance of Shiras Vagbhata

correlates it to the root of tree (Urdhwa Mula) and body to the trunk of tree

(Adha Shaka)

Sushruta has deal with Mukha Roga in Nidan Shan and its treatment in

Chikitsasthan The description regarding the disease of eye ear nose and

head are found only in UttaraSthan Sushruta specially describes the

disease of Shalakyatantra as told by Videha in the beginning of Uttartantra

itself[16]

Shalakyatantra Itihas-

India Exhibits traditional of more than thousands of years in art literature

language logic and philosophy etc The convention was in its sophisticated

and advanced attire throughout the Vedic period

Vedic period ndash

1 Natush was treated for deafness by Ashwinikumars (Rigveda)

2 Rujaswa and Kanva were treated for blindness by Ashwani Kumaras

(Rigvedas)

Page | 11

3 There are several prayers mentioned for normal functioning of sense

organs (Yajurveda)

4 Structures and functions of Mastishka are described (Atharveda)

5 Mantras having reference to disease of Eye Ear Oral cavity etc are

found (Atharvaveda)

Upanishada Period ndash

1 Samhita Period

a) Sushrut Samhita ndash

bull Explanation regarding Netra Nasa and Shirorogas (Uttartantra 1-

26th chapter)

bull Details regarding Mukha and Karna Roga Nidan and

Chikitsa(Nidansthan 16th and Chikitsasthan 22nd chapter)

bull Description regarding Karna Chedana Sandhana Nasa

Ostasandhana Sutra Sthan 16th chapter

b) Charaka Samhita -

bull Explanation regarding Shirorogas (Sutrasthan 17th chapter)

bull Explanation of Gala rogas like Upajivika Galshundi and Rohini

bull Nasa Shiro Mukha Karna and Netra Chikitsa (Chikitsa sthan 26th

chapter)

bull Description regarding Lakshana and Chikitsa of Shankhaka

Ardhavbhedaka Shirovirechana and Shiro basti (siddhi sthan 9th

chapter)

c)Ashtnga Sangraha ndash

bull Detailed description regarding Shalakyatantara (Uttartantra 11-28

chapter)

bull Description of Kriyakalpa (Sutrasthan 32nd and 33rd)

Page | 12

d)Ashtang Hrudayam

bull Detailed description on Shalakya Tantra (Uttar tantra 8-24 chapters)

bull Kriyakalpas (Sutrasthan 23rd and 24th chapter)

e) Bhela Samhita

bull Chakshushya Vaisheshik and Buddhi Vaisheshik Alochaka pitta

f) Harita Samhita- Branch of Medical science offering elaborating

information about the procedure like Nasya Anjan Gandusha etc

comprehended with their applications in disease of Head Eyes Ears

Eyebrows Throat Temporal region and cervical spine is known as

Shalakyatantara

शशरोरोगा नतररोगा कणवरोगा वशषताः भरकरठशङकमरयास य रोगा समिनदरत दह १३

तषा परततकारकम व नसतयतपयवणजनातन च अभयङगमखगणडषकियााः शालकयसशमतााः १४

इतत शालाकयनाम [17]

Documentation of different ancient literature gives various references

regarding all aspects of Karnasrava in various periods It is very much

important to know the history of Karnasrava from Vedic Pauranic Samhita

and Samgraha period

Vedic period ndash The Vedas being the oldest source of knowledge have no

direct mentioning of Karnasrava

Page | 13

Samhita and Samgraha period ndash

Aacharya Sushruta described about Karnaroga Karnasrava Nidan

Roopa and Chikitsa The detail description is available in Sushrut

Samhita Uttartantra 20 and 21st chapters

Aacharya Charaka did not specify Karnasrava but mentioned 4 types

of Karnarogas that is Vataj Pittaj Kaphaja and Sannipataja and their

treatment in 26th chapter of Chikitsasthan

In Ashtang Hrudaya karnasrava is not explained as a separate disease

but Chikitsa is mentioned in 18th chapter of Astanga Hrudaya

uttartantra

In Ashtang Samgraha Chikitsa is mentioned in 22nd chapter of Astang

Samgraha Uttartantra

The details about Karnasrava are explained in Bhavprakasha

Madhyamakhanda 64th chapter

Madhavakara has explained about Karnasrava in 57th chapter of

Madhymakhanda

Karnasrava is also explained in Sharangadara Samhita Uttarkhand 11th

chapter

The reference for treatment of Karnasrava is available in

Yogaratnakara

In Gadhnigraha Karnasrava and its treatment is mentioned in

Karnarogadhikara Adhaya

Vangasena had mentioned about the disease and treatment in 69th

chapter

Chakradatta explained Karnasrava in 57th chapter

Dalhana has given commentary on Sushrut Samhita Uttartantra 20th

and 21st chapter

Sankhya Samprapti of Karnasrava ndash

Aachary Sushruta explains 28 Karnaroga in Uttaratantra Karnaroga

Vigyniyam Aadhaya Aacharya charaka explain 4 Karnaroga in

Page | 14

Karnarohvigyniyam Adhaya based on doshas Acharya Vagabhata in

Ashtang Hrudaya explain 25 Karnaroga in Adhyaya

कणवशल परणादशरच बाशरियव कषड ए च

कणवसरााः कणवकणडाः कणव चवसतततर च

कशमकणवपरततनाहौ विशरिदवविसततरा

कणवपाकाः पततकणवसततराशवशरचतवविम

कणावबवद सपतवि शोफशरचावप चतवविाः

ऎत कणवगता रोगा अटिावशततरीररतााः

स उ २०- ३ त ५[18]

ातकणवरोग वपततकणवरोग कफकणवरोग

रकतकणवरोग सनदरनपातकणवरोग कणवनाद

बशरिरतप परततनाह कणडाः शोफ पततकणवक

किशमकणवक उियरपविरधयअशो अबवद

कशरचकणवक वपपपली वदाररका पाळीशोष

ततिका पररपोिो उतपपातो उरमरर दाःखिवन

शलहाखयााः परचवशनदरतकणवरोगा उकतााः

इदिीका अ स उ २१ [19]

चतपाराः कणवरोगााः

च स [20]

Page | 15

KARNA

Karna ndash करोतत शबद गरहण [21]

The organ of hearing

Karnasrava- कणवसतय कणवयोाव ससराा [22]

Discharge from the ear is referred as Karnasrava

KARNA SHAREERA

bull Nirukti

कणयवत अकणयवत अनन इती [23]

It means reception and conduction of sound waves

These are the functions of external and middle ear

bull Nirukti of Sravanam

शरयत अनन इती शरणम[24]

It means perception of sound

It can be attributed to the internal ear function

bull Karna Utpatti-

Karna is an organ formed by Akash Mahabhuta[25]

The fundamental characteristic is as follows

Indriya ndash Srotram [26]

Indriya Adhisthan ndash Karna [27]

Indriya Dravy ndash Akasha [28]

Indriya Arth ndashShabdha [29]

Indriya buddhi ndash Srotobyddhi

Page | 16

bull Paryaya of Karna- Shabdapatha Srotrapatha Sravanam shruti

Kuhuram Dwanigraham etc

bull Definition of Karna-

कणवशटकलयनदछिरनमिटिोपगरदहत शरोतरमछयत [30]

मा तन ५७१

The definition of Karna is stated in Madhav Nidanam Indriya which is not

seen with naked eye along with Shashkuli is called Shrotra that is Karna

Indriya is so minute that it is not perceived with any sense organ

In Charak Samhita the word Karna explain as the Indriya Adhisthan of

Shabdha Karna is described as one of the Prathyangas of the body He

emphasizes that all Indriyas manifest during the 3rd month of gestation

period

Acharya Sushruta while describing formation of Purusha from Prakriti or

Avyakta narrated that all Indriyas are developing from the Vikarika and

Taijas Ahankara Both Vagabhata and Sushruta stated that Karna as one of

the Bahirsrotas

शरण नयन दन घराण गदमढराणण न सततरोताशसराणा बदहमवखातन [31]

स शा ५-१०

In Ashtang Hradaya Vagbhata has states that all Indriyas are Atmaja

According to him lower lobule elevated helix projected posterior portion

fleshy and adherent ear are indications of long span of life[32]

ततरखातखातन दह अनदसतमन शरोतर शबद ववकतता [33]

ा शा ३-३

शबदाः शबदनदरिय सवनदछििसमहो ववकतता [34]

स शा १-२६

Page | 17

Ear has the prominence of Akash Mahabhuta The prominent dosha of ear

is Vata It is important seat of Vata The prominent Dhatus are Asthi and

Mamsa Karna is one of the Panchgnanendriyas and it meant for hearing

Sushruta narrated that Karnasthita Asthi and Sandhi

घराणकणवगरीाकषिकोषष तरणातन [35]

सशा ५-२२

शरोतरशरगािकष शखाताव [36]

सशा ५-३२

गडकणवशखटककम [37]

स शा ५-२२

One Sandhi and one Tarunasthi in ear

Sandhi ndash Karna contain two Sandhi one in each ear Type of Sandhi is

Shankhavartha which is present in Shringataka

Mansapeshi ndash 2[38]

Siras ndash 10 [39]

Vataj Sira - 4

Pittaj sira - 2

Kaphaj sira - 2

Raktaj Sira - 2

Avedhya sira-

कणवयोदवश तासा शबदादहनीनामकका पररहरत

सशा ७-२५[40]

Amongst above mentioned ten Siras each Karna lodges one Shabdavaha

Sira It is Avedhya

Page | 18

Dhamani -2

Length of ear is 4 Angula

Karna moola ndash 2 Angula

कणाविरतर चतदवशअगलम

स शा ३५-१४[41]

The distance between two ears through the back of the neck is 14 Angula

bull Marmas of Karna-

1 Vidhuras-

कणवपटठतो अिाःसशरशरत विर ततर बशरियवम

सशा ६-३७[42]

कणतपयादद सतनायममवणी ककनदचचनदरनममनाकर कलयकररणणच

डलहणाचयव[43]

अिसततात कणवयोतनवमन विर शरततहाररणण

ा शा ४-२९[44]

Sankhya-2

Vistara- frac12 Angula

Type- Snayumarma (Susha)

- Dhamanimarma(AH)

- Vaikalykar

Sthana- It is situated in the depressed portion in the back of the ear

Injury to them causes loss of hearing

Page | 19

2 Shringataka marma-

नदजवहाकषिनाशसकाशरोतरखचतटियसरमम

तालरयासतयातन चतपारर सरोतसा तष ममवस

वदि शरगातकाखयष सददसततपयजतत जीवतम

मा तन ५७१ [45]

Sankhya- 4

Type- Siramarma

Sthana- It is in head that is amidst Siras (blood vessels) nursing sense

organ

A palm size area near Talu

Injury to this Marma causes death

In modern anatomy ear divides into Bhayakarna or External ear Mdhyakarn

or Middle ear Antahkarna or Internal ear This is extremely appropriate

Even though the ear is divided into three divisions in the point of modern

anatomy Ayurveda denotes ear organ is one Ayurveda treats disease by

way of assessing Dosha and Dushya Here Dushya is one that is Karnendria

Dosha difference will call for different treatment for different disease Hence

treating the vitiated Dosha will cure the disease irrespective whether it is in

external middle or internal ear The thought is based on different

fundamental principle from Ayurveda

bull Parts of Karna

In Ayurveda classics detailed description about anatomy of ear is not

available But the various parts are mentioned as follows

Bhayakarna- External ear

Mdhyakarna ndash Middle ear

Antahkarna- Internal ear

Page | 20

द कणवशटकशलक दॊ कणवपतरकौ

च शा 7-11[46]

कणवशटकशलक कणवगतातवकौ कणवपतरकौ त बाहयकणा

चिदतत च शा 7-11[47]

शटकली बाहयपालयाशरिटिानम

डलहन- स शरच 25-1 12[48]

Karna Shashkulika ndash It is also called as Karna Shashakuli Charaka has

mentioned this term while describing different Pratyngas of the body

Acharaya Gananatha sen has given the clarification for it as a pinna or

auricle[49]

Karnapali ndash It is popularly known as lobule of the ear Daivakrita Chidra is

present in it

Karnaputrika- Ayurvedic scholars accepted two terms in this cortex They

are Karnaputrika and Karnaputrika The former is considered as Tragus and

antitragus[50]

Karna Prushtha- It can be taken as the cranial surface of mastoid or

auricle[51]

Karnapeetha- Aacharaya Sushruta firstly mention the term Karnapeetha

It is mentioned first by Sushruta while describing the procedure of

Karnavyadana Vagbhata has mentioned that it is Adhobhaga of Karna

Dalhana has clarified that it is the region above the Karnaputrika that is the

region which is at the bottom of the concha

Karnamoola ndash It can be considered as parotid region[52]

Karna lathika ndashAcharaya Dalhana mentioned lobule as a Karna Lathika

Page | 21

Karnaavatu ndashThis term is used by Sushruta while describing the

measurements of different Angapratyangas where he has mentioned that

the distance between the Karnaavatu is 14 Angul Dalhana has comments

that it can be taken as the distance between two ears from behind[53]

Shabdhavahasrotas ndash It also called as Shabdapatha or Srotapatha The

whole passage through which the sound waves pass can be taken as

Shabdavahasrotas[54]

Shrotashringataka ndash It can be taken as the labyrinth of ear[55]

bull Dosha in context to Karna-

Karna is principal location of Vayu

1 Prana Vayu- Prana Vayu circulating in oral cavity is responsible for

Dehadhruka that is keeping all body parts active Indriyadruka that is

keeping all Dnyanendriya healthy by proper nourishment (Purana) helps in

deglutition of food material and convey the stimulation of Indriyabuddhi

and atma

2 Udana Vayu- Bala(strength) Varna speech singing are its function It

is responsible for facial expressions due to pleasure sorrow anger love

frustration etc in general its circulation and actions are just opposite to

Pranavayu

3 Vyana Vayu- Its principal functions are circulation of Rasa and Rakta

through body and various movements Its main location is Hrudaya Five

types of movements for which it is responsible are expansion contraction

upward downward and oblique other activities are opening closure of

eyelid yawning perspiration During circulation if it gets obstructed due

to Srotodushti it generates disease of that Srotas Vyana Vayu gets vitiated

by disease of Rasa Rakta Oja and Chetanadhatu

Page | 22

4 Samana Vayu- It is circulating in the vicinity of stomach and intestine

and helps in keeping the Jatharagni (digestive juices and enzymes) in

equilibrium Disturbance in Jatharagni precipitates disease

5 Tarpaka Kapha- Entire body functions movements are controlled and

executed by various centers in the brain Sensation perceived by sense

organs is conveyed to Mann and Aatma residing in Hrudaya The motor

signals from them are then conveyed to the functioning

organsKarmendriya through Prana Vayu Shira head is therefore a

location of continuous activities motions of Vata All these centers are in

unctuous Majjadhatu in the Shira For stabilizing this ever-active Vata and

to nourish the Majja dhatu very unctuous Tarpaka Kapha situated in Shira

plays an important role

bull Ayurvedic aspect of sound perception [56]

According to Ayurveda Pratyaksha Dnyan or Perception of any sensation

including Shabda occurs due to interaction of the Karnendriya and the

Indriya- Arth -Karma resulting in Sravana

External Environmental acquaintance with living body is executed by five

sense organs namely Netra Karna Nasa Jivha and Twaka All

Dnyanendriya that is sense organ are Panchmahabhautic combination

Despite this fact every Indrya sense organ perceives object Tanmatra of

that Mahabhuta only from which it is originated from Akash Mahabhuta and

hence perceives Shabd only that is audio perception Shrotrendriya is one

of the principal locations of Vata and its function is to perceive Shabda that

is sound waves This sensation is conveyed through Shabdavahi Dhamanis

to Mana and Atma through Pranavayu and the sequence is responsible for

perception of sound in this way external sound is perceived and interpreted

when Atma is linked with Mann Mann is linked with Indriyabuddhi that is

minute virtual Dnyanendriya located in brain Indriyabuddhi is linked with

Adhishthana with prominent Mahabhuta and lastly with Indriya

ArthShabdatanmatra that is sense object Once this sequence is completed

Page | 23

the meaning of a particular sound is interpreted and understood In this

entire process of perception and interpretation of sound waves Pranavayu

and Tarpaka Kapha located in Shira play extremely important role Hence

the healthy status of all the sense organ depends upon the normal

physiologically homeostatic condition of Pranavayu and Tarpaka Kapha

MANAS

ATAMA

BUDDHI

AHANKARA

ARTHA

Page | 24

EAR ANATOMY

bull Embryology of the Ear [57]

1 The sound conducting apparatus develops from the branchial apparatus

whereas the sound perceptive apparatus from the ectodermal otocyst

2 The pinna develops from the six hillocks around the 1st branchial cleft

3 External auditory canal develops from 1st branchial cleft

4 The outpouching of the 1st pharyngeal pouch gives rise to a proximal

narrow part that forms the eustachian tube and distal dilated part that

forms the middle ear cavity

5 Prussakrsquos space is a potential space lateral to the Shrapnellrsquos membrane

and medically by the neck of malleus that can be involved during the

extension of cholesteatoma

6 Development starts in the 3rd week of the intrauterine life and is

completed by 16th week of intrauterine life Membranous and boney

labyrinth develops from the otic capsule

The Ear is divided into

1 External Ear

2 Middle Ear

3 Internal Ear or the labyrinth

Page | 25

Fig 1 Ear Anatomy

EXTERNAL EAR [58]

The outside ear contains pinna and lobule

Pinna is the noticeable piece of outer ear made from single sheet of yellow

flexible ligament covered by subcutaneous tissue and skin It has two

surfaces average and parallel It is intently disciple to perichondrium on its

sidelong surface while it is somewhat free on average surface Pinna

incorporates tragus helix against helix fossa three-sided scaphoid fossa

incisura terminalis

External auditory Canal ndash It extends from the bottom of the conchea to

the tympanic membrane and measures about 24 mm along its posterior

wallit is S shaped

Parts 1 Cartilaginous part

2 Bony part

Page | 26

Cartilaginous part ndash The outer one third is cartilaginous consist of fibro

cartilage is directed first inward backward and upward It has Fissure of

Santorium The skin of this part of the canal contains hair follicles

sebaceous gland and cruminous gland

Bony part ndash The inner two third part is boney It goes forward downward

and medially skin lined in this part is very thin Isthmus is the narrowest

part of the canal lying medial to junction of bony and cartilaginous part

nearly 5 mm lateral to tympanic membrane

The roof and posterior wall of the external auditory canal shorter than floor

and anterior wall The skin lining the tympanic membrane and boney canal

has a self-cleansing property due to migration of keratin layer of epithelium

from drum towards the cartilaginous portion

Relations- Anteriorly- Temporomandibular joint and parotid gland

Superiorly- Middle cranial fossa

Inferiorly- parotid gland

Posterior- Mastoid antrum mastoid air cells and facial nerve

Nerve supply ndashSensory nerve supply of the external ear The auricle

supplied by fibers of the great auricular nerve (C2 and C3) and lesser

occipital nerve (C2) Auriculo temporal branch of the 5th cranial nerve and

auricle branch of the vagus (Arnoldrsquos nerve) supply external canal Facial

nerve has small sensory contribution on posterior-inferior wall

Tympanic Membrane -It is the partition between EAC and middle ear It

is a thin semitranslucent membrane pearly white in colored lying obliquely

in the medial end of EAC with the angle of 55 It is forming major part of

lateral wall of middle ear Annulus tympanicus is attached at its

circumference to the sulcus The TM is oval shape It measures

approximately 10 mm in vertical diameter and 90 mm in horizontal

diameter

Page | 27

Layers ndash Tympanic membrane consist of three layers

1 Outer Epithelium or cuticular layer which is continuous with skin of

external ear

2 Middle fibrous layer has both circular and radial fibers middle layer

missing in upper part

3 Inner layer- Inner mucosal layer which is continuous with middle ear

mucosa

Parts ndash Tympanic membrane consist of two parts

1 Pars tensa -It is largest part below the malleolar folds The inner

surface at the center attached to the handle of malleus Angle of cone

is most illuminated part in the pars tensa at anteroinferior part of pars

tensa

2 Pars flaccida Sharpnells membrane -it is triangular area above the

malleolar folds which are thin and devoid of fibrous tissue and

annulus It fits into notch of Rivinous

Nerve supply 1 Anterior half of lateral surface Auriculotemporal V3

2 Posterior half of lateral surface Auricular branch of vagus cn 10

3 Medial Surface Tympanic branch of CN 9 (Jacobsons nerve)

Fig 2 Tympanic membrane of ear

Page | 28

MIDDLE EAR [59]

The middle ear or tympanic cavity is an irregular laterally compressed

space within the temporal bone It is filled with air that is supplied to you

from the nasal part of the throat through the ear canal It contains a chain

of mobile bones that connect its side with the medial wall and serve to

transmit vibrations transmitted to the eardrum through the cavity to the

inner ear Including the parapet the vertical and anteroposterior diameters

of the cavity are each approximately 15 mm The transverse diameter

measures about 6mm at the top and 4mm at the bottom Compared to the

eardrum it is only about 2mm The eardrum is limited laterally by the

eardrum medially by the lateral wall of the inner ear It communicates

behind with the tympanic antrum and through it with the air cells of the

mastoid and in front with the auditory canal The middle ear together with

the Eustachian tube aditus antral and mastoid air cells is called the

middle ear cleft It is lined by mucus membrane and filled with air

It is divided into 3 parts

1 Mesotympanum (located in front of the pars tensa)

2 Epitympanum or attic (located above the pars tensa but medial to

Sharpnells membrane and the lateral bony wall of the attic)

3 Hypotympanum (located under pars tensa) The middle ear is like a

hexagonal box with a roof

Carotid or Anterior wall- It separates middle ear cavity from internal

carotid artery The various structure passing through anterior wall of

tympanic cavity

bull Canal of chorda tympani nerve

bull Canal of tensor tympani muscle

bull Eustachian tube

bull Anterior malleolar ligament

bull Anterior tympanic artery

Page | 29

Posterior or mastoid wall ndash The upper part of the back wall shows the

opening of the auditorium Below the auditory is a triangular bony

projection known as the pyramidalis processors The stapedial tendon is

transmitted through the apex of the pyramidalis processes The vertical

portion of the facial nerve descends along the posterior wall until it opens

into the stylomastoid foramen

Roof or Tegmental wall (Pars terminalis)- It is formed by a thin bone

plate called the tegman tympanum that separates the skull and tympanic

cavities It is located on the anterior surface of the rocky part of the

temporal bone near the junction with the temporal shell it extends back to

the roof in the tympanic membrane and anteriorly to cover the half canal

of the tensor tympanic muscle The lateral border corresponds to the

remains of the Petro scaly suture

Floor ndash It is formed by a thin plate of bone which separate middle ear from

the bulb of the internal jugular vein lodged in the jugular fossa

Lateral wall ndash It is formed by tympanic membrane and partly by a portion

of squamous part of the temporal bone It separates the middle ear from

external ear

Medial wall- It separates the middle ear from the inner ear

bull The promontory is the most prominent and convex part formed by the

basal rotation of the cochlea

bull The bony lateral semicircular canal is postero-superior to the promontory

above the oval window

bull The oval window is located between the middle ear and the vestibular

slope of the cochlea It is closed by the stirrup footrest and the annular

ligament

Page | 30

bull The round window is located under and behind the cape The round

window recess is directed to the rear It is closed by the secondary eardrum

and separates the middle ear of the Scala tympani from the cochlea

bull The facial nerve passes through the bony fallopian tube above the oval

window

Mastoid Antrum ndash It is a large space with air in the upper part of the

mastoid and communicates with the attic through the aditus The roof is

formed by the antri tegmen which extends and separates the tympani

tegmen from the middle cranial fossa The lateral wall of the antrum is

formed by a bony plate that is on average 15 cm thick in adults It is

marked externally on the surface of the mastoid by the suprameatal triangle

(MacEwen)

Aditus and Antrum- Aditus is a gap through which the attic communicates

with the antrum The boney prominence of the horizontal canal lies on its

medial aspect even as the fossa incudes to thats attaches the quick system

of incus lies laterally Facial nerve publications simply underneath the

aditus

The mastoid and its air cell system-

The mastoid consists of bone cortex with a honeycomb of air cell

underneath Depending on development of air cell three types of mastoids

have been described

1Well-pneumatized or cellular- Mastoid cells are well developed and

intervening septa are thin

2Diploetic- Mastoid consist of marrow spaces and a few air cells

3Sclerotic or acellular ndash There are no cells or marrow spaces

With any type of mastoid pneumatization antrum is always present In

sclerotic mastoids antrum is usually small and the sigmoid sinus is

anteposed

Page | 31

Depending on the location mastoid air cells are divided into

1 Zygomatic cells (In the root of zygoma)

2 Tegman cell (Extending into tegmen tympani)

3 Perisinus cells (overlying the sinus plate)

4 Retrofecial cells (round the facial nerve)

5 Peri labyrinthine cells (located above below and behind the

labyrinthine some of them pass through the arch of superior

semicircular canal These cells may communicate with the petrous

apex)

6 Peritubal (around the Eustachian tube Along with hypotymoanic

cells they also communicate with the petrous apex)

7 Tip cells (which are quite large and lie medial and lateral to the

digastric ridge in the tip of mastoid)

8 Marginal cells (Lying behind the sinus plate and may extend into

the occipital bone)

9 Squamosal cells (Lying in the squamous part of temporal bone)

Development of Mastoid ndash

The mastoid develops from the scaly petrous bone The petrosquamosal

suture may persist in the form of a bone plate - Korners septum which

separates the superficial squamosal cells from the deep rock cells Korners

septum is surgically important because it can cause problems locating the

antrum and deeper cells and thus lead to incomplete removal of the disease

during mastoidectomy The mastoid antrum can only be reached if Korners

septum is removed

Page | 32

Fig 3 Cross section of Mastoid

Contents of the middle ear

Ossicles ndash Three tiny bones which conduct the sound from eardrum to oval

window

Malleus ndash It is the largest and most lateral ossicle measuring 8 mm in

length It has head neck handle anterior and lateral processes The head

is situated in the epitympanum A lateral process project laterally from the

neck while the handle is firmly fixed to the pars tensa of the ear drum

Incus- It has a body short process and long process The body short

process and long process The body articulate with the head of mallelus in

the attic and the short process project into the attic The long process

projects downwards behind the handle of malleus running parallel to it and

articulate with the head of the stapes via the lenticular process

Stapes ndash It is the smallest ossicle measuring about 35 mm and consist of

head neck footplate and anterior and posterior curcura The footplate of

stapes is held to the oval window by the annular ligament

Page | 33

Muscles ndash

1Tensor tympani ndash It is inserted is a branch of the facial nerve which carries

the sense of taste It is first arch muscle supplied by branch of mandibular

nerve V3

2 Stapedious muscles ndash It is inserted to the neck of stapes It is the second

arch muscle supplied by branch of facial nerve that is nerve to stapedius

Fig 4 Contents of the middle ear

Blood supply of Middle Ear

bull Anterior tympanic branch of maxillary artery which supplies tympanic

membrane

bull Stylomastoid branch of posterior auricular artery which supplies middle

ear and mastoid air cells

Page | 34

Four minor vessels are

bull Petrosal branch of middle meningeal artery runs along greater petrosal

nerve

bull Superior tympanic branch of middle meningeal srtery traversing along

the canal for tensor tympanic muscle

bull Branch of artery of pterygoid carotid

bull Tympanic branch of internal carotid

Lymphatic Drainage of Ear

Lymphatics from the middle ear drain into retropharyngeal and parotid

nodes while those of the Surgical Importance ndash Eustachian tube drain into

retropharyngeal group

1 The middle ear is part of contiguous organs including nose nasopharynx

Eustachian tube and mastoid bone lined by respiratory mucosa Any

respiratory infection or allergy is likely to pass to middle is likely to pass to

middle ear

2 Moreover middle ear suppurative disease may spread to adjacent organs

and produce complication eg Labyrinthitis meningitis facial nerve palsy

etc

3 Lenticular process is vulnerable in suppurative ear diseases and causes

ocular disruption

4 Prussac space is the site of primary acquired cholesteatoma

Page | 35

INNER EAR [60]

Inner ear is divided into two parts

1 Bony Labyrinth

2 Membranous labyrinth

Anatomy of bony labyrinth

It is divided into two parts

1 Vestibule

2 Cochlea

3 Semicircular canal

The vestibule is located between the medial wall of the middle ear and the

lateral to internal acoustic meatus anterior to the semicircular canal and

posterior to the cochlea The vestibule is the central part of the inner ear

On its side is the oval window opening which is closed by the bracket foot

plate The bony cochlea is located in front of the vestibule It has 275 turns

wound around a bony axis called a modiolus The cochlea is about 30 mm

long The hollow center of the modiolus is a spiral canal that contains the

fibers and ganglion cells of the cochlear nerve A thin bony sheet the bony

lamina winda around the modiolus This divides the cochlear duct into two

galleries the Scala vestibuli above and the scala tympani below

There are three semicircular canals superior posterior and lateral They

are semicircular in shape and open into the vestibule One end of the

semicircle is enlarged and is known as the sphere

The membranous labyrinth is in the bony labyrinth It is connected to the

bony labyrinth by fibrous trabeculae and is surrounded by perilymph The

endolymph is located in the membranous labyrinth

Page | 36

The utricle is in the upper part of the vestibule while the saccule is found

below Both the utricle and saccule contain a single sensory patch called

the macula Each macula is covered with a neuroepithelium made up of

neuroepithelium made up of sensory hair cells and support cells these cells

are separated by a basement membrane Fibers of the vestibulo-cochlear

nerve enter the macula and pierce the basement membrane to terminate

at the base of the hair cell or cell bodies The utricle and the saccule with

their macula are called otolith organs Membrane semicircular canals are

the membrane canals of the corresponding bony semicircular canals They

open into the utricle through five openings One end of the opening of each

channel is dilated called the sphere in which the sensory organ of each

channel is located The cross section of the Scala standard looks like a right

angle The base is formed by the basilar membrane Sensory cells are

arranged on the surface of the basilar membrane These sensory cells with

their supporting cells form a complex neuroepithelium called the basilar

papilla or the cortical organ named after an Italian microscopist The

organs of the corti have a gelatinous membrane called the tectorial

membrane and they are supported by the pillar of the corti The cortical

pillars enclose a space called the corti tunnel which contains a fluid called

cortical lymph Vestibule is lies between the medial wall of the middle ear

and lateral to internal acoustic meatus anterior to semicircular canal and

posterior to the cochlea Vestibule is the central part of the internal ear On

its lateral surface is the opening of oval window which is closed by the foot

plate of stapes Boney cochlea lies in front of the vestibule It has 275 turns

coiling around boney axis called modiolus Cochlea is approximately 30 mm

in length The hollow center of the modiolus is a spiral canal containing the

fibers and ganglion cells of cochlear nerve A thin boney sheet the osseous

lamina winda around the modiolus This divides the cochlear canal into two

galleries the Scala vestibuli above and the scala tympani below

Page | 37

Semicircular canals are three in number superior posterior and lateral

They are semicircular in shape and opens into the vestibule One of the

ends of the semicircular is enlarged and is known as ampulla

Membranous labyrinth is situated within the boney labyrinth It is connected

to the bony labyrinth by fibrous trabeculae and is surrounded by perilymph

Endolymph is situated within the membranous labyrinth

The utricle lies in the upper part of the vestibule while the saccule lies below

Utricle and saccule both contain single sensory patch called macula Each

macula is covered by neuroepithelium consist of Neuroepithelium consists

of sensory hair cells and supporting cells these cells are separated by

basement membrane Fibers from the vestibulo cochlear nerve enter the

macula and pierce the basement membrane to end either at the base of the

hair cell or cell bodies The utricle and saccule with their macula are referred

to as otolith organs Membranous semicircular ducts are the membranous

ducts in the corresponding bony semicircular canals They open into the

utricle by five openings One end of the opening of each canal is dilated

called ampulla in which the sensory organ of each canal is located The

cross section of Scala media resembles a right angle Its base is formed by

basilar membrane Upon the surface of the basilar membrane the sensory

cells are arranged These sensory cells with their supporting cells form a

complex neuroepithelium called the basilar papilla or Organ of corti named

after an Italian Microscopist Organ of corti has a gelatinous membrane

called tectorial membrane and they are supported by pillar of corti The

pillars of corti enclose a space called tunnel of corti which contains fluid

called corti lymph

Page | 38

Fig 5 Inner Ear

Blood supply of labyrinth

Labyrinthine artery

Common cochlear Anterior vestibular Artery

Vestibulocochlear artery Main cochlear artery

Cochlear branch posterior vestibular artery

Page | 39

PHYSIOLOGY OF HEARING [61]

A sound signal in the environment is collected by the pinna passes through

external auditory canal and strikes the tympanic membrane Vibrations of

the tympanic membrane are transmitted to stapes footplate through a chain

of ossicles coupled to the tympanic membrane Movements of stapes foot

plate cause pressure changes in labyrinthine fluids which move the basilar

membrane This stimulates the hair cells of the Organ of corti It is these

hair cells which act as transducers and convert mechanical energy to

electrical impulses which travel along the auditory nerve

Thus the mechanism of hearing can be broadly divided into

bull Mechanical conduction of sound (conductive apparatus)

bull Transduction of mechanical energy to electrical impulses (sensory

system of cochlea)

bull Conduction of electrical impulses to brain (neural

Fig 6 PHYSIOLOGY OF HEARING

Page | 40

Conduction of sound

Under the surface of water we cannot hear the sound made in air because

9995 of sound energy are reflected away from the surface of water because

of the impedance offered by it A similar situation exists in the ear when

air-conducted sound must travel to cochlear fluids Nature has

compensated for this loss of sound energy by interposing the middle ear

which converts sound of greater amplitude but lesser force to that of lesser

amplitude and greater force This function of middle ear is called impedance

matching mechanism or the transformer action It is accompanied by

a) Lever action of the ossicles

Handle of malleus is 13 times longer than long process of incus providing

a mechanical advantage of 13

b) Hydraulic action of tympanic membrane

The area of tympanic membrane is much larger than the area of stapes foot

plate the average ratio between the two beings 211 As the effective

vibratory area of the tympanic membrane is only two- thirds the effective

areal ratio is reduced to 141 and this is the mechanical advantage

provided by the tympanic membrane

c) curved membrane effect

Movements of tympanic membrane are more at the periphery than at the

center where handle of malleus is attached This too provides some

leverage

Transduction of mechanical energy to electrical impulses

Movements of stapes footplate transmitted to cochlear fluids move the

basilar membrane setting up shearing force between the tectorial

membrane and hair cells The distraction of hair cells gives rise to cochlear

microphonics which triggers the nerve impulse

Page | 41

Neural pathways

Hair cells get innervation from bipolar cells of spiral ganglion Central axons

of these cells collect to form cochlear nerve which goes to ventral and dorsal

cochlear nuclei From there both crossed and uncrossed fibers travel to

superior olivary nucleus lateral lemniscus inferior colliculus and medial

geniculate body and finally reach the auditory cortex of the temporal lobe

Page | 42

DISEASES REVIEW

करणसराव

Nirukti - करणसय कणवयोाव ससराा [62]

Nidana- Acharya Sushruta and Vagbhata describe the common etiological

factors for the Karnaroga

अशयाय जलिीडा कणवकणडयन मरत

शमथययोगन शसततरसतय कवपतो अरय च कोपन ||

सउ २० १२

1 Avashaya or Pratishaya

(Excessive exposure to cold)

2 Jalakrida

(Excessive swimming)

3 Karnakandunyanum

(Excessive scracing due to itching)

4 Mithyayogena Shatrasya

(Improper instrumentation during wax removal or foreign body removal)

5Shabdasya

(Louder sound for long durationperverted contact of sound)

6 Abhighata (Trauma)

7 Vitiation of Tridoshas

Page | 43

Samanya Nidana according to different Samhita

Vishesh Nidan of Karnasrava

Acharya Charaka has not mentioned any kind of Nidana regarding Karnaroga

but has described Utapati of Karnaroga from Siroroga in Karnasirasym

Adhyaya[67]

शशरोअशिघातादरा तनमजजतो जल परपकादरा अवप विि

सरतत पय शरणॊ अतनलात स कणवससरा इतत परककतीत

सउ २० १०

असस ३७२५ [68]

1 Shiroabhighatat - Head Injury-Fracture of middle cranial fossa

2 Jala nimajjana - CSF otorrhoea fracture of middle cranial fossa

3 Karnaprapaka

4 Karna Vidhradhi -Puyasrava

Sr

no

Samanya Nidana SU AH[63] AS[64] YR[65] MN[66]

1 Avashaya + + +

2 Pratishaya + +

3 Shabdha

mithyayoga

+

4 Shashtra

mithyayoga

+ + +

5 Karnakandooyan + + + + +

6 Jalkrida + + + + +

7 Abhighata + + +

Page | 44

Samanya samprapti

परापय शरोतरशसरा कयावत शल शरोतशस गान

त कणवगता रोगा अटिावशततरीता

सउ २० १२

Due to common and specific etiology factors the vitiated Doshas gets

Sthanasamshraya in Karna and causes Karnasrava It is the stages of

Samprapti were Doshas gets lodged in Srotas and start processes of Dosh

Dushya Sammurchsna Due to Shiroabhighata Jalanimmajana Karna Paka

Karna Vidhradi vitiated Vata Dosha and Karna becomes Avruta by Vata and

results in Karnasrava Normal physiology of Dosha Dhatus and Malas entirely

depends on the normality of Srotas Dosh Dushya Sammurchana or

manifestation of diseases will not take place if only vitiation of Doshas take

place without deformity of Srotas Here in Karnasrava vitiation of Srotas are

Atipravritti Sanga and Vimargagamana take place Atipravritti is being excess

production of fungus Sanga is obstruction in external acoustic canal

Vimargagamana is the propagation of discharge through ear

Vishesh Samprapti

Karnasrava occurs due to Nij nidana is Pratishaya while Agantuja nidanas are

Avashya Jalkrida and Karnakanduyan Due to etiological factors which are

Vata-Kapha provocative in nature gradual vitiation of Doshas will occur After

vitiation they get accumulated (Sthan samshraya) in external auditory canal

In other hand when patient does Sevana of Agantuj Nidan like water enter in

external ear scratching of ear unsterile instrumentation leads to Dosh

Prakopa These cause Twak and Mamsa Dhatu Dushti which leads to

discontinuity of epithelium of ear canal which creates suitable atmosphere for

fungal pathogen to grow The vitiated Vata will produce symptoms such as

Page | 45

pain hearing impairment and vitiated Kapha causes symptoms like itching

discharge ear blockage By assessing the symptoms it can be said that Kapha

Avrita Vata Dosha is responsible for the manifestation of clinical features like

pain itching discharge Which are seen in Karnasrava that is otomycosis

Acharya Charaka has mentioned while explaining Samanya Chikitsa of

Karnaroga that it should be treated like Vrana when Paka and Srava is present

as a symptom Fungal spores invade in the epithelial layer of EAC In response

to infection inflammatory process is start This is a Paka Avastha After

removing the fungal mass ulceration in external acoustic canal is commonly

seen As a result of infection process exudates was produced which will mix

up- with fungal colonies and appear as discharge As per Dosha involvement

in Vrana Shoola Srava can be differ According to Acharya Sushruta Ruk is

the Samanya Lakshana of Vrana and Vishesha Lakshana of Vrana includes

pain discharge discoloration itching etc according to Dosha involvement

which are also seen in otomycosis In otomycosis mainly watery and purulent

type of discharge is present which indicates Paka avastha If there is Dosha

involve in Vrana is called Dushta Vrana Acharya Sushruta and Acharya

Vagabhata have mentioned verity of Srava in Twak and Mamsa Vranavastu

which is found in otomycosis Based on this description otomycosis can be

correlated with Karnasrava

Page | 46

Representing the Samprapti of Karnasrava

Vishesh Nidana ndash Shiroabhighatat

Jala nimajjana

Prapaka Vidhradhi

Vitited vata

Avarana by kapha

Vimargagamana of Vata

Karnasrava

Samprapti Ghataka

Dosha ndash Kapha and Vata

Dushya ndash Rasa Rakta and Mansa

Strotodushti ndash Vimargagamana and Sang

Adhishthana ndash Karna (Bhayakarna)

Rogmarga ndash Madhyama

Page | 47

Purvarupa

The Purvarupa of Karnasrava are not mentioned separately in any ayurvedic

classics In routine practice cretin Purvarupa are noted

1 Karnakandu

2 Karnagurutwa

3 Alpa karnashoola

4 Discomfort in ear

Rupa

1 Karnashoola

2 Karnakandu

3 Karnasrava

4 karnabadhirya

5 Cotton wool like or wet newspaper like grayish brown or black colored mass

is seen

6 External auditory canal skin appears edematous and red

Upashaya and Anupashaya

Appropriate application of Aushadhi Ahara and Vihara when produces relief in

the symptom is called as Upashaya and when aggravates the symptoms is

called Anaupashaya There is not any reference available in the classics about

the Upashaya and Anupashaya of karnasrava

Sadhyasadhyata

Sushruta has not mentioned specially the Sadhyasadhyata of Karnarogas But

Vagbhata has mentioned Karnasrava as a Sadhyavyadhi[69]

Sadhysadhyatagives the clear picture of prognosis of the disease It depends

on many factors like nature of disease severity of disease Vaya Prakriti Bala

of the patient etc

Page | 48

Upadrava of Karnasrava

In Samhita there is no reference available regarding the Upadrava of

Karnasrava

Samanya Chikitsa ndash

The common treatment principle for all Karnaroga is Ghritapana Use of

Rasayana Bhrahmacharya Avyayama Shirasnana and Atibhashaya

सामरय कणवरोगष घतपान रसयनम

अवयायमो शशराःसतनान बरमहचयवम कतपरनम

स उ२१३

Ghratapana - Ghrita is a Yogavahi and follow Sanskara in addition to these

acquired properties and capable of retaining its own properties So Ghritapana

is effective in Karnasrava

Rasayana - Rasayana represent the basic approach of Ayurveda which

comprise preventive promotive and curative aspect of health

Brahmacharyaapalana -It is like Sadvrittapalana and is equals to Rasayana

effect

Vyayama - It leads to vitiation if Vatas a Karna is a Sthana of vata and

exercise causes Kshayaj Samprapti hence it is important to avoid exercise in

Karnasrava

Shirasnana- In Shirasnana water enters in external acoustic canal it changes

the PH of meatus skin from acid to alkali which favors the growth of pathogens

Atibhashya - Excessive speaking causes Vata Prakopa and Vatapraokopa is

basic Samprapti for Karnasrava as the preventive aspect avoidance of

excessive speaking is necessary

Page | 49

Ghritapana Rasayana and Brahmacharyapalana should be followed for

preservation of dhatu Samyata and restriction of vitiation of Vata Vayayama

Shirasnana and Atibhashaya should be avoided in Karnasrava to protect the

Siras from the affliction of Vata and Kapha

Vishesha Chikitsa ndash

The general treatment principle of Karnasrava described in classics is closely

related to Dushtavrana Chikitsa

शशरोवरचन च ए िपन परण तरा

परमाजवन िान च ीकषय ीकषय़ाचारत [70]

स उ २१४०

कणवसततरा ोददत कयावत पततकशमकणवयो [71]

ाउ १८३५

उपददि च सततरोत साय परात वपचततवशि परमजय

य अगर मदन सघत गगलना ा िपतयतपा मिना परयत [72]

असउ २२४२४३

In addition to that Shirovirechana Karnadhoopana Karnapurana

karnapramarjana Karnadhavana are also indicated

Page | 50

Treatment is also mentioned for Karnasrava

1 Karnaprakshalana Yoga - with Aargawadadi Gana Kashaya and Surasadi

Gana Kashaya [73]

2 Avachurnana Yoga ndash with Aargawadadi Gana Churna and Surasadi Gana

Churna[74]

3 Karnapoorna Yoga ndash

bull Rasanjana Laksha with Sarjachoorna[75]

bull Panchkashaya with Kapittha swarasa and Madhu[76]

bull Jambu AmrapallavShivalaKshuodra Mahavriksha and Madhuki all are

taken in equal quantity and Kalka is prepared and 4 times Taila is taken

and 16 parts of Kwatha is added and Taila Paka is done[77]

bull Sarjatwak Choorna with Karpashiphalarasa and Madhu[78]

bull Abhaya LodraTindukaSamanga(Manjista) Kwatha of this Dravyas mixed

with Madhu and Kapittha Rasa[79]

bull Yogratnakara mention the following drugs for Karnapoorana-

a Samudraphena Churna[80]

b Jambwambpatra Yoga

4 Karnadhoopana Yoga ndash

bull Dhoopana with Churna of Bilvapatra Haridra Palandu[81]

bull Vartak Dhoopana [82]

5 Internal Medications-

bull Rasnadi Guggula [83]

bull Triphala Guggula [84]

bull Sarivadi Vati [85]

bull Gandhaka Rasayana [86]

Page | 51

According to Vagbhata-

Ear should be cleaned with the Pichu and Varti followed by Guggula Dhoopana

and then Karnapoorana with Madhu Followed by Avachurnanana with

Sukshmachootana of Surasadigana

Pathyaapathya ndash Pathya and Apathy mentioned for Samanya Karnaroga is

recommended in Karnasrava also

पथय[87]

सतदो वरको मन नसतय िमाः शशरावयिाः

गोिमाः शालयो मदगााः याशच परतन हवाः 80

लाो मयरो हररणानदसततततरो नकककिाः

पिोल शशगर ातावक सतनषराण कदठललकम

रसायनातन सवणण बरमहचयवमिाषणाम |

उपयकत यरादोषशमद कणावमय दहतम ||81||

िापर २१

Aharaja Upacharaja

bull Godhuma bull Vamana

bull Shala bull Virechana

bull Mudga bull Nasya

bull Yava bull Dhoomapana

bull Puranagitra bull Kavala

bull Lava Harina Tittiramamsa

Page | 52

अपथय[88]

दरत काटठ शशरसतनान वययाम शलटमल गर

कणडयन तषारशच कणवरोगी पररतपयजत

िापर २१

Viharaja

bull Patola ShigruVartaka bull Bhramacharaya

bull Sunishannaka bull Avyayama

bull Katthlika bull Aakthanam

bull All types of Rasayana bull Upacharaja

bull Vamana

Apathyas

bull Abhishyandakara Aharas

bull Shirasnana

bull Karna kandooyana

bull Tushara sevana

bull Guru Kaphakaraka Aaharas

bull Dantdhavana

Page | 53

OTOMYCOSIS

Definition-

Otomycosis is a superficial acute sub-acute or chronic infection of external

ear canal It is mostly unilateral It is characterized by inflammation purities

and scaling Otomycosis is a common condition encountered in ENT practice

more in chronic and persistent ear infection

The Fungal infections are not communicable in the usual sense but the

humans become an accidental host by their introduction into tissue trauma

The virulence factors favoring colonization of fungus in human host are yet to

be identified Ability of the fungus to grow at 37 C and elaboration of a variety

of enzymes and toxins are speculated to contribute to virulence Only 100 to

150 species are generally recognized as a cause of disease in humans[89]

Prevalence-

Otomycosis is a word wide in distribution and in various record stated that 5

to 20 of all cases of infective otitis externa Otomycosis prevalent is more in

warm and humid climates It is one of the commonest manifestations in India

during rainy season It occurs mostly in humid atmosphere otitis externa due

to fungal infection may resembles the desquamative form of diffuse infective

otitis externa The incidence in temperature climates has increased in

proportion to the use of topical antibiotics which have a medium sterilized of

other organism in which the fungus may flourish

Page | 54

Predisposing factors- [90]

1 Environmental factors such as climate contagious and polluting hygiene

more frequently during rainy season as the humidity increases

2 Individual susceptibility ndashGeneral Immunological status of the Individual

eg HIV infection Radiotherapy chemotherapy Diabetes mellitus

3 Self-inflicted trauma that is use of pins to clean the itching ear or use of ear

bud to clean the wax

4 Wide spread of topical antibiotics steroid preparations which have medium

sterilized of other organism in which the fungus may grow

5 Failure of defense mechanism in External auditory canal

6 During swimming or head bath water enters in External acoustic canal

causes quantitative and qualitative change in ear wax It causes change in pH

7 Long term use of hearing aids

Pathophysiology ndash

The life cycle of the average mold encountered in the ear may be reckoned

as two weeks and flare ups may be anticipated at such intervals Swimming is

held responsible for infection in many cases The sequence sequence of

pathogenic changes produced by molds in the external ear is as follows ndash

1 Implantation of the organism in external ear

2 Growth of organism follows the rate depending on condition of temperature

moisture or preexisting irritation

3 Invasion of epithelium occurs with attendant itching and discomfort which

may be quite severe

Page | 55

4 Exfoliation of epithelium occurs as nature attempts to overcome the

infection by casting off upper most cells

5 Denudation occurs from exfoliation as the top layers of epithelium are cast

off and the canal becomes filled with debris

6 Superficial ulceration and lizematoid dermatitis results if the pathologic

process goes for enough The changes do not always proceed through the

entire sequence sometimes the molds produce changes of the mildest

imaginable character which may be overlooked[91]

Clinical features -

Symptoms-

1 Irritation and itching ndash Irritation is mostly found when the infective

organism is aspergillus niger There is sensation of discomfort which is more

diffuse in the ear canal then localized in the deeper part Candida infection

causes marked itching In external ear it is intense and worse at night

2 Discharge through ear- Intermittent scanty colorless discharge through

ear Mucus being a fungal metabolic product appears as discharge Excessive

discharge is associated with mixed infection

3 Pain and discomfort ndash Mild to severe pain in the ear occasionally Mostly

seen in cases where ear is infected with Aspergillus flavus mixed infection

with gram negative organism or mixed infection with candida and aspergillus

Headache is sometimes associated with pain

4 Deafness- Varying degree of mild to moderate conductive deafness

5 A sensation of fullness in ear

6 Tinnitus 7 Vertigo

Page | 56

Signs ndash

1 The external acoustic meatus may contain a mass formed of epithelial

debris exudates cerumen and fungus

2 Erythematous external canal

Fungal appearance

A Niger - The color of the mass which is usually grey or black is mainly

determined by the type of fungus concerned Its appearance is like wet

newspaper or blotting paper or a cotton wool It has a peculiar musty odor In

this infection fruiting heads may be seen as black specks in the debris

Occasionally as inactive form occurs in which the canal is lined by mold giving

a fluffy appearance due to the presence of tiny mycelia

Candida ndash Candida infections generally show as white deposits on magenta

colored skin when the debris is removed it rapidly recovers in 24 hrs

The underlying canal skin is often inflamed and granular due to invasion by

fungal mycelia and be seen in all cases In rare cases excoriation and

ulceration with marked extensive shedding of the epithelium and deep

ulceration can be seen usually associated with a flavus and with pathogenic

bacteria[92]

Otoscope Appearance

1 Aspergillus Niger ndash Black headed

2 Aspergillus Fumigators ndash pale blue or green

3 Candida Albicans ndash White- or cream-colored deposits

Page | 57

4 Auricle is normal in most cases In severe cases small ulceration with crust

formation may be present on lateral surface

5 Tympanic Membrane

In most cases it is normal with normal mobility and normal hearing In a few

cases the surface of the tympanic membrane is congested and scaly There is

erosion or ulceration of the external epithelial layer and the membrane itself

may be edematous

Diagnosis

1 Above mentioned symptoms and signs

2 In the stage at which patient with otitis externa usually first present

themselves mycelia threads conidiophors not visible to naked eye may

sometimes be identified with the microscope

3 Confirmed by culture

Page | 58

Fig7 Aspergillus Niger Fig8 Candida Albicans

Fig9 Aspergillus Fumigators Fig 10 Wet Paper like appearance

Page | 59

Treatment

1 Antibiotic or steroid drops should be discontinued if they are being instilled

since long time

2 Removal of fungal mass epithelial debris and discharge from the external

canal or mastoid cavity repeatedly and thoroughly by forcepa or suction or

syringing or cautiously blow a stream of air into the canal through a fine

cannula and dry thoroughly by swabbing liquid petroleum on swab used in

cleaning the ear lessens the burning sensation when metacresy acetate is to

be employed in the subsequent treatment

Furuncle is developed as a complication if there is no gentleness in cleaning

Cleansing may have to be delayed until local sensitiveness is lessened which

can usually be accomplished within twenty-four hours If there is excessive

epithelial debris along with otomycosis then metacresyl acetate which is a

keratolytic in introduction into the external auditory canal on cotton wick and

is allowed to remain for twenty-four hours After twenty-four hours the cotton

wick is removed at which time the canal can usually be cleansed with little

discomfort as the medication is also anesthetic The epithelium of the canal

was white from contact with the drug The top layer was detached and this

epithelial debris can be easily wiped away The wick is reinserted and wet with

metacresyl acetate

The treatment is employed for three to four days in succession and then a

bland application is substituted Icthyol iodine is of value at this stage Iodine

ointment 2 in combination with Tannic acid 2 is also an excellent local

application following cresatin treatment

Next one of the fungicides may be applied

Page | 60

1 Nystin Effective for candida infection but less active against aspergillus

group Nystatin in boric powder consisting of 100000units of nystatingm of

powder 3 times week for 3 weeks

2 Clotrimazole Available as 11 cream or drops or lotions Phenyl

(zchlorophenyl) 1 ndash imidazole ndash methane is a chlorinated trityl imidazol 1

effective against candida and dermatophytes and for aspergilli infection

3 Amphotericin B Available as cream and as 3 solution and 015 drops

for topical application Very effective for candida infection can be fungistatic

or fungicidal

4 Econazole Available as solution (Econazole nitrate) and as cream (1)

Broad spectrum ndash more effective for Aspergillus Also active against some

gram-positive bacteria (Staphylococci and Streptococci and Dermatophytes)

5 Miconazole Highly effective against dermatophytes and candida infections

used as a 21 cream applied once or twice a day for 10 days

6 Gentian violet 21 Available as drops (recently some evidence of

carcinogenicity) Discolors the ear canal and this interfere with clinical

examination

Other topical antifungal agents are ketoconazole Natamycin Tolciclat Bifonas

zole Fenticonzole Oxiconazole Tioconazole ciclopiroxolomine Tolnafate

Haloprogin Flucytosine Acetic acid Whit field ointment selenium sulfide

undcyclenic acid triacetin etc

Page | 61

Minimal length of treatment

A month of drug treatment is usually required because the antifungal agents

used are not sporicidal and it is necessary that the period of treatment covers

germination time It may be advisable to give short gaps in the period of

treatment to ensure all spores have germinated before deciding to terminate

therapy

Prevention

Accomplished by strict attention to the predisposing causes

1 Water should be prevented from entering the ear

2 Avoidance of external ear trauma

3 Use of alcohol medicated or plain in the ears after swimming mercuric

cyanide (15000) in ethyl alcohol (70) is a satisfactory liquid to use

Ear stoppers do no good unless their use is followed by some antiseptic in the

canal Divers exposed to water for long periods of time may also use acidic

alcohol

4 During Summer months with their high humidity special efforts are needed

to maintain ear dry 5 Indiscriminate use of topical antibiotics steroid

preparations should be avoided

Page | 62

DRUG REVIEW

1 GUGGULA

Fig11 - Guggula

Historical review of Guggula [93]

bull Atharvaveda one of the well-known Vedas of Hindus The earliest

reference given by Atharvaveda medicinal and therapeutic properties of

Guggula Guggula has long history of use in Ayurveda

bull Acharya Charaka Sushruta and Vagbhata describe detail regarding the

actions uses and indication as well as the variety of Guggula

Page | 63

bull Various Nighantus (Medical lexicons) were written between 12th and 14th

centuries AD was based on the Ayurvedic literature also describes

Guggula

bull The explanation of word Guggula is that Gunjo Vyadhegurdti Rakshati

which means to relief against different diseases

bull Guggula is the best medicine because it develops through the rays of

hot sun on specific circumstances

bull Guggula has an aromatic odor

गगलो कणवदौगवररधय िपन शरटठमछयत[94]

स उ २२११२

Latin name- Commiphora mukul

Family ndash Burseraceae

Rasa- Tikta Katu

Guna ndash Laghu Rukshasukshma vishada sara

Veerya ndash Ushna

Vipaka ndash Katu

Action- Rasayana Lekhana

Doshaghanta - Tridoshhara

Page | 64

Chemical composition [95]

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Oleoresin-Z-Guggulsterone E-Guggulsterone

Gum- guggulignans 1 and 2 guggula Tetrols mukulol allylcembrol c

27

Guggulusterol 1 2 ans 3 Z and E ndash guggulusterol

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Parts Used ndash Gum oleoresin

Guggula purity test

1 Yellowish brown emulsion is obtained when Guggula is triturated with

water

2 An ethereal solution of the drug attains reddish colour when treated

with br2 vapors and purple colour when moistened with nitric acid

Biochemical action ndash Antiseptic Anti-inflammatory Disinfectant Diuretic

Immunostimulant stimulating expectorant Ant suppurative Antipyretic

Enhance phagocytosis

Karma- Rasayana cardiovascular disease

Page | 65

2 AGARU-

Fig 12 Agaru

Historical review of Agaru [96]

bull The word Agaru literally means the one which is the heaviest and no

aromatic wood is heavier than it Since thousands of years Agaru lsquoThe

wood of Godrsquo has been used for multiple purpose like commercial

medicinal spiritual aromatic historical

bull The medicinal use of Agaru have been recorded in many pieces of India

Greek Roman Chinese Middle eastern and European since ancient times

bull Acharya Charaka used Agaru and pest of Rasna to counteract the effect of

cold in Agraya Dravyas

bull Acharya Sushruta used Agaru as a Dhoopana Dravya along with Guggula

Ral and Shoma in the treatment of Karnasweda and Vrana

Page | 66

Types-

bull Dhanwantsri Nighantu describes Kaleyaka as a type of Agaru

bull Sodhala Nighantu describes three types of Agaru ndash Agaru Krishna

Agaru Kakatunda Agaru

bull Raj Nighantu describes five types of Agaru ndash Krishna Agaru Kasht

Agaru Daha Agaru Mangalya Agaru and Agurusaar

bull Arthashasstra describes three Agaru wood product

1 Jongaka ndash Black or variegated black in colour and having variegated

spots

2 Dongaka ndash Black in color

3 Parasamudraka- Black in colour and smells like Navamallika

अगर उटण कि तपछय ततकत ततकषण च वपततलम

लघ कणाविरोगघन शीत ात कफपरणत

िापर २१ [97]

Family- Thymelaccensis

Latin name- Aquilaria agallocha

Guna- Laghu Ruksha Tikshan

Rasa- Katu Tikta

Vipaka ndash Katu

Virya ndash Ushna

Karma- Sheetaprasasmana Vranaorasadan Tvachya Pittavardhaka

Shirovirechana Mangalya Sugandhik and Rochaka in properties [100]

Krishna Agaru karma- Katu Tikta rasa Ushna Sheeta when applied externally

and Pittahara when taken orally

Page | 67

Chemical Constituents -

Agaru hardwood is rich in essential oil resins alkaloids saponins Steroids

terpenoids tannins flavonoids and phenolic compound Agaru wood

predominantly contains 2-[-2-phenylethy]-4H-chromen-4-one derivatives and

sesquiterpenes Agaru oil contains selinene dihydroselinene agarnol b-

agarofuran vetispira-2(11)valerianol dihydrokaranone and tetradecanoic

acids[99]

Part Used ndash

Heartwood- Dark resinous wood which is formed when the plant becomes

infected with a type of fungus (ascomycetous mold) Species of Aspergillus

fusarium and penicillium are reported to be associated with the development

of infection Prior to infection the heartwood is odorless relatively light and

pale colored however as the infection progresses the tree produces a dark

aromatic resin in the heartwood The infected resin in response to the attack

which results in accumulation of a very dense dark resin in the heartwood

The infected resin embedded wood is known as Agarwood Infection is more

common on the trunk roots and the area when branches divide The formation

of Agarwood starts when the tree attains the age of 20 years On an average

approximately 30 ml oil is extracted from 100 kg of infected Agarwood[98]

Qualities of best Agaru-

It should be black in color

It should be extremely heavy and aromatic

It should be oily in appearance and test

It should be sink in water

It should burn easily with bright flame with a bright flame giving off a pleasant

smell

Page | 68

3 MADANA

Fig 13 MADANA

Madana consist of dried fruit of Xeromphis spinosa It is a deciduous thorny

shrub or a small tree reaching a high up to 9 m and girth about a meter

branches numerous thick and horizontal found in sub-Himalayan tracts[101]

मदनो मिरनदसततकतो ीयोटणो लखनो लघ

ानदरतिदवििीहर परततशयायवरणारतक

रि कटठकफ़ानाहशोथगलमवरणापह[102]

िा पर १६० १६1

Page | 69

Latin name-Randia dumetorum

Familly ndash Rubiaceae

Rasa - Madhura Tikta

Guna-Laghu Ruksha

Virya- Ushna

Vipaka ndash Katu

Karma- Vamana and Lekhana

Chemical Composition-

Essential Oil Valerianic acid Saponin tannin resin [103]

Page | 70

YAWA [104]

Fig 14 Yawa

1 In Samhitakala Aacharya Charaka Acharya Sushruta explain detail about

medicinal properties of Yawa

2The use of Yawa in Aaharya Dravya mainly described by Dhanwantari

Nighantu Raj Nighantu Bhavprakash Nighantu[105]

Macroscopic Description-

Fruit a caryopsis elliptical oblong Ovoid and tapering at both ends smooth

about 1cm long and 02- 03cm wide dorsally compressed and flattened on

the sides with a shallow longitudinal furrow 3-5 ridges having shallow

depression between them grains tightly enclosed and adhering the lemma

and palea pale greenish yellow odor not distinct taste sweetish acrid

Page | 71

Latin Name ndash Hordenum vulgare

Family- Poaceae

Rasa- Kashaya Madhura

Virya- Sita

Vipaka- Katu

Karma- Vatakrt Pittahara Kaphahara Medahara Balya Visrya

SthairyakaraLekhana

Page | 72

PROCEDURE REVIEW [105]

In Ayurvedic classics there are many references regarding Dhoopana Dravya

Dhoopana is administering Dhuma with the help of Dhoopana Dravya

In Kashyapa Samhita there are 40 types of Dhoopana advised for children

Anesthesia (Mohajananam Dhoopa) is also mentioned For this Dhoopana the

drug used were herbs hairs of animals legs horns old cloths of Buddhist

monks

From the references available regarding Dhoopana we can understand that

Karna can be protected from maggots (krimi) Bactria (Rakshogna) lice etc

References clearly indicate the analgesic and disinfectant effect of Dhoopana

Karma Dhoopana is mentioned for Dushta Vrana Chikitsa It reduces Vedana

Srava Pootigandha of Dushtavrana It also helps in Vranaropana

Dushtavrana Chikitsa is mentioned in the treatment of Karnasrava[106]

Origin of Dhoopana-

In ancient period children of sages were constantly harassed by the

Rakshasas Hence the sages approached lord Agni for shelter Agni in turn

gave them Dhoopana Dravya and asked sages to use the Dhoopana for

protection against Rakshasas bhutas pishachas

Classification of Dhoopana

1 It is classified into Dhupa Anudhupa Pratidhupa

2 On the basis of Origin it is classified into Jangama and Sthavara

Selection of Guggula for Dhoopana

Page | 73

bull Guggul is a best Vatahara

bull It is Krimighana

bull It contains Oleoresin

bull In Ashtang Hrudaya Guggula Dhoopana mentioned for Karnasrava

Selection of Agaru for Dhoopana

bull Agaru is Laghu Ruksha Katu Tikshna

bull Vranaorasadan Tvachya

bull It should burn easily with bright flame with a bright flame giving off a

pleasant smell

Karna Dhoopana Indication

1 Karnaarava

2 Putikarna

3 Krimikarna

4Vataj Karnashula

Contraindications

Especially for Karnadhoopan contraindication is not mentioned in classic texts

But Dhoopana is contraindicated in Pittaj vaydhi Sharad and Grishma Rutu

Page | 74

MATERIAL AND METHOD

Page | 75

For randomize comparative clinical trial to study the effect of Agaruwadi

Karnadhoopana and Guggula Karnadhoopana in Karnasrava following material

and method were required

Source of data

Patient irrespective of gender occupation religion social economic status

signs and symptoms of classical features of Karnasrava (Otomycosis) selected

from the OPD of Shalakyatantra department

Materials ndash

1Patients

2 Drugs-Agaruwadi Dhoopana

Guggula Dhoopana

3Torch

4Otoscope

5 Tuning fork

6Jobson horn probe

7Cotton

8Case record form

DRUG

Group A Trial Group

1Churana of Agaru Yawa Madan

2Ghrita

3Jala

Group B Control Group

1Googula Churna

Page | 76

Properties of Drug

Table no 1 Properties of Drug

Drug

Family

Rasa Veerya Vipaka Effect

on

Dosha

Guna Karma

Agaru

(Aquilegria

Agallocha)

Thymelaca

ceae

Katu

Tikta

Ushna Katu KV Laghu

Ruksha

Tikshna

Shitaprashamana

Shothahara

Vedanasthapak

Durghandhihara

Madan

(Randia

spinosa)

Rubiaceace

Kashaya

Madhur

Tikat

Katu

Ushna Katu KV Ruksha

Laghu

Vatakaphaghana

Shothahara

Vedanasthapak

Vranashodhak

Yawa

Poaceae

Hordeum

Vulgare

Kashaya

Madhur

Sheeta Madhur KP Ruksha

Laghu

Vataghana

Vernashodhana

Raktshodhaka

Guggula

Commiphora

Mukul

Burseracea

e

Tikta

Kashaya

Anushna Katu VPK Laghu

Ruksha

Shothahara

Vedanasthapaka

Kandughna

Ghrita Madhura Sheet Madhur VK Snigdha Vataghana

Shothahara

Vedanasthapaka

Page | 77

METHODOLOGY

SELECTION CRITERIA

1)INCLUSION CRITERIA

1 Patients having signs and symptoms of Karnasrava (Otomycosis) ie करणशल

( pain ) करणकणड ( Itching ) करणसतराव ( Discharge )बाधिरण ( conductive Loss of

hearing )

2 Patient from age group 19 to 70 years

3 Any Gender

2)EXCLUSION CRITERIA

1 Patients suffering from any systemic disease like DM TB HTN

2 Chronic suppurative otitis media (CSOM)

3 Acute supportive otitis media (ASOM)

3 Perforation of Tympanic membrane

4 Chronic otitis media

3)WITHDRAWAL CRITERIA

1If patient develops any adverse effect such as irritation pain burning

sensation in ear loss of hearing and such patients was withdrawn from trial

and receive prompt appropriate medical attention

2If patient shows aggravation in symptoms

3If patient refuses to continue with the treatment

Page | 78

STUDY SETTING

Types of study - Randomized Clinical comparative Trial

Place of work - OPD of Shalakyatantra

Duration of study - 18 months

Study Population - Patients of Karnasrava in Shalakyatantra OPD

SAMPLE SIZE CALCULATION

Sampling Method ndash Purposive sampling followed by random allocation in two

groups

Sample size calculation-

n = z2 p (1-p)

d2

Were

n = sample size

P = prevalence of disease=10

z = standard normal variable ie 196

d = error ie005

desired Sample Size would be

n = Z2 P(1-P)d2

= (196)2x (0021) x(0979)(005)2

= 34

Visiting ENT OPD (ShalakyaTantra) and IPD (ShalakyaTantra) 21 = 34

n raquo34

So one group includes 34patients

Page | 79

Sampling Method

Total 68 patient of Karnasrava are selected by Purposive sampling followed by

random allocation in two groups Written informed consent is taken prior to

commencement of trial They are divided in 2 groups

Group A (Trial Group) 34 patients treated with Agaruwadi Dhoopana for 7

days

Dose 5 minutes twice in a day

Group B (Control Group) 34 patients treated with Guggula Dhoopana for 7

days

Dose 5 minutes twice in a day

STUDY DESIGN ndash

Open labeled Randomized Comparative Clinical trial

STUDY DESIGN

Screening of patient

Inclusion criteria satisfied Exclusion criteria

Initial assessment Excluded

Counseling of patient Treated accordingly

Patient selection by Simple Random Sampling Method

Page | 80

68 Patients were divided in two groups lsquoArsquo and lsquoBrsquo

Trial group A-34 patients were given

Agaruwadi Dhoopana

Control group B- 34 patients were

given Guggul Dhoopana

Informed written consent

Treatment was given for 7 days

Assessment on 1st 4th and 7th day

Post assessments follow up on 15th day

Observation

Data Collection

Statistical analysis of data

Conclusion

Page | 81

(A) Agaruwadi Varti for group A (Trial group)

Table no 2

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

B) Guggula Varti for group B (Control group)

SOP of it is same as above Agaruwadi Varti

Table no 3

Drug Guggula Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

FOLLOW UP

For both groups follow ups were done on 1st 4th and 7th and post

assessment follow up15th day

EXAMINATIONS

Torch for Local examination of ear

Otoscope examination

Tuning fork Test

Page | 82

OBSERVATION TABLE

Table no 4

Sr no Subjective criteria Day 1 Day 4 Day 7 Day 15

1 करणशल

(pain)

2 करणकणड

(Itching)

3 करणसतराव (Discharge )

4 बाधिरण (Conductive Deafness)

OBSERVATIONS

a) करणशल (Pain) -

0 - Absent

1 ndash Present

b) करणकणड (Itching) -

0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

Page | 83

c) करणसतराव (Discharge)

0- Absent

1- Mild -Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाधिरण (conductive Loss of hearing)

0 - Absent

1- Present

Observations were carried out before and after completion of treatment and

during each follow up After observations the data collected and presented in

the form of graphs charts and table

Page | 84

TRIAL DRUG

Authentication and standardization of raw drug material done After

authentication and standardizing of raw drug material Agaruwadi Varti was

prepared by Varti as explained in Ayurvedic classics

Method of Varti preparations

Panchavidh Kashaya Kalpana that is five method of pharmaceutical

preparation constitutes the fundamental process of Ayurvedic pharmaceutics

which is well explained in Sushrut Samhita Varti Kalpana is one among them

which can be included in Kalka Kalpana

तीररसतरपतपतीनामपरककव तीत [106]

स डलहण शरच 151

Medicines are powered triturated and given the Varti shape that is like wick

of lamp so it is called as Varti Kalpana

Drug content Agaru Madan Yawa

Route of Administration Local

Dose Two times a day

Duration 7 days

Page | 85

Methodology

Standard operating procedure (SOP) of Agaruwadi Varti

Agaruwadi Varti is prepared according to the classical text

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization was done as recommended in pharmacy procedure The

raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 mixed together in

equal quantity to make Agaruwadi churn

Quantity of each churn is 4 grams all are mixed when the Varti get dry total

weight of Varti was 10gram

STEP 4 - Agaruwadi churn triturated with appropriate quantity of water or

Ghrita and prepared Varti in GMP Certified Ayurvedic pharmacy Standard

aseptic precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Varti was packed in sterile air packed container

STEP 6 - Agaruwadi Dhoopana was given with the help of Dhoopana yantra

Authentication and Standardization of raw drug of Agaruwadi Varti was done

Sterilization was done as recommended in pharmacy procedure Sterile

preparation packed in sterile container of suitable size Under all aseptic

precaution Karnadhoopana given to infected ear

Page | 86

Containers for packaging and their sterilization-

Sterilization of the containers for storing Varties was done by Ethylene Oxide

(Eto) method

Ethylene Oxide (Eto) procedure-

It includes exposure of materials to ethylene oxide gas under vacuum in a

sealed chamber It consists of four primary variables

1Gas Concentration

2Humidity

3Temperature

4 Time

EtO gas is an alkylating agent which disturbs the DNA of microorganism

preventing them from reproducing It penetrates the breathable packaging

and sterilizes all the accessible surface of the product to render products

sterility by alkylation of essentials proteins for cell reproduction

Most Eto sterilization methods involves three different stages These can be

separated into three different on the size or number of devices to treat

1Preconditioning stage-

First products are passed through a preconditioning phase to make

microorganism grow The batch load goes through a well time under a

controlled environment of temperature and humidity

2Sterilizer stage-

Performed using process phase specially designed to provide the required level

of EtO exposure to assure sterility for a device or family of devices

3Degasser Aerration stage-

Finally products need to go through a degassing phase to remove any residual

particles of Eto The batch load goes over well time under a temperature-

controlled environment

The sterile containers were then used to store Agaruwadi Varti and handed to

patients included in the study

Page | 87

Packing of Agaruwadi Varti

The ETO sterilize plastic container were used for packing of Agaruwadi Varti

Varti was filled into these sterilize containers (7 in each) In an aseptic

environment plugging and capping was done under aseptic precautions In this

way packing of Agaruwadi Varti done These Varti were given to patient and

advise to take two times a day under all hygienic precautions

History and Examination

bull Proper history and presenting complains was recorded on case record form

bull Ear examination with otoscope was done during initial assessment and each

follow up

bull Otoscopic examination was done during initial assessment and each follow

up

bull Systemic Examination that is Blood Pressure Temperature Respiration

rate Pulse was recorded on case record form

Page | 88

Raw material

Fig14 यव चरण Fig15 मदनफळ चरण

Fig16 अगर चरण Fig17 गगगळ चरण

Page | 89

Preparation of Agaruwadi Varti

Fig18 Preparation of Agaruwadi Varti

Fig19 अगरवादी वरती

Page | 90

Fig20 Instruments used for examination of Karnasrava

Fig19 Karnadhoopana Yantra

Page | 91

Karnadhoopana Procedure

Fig 22 Karnadhoopana Procedure

Page | 92

OBSERVATIONS AND RESULTS

Page | 93

BASED ON DRUGS

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 94

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

AUTHENTICATION CERTIFICATE

Page | 95

BASED ON STASTICIAL ANALYSIS OF DEMOGRAPHIC DATA

68 patients of Karnasrava ndash Otomycosis

Table no 5

No of Patients Total

Group A Group B

Registered 38 37 75

Completed 34 34 68

Discontinue 04 03 07

Total 68 patients were enrolled in study 38 patients registered in group A

amongst them 34 patients completed the treatment and04 patients

discontinued the treatment However in group B 37 patients completed the

treatment and 03 patients discontinued the treatment out of 37 registered

patients

Hence the total number of patients registered in the present study was 75

and out of which 68 patients were discontinued the treatment So they

dropped out from the study While 68 patients were successfully completed

the treatment So observations and result of 68 patients were given below

Here we are going to discuss the statistical analysis of the data obtained in

the form of master chart that was prepared in accordance with the data

collected from the patients that had been included in the study The purpose

of statistical analysis was to analyzed the relation between age gender

occupation diet addiction and education

Page | 96

1 Age wise distribution of patients

Table no 6

In trial group 10 (29412) patients were from age group 18-25 years 14

(41176) patients were from age group 25-35 years 8 (23529) patients

were from age group 35-45 years and 2 (58824) patients were from age

group 45-60 yearsIn control group 6 (17647) patients were from age group

18-25 years 14 (41176) patients were from age group 25-35 years 7

(20588) patients were from age group 35-45 years and 7 (20588)

patients were from age group 45-60 years

Fig 23 Age wise distribution of patients

0

2

4

6

8

10

12

14

15 -25 25-35 35-45 45-60

10

14

8

2

6

14

7 7

Age Distribution

Trial Group N Control Group N

Age Distribution

Trial Group Control Group

N N

18 -25 10 29412 6 17647

25-35 14 41176 14 41176

35-45 8 23529 7 20588

45-60 2 58824 7 20588

Total 34 100 34 100

Page | 97

1 Gender wise distribution of patients

Table no 7

Sex

Trial Group Control Group

N N

Female 23 67647 15 44118

Male 11 32353 19 55882

Total 34 100 34 100

In trial group 23 (67647) patients were female and 11 (32353) patients

were male

In Control group 15 (44118) patients were female and 19 (55882)

patients were male

Fig 24 Gender wise distribution of patients

0

5

10

15

20

25

N N

TRIAL GROUP CONTROL GROUP

23

15

11

19

Gender

Female Male

Page | 98

2 Education wise distribution of patients

Table no 8

Education

Trial Group Control Group

N N

Illiterate 4 11765 3 88235

SSC 4 11765 3 88235

HSC 8 23529 9 26471

Graduation 16 47059 10 29412

Primary 1 29412 3 88235

Post-Graduation 1 29412 6 17647

Total 34 100 34 100

In trial group 4 (11765) patients were illiterate 4 (11765) patients were

SSC educated 8 (23529) patients were HSC educated 16 (47059)

patients were graduated 1 (29412) patients were primary educated and

1(29412) patients were post graduated

In control grou 3 (88235) patients were illiterate 3 (88235) patients

were SSC educated 9 (26471) patients were HSC educated 10 (29412)

patients were graduated 3 (88235) patients were primary educated and

6 (17647) patients were post graduated

Page | 99

Fig 25 Education wise distribution of patients

0

2

4

6

8

10

12

14

16

ILLITERATE SSC HSC GRADUATION PRIMARY POST GRADUATION

4 4

8

16

1 1

3 3

910

3

6

Education

Trial Group N Control Group N

Page | 100

3 Occupation wise distribution of patients

Table no 9

Occupation

Trial Group Control Group

N N

Accountant 1 294 2 588

Housewife 11 3235 8 2353

Engineer 1 294 1 294

Job 1 294 4 1176

Labor 1 294 3 882

Mess 1 294 0 000

Naturotherapyst 1 294 0 000

Pharma 1 294 0 000

Shopkeeper 4 1176 2 588

Singer 1 294 0 000

Student 8 2353 4 1176

Tailor 1 294 1 294

Teacher 1 294 1 294

Worker 1 294 3 882

Farmer 0 000 1 294

Lab Tech 0 000 1 294

Page | 101

Daily Collection 0 000 1 294

Fruit seller 0 000 1 294

Bus Driver 0 000 1 294

Total 34 10000 34 10000

In trial group 11 (3235 ) were housewife 8(2353) were students

4(1176) were shopkeeper 1(294) was accountant 1(294) was

engineer 1(294) was doing job 1(294)was labour 1(294) was

catering 1(294) was Naturotherapyst 1(294) was Pharma 1(294)

was Singer 1(294) was Tailor 1(294) was Teacher and 1(294) was

worker

In Control group 8 (2353)were housewife 4(1176) were students

2(588) were shopkeeper 2(588) was accountant 1(294) was

engineer 4( 1176) was doing job 3(882)was labor 1(294) was

Farmer 1(294) was Lab tech 1(294) was Daily collection 1(294)

was Tailor 1(294) was Teacher and 3(882) was worker 1(294) was

Fruit seller and 1(294) Bus driver

Fig 26 Education wise distribution of patients

0

2

4

6

8

10

12

1

11

1 1 1 1 1 1

4

1

8

1 1 10 0 0 0 0

2

8

1

43

0 0 02

0

4

1 13

1 1 1 1 1

Occupation

Trial Group N Control Group N

Page | 102

4 Religion wise distribution of patients

Table no 10

Religion

Trial Group Control Group

N N

Hindu 31 9118 33 9706

Muslim 3 882 1 294

Total 34 10000 34 10000

In trial group 31 (9118) patients were Hindu and 3 (882) patients were

Muslim

In control group 33 (9706) patients were Hindu and 1 (294) patient

were Muslim

Fig 27 Religion wise distribution of patients

0

5

10

15

20

25

30

35

N N

TRIAL GROUP CONTROL GROUP

3133

31

Religion

Hindu Muslim

Page | 103

5 Diet wise distribution of patients

Table no 11

Diet

Trial Group Control Group

N N

Veg 14 4118 20 5882

Non-Veg 20 5882 14 4118

Total 34 10000 34 10000

In trial group 14 (4118) patients were vegetarian and 20 (5882)

patients were Non vegetarian

In control group 20 (5882) patients were vegetarian and 14 (4118)

patients were Non-Veg

Fig 28 Diet wise distribution of patients

0

5

10

15

20

N N

TRIAL GROUP CONTROL GROUP

14

2020

14

Diet

Veg Non Veg

Page | 104

6 Addiction wise distribution of patients

Table no 12

Addiction

Trial Group Control Group

N N

None 30 8824 27 7941

Alcohol 2 588 0 000

Tobacco 1 294 2 588

Mishri 0 000 1 294

Smoking 1 294 4 1176

Total 34 10000 34 10000

In trial group 30 (8824) patients have no addiction 2 (588) patients

have addiction of alcohol 1 (294) patients have addiction of Tobacco 0

(0) patients have addiction of Mishri and 1 (294) patients have addiction

of smoking

In control group 27 (7941) patients have no addiction 0 (0) patients

have addiction of alcohol 2 (588) patients have addiction of Tobacco 1

(294) patients have addiction of Mishri and 11 (1176) patients have

addiction of smoking

Page | 105

Fig 29 Addiction wise distribution of patients

0

5

10

15

20

25

30

NONE ALCOHOL TOBACCO MISHRI SMOKING

30

21

01

27

0

21

4

Addiction

Trial Group N Control Group N

Page | 106

Statistical Analysis and Results

Effect of study on Karnashoola-

Table no 13

Karnashoola

Group A Group B

BT AT BT AT

N N N N

Grade 2 0 000 0 000 0 000 0 000

Grade 1 30 10000 7 2333 32 10667 5 1667

Grade 0 4 1333 27 9000 2 667 29 9667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 30 Effect of study on Karnashoola

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

30

7

32

54

27

2

29

Karnashoola

Grade 2 Grade 1 Grade 0

Page | 107

Table no 14

Karnashoola Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 088 100 033 006

969 2829E-

08 7667 HS

AT 021 000 041 007

Group

B

BT 094 100 024 004

1037 7103E-

11 8438 HS

AT 015 000 036 007

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 31

000010020030040050060070080090100

BT AT BT AT

GROUP A GROUP B

088

021

094

015

Karnashoola

Mean

Page | 108

Table no 15

Karnashoola

Mean SD Effect

Group

A

Group

B Trial Control Trial Control

Day 1 088 094 033 024 000 000

Day 3 065 071 049 046 2667 2500

Day 5 024 038 043 049 7333 5938

Day 14 021 015 041 036 7667 8438

000

010

020

030

040

050

060

070

080

090

100

Day 1 Day 3 Day 5 Day 14

Karnashoola

Mean Group A Mean Group B

Page | 109

Table no 16

Karnashoola N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3250 110500

510000 275 Control group 34 3650 124100

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 110

Effect of study on Karnakandu

Table no 17

Karnakandu

Group A Group B

BT AT BT AT

N N N N

Grade 3 7 2333 0 000 4 1333 0 000

Grade 2 18 6000 0 000 18 6000 0 000

Grade 1 7 2333 7 2333 10 3333 15 5000

Grade 0 2 667 27 9000 2 667 19 6333

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 32 Effect of study on Karnakandu

0

5

10

15

20

25

30

N N N N

BT AT BT AT

GROUP A GROUP B

7

0

4

0

18

0

18

0

7 7

10

15

2

27

2

19

karnakandu

Grade 3 Grade 2 Grade 1 Grade 0

Page | 111

Table no 18

Karnakandu Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 188 200 081 015

1091 3119E-

10 8906 HS

AT 021 000 041 007

Group

B

BT 171 200 076 014

1032 4746E-

09 7414 HS

AT 044 000 050 009

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Page | 112

Fig 33

Table no 19

Karnakandu

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 188 171 081 076 000 000

Day 3 126 118 057 058 3281 3103

Day 5 071 074 046 051 6250 5690

Day 14 021 044 041 050 8906 7414

000

020

040

060

080

100

120

140

160

180

200

BT AT BT AT

GROUP A GROUP B

188

021

171

044

Karnakandu

Mean

Page | 113

Table no 20

Karnakandu N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 4051 137750

373500 006 Control group 34 2849 96850

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is less than

005 Hence we conclude that there is significant difference between Trial

Group and Control Group

000

020

040

060

080

100

120

140

160

180

200

Day 1 Day 3 Day 5 Day 14

Karnakandu

Mean Group A Mean Group B

Page | 114

Effect of study on Karnasrava

Table no 21

Karnasrava

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 11 3667 0 000 8 2667 0 000

Grade 1 23 7667 3 1000 26 8667 2 667

Grade 0 0 000 31 10333 0 000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 34

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

11

0

8

0

23

3

26

20

31

0

32

Karnasrava

Grade 3 Grade 2 Grade 1 Grade 0

Page | 115

Table no 22

Karnasrava Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 132 100 047 009

1122 4356E-

13 9333 HS

AT 009 000 029 005

Group

B

BT 124 100 043 008

1130 9364E-

14 9524 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 35

000

020

040

060

080

100

120

140

BT AT BT AT

GROUP A GROUP B

132

009

124

006

Karnasrava

Mean

Page | 116

Table no 23

Karnasrava

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 132 124 047 043 000 000

Day 3 100 100 025 025 2444 1905

Day 5 047 038 051 049 6444 6905

Day 14 009 006 029 024 9333 9524

000

020

040

060

080

100

120

140

Day 1 Day 3 Day 5 Day 14

Karnasrava

Mean Group A Mean Group B

Page | 117

Table no 24

Karnasrava N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3535 120200

549000 655 Control

group 34 3365 114400

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 118

Effect of study on Karnabadhirya

Table no 25

Karn

Badhirya

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 0 000 0 000 0 000 0 000

Grade 1 13 4333 0 000 16 5333 2 667

Grade 0 21 7000 34 11333 18 6000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 36

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 00 0 0 0

13

0

16

2

21

34

18

32

Karnabadhirya

Grade 3 Grade 2 Grade 1 Grade 0

Page | 119

Table no 26

Karn

Badhirya Mean Median SD SE

Wilcoxon

W P-Value

Effect Result

Group

A

BT 038 000 049 009

799 7173E-

05 10000 HS

AT 000 000 000 000

Group

B

BT 047 000 051 009

816 0000138 8750 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 38

000

005

010

015

020

025

030

035

040

045

050

BT AT BT AT

GROUP A GROUP B

038

000

047

006

Karnbadhirya

Mean

Page | 120

Table no 27

Karn

Badhirya

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 038 047 049 051 000 000

Day 3 009 006 029 024 7692 8750

Day 5 003 006 017 024 9231 8750

Day 14 000 006 000 024 10000 8750

000

005

010

015

020

025

030

035

040

045

050

Day 1 Day 3 Day 5 Day 14

Karn Badhirya

Mean Group A Mean Group B

Page | 121

Table no 28

Karn

Badhirya N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3400 115600

561000 806 Control

group 34 3500 119000

Total 68

Page | 122

COMPARISION BETWEEN GROUP A AND GROUP B

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Table no 29

Overall Effect

Trial Group Control Group

N N

Marked Improvement 21 6176 16 4706

Moderate Improvement 8 2353 13 3824

Mild Improvement 4 1176 5 1471

No Change 1 2941 0 0

TOTAL 34 100 34 100

Fig 39

0

5

10

15

20

25

MARKED IMPROVEMENT

MODERATE IMPROVEMENT

MILD IMPROVEMENT NO CHANGE

21

8

41

1613

5

0

Overall Effect

Trial Group N Control Group N

Page | 123

DISCUSSION

Page | 124

Discussion is nothing but the logical reasoning of observations In

every research work discussion part is very important because it brings into

light about the logical analysis which are helpful in filling the research gap in

the scientific world

The discussion is categorized into following ways for the ease of

understanding

1 Discussion on selection of topic

2 Discussion on review of literature

3 Discussion on drugs their mode of action on the disease mode of action

of Karnadhoopana

4 Discussion on observation and results

1 Discussion on selection of topic

Otomycosis is commonly encountered in day-to-day practice Majority

of Indian people affected with this pathology This disease commonly

manifests in developing countries low socio-economic standard and lack

of hygiene Now a days due to busy lifestyle people are not able to follow

the proper instruction of care of ear which may be responsible for the

recurrent nature of disease So for the management of this we use

Karnadhoopana with the help of Agaruwadi Varti Dhoopana is simple

easy cost-effective procedure which can be done even at OPD levelso

for the disease Karnasrava we selected Karna Dhoopana as therapeutic

procedure Karnadhoopana was done with Agaruwadi Varti and Guggula

Varti which was very effective for treatment

Page | 125

2 Discussion on review of literature

Karnasrava is one such disease among 28 Karnarogas mentioned by

Acharya Sushruta in the chapter named Karna Roga Vigyana Acharya

Charaka included Karnasrava as symptom under the four types of

Karnarogas due to vitiation of different doshas Acharya Vagbhata has

not described Karnasrava separately It is a fact that systemic

description of Karnarogas is available in all the ancients of pus from a

Vata afflicted ear may results from head injury or immersion in water

Karnasrava is a clinical entity which can be correlated with Otomycosis

Karnasrava is explained as symptom as well as a disease in Ayurveda

Nidana- Karnasrava occur due to Samanya Nidana and Vishesh Nidana

Vishesh Nidana like Shirobhighata Nimmajato jale Mithyayoga of Shashtra

The exact pathology behind Karnasrava is not understood clearly

Purvarupa ndash No specific Purvarupa are found for Karnasrava in classical

literature Acharya Madhukara describe Purvarupa as expression of

Rupa(lakshana) with less intensity that is less intensity itching sound in ear

may considered as Purvarupa of Lakshana

Samprapti- Aacharya Sushruta not explained the Samprapti of Karnasrava

separately and we must consider the general Samprapti of Karnaroga Due to

various aetiologias as cited above ear afflicted by Vata dosha causes Twak

Rakta Mamsa dushti results in Karnasrava According to Acharya Sushruta

Vata-Kapha dose is dominance in Karnasrava

Page | 126

Nidan

Nija Agantuja

Vata ndash kapha prakopak nidana Shirobhighata Nimmajato-jale

Mithya yoga of Shastra

Vata- kapha Prakopaka(Chaya prakopak) Vata-kapha prakopaka

( Achay prakopak)

Twak Rakta Mamsa dushti

Karnasrava

Page | 127

Chikitsa

The curative aspect and this must be done simultaneously giving due

importance to Nidan Parivarjana that is preventive measures So Nidan

Parivarjana that is avoidance of causative factors like Jalkrida Mithyayogen

shashtrasya Karnakandu Shirasnan Pratishaya is the first step in combating

the disease and form the part of line of treatment

Above Samprapti helps us to proceed towards the treatment of Karnasrava

The main protocol of treatment is removal of fungus and wound management

which include various measures to keep area day clean clear of microbes and

providing ideal condition for healing

Samany Chikitsa- Acharya Sushruta described general treatment for

Karnaroga as Snehapana (Drinking ghee) Rasayana (Rejuvenation therapy)

Bhramacharya Avoid excessive speaking Avoidance of physical exercise and

head bath

Vishesha Chikitsa ndash Acharya Sushruta mentioned some procedures in the

treatment of Karnasrava which is Shirovirechana Karnadhoopana

Karnapurana Karanpramarjana Dhavan Avachurnana Karnapurana Above

various procedures described in Ayurveda for management of fungus growth

in ear discharging ear fulfill these requirements of wound management

Page | 128

Discussion on observation and Result

Out of 68 patients 34 patients included for the trial The incidence of

Karnasrava is observed in trial and control groups

The statistical analysis provided the following data

AGE

Trial group- Maximum no of patients that is 14 (41176) patients were from

age group 25-35 years followed by 29412 patients were from age group

18-25 years 23529patients were from age group 35-45 years and

58824 patients were from age group 45-60 years

Control group - Maximum no of patients that is 14 (41176) patients were

from age group 25-35 years followed by 20588 patients were from age

group 35-45 years and 20588 patients were from age group 45-60 years

17647 patients were from age group 15-25 years

The maximum no of cases of Karnasrava found in age group between 25 to

35 years The reason behind this is repeated use of ear bud or emersed water

in ear More use of earphone or working more in cold environment

GENDER

Trial group ndash A higher prevalence seen in females 6764 and 3235 in

males

Control group - A higher prevalence seen in males 5588 and 4411 in

females

Females and males both are prone to disease

Page | 129

EDUCATION

Trial group-It is observed that amongst 34 patients maximum ie16

(47059) patients were graduated 8 (23529) patients were HSC

educated 4 (11765) patients were SSC educated 4 (11765) patients

were illiterate 1 (29412) patient were primary educated and 1(29412)

patient were post graduated

Control group- It is observed that 10 (29412) patients were graduated 9

(26471) patients were HSC educated 6 (17647) patients were post

graduated 3 (88235) patients were SSC educated 3 (88235) patients

were primary educated3 (88235) patients were illiterate

There is no direct relation between education and Otomycosis

RELIGION

Trial group- The incidence of patients of Hindu religion are 9118 and Muslim

religion are 882

Control group- The incidence of patients of Hindu religion are 9706 and

Muslim religion are 294

There is no probable explanation for this maximum number of patients in

Hindu religion it depends upon the patients attend the hospital and

community residing there

Page | 130

DIET

Trial group It was found that maximum ie5882 patients were taking

mixed diet while 4118 were taking vegetarian diet

Control group It was found that maximum ie5882 were taking

vegetarian diet while 4118 patients were taking mixed diet

The dietary habit of person is based on choice availability and religious

customs of the person

ADDICTION-

Trial group- It was found that maximum ie 30 (8824) patients have no

addiction 2 (588) patients have addiction of alcohol 1 (294) patients

have addiction of Tobacco 1 (294) patients have addiction of smoking and

0 (0) patients have addiction of Mishri

Control group - It was found that maximum ie 27 (7941) patients have

no addiction 4(1176) patients have addiction of smoking 2 (588)

patients have addiction of Tobacco 1 (294) patients have addiction of

Mishri and 0 (0) patients have addiction of alcohol

Very few patients were addicted to Alcohol Smoking Tobacco and Mishri

These factors can be taken as provoking factors for Otomycosis

Page | 131

Discussion based on probable Mode of action of Karnadhoopana

In Ayurveda classics Karna Dhoopana is therapeutic procedure explain for

Karnasrava Dhoopana is administration of Dhooma (Fumes) with the help of

Dhoopan Dravya References indicates that analgesic and disinfectant effect

of Dhoopana karma and mention for Dushta Vrana Chikitsa It reduces

Vedana Srava amp also does Vrana Ropana action

Various Dhoopanas and Dhoopan Dravas for different element in various

Samhitas of Ayurveda but there is a lacuna of availability of reference

regarding how to do it and method of procedure Matra Kala Contraindication

etc

Currently simple modified way of Karnadhoopana according to Yukti Praman

and experience but there is lac of standardization

Karnadhoopana is one among the topical Bahiparimajan type of treatment

Karna Parmarjana is procedure of cleaning ear with the help of cotton or gauze

piece soaked in honey

Page | 132

Dhoopan

The fumes coming out on burning Agaruwadi Varti

Administrated directly into external ear canal

Causes vasodilation

Due to this increase blood supply in external ear canal

It helps in absorption of drug

Fumes dries up Srava and bring the analgesic effect

Karnagata Kapha amp Avrut Vata Dosha Shaman

Decrease in signs and symptoms like karnasrava Karnshool Karnabadhirya amp

Karnandu

Page | 133

3 Discussion based on probable mode of action of Agaruwadi

Dhoopana

Agaru ndash

I Agaru is a fragrant tree aroma is a result of fungal pathogenesis when the

wood of tree is contaminated by fungi at wounds it develops scrap filled

with resin and turn out to be aroma Medicinal use of Agaru have been

recorded in ancient medicinal science in in inflammatory disease and some

infective disease

II Acharya Charaka has referred to Agaru as an Ushna dravya despite having

Tikta Rasa Ashtang Samgraha used Agaru as Dhupana Dravya along with

Madan and Yawa in Karnasrava Nighantu recommended is use as a

Dhoopana

III In various Samhitas and Nighantus Agaru described as Tikta Snighdha

Sheetaprashamana Vranaprasadana Tvachya Due to these properties

Agaru is used in the treatment of Karna-Akashi Roga and Dushta Vrana

Shodhaka

IV Agaru is reported to have Antimicrobial Analgesic Antioxidants

Antihistaminic and anxiolytic properties Its Antihistaminic property gives

relief from itching which is cardinal feature of Otomycosis Due to Katu

Ushna Tikta Guna improves blood circulation Bheda stage develop It is

Niram Awastha of Dosha Karnagata kapha and vata get decrease and

symptoms like karnashoolakarnasrava get decrease Agaru also have a

Antioxidant properties

V Chemically Agaru Contain 2-(2-Phenylethyl) Chromones Terpenoids

Flavonoids

VI Natural Agarwood had inhibitive activities towards Staphylococcus Aures

The chloroform extract of Agarwood prolongs the pain threshold[108]

Page | 134

Madan

I Madanphala have therapeutic properties like Anti-inflammatory

Antiallergic Analgesic and Wound healing

II It is Useful in treatment of disease like Shotha (inflammation) Vidradhi

(Abscess) Pratishaya (Common cold) Kushta(Skin disease)

III Extract of Madanphala mainly contain Glcosides Tritorpenct

Glycosides Saponin

IV Saponin glycosides are act as fire extinguisher This property is helpful

for vartiIt also act as a detergent which clean the surface of fungus

V Tritorpenct act as a anti-inflammatory antimicrobial and

immunomodulator compound Interaction of glycosides with sterol

causes disturbance of selective permeability in plasmic membraneso

exudates and discharge get decrease

VI Pharmacological activity [109]

Antibacterial Activity The preliminary antibacterial activity of Methanolic

extract of Randia D lam was done on some standard and wild pathogenic

strains The inhibition of the bacterial growth was more pronounced on E coli

as compared to the other tested organism This shows the antibacterial action

of Randia D secondary infection can prevent

Anti-Allergic Activity In Ayurveda Randia D Extract and its fraction of milk

induced leukocytosis and eosinophilia in mice

Anti-Inflammatory Activity The crude methanol extract of fruit of Randia D

effectively reduced the carrageenin induced oedema in hind paw of the rats

significant reduction in granular tissue formation was recorded This activity

seems to be significant at various acute phases of inflammation and om

formation of granular tissue This proves action of Madanaphala in shopa

(inflammation)

Page | 135

Analgesic Activity Analgesic activity was tested in mice weighing between 20-

250 with six number of animals in each group Methanlic extract of fruit Randia

d give analgesic activity in both models This proves its Shoolanashaka (pain

killer) action

Immunomodulatory Activity Randia D has immunostimulant activity and

chloroform fraction which strongly affected immune system seems to be

bioactive fraction of this plant

The overall effect of Agaru Mandanphala Yawa having Anti-inflammatory

Antiseptic Antimicrobial Property Active ingredient shows these properties

Agaru Yawa Madanphala

Vatakaphaghna

Act as

Vranashodhak

Vedanasthapaka

Sheetaprashamana

Shothara

Avarana of Vata get decrease so helps to Shaman of Vata dosha

Karnakandu Karnashoola Karnasrava

Prashamana

Page | 136

This fact can be taken into consideration and probably acknowledge that

Karnadhoopana with Agaruwadi Varti had not leave any residue in the ear

Removal of fibrin keratinocyte migration and in growth of epithelial tissue

plays a major role in healing It is technique of fumigation of ear with the

smoke of anti-infective drug In Karnadhoopana Sthanik Swedana increase the

blood supply and helps in absorption of the drug reduce Karnakandu amp

Karnshoola associated with infection

Page | 137

SUMMARY AND CONCLUSION

Page | 138

The dissertation entitled randomize comparative clinical trial to study the

effect of Agaruwadi Karnadhoopan and Guggula Karnadhoopan In Karnasrava

wsr to Otomycosis

The dissertation is divided into fallowing parts

Introduction

Review of literature

Ayurvedic review

Modern Review

Drug review

Procedure review

Material and Method

Observation and result

Discussion

Summary and conclusion

bull INTRODUCTION

It includes importance of Shalakyatantra in Sushrut Samhita Charka

Samhita And Ashtang Samgraha

Common and specific causes of Karnasrava

Karnasrava is a clinical entity which can be corelate with Otomycosis

In Ashtang Samgraha stated the procedure like Karnadhoopana with

Agaru Yawa Madanphala in Karnasrava

Page | 139

bull REVIEW OF LITERATURE

1 Ayurvedic review

2 Modern review

3 Drug review

Ayurvedic review-

It includes Rachana-Sharir and Kriya-Sharir of Karna detail description of

Karnaroga and its types Karnaroga Samanya hetu Poorvaroopa Rupa

Samprapti Upadrava Pathya-Apathya of Karnasrava Vishesh Nidan and

Chikitsa of Karnasrava Detail description of Karnadhoopana according to

various Acharays have been mentioned

Modern review-

It includes anatomy and physiology of Ear brief anatomy of ear anatomy of

External middle and Internal ear Detail description of the disease

Otomycosis mechanism of fungal infection in external canal pathophysiology

investigations diagnosis and management

Drug review-

Detail description of Agaru Yawa Madan Guggula and its synonyms

Ayurvedic properties Karma uses Pharmacological action and their

pharmacodynamic properties

Page | 140

MATERIAL AND METHOD

It includes description regarding materials required for the study Preparation

of Agaruwadi Varti its Standardization Sterilization and packaging

Plan of study

1 Total 68 patients completed the treatment Age criteria was kept

between 18-60 years Patient selection was done by done by simple

random sampling method and divided into two groups A (Trial) and

Group B (Control) 34 patients in each group

2 Patients in Group A were treated with Karnadhoopana with Agaruwadi

Varti for 7 days two times in a day while patients in Group B were treated

with Karnadhoopana with Guggula for 7 days two times in a day

3 Clinical examination done during each follow up ie 0th 4rd 7th and

observation were recorded

Page | 141

OBSERVATIONS AND RESULTS

Page | 142

1 It was observed that higher incidence of disease Karnasrava ie

Otomycosis found in age group 25-35 years

2 Disease otomycosis was equal in both male and female

3 The trial group there was significant relief in Karnakandu (8906)

Karnasrava(9333) Karnashoola(7667) and karnabadhirya(100)

4 In control group there was significant relief in Karnakandu (7414)

Karnasrava(9524) Karnashoola(8438) and

karnabadhirya(8750)

Page | 143

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Tatva-Sandipika hindi commentary Nidansthan Published by Chaukhamba

Page | 150

Sanskrit SansthanVaranasi Vatvydhinidansa Adhaya Shlok no183 page

no- 304

55 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Sharirsthan Published by

Chaukhamba Sanskrit SansthanVaranasi Sharirsankhyavaykaransharir

Adhaya Shlok no-532 page no61

56 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sutrasthan published by

Chaukhamba Orientalia Tristaisniya adhaya Shlok no 1120 page no-

163

57 P Hazarika Dr Nayaka R Balkrishnan Textbook of EarNoseThroat and

Head-Neck Surgery CBS Publication Anatomy of Ear

58 DrKB Bhargava DrSKBhargava DrTMShaha A short book of ENT

Diseases Published by Usha Publication 10th edition page no10

59 MrSalah Mansour MrJacques MagnanMr Hassan Haidar MrKaren

Nicolas MRStephan Louryan Comprehensive and clinical anatomy of the

Middle Ear Published by Springer publication Chapter -Middle Ear cavity

Page no 19 to 121

60 DrPLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition Diseases of external ear

Chapter no 7

61 James OPickles An introduction to Physiology of Hearing Published by

Emerald publication 4th edition page no- 1 to 265

62 Raja Radhakantadeva Shabdakalpadruma Naga PublicationsDelhi 3rd

edition -2006 Volume 2 Page no 42

63 VdBramhand Tripathi Ashtanghradaya Uttarsthan Published by

Chaukhamba prakashana 2005 Karnaroga vigyniyam adhaya Shlok

no1713 page no- 998

Page | 151

64 Acharya Trivedi Raguveer Prasad Ashtang sangrah uttartantra

published by Vaidyanath Ayurveda bhavan pvt Shlok no- 212 page no-

730

65 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya Shlok no

1-2 page no- 309

66 Shree Yadunandanopadhyaya Madhavnidan with madhukosh

teekapublished by Chaukhamba Prakashana

67 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary Sutrasthan published by

Chaukhamba Orientalia Kiyantshirasiya Adhaya Shlok no 1713 page no-

258

68 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya Shlok no-

6 page no- 310

69 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005 Karnarogavigyniym Shlok no- 1725-26 Page no-

1003

70 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2140 page

no 131

71 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005 Adhyay 18 shlok 35

72 Acharya Trivedi Raguveer Prasad Ashtang sangrah uttartantra

published by Vaidyanath Ayurveda bhavan pvt

Karnarogapratishedhoadhya Shlok no-2211 Page no- 735

73 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Page | 152

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2141 page

no 131

74 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2142 page

no 131

75 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2144 page

no 131

76 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 34 page no- 649

77 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2145page

no 131

78 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 37 page no- 649

79 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2146page

no

80 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya page no-

316

81 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-

Tatva-Sandipika hindi commentary Uttartantra Published by Chaukhamba

Page | 153

Sanskrit SansthanVaranasi Karnarogapratishedho Shlok no-2143page

no

82 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publication Krnarogadhikara adhaya page no-

318

83 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary

Madhyamkhand Vatkalpana shlok no- 782-83 page no- 137

84 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 72-77 page no- 651

85 Vd Shree Laxmipatishastri Yogratnakara with Vidyodini tika hindi

commentary Chaukhamba publicationKrnarogadhikara adhaya page no-

316

86 Vd Shree Laxmipatishastri Yogratnakara

87 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

Karnarogadhikara Shlok no- 808182 page no- 652

88 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

KarnarogadhikaraShlok no- 83 page no- 652

89 (PDF) Otomycosis A Comprehensive Review (researchgatenet)

90 httpswwwncbinlmnihgovpubmed24948980

91 A Simon Carney Scott-Browns Otorhinolaryngology Head and Neck

Surgery CRC press 8th publication Otitis externa and otomycosis

92 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition Diseases of external ear

Chapter no Page no -

93 wwwguggulipidcomtradhtm

Page | 154

94 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

95 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 1 chapter no-28 page no-

43

96 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009Agaru page

no726-728

97 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishra chapter Karpuradi varga Shlok no-31-

43 Page no- 116

98 httpswwwthiemeinimagecatlogsample_chapter_GOMPpdf

99 (PDF) Chemical Constituents and Pharmacological Activity of Agarwood

and Aquilaria Plants (researchgatenet)

100 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 4 chapter no-2 page no-4

101 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 chapter no-152 Madanpage

no376-379

102 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

103 The Ayurvedic Pharmacopeia of India Ministry of Health and family

welfare department of Ayush Part 1 Volume 1 chapter no-54 page no-

84

104 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009 page no697-699

patol-yawa

Page | 155

105 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi

commantry Purvakhand Mishr Chapter Karpuradi varga Shlok no-31-43

Page no- 117

106 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

Dhoompanvidhi page no- 252-254

107 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012Chikitasasthan Shlok

no- 151page no-406

108 httpswwwmdpicom1420-3049232342pdf

109 httpswwwijamcoinindexphpijamarticledownload0610201530

0

Page | 156

BIBILOGRAPHY

Page | 157

1 Shree Govindadasvirachita Pandit Shree Lalachandraji Vaidya

Bhaishajyaratnawai Banarasidas prakashana-8th edition

2 Scott-Brown WG Diseases of the EarNose and Throat Landon

Botterworth and co(publishers) Ltd1952 Volume 2

3 Vaidya Yadavaji Trikamji Acharya Sushrut Samhita of Sushruta with

Nibandhasangraha commentary of Shri DalhanacharyaPublished by-

Chaukhamba Sanskrit sansthanedition reprint 2012

4 Acharya Priyavat Sharma Dravyaguna Vijnaanavol 2

Chaukhamba Bharati Academyreprint 2009

5 Vaidy Purushottm Ganesh Nanal Sarth Bhavprakash Marathi commantry

Purvakhand and Madhyamkhand

6 Dr Bramhanand Tripathi Sharandhar Samhita containing Anjananida of

Maharshi Agnivesha an noted with Dipika Hindi commentary Uttarkhand

7 Kaviraj Ambikadatta shashtri Sushrut Smhita edited with Ayurveda-Tatva-

Sandipika hindi commentary Published by Chaukhamba Sanskrit

SansthanVaranasi

8 The Ayurvedic Pharmacopeia of India Ministry of Health and family welfare

department of Ayush Part 1 and part 4

9 Vd Bramhanand Tripathi Ashtangridhyam Uttartantra published by

Chaukhamba2005

10 Acharya Trivedi Raguveer Prasad Ashtang sangrah published by

Vaidyanath Ayurveda bhavan pvt

11 Dr PLDhingra and DrShruti Dhingra Diseases of Ear Nose Throat

published by ELSEVIER Publication 6th edition

12 Vd Harish chandra singh Kushwaha Charak Samhita edited with

Ayurved Dipikarsquos Ayusi Hindi Commentary published by Chaukhamba

Orientalia

Page | 158

ANNEXURE

Page | 159

ANNEXURE- 1

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

CASE RECORD FORM

RESEARCH PROFORMA FOR MS (AYU) DESSERTATION

DEPARTMENT OF SHALAKYATANTRA

NAME -

ADDRESS -

GENDER - AGE - OCCUPATION-

RELIGION - EDUCATION - MARITAL STATUS-

OPD IPD NO-

DATE OF ADMISSIONCOMMESEMENT-

DATE OF DISCHARGECOMPLITION-

DATE OF COUNSELLING-

TEL NO-

CHIEF COMPLAINTS-

PAST MEDICAL AND SURGICAL HISTORY-

TREATMENT HISTORY-

FAMILY HISTORY-

Page | 160

PERSONAL HISTORY-

a) Ahar(Diet)

b) Vihar

c) History of addiction

GENERAL EXAMINATION

PULSE - MIN BP - mm of hg

TEMP - 0F RR - MIN

ASHATAVIDHA PARIKSHANA

Nadi- Mutra- Mala-

Jivha- Shabda- Sparsha-

Drik- Aakruti-

SYSTEMIC EXAMINATION

RS ndash

CNS-

CVS ndash

Page | 161

LOCAL EXAMINATION (KARNA PARIKSHAN)

OBSERVATION TABLE FOR SUBJECTIVE CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching )

RIGHT EAR LEFT EAR

KARNASHASHUKULI

KARNAPUTRAK

KARNAPALI

KARNAKUHARA -

SRAVA

GANDH

VARNA

SWARUPA

KARNAPATALA (TM)

Page | 162

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

Hearing Test

1Renne Test ndash

2 Weber Test -

Examination of Ear-

Pathological Investigation-

Other Examination-

Nidan Panchak-

1Hetu-

2Purvarup-

3Rupa-

4Upashayanupashaya-

5Samprapti

Signature of Guide Signature of Doctor(Researcher)

Page | 163

ANNEXURE 12

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Dhoopana Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization were done as recommended in pharmacy procedure

The raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 were mixed together

in equal quantity to make Agaruwadi churn

STEP 4 - Agaruwadi churn were triturated with appropriate quantity of water

and prepared Varti in GMP Certified Ayurvedic pharmacy Standard aseptic

precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Dhoopana Varti was packed in sterile air packed

container

STEP 6 - Agaruwadi Dhoopan was given with the help of Dhoopan yantra

TREATMENT DETAIL-

Purvakarma -

1 The patient is asked to sit comfortably on chair having sufficient light and

less amount of dust

2 The EAC is cleaned thoroughly by Pichu Varti (cotton swab) to remove the

discharge and other debris

Pradhankarma -

1 The patient is asked to relax completely on the chair

Page | 164

2 Fumes are passed to the ear with Dhoopana Yantra

3 Dhoopana yantra is funnel shaped and its one end will keep the ear covered

for the passage of Dhooma into the ear canal and other end where Agaruwadi

Dhoopana Varti were placed which produces fumes

4 This Dhoopana was given for 5 min

Pashchat karma -

1 The patient were advised to avoid cold refrigerated food drinks cold water

bath cold wind fog and prevent water from entering the ear

(A) Agaruwadi Dhoopana Varti

B) Guggula Dhoopana Varti SOP of it is same as above Agaruwadi Dhoopana

Varti

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Page | 165

ANNEXURE 21

INFORMED CONSENT DOCUMENT

Study Title

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

Introduction

- You are invited to take part in a research study RANDOMSIED COMPARATIVE

CLINICAL TRIAL TO STUDY THE EFFECT OF AGARUWADI DHOOPANA AND

GUGGULA DHOOPANA IN KARNASRAVA

- Before you decide it is important for you to understand why the

research is being done and what it will involve

- Please take time to read the following information carefully and discuss

it with friends relatives and your doctor if you wish

- Ask us if there is anything that is not clear or if you would like more

information

Purpose amp Nature of Study

- In this research project by examine you and ldquoKarnasravardquo (Otomycosis)

disease were treated

- In the part of treatment Agaruwadi Dhoopana or Guggula Dhoopan were

given

- Dhoopana means medicated drug fumes were given in ear with the help of

Dhoopan Yantra

Page | 166

- Treatment was given for 7 days

Study Duration

7days

Participation

- Your participation is entirely voluntary

- If you do decide to take part you were given this information sheet to keep

and be asked to sign a informed consent form

- If you decide to take part you are still free to withdraw at any time and

without giving a reason This will not affect the standard of current or future

medical care you may receive

Confidentiality

- All information which is collected about you during the research were

kept strictly confidential

- Any information about you which is collected from the center will have

your identity in the form of a code number so that it will remain confidential

Benefits Of Study

- The results obtained from this study would be helpful for providing better

quality of treatment amp other essential facilities for Karnasrava (Discharge)

patients

- You will get clinical benefit from the study

Page | 167

Risks Of Study

- In this treatment there are few chances of Irritation of Ear Nose and

congestion at EAC if any of these happens then treatment were given

Results Of Study

- If the Results obtained are profitable then they may get published

without disclosing your details

Signature of patient

Date

Time

Phone no of Researcher

Page | 168

रण मादहती पतरक

सशोिनाच शीषवक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE

EFFECT OF AGARUWADI DHOOPANA AND GUGGULA DHOOPANA

IN KARNASRAVA

परसतताना

- आपणास या सशोिनातपमक अभयासात सहिागी होणय़ाच आाहन करणयात यत आह

- सशोिनातील सहिाग तननदशचत करणयापी सशोिनाच उददश समजन घया

- खालील मादहती काळजीपवक ाचा आणण आशयक ािलयास आपलया डॉकिराशी कका

दहतशरचतकाशी चचाव करा

- काही सददिता असलयास कका आणखी मादहती ही असलयास आमछयाशी चचाव करा

सशोिनाच उददीटि सतरप

- सदर सशोिन परकलपामरधय आपलयाला तपासणी करन कणवसरा या वयाशरिची शरचककतपसा दणयात

यणार आह

- सदर वयाशरिची शरचककतपसा महणन आपणास अगरादी िपन कका गगल िपन

दणयात यणार आह

- सदर औषि आपणास 7 ददस घयायाच आह

Page | 169

कालािी

- 7 ददस

सहिाग

- आपला सहिाग हा पणवपण ऎनदछिक आह

- आपला सहिाग तननदशचत असलयास आपणास ही मादहती पतरतरका दणयात यईल आपणास यातील

समती पतरकार सही कराी लागल

- सहिाग तननदशचत असनही आपण कोणतपयाही ळस कोणतही कारण न दता माघार घ शकता

याचा आपलया दयकीय सविर कोणताही पररणाम होणार नाही

गोपनीयता

- सशोिना दरमयान गोळा कलली आपलया वषयाची सव मादहती गोपनीय ठणयात यईल

- आपली यनदकतक मादहती साकततक सतरपात गोपनीय ठणयात यईल

सशोिनाच फ़ायद

- सशोिनाच तनटकषव कणवसरा बाशरित रणाछया दयकीय इतर सविाचा दजाव सिारणयास

फायदशीर ठरतील

सशोिनातील जोणखम

- य़ा शरचककतपसमरधय कान दखण डॊळय़ातन नाकातन पाणी य़ण नाकात जळजळण डोक जड

होण ही लिण ददस शकतात यापकी लिण तनमावण झालयास तपयाची शरचककतपसा कली जाईल

Page | 170

सशोिनाच तनटकषव

सशोिनाच तनटकषव फ़ायदशीर ठरलयास आपली मादहती गोपनीय ठन परकाशशत करणय़ात यईल

रण सतािरी-

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

Page | 171

ANNEXURE 31

INFORMED CONSENT FORM

Patient OPD no __________

Subjectrsquos Identifier

Date of Birth Age Gender

I _____________________________________ age___________ years

exercising my free power of choice hereby give my consent to be included

as a participant in the clinical study entitled

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

1 I confirm that I have read have been read and understood the information

sheet for the above study and can ask questions

2 I understand that my participation in the study is voluntary and that I am

free to withdraw at any time without giving any reason without affecting my

medical care or legal rights

3 I understand that the Ethics Committee members investigators and study

doctors will not need my permission to look at my health records both in

respect of the current study and any further research that may be conducted

in relation to it even if I withdraw from the trial I agree to his access

However I understand that my identity will not be revealed in information

released to third parties or published

4I agree not to restrict the use of any data or results that arisefrom this study

provided such a use only for scientific purpose

5 I agree to take part in the above study

Page | 172

signature with Date-

Left hand thumb impression

Name amp signature of the witness ndash

Name amp signature of the student ndash

Page | 173

ANNEXURE 32

समतीपतरक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

वयकतीच य

ददनाक जरमददनाक

1) मी ह तननदशचत कररत आह ककसदर सशोिन परकलपाबाबतची सपणव मदहती मी ाचली असनमला ती

समजली आहतपयाबददल मला परशन वचारणयाची पणव मिा आह सदर मादहतीन माझ समािान झाल

आह

2) मी सदर सशोिनातन माझया मजीनसार किीही बाहर पड शकतो या माझया अशरिकाराची मला कलपना

आह

3) माझी दयककय मादहती तपासणयाची कागदपतर कळ सशोिनाकररता ापरली जाणार आहत याची

मला मादहती आहसदर सशोिन परकलपातील सबशरित घिकाना माझी दयककय मादहती पाहणयाची मी

समती दत आहतरावप या सदिावतील माझी ओळख दशववणारी मादहती कोणासही ददली जाणार नाहीयाची

मला कलपना दणयात आली आह

4) सदर अभयासातन शमळणारी मादहती अरा तनटकषव कळ शासततरीय हतसाठी ापरल जाणयासाठी माझी

समती आह

5) रील अभयासात सहिागी होणयास माझी समती आह

रण सतािरी-

Page | 174

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

ASSESSMENT CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching)

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

a) कणवशल ( pain )- 0 - Absent

1 ndash Present

Page | 175

b) कणवकणड (Itching)- 0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

c) कणवसततरा ( Discharge )

0- Absent

1-Mild- Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाशरियव ( conductive Loss of hearing )

0 - Present

1 - Absent

Page | 176

Page | 177

Page | 178

Page | 179

Page | 180

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

Page | 181

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 182

AUTHENTIFICATION CERTIFICATE

Page | 11

3 There are several prayers mentioned for normal functioning of sense

organs (Yajurveda)

4 Structures and functions of Mastishka are described (Atharveda)

5 Mantras having reference to disease of Eye Ear Oral cavity etc are

found (Atharvaveda)

Upanishada Period ndash

1 Samhita Period

a) Sushrut Samhita ndash

bull Explanation regarding Netra Nasa and Shirorogas (Uttartantra 1-

26th chapter)

bull Details regarding Mukha and Karna Roga Nidan and

Chikitsa(Nidansthan 16th and Chikitsasthan 22nd chapter)

bull Description regarding Karna Chedana Sandhana Nasa

Ostasandhana Sutra Sthan 16th chapter

b) Charaka Samhita -

bull Explanation regarding Shirorogas (Sutrasthan 17th chapter)

bull Explanation of Gala rogas like Upajivika Galshundi and Rohini

bull Nasa Shiro Mukha Karna and Netra Chikitsa (Chikitsa sthan 26th

chapter)

bull Description regarding Lakshana and Chikitsa of Shankhaka

Ardhavbhedaka Shirovirechana and Shiro basti (siddhi sthan 9th

chapter)

c)Ashtnga Sangraha ndash

bull Detailed description regarding Shalakyatantara (Uttartantra 11-28

chapter)

bull Description of Kriyakalpa (Sutrasthan 32nd and 33rd)

Page | 12

d)Ashtang Hrudayam

bull Detailed description on Shalakya Tantra (Uttar tantra 8-24 chapters)

bull Kriyakalpas (Sutrasthan 23rd and 24th chapter)

e) Bhela Samhita

bull Chakshushya Vaisheshik and Buddhi Vaisheshik Alochaka pitta

f) Harita Samhita- Branch of Medical science offering elaborating

information about the procedure like Nasya Anjan Gandusha etc

comprehended with their applications in disease of Head Eyes Ears

Eyebrows Throat Temporal region and cervical spine is known as

Shalakyatantara

शशरोरोगा नतररोगा कणवरोगा वशषताः भरकरठशङकमरयास य रोगा समिनदरत दह १३

तषा परततकारकम व नसतयतपयवणजनातन च अभयङगमखगणडषकियााः शालकयसशमतााः १४

इतत शालाकयनाम [17]

Documentation of different ancient literature gives various references

regarding all aspects of Karnasrava in various periods It is very much

important to know the history of Karnasrava from Vedic Pauranic Samhita

and Samgraha period

Vedic period ndash The Vedas being the oldest source of knowledge have no

direct mentioning of Karnasrava

Page | 13

Samhita and Samgraha period ndash

Aacharya Sushruta described about Karnaroga Karnasrava Nidan

Roopa and Chikitsa The detail description is available in Sushrut

Samhita Uttartantra 20 and 21st chapters

Aacharya Charaka did not specify Karnasrava but mentioned 4 types

of Karnarogas that is Vataj Pittaj Kaphaja and Sannipataja and their

treatment in 26th chapter of Chikitsasthan

In Ashtang Hrudaya karnasrava is not explained as a separate disease

but Chikitsa is mentioned in 18th chapter of Astanga Hrudaya

uttartantra

In Ashtang Samgraha Chikitsa is mentioned in 22nd chapter of Astang

Samgraha Uttartantra

The details about Karnasrava are explained in Bhavprakasha

Madhyamakhanda 64th chapter

Madhavakara has explained about Karnasrava in 57th chapter of

Madhymakhanda

Karnasrava is also explained in Sharangadara Samhita Uttarkhand 11th

chapter

The reference for treatment of Karnasrava is available in

Yogaratnakara

In Gadhnigraha Karnasrava and its treatment is mentioned in

Karnarogadhikara Adhaya

Vangasena had mentioned about the disease and treatment in 69th

chapter

Chakradatta explained Karnasrava in 57th chapter

Dalhana has given commentary on Sushrut Samhita Uttartantra 20th

and 21st chapter

Sankhya Samprapti of Karnasrava ndash

Aachary Sushruta explains 28 Karnaroga in Uttaratantra Karnaroga

Vigyniyam Aadhaya Aacharya charaka explain 4 Karnaroga in

Page | 14

Karnarohvigyniyam Adhaya based on doshas Acharya Vagabhata in

Ashtang Hrudaya explain 25 Karnaroga in Adhyaya

कणवशल परणादशरच बाशरियव कषड ए च

कणवसरााः कणवकणडाः कणव चवसतततर च

कशमकणवपरततनाहौ विशरिदवविसततरा

कणवपाकाः पततकणवसततराशवशरचतवविम

कणावबवद सपतवि शोफशरचावप चतवविाः

ऎत कणवगता रोगा अटिावशततरीररतााः

स उ २०- ३ त ५[18]

ातकणवरोग वपततकणवरोग कफकणवरोग

रकतकणवरोग सनदरनपातकणवरोग कणवनाद

बशरिरतप परततनाह कणडाः शोफ पततकणवक

किशमकणवक उियरपविरधयअशो अबवद

कशरचकणवक वपपपली वदाररका पाळीशोष

ततिका पररपोिो उतपपातो उरमरर दाःखिवन

शलहाखयााः परचवशनदरतकणवरोगा उकतााः

इदिीका अ स उ २१ [19]

चतपाराः कणवरोगााः

च स [20]

Page | 15

KARNA

Karna ndash करोतत शबद गरहण [21]

The organ of hearing

Karnasrava- कणवसतय कणवयोाव ससराा [22]

Discharge from the ear is referred as Karnasrava

KARNA SHAREERA

bull Nirukti

कणयवत अकणयवत अनन इती [23]

It means reception and conduction of sound waves

These are the functions of external and middle ear

bull Nirukti of Sravanam

शरयत अनन इती शरणम[24]

It means perception of sound

It can be attributed to the internal ear function

bull Karna Utpatti-

Karna is an organ formed by Akash Mahabhuta[25]

The fundamental characteristic is as follows

Indriya ndash Srotram [26]

Indriya Adhisthan ndash Karna [27]

Indriya Dravy ndash Akasha [28]

Indriya Arth ndashShabdha [29]

Indriya buddhi ndash Srotobyddhi

Page | 16

bull Paryaya of Karna- Shabdapatha Srotrapatha Sravanam shruti

Kuhuram Dwanigraham etc

bull Definition of Karna-

कणवशटकलयनदछिरनमिटिोपगरदहत शरोतरमछयत [30]

मा तन ५७१

The definition of Karna is stated in Madhav Nidanam Indriya which is not

seen with naked eye along with Shashkuli is called Shrotra that is Karna

Indriya is so minute that it is not perceived with any sense organ

In Charak Samhita the word Karna explain as the Indriya Adhisthan of

Shabdha Karna is described as one of the Prathyangas of the body He

emphasizes that all Indriyas manifest during the 3rd month of gestation

period

Acharya Sushruta while describing formation of Purusha from Prakriti or

Avyakta narrated that all Indriyas are developing from the Vikarika and

Taijas Ahankara Both Vagabhata and Sushruta stated that Karna as one of

the Bahirsrotas

शरण नयन दन घराण गदमढराणण न सततरोताशसराणा बदहमवखातन [31]

स शा ५-१०

In Ashtang Hradaya Vagbhata has states that all Indriyas are Atmaja

According to him lower lobule elevated helix projected posterior portion

fleshy and adherent ear are indications of long span of life[32]

ततरखातखातन दह अनदसतमन शरोतर शबद ववकतता [33]

ा शा ३-३

शबदाः शबदनदरिय सवनदछििसमहो ववकतता [34]

स शा १-२६

Page | 17

Ear has the prominence of Akash Mahabhuta The prominent dosha of ear

is Vata It is important seat of Vata The prominent Dhatus are Asthi and

Mamsa Karna is one of the Panchgnanendriyas and it meant for hearing

Sushruta narrated that Karnasthita Asthi and Sandhi

घराणकणवगरीाकषिकोषष तरणातन [35]

सशा ५-२२

शरोतरशरगािकष शखाताव [36]

सशा ५-३२

गडकणवशखटककम [37]

स शा ५-२२

One Sandhi and one Tarunasthi in ear

Sandhi ndash Karna contain two Sandhi one in each ear Type of Sandhi is

Shankhavartha which is present in Shringataka

Mansapeshi ndash 2[38]

Siras ndash 10 [39]

Vataj Sira - 4

Pittaj sira - 2

Kaphaj sira - 2

Raktaj Sira - 2

Avedhya sira-

कणवयोदवश तासा शबदादहनीनामकका पररहरत

सशा ७-२५[40]

Amongst above mentioned ten Siras each Karna lodges one Shabdavaha

Sira It is Avedhya

Page | 18

Dhamani -2

Length of ear is 4 Angula

Karna moola ndash 2 Angula

कणाविरतर चतदवशअगलम

स शा ३५-१४[41]

The distance between two ears through the back of the neck is 14 Angula

bull Marmas of Karna-

1 Vidhuras-

कणवपटठतो अिाःसशरशरत विर ततर बशरियवम

सशा ६-३७[42]

कणतपयादद सतनायममवणी ककनदचचनदरनममनाकर कलयकररणणच

डलहणाचयव[43]

अिसततात कणवयोतनवमन विर शरततहाररणण

ा शा ४-२९[44]

Sankhya-2

Vistara- frac12 Angula

Type- Snayumarma (Susha)

- Dhamanimarma(AH)

- Vaikalykar

Sthana- It is situated in the depressed portion in the back of the ear

Injury to them causes loss of hearing

Page | 19

2 Shringataka marma-

नदजवहाकषिनाशसकाशरोतरखचतटियसरमम

तालरयासतयातन चतपारर सरोतसा तष ममवस

वदि शरगातकाखयष सददसततपयजतत जीवतम

मा तन ५७१ [45]

Sankhya- 4

Type- Siramarma

Sthana- It is in head that is amidst Siras (blood vessels) nursing sense

organ

A palm size area near Talu

Injury to this Marma causes death

In modern anatomy ear divides into Bhayakarna or External ear Mdhyakarn

or Middle ear Antahkarna or Internal ear This is extremely appropriate

Even though the ear is divided into three divisions in the point of modern

anatomy Ayurveda denotes ear organ is one Ayurveda treats disease by

way of assessing Dosha and Dushya Here Dushya is one that is Karnendria

Dosha difference will call for different treatment for different disease Hence

treating the vitiated Dosha will cure the disease irrespective whether it is in

external middle or internal ear The thought is based on different

fundamental principle from Ayurveda

bull Parts of Karna

In Ayurveda classics detailed description about anatomy of ear is not

available But the various parts are mentioned as follows

Bhayakarna- External ear

Mdhyakarna ndash Middle ear

Antahkarna- Internal ear

Page | 20

द कणवशटकशलक दॊ कणवपतरकौ

च शा 7-11[46]

कणवशटकशलक कणवगतातवकौ कणवपतरकौ त बाहयकणा

चिदतत च शा 7-11[47]

शटकली बाहयपालयाशरिटिानम

डलहन- स शरच 25-1 12[48]

Karna Shashkulika ndash It is also called as Karna Shashakuli Charaka has

mentioned this term while describing different Pratyngas of the body

Acharaya Gananatha sen has given the clarification for it as a pinna or

auricle[49]

Karnapali ndash It is popularly known as lobule of the ear Daivakrita Chidra is

present in it

Karnaputrika- Ayurvedic scholars accepted two terms in this cortex They

are Karnaputrika and Karnaputrika The former is considered as Tragus and

antitragus[50]

Karna Prushtha- It can be taken as the cranial surface of mastoid or

auricle[51]

Karnapeetha- Aacharaya Sushruta firstly mention the term Karnapeetha

It is mentioned first by Sushruta while describing the procedure of

Karnavyadana Vagbhata has mentioned that it is Adhobhaga of Karna

Dalhana has clarified that it is the region above the Karnaputrika that is the

region which is at the bottom of the concha

Karnamoola ndash It can be considered as parotid region[52]

Karna lathika ndashAcharaya Dalhana mentioned lobule as a Karna Lathika

Page | 21

Karnaavatu ndashThis term is used by Sushruta while describing the

measurements of different Angapratyangas where he has mentioned that

the distance between the Karnaavatu is 14 Angul Dalhana has comments

that it can be taken as the distance between two ears from behind[53]

Shabdhavahasrotas ndash It also called as Shabdapatha or Srotapatha The

whole passage through which the sound waves pass can be taken as

Shabdavahasrotas[54]

Shrotashringataka ndash It can be taken as the labyrinth of ear[55]

bull Dosha in context to Karna-

Karna is principal location of Vayu

1 Prana Vayu- Prana Vayu circulating in oral cavity is responsible for

Dehadhruka that is keeping all body parts active Indriyadruka that is

keeping all Dnyanendriya healthy by proper nourishment (Purana) helps in

deglutition of food material and convey the stimulation of Indriyabuddhi

and atma

2 Udana Vayu- Bala(strength) Varna speech singing are its function It

is responsible for facial expressions due to pleasure sorrow anger love

frustration etc in general its circulation and actions are just opposite to

Pranavayu

3 Vyana Vayu- Its principal functions are circulation of Rasa and Rakta

through body and various movements Its main location is Hrudaya Five

types of movements for which it is responsible are expansion contraction

upward downward and oblique other activities are opening closure of

eyelid yawning perspiration During circulation if it gets obstructed due

to Srotodushti it generates disease of that Srotas Vyana Vayu gets vitiated

by disease of Rasa Rakta Oja and Chetanadhatu

Page | 22

4 Samana Vayu- It is circulating in the vicinity of stomach and intestine

and helps in keeping the Jatharagni (digestive juices and enzymes) in

equilibrium Disturbance in Jatharagni precipitates disease

5 Tarpaka Kapha- Entire body functions movements are controlled and

executed by various centers in the brain Sensation perceived by sense

organs is conveyed to Mann and Aatma residing in Hrudaya The motor

signals from them are then conveyed to the functioning

organsKarmendriya through Prana Vayu Shira head is therefore a

location of continuous activities motions of Vata All these centers are in

unctuous Majjadhatu in the Shira For stabilizing this ever-active Vata and

to nourish the Majja dhatu very unctuous Tarpaka Kapha situated in Shira

plays an important role

bull Ayurvedic aspect of sound perception [56]

According to Ayurveda Pratyaksha Dnyan or Perception of any sensation

including Shabda occurs due to interaction of the Karnendriya and the

Indriya- Arth -Karma resulting in Sravana

External Environmental acquaintance with living body is executed by five

sense organs namely Netra Karna Nasa Jivha and Twaka All

Dnyanendriya that is sense organ are Panchmahabhautic combination

Despite this fact every Indrya sense organ perceives object Tanmatra of

that Mahabhuta only from which it is originated from Akash Mahabhuta and

hence perceives Shabd only that is audio perception Shrotrendriya is one

of the principal locations of Vata and its function is to perceive Shabda that

is sound waves This sensation is conveyed through Shabdavahi Dhamanis

to Mana and Atma through Pranavayu and the sequence is responsible for

perception of sound in this way external sound is perceived and interpreted

when Atma is linked with Mann Mann is linked with Indriyabuddhi that is

minute virtual Dnyanendriya located in brain Indriyabuddhi is linked with

Adhishthana with prominent Mahabhuta and lastly with Indriya

ArthShabdatanmatra that is sense object Once this sequence is completed

Page | 23

the meaning of a particular sound is interpreted and understood In this

entire process of perception and interpretation of sound waves Pranavayu

and Tarpaka Kapha located in Shira play extremely important role Hence

the healthy status of all the sense organ depends upon the normal

physiologically homeostatic condition of Pranavayu and Tarpaka Kapha

MANAS

ATAMA

BUDDHI

AHANKARA

ARTHA

Page | 24

EAR ANATOMY

bull Embryology of the Ear [57]

1 The sound conducting apparatus develops from the branchial apparatus

whereas the sound perceptive apparatus from the ectodermal otocyst

2 The pinna develops from the six hillocks around the 1st branchial cleft

3 External auditory canal develops from 1st branchial cleft

4 The outpouching of the 1st pharyngeal pouch gives rise to a proximal

narrow part that forms the eustachian tube and distal dilated part that

forms the middle ear cavity

5 Prussakrsquos space is a potential space lateral to the Shrapnellrsquos membrane

and medically by the neck of malleus that can be involved during the

extension of cholesteatoma

6 Development starts in the 3rd week of the intrauterine life and is

completed by 16th week of intrauterine life Membranous and boney

labyrinth develops from the otic capsule

The Ear is divided into

1 External Ear

2 Middle Ear

3 Internal Ear or the labyrinth

Page | 25

Fig 1 Ear Anatomy

EXTERNAL EAR [58]

The outside ear contains pinna and lobule

Pinna is the noticeable piece of outer ear made from single sheet of yellow

flexible ligament covered by subcutaneous tissue and skin It has two

surfaces average and parallel It is intently disciple to perichondrium on its

sidelong surface while it is somewhat free on average surface Pinna

incorporates tragus helix against helix fossa three-sided scaphoid fossa

incisura terminalis

External auditory Canal ndash It extends from the bottom of the conchea to

the tympanic membrane and measures about 24 mm along its posterior

wallit is S shaped

Parts 1 Cartilaginous part

2 Bony part

Page | 26

Cartilaginous part ndash The outer one third is cartilaginous consist of fibro

cartilage is directed first inward backward and upward It has Fissure of

Santorium The skin of this part of the canal contains hair follicles

sebaceous gland and cruminous gland

Bony part ndash The inner two third part is boney It goes forward downward

and medially skin lined in this part is very thin Isthmus is the narrowest

part of the canal lying medial to junction of bony and cartilaginous part

nearly 5 mm lateral to tympanic membrane

The roof and posterior wall of the external auditory canal shorter than floor

and anterior wall The skin lining the tympanic membrane and boney canal

has a self-cleansing property due to migration of keratin layer of epithelium

from drum towards the cartilaginous portion

Relations- Anteriorly- Temporomandibular joint and parotid gland

Superiorly- Middle cranial fossa

Inferiorly- parotid gland

Posterior- Mastoid antrum mastoid air cells and facial nerve

Nerve supply ndashSensory nerve supply of the external ear The auricle

supplied by fibers of the great auricular nerve (C2 and C3) and lesser

occipital nerve (C2) Auriculo temporal branch of the 5th cranial nerve and

auricle branch of the vagus (Arnoldrsquos nerve) supply external canal Facial

nerve has small sensory contribution on posterior-inferior wall

Tympanic Membrane -It is the partition between EAC and middle ear It

is a thin semitranslucent membrane pearly white in colored lying obliquely

in the medial end of EAC with the angle of 55 It is forming major part of

lateral wall of middle ear Annulus tympanicus is attached at its

circumference to the sulcus The TM is oval shape It measures

approximately 10 mm in vertical diameter and 90 mm in horizontal

diameter

Page | 27

Layers ndash Tympanic membrane consist of three layers

1 Outer Epithelium or cuticular layer which is continuous with skin of

external ear

2 Middle fibrous layer has both circular and radial fibers middle layer

missing in upper part

3 Inner layer- Inner mucosal layer which is continuous with middle ear

mucosa

Parts ndash Tympanic membrane consist of two parts

1 Pars tensa -It is largest part below the malleolar folds The inner

surface at the center attached to the handle of malleus Angle of cone

is most illuminated part in the pars tensa at anteroinferior part of pars

tensa

2 Pars flaccida Sharpnells membrane -it is triangular area above the

malleolar folds which are thin and devoid of fibrous tissue and

annulus It fits into notch of Rivinous

Nerve supply 1 Anterior half of lateral surface Auriculotemporal V3

2 Posterior half of lateral surface Auricular branch of vagus cn 10

3 Medial Surface Tympanic branch of CN 9 (Jacobsons nerve)

Fig 2 Tympanic membrane of ear

Page | 28

MIDDLE EAR [59]

The middle ear or tympanic cavity is an irregular laterally compressed

space within the temporal bone It is filled with air that is supplied to you

from the nasal part of the throat through the ear canal It contains a chain

of mobile bones that connect its side with the medial wall and serve to

transmit vibrations transmitted to the eardrum through the cavity to the

inner ear Including the parapet the vertical and anteroposterior diameters

of the cavity are each approximately 15 mm The transverse diameter

measures about 6mm at the top and 4mm at the bottom Compared to the

eardrum it is only about 2mm The eardrum is limited laterally by the

eardrum medially by the lateral wall of the inner ear It communicates

behind with the tympanic antrum and through it with the air cells of the

mastoid and in front with the auditory canal The middle ear together with

the Eustachian tube aditus antral and mastoid air cells is called the

middle ear cleft It is lined by mucus membrane and filled with air

It is divided into 3 parts

1 Mesotympanum (located in front of the pars tensa)

2 Epitympanum or attic (located above the pars tensa but medial to

Sharpnells membrane and the lateral bony wall of the attic)

3 Hypotympanum (located under pars tensa) The middle ear is like a

hexagonal box with a roof

Carotid or Anterior wall- It separates middle ear cavity from internal

carotid artery The various structure passing through anterior wall of

tympanic cavity

bull Canal of chorda tympani nerve

bull Canal of tensor tympani muscle

bull Eustachian tube

bull Anterior malleolar ligament

bull Anterior tympanic artery

Page | 29

Posterior or mastoid wall ndash The upper part of the back wall shows the

opening of the auditorium Below the auditory is a triangular bony

projection known as the pyramidalis processors The stapedial tendon is

transmitted through the apex of the pyramidalis processes The vertical

portion of the facial nerve descends along the posterior wall until it opens

into the stylomastoid foramen

Roof or Tegmental wall (Pars terminalis)- It is formed by a thin bone

plate called the tegman tympanum that separates the skull and tympanic

cavities It is located on the anterior surface of the rocky part of the

temporal bone near the junction with the temporal shell it extends back to

the roof in the tympanic membrane and anteriorly to cover the half canal

of the tensor tympanic muscle The lateral border corresponds to the

remains of the Petro scaly suture

Floor ndash It is formed by a thin plate of bone which separate middle ear from

the bulb of the internal jugular vein lodged in the jugular fossa

Lateral wall ndash It is formed by tympanic membrane and partly by a portion

of squamous part of the temporal bone It separates the middle ear from

external ear

Medial wall- It separates the middle ear from the inner ear

bull The promontory is the most prominent and convex part formed by the

basal rotation of the cochlea

bull The bony lateral semicircular canal is postero-superior to the promontory

above the oval window

bull The oval window is located between the middle ear and the vestibular

slope of the cochlea It is closed by the stirrup footrest and the annular

ligament

Page | 30

bull The round window is located under and behind the cape The round

window recess is directed to the rear It is closed by the secondary eardrum

and separates the middle ear of the Scala tympani from the cochlea

bull The facial nerve passes through the bony fallopian tube above the oval

window

Mastoid Antrum ndash It is a large space with air in the upper part of the

mastoid and communicates with the attic through the aditus The roof is

formed by the antri tegmen which extends and separates the tympani

tegmen from the middle cranial fossa The lateral wall of the antrum is

formed by a bony plate that is on average 15 cm thick in adults It is

marked externally on the surface of the mastoid by the suprameatal triangle

(MacEwen)

Aditus and Antrum- Aditus is a gap through which the attic communicates

with the antrum The boney prominence of the horizontal canal lies on its

medial aspect even as the fossa incudes to thats attaches the quick system

of incus lies laterally Facial nerve publications simply underneath the

aditus

The mastoid and its air cell system-

The mastoid consists of bone cortex with a honeycomb of air cell

underneath Depending on development of air cell three types of mastoids

have been described

1Well-pneumatized or cellular- Mastoid cells are well developed and

intervening septa are thin

2Diploetic- Mastoid consist of marrow spaces and a few air cells

3Sclerotic or acellular ndash There are no cells or marrow spaces

With any type of mastoid pneumatization antrum is always present In

sclerotic mastoids antrum is usually small and the sigmoid sinus is

anteposed

Page | 31

Depending on the location mastoid air cells are divided into

1 Zygomatic cells (In the root of zygoma)

2 Tegman cell (Extending into tegmen tympani)

3 Perisinus cells (overlying the sinus plate)

4 Retrofecial cells (round the facial nerve)

5 Peri labyrinthine cells (located above below and behind the

labyrinthine some of them pass through the arch of superior

semicircular canal These cells may communicate with the petrous

apex)

6 Peritubal (around the Eustachian tube Along with hypotymoanic

cells they also communicate with the petrous apex)

7 Tip cells (which are quite large and lie medial and lateral to the

digastric ridge in the tip of mastoid)

8 Marginal cells (Lying behind the sinus plate and may extend into

the occipital bone)

9 Squamosal cells (Lying in the squamous part of temporal bone)

Development of Mastoid ndash

The mastoid develops from the scaly petrous bone The petrosquamosal

suture may persist in the form of a bone plate - Korners septum which

separates the superficial squamosal cells from the deep rock cells Korners

septum is surgically important because it can cause problems locating the

antrum and deeper cells and thus lead to incomplete removal of the disease

during mastoidectomy The mastoid antrum can only be reached if Korners

septum is removed

Page | 32

Fig 3 Cross section of Mastoid

Contents of the middle ear

Ossicles ndash Three tiny bones which conduct the sound from eardrum to oval

window

Malleus ndash It is the largest and most lateral ossicle measuring 8 mm in

length It has head neck handle anterior and lateral processes The head

is situated in the epitympanum A lateral process project laterally from the

neck while the handle is firmly fixed to the pars tensa of the ear drum

Incus- It has a body short process and long process The body short

process and long process The body articulate with the head of mallelus in

the attic and the short process project into the attic The long process

projects downwards behind the handle of malleus running parallel to it and

articulate with the head of the stapes via the lenticular process

Stapes ndash It is the smallest ossicle measuring about 35 mm and consist of

head neck footplate and anterior and posterior curcura The footplate of

stapes is held to the oval window by the annular ligament

Page | 33

Muscles ndash

1Tensor tympani ndash It is inserted is a branch of the facial nerve which carries

the sense of taste It is first arch muscle supplied by branch of mandibular

nerve V3

2 Stapedious muscles ndash It is inserted to the neck of stapes It is the second

arch muscle supplied by branch of facial nerve that is nerve to stapedius

Fig 4 Contents of the middle ear

Blood supply of Middle Ear

bull Anterior tympanic branch of maxillary artery which supplies tympanic

membrane

bull Stylomastoid branch of posterior auricular artery which supplies middle

ear and mastoid air cells

Page | 34

Four minor vessels are

bull Petrosal branch of middle meningeal artery runs along greater petrosal

nerve

bull Superior tympanic branch of middle meningeal srtery traversing along

the canal for tensor tympanic muscle

bull Branch of artery of pterygoid carotid

bull Tympanic branch of internal carotid

Lymphatic Drainage of Ear

Lymphatics from the middle ear drain into retropharyngeal and parotid

nodes while those of the Surgical Importance ndash Eustachian tube drain into

retropharyngeal group

1 The middle ear is part of contiguous organs including nose nasopharynx

Eustachian tube and mastoid bone lined by respiratory mucosa Any

respiratory infection or allergy is likely to pass to middle is likely to pass to

middle ear

2 Moreover middle ear suppurative disease may spread to adjacent organs

and produce complication eg Labyrinthitis meningitis facial nerve palsy

etc

3 Lenticular process is vulnerable in suppurative ear diseases and causes

ocular disruption

4 Prussac space is the site of primary acquired cholesteatoma

Page | 35

INNER EAR [60]

Inner ear is divided into two parts

1 Bony Labyrinth

2 Membranous labyrinth

Anatomy of bony labyrinth

It is divided into two parts

1 Vestibule

2 Cochlea

3 Semicircular canal

The vestibule is located between the medial wall of the middle ear and the

lateral to internal acoustic meatus anterior to the semicircular canal and

posterior to the cochlea The vestibule is the central part of the inner ear

On its side is the oval window opening which is closed by the bracket foot

plate The bony cochlea is located in front of the vestibule It has 275 turns

wound around a bony axis called a modiolus The cochlea is about 30 mm

long The hollow center of the modiolus is a spiral canal that contains the

fibers and ganglion cells of the cochlear nerve A thin bony sheet the bony

lamina winda around the modiolus This divides the cochlear duct into two

galleries the Scala vestibuli above and the scala tympani below

There are three semicircular canals superior posterior and lateral They

are semicircular in shape and open into the vestibule One end of the

semicircle is enlarged and is known as the sphere

The membranous labyrinth is in the bony labyrinth It is connected to the

bony labyrinth by fibrous trabeculae and is surrounded by perilymph The

endolymph is located in the membranous labyrinth

Page | 36

The utricle is in the upper part of the vestibule while the saccule is found

below Both the utricle and saccule contain a single sensory patch called

the macula Each macula is covered with a neuroepithelium made up of

neuroepithelium made up of sensory hair cells and support cells these cells

are separated by a basement membrane Fibers of the vestibulo-cochlear

nerve enter the macula and pierce the basement membrane to terminate

at the base of the hair cell or cell bodies The utricle and the saccule with

their macula are called otolith organs Membrane semicircular canals are

the membrane canals of the corresponding bony semicircular canals They

open into the utricle through five openings One end of the opening of each

channel is dilated called the sphere in which the sensory organ of each

channel is located The cross section of the Scala standard looks like a right

angle The base is formed by the basilar membrane Sensory cells are

arranged on the surface of the basilar membrane These sensory cells with

their supporting cells form a complex neuroepithelium called the basilar

papilla or the cortical organ named after an Italian microscopist The

organs of the corti have a gelatinous membrane called the tectorial

membrane and they are supported by the pillar of the corti The cortical

pillars enclose a space called the corti tunnel which contains a fluid called

cortical lymph Vestibule is lies between the medial wall of the middle ear

and lateral to internal acoustic meatus anterior to semicircular canal and

posterior to the cochlea Vestibule is the central part of the internal ear On

its lateral surface is the opening of oval window which is closed by the foot

plate of stapes Boney cochlea lies in front of the vestibule It has 275 turns

coiling around boney axis called modiolus Cochlea is approximately 30 mm

in length The hollow center of the modiolus is a spiral canal containing the

fibers and ganglion cells of cochlear nerve A thin boney sheet the osseous

lamina winda around the modiolus This divides the cochlear canal into two

galleries the Scala vestibuli above and the scala tympani below

Page | 37

Semicircular canals are three in number superior posterior and lateral

They are semicircular in shape and opens into the vestibule One of the

ends of the semicircular is enlarged and is known as ampulla

Membranous labyrinth is situated within the boney labyrinth It is connected

to the bony labyrinth by fibrous trabeculae and is surrounded by perilymph

Endolymph is situated within the membranous labyrinth

The utricle lies in the upper part of the vestibule while the saccule lies below

Utricle and saccule both contain single sensory patch called macula Each

macula is covered by neuroepithelium consist of Neuroepithelium consists

of sensory hair cells and supporting cells these cells are separated by

basement membrane Fibers from the vestibulo cochlear nerve enter the

macula and pierce the basement membrane to end either at the base of the

hair cell or cell bodies The utricle and saccule with their macula are referred

to as otolith organs Membranous semicircular ducts are the membranous

ducts in the corresponding bony semicircular canals They open into the

utricle by five openings One end of the opening of each canal is dilated

called ampulla in which the sensory organ of each canal is located The

cross section of Scala media resembles a right angle Its base is formed by

basilar membrane Upon the surface of the basilar membrane the sensory

cells are arranged These sensory cells with their supporting cells form a

complex neuroepithelium called the basilar papilla or Organ of corti named

after an Italian Microscopist Organ of corti has a gelatinous membrane

called tectorial membrane and they are supported by pillar of corti The

pillars of corti enclose a space called tunnel of corti which contains fluid

called corti lymph

Page | 38

Fig 5 Inner Ear

Blood supply of labyrinth

Labyrinthine artery

Common cochlear Anterior vestibular Artery

Vestibulocochlear artery Main cochlear artery

Cochlear branch posterior vestibular artery

Page | 39

PHYSIOLOGY OF HEARING [61]

A sound signal in the environment is collected by the pinna passes through

external auditory canal and strikes the tympanic membrane Vibrations of

the tympanic membrane are transmitted to stapes footplate through a chain

of ossicles coupled to the tympanic membrane Movements of stapes foot

plate cause pressure changes in labyrinthine fluids which move the basilar

membrane This stimulates the hair cells of the Organ of corti It is these

hair cells which act as transducers and convert mechanical energy to

electrical impulses which travel along the auditory nerve

Thus the mechanism of hearing can be broadly divided into

bull Mechanical conduction of sound (conductive apparatus)

bull Transduction of mechanical energy to electrical impulses (sensory

system of cochlea)

bull Conduction of electrical impulses to brain (neural

Fig 6 PHYSIOLOGY OF HEARING

Page | 40

Conduction of sound

Under the surface of water we cannot hear the sound made in air because

9995 of sound energy are reflected away from the surface of water because

of the impedance offered by it A similar situation exists in the ear when

air-conducted sound must travel to cochlear fluids Nature has

compensated for this loss of sound energy by interposing the middle ear

which converts sound of greater amplitude but lesser force to that of lesser

amplitude and greater force This function of middle ear is called impedance

matching mechanism or the transformer action It is accompanied by

a) Lever action of the ossicles

Handle of malleus is 13 times longer than long process of incus providing

a mechanical advantage of 13

b) Hydraulic action of tympanic membrane

The area of tympanic membrane is much larger than the area of stapes foot

plate the average ratio between the two beings 211 As the effective

vibratory area of the tympanic membrane is only two- thirds the effective

areal ratio is reduced to 141 and this is the mechanical advantage

provided by the tympanic membrane

c) curved membrane effect

Movements of tympanic membrane are more at the periphery than at the

center where handle of malleus is attached This too provides some

leverage

Transduction of mechanical energy to electrical impulses

Movements of stapes footplate transmitted to cochlear fluids move the

basilar membrane setting up shearing force between the tectorial

membrane and hair cells The distraction of hair cells gives rise to cochlear

microphonics which triggers the nerve impulse

Page | 41

Neural pathways

Hair cells get innervation from bipolar cells of spiral ganglion Central axons

of these cells collect to form cochlear nerve which goes to ventral and dorsal

cochlear nuclei From there both crossed and uncrossed fibers travel to

superior olivary nucleus lateral lemniscus inferior colliculus and medial

geniculate body and finally reach the auditory cortex of the temporal lobe

Page | 42

DISEASES REVIEW

करणसराव

Nirukti - करणसय कणवयोाव ससराा [62]

Nidana- Acharya Sushruta and Vagbhata describe the common etiological

factors for the Karnaroga

अशयाय जलिीडा कणवकणडयन मरत

शमथययोगन शसततरसतय कवपतो अरय च कोपन ||

सउ २० १२

1 Avashaya or Pratishaya

(Excessive exposure to cold)

2 Jalakrida

(Excessive swimming)

3 Karnakandunyanum

(Excessive scracing due to itching)

4 Mithyayogena Shatrasya

(Improper instrumentation during wax removal or foreign body removal)

5Shabdasya

(Louder sound for long durationperverted contact of sound)

6 Abhighata (Trauma)

7 Vitiation of Tridoshas

Page | 43

Samanya Nidana according to different Samhita

Vishesh Nidan of Karnasrava

Acharya Charaka has not mentioned any kind of Nidana regarding Karnaroga

but has described Utapati of Karnaroga from Siroroga in Karnasirasym

Adhyaya[67]

शशरोअशिघातादरा तनमजजतो जल परपकादरा अवप विि

सरतत पय शरणॊ अतनलात स कणवससरा इतत परककतीत

सउ २० १०

असस ३७२५ [68]

1 Shiroabhighatat - Head Injury-Fracture of middle cranial fossa

2 Jala nimajjana - CSF otorrhoea fracture of middle cranial fossa

3 Karnaprapaka

4 Karna Vidhradhi -Puyasrava

Sr

no

Samanya Nidana SU AH[63] AS[64] YR[65] MN[66]

1 Avashaya + + +

2 Pratishaya + +

3 Shabdha

mithyayoga

+

4 Shashtra

mithyayoga

+ + +

5 Karnakandooyan + + + + +

6 Jalkrida + + + + +

7 Abhighata + + +

Page | 44

Samanya samprapti

परापय शरोतरशसरा कयावत शल शरोतशस गान

त कणवगता रोगा अटिावशततरीता

सउ २० १२

Due to common and specific etiology factors the vitiated Doshas gets

Sthanasamshraya in Karna and causes Karnasrava It is the stages of

Samprapti were Doshas gets lodged in Srotas and start processes of Dosh

Dushya Sammurchsna Due to Shiroabhighata Jalanimmajana Karna Paka

Karna Vidhradi vitiated Vata Dosha and Karna becomes Avruta by Vata and

results in Karnasrava Normal physiology of Dosha Dhatus and Malas entirely

depends on the normality of Srotas Dosh Dushya Sammurchana or

manifestation of diseases will not take place if only vitiation of Doshas take

place without deformity of Srotas Here in Karnasrava vitiation of Srotas are

Atipravritti Sanga and Vimargagamana take place Atipravritti is being excess

production of fungus Sanga is obstruction in external acoustic canal

Vimargagamana is the propagation of discharge through ear

Vishesh Samprapti

Karnasrava occurs due to Nij nidana is Pratishaya while Agantuja nidanas are

Avashya Jalkrida and Karnakanduyan Due to etiological factors which are

Vata-Kapha provocative in nature gradual vitiation of Doshas will occur After

vitiation they get accumulated (Sthan samshraya) in external auditory canal

In other hand when patient does Sevana of Agantuj Nidan like water enter in

external ear scratching of ear unsterile instrumentation leads to Dosh

Prakopa These cause Twak and Mamsa Dhatu Dushti which leads to

discontinuity of epithelium of ear canal which creates suitable atmosphere for

fungal pathogen to grow The vitiated Vata will produce symptoms such as

Page | 45

pain hearing impairment and vitiated Kapha causes symptoms like itching

discharge ear blockage By assessing the symptoms it can be said that Kapha

Avrita Vata Dosha is responsible for the manifestation of clinical features like

pain itching discharge Which are seen in Karnasrava that is otomycosis

Acharya Charaka has mentioned while explaining Samanya Chikitsa of

Karnaroga that it should be treated like Vrana when Paka and Srava is present

as a symptom Fungal spores invade in the epithelial layer of EAC In response

to infection inflammatory process is start This is a Paka Avastha After

removing the fungal mass ulceration in external acoustic canal is commonly

seen As a result of infection process exudates was produced which will mix

up- with fungal colonies and appear as discharge As per Dosha involvement

in Vrana Shoola Srava can be differ According to Acharya Sushruta Ruk is

the Samanya Lakshana of Vrana and Vishesha Lakshana of Vrana includes

pain discharge discoloration itching etc according to Dosha involvement

which are also seen in otomycosis In otomycosis mainly watery and purulent

type of discharge is present which indicates Paka avastha If there is Dosha

involve in Vrana is called Dushta Vrana Acharya Sushruta and Acharya

Vagabhata have mentioned verity of Srava in Twak and Mamsa Vranavastu

which is found in otomycosis Based on this description otomycosis can be

correlated with Karnasrava

Page | 46

Representing the Samprapti of Karnasrava

Vishesh Nidana ndash Shiroabhighatat

Jala nimajjana

Prapaka Vidhradhi

Vitited vata

Avarana by kapha

Vimargagamana of Vata

Karnasrava

Samprapti Ghataka

Dosha ndash Kapha and Vata

Dushya ndash Rasa Rakta and Mansa

Strotodushti ndash Vimargagamana and Sang

Adhishthana ndash Karna (Bhayakarna)

Rogmarga ndash Madhyama

Page | 47

Purvarupa

The Purvarupa of Karnasrava are not mentioned separately in any ayurvedic

classics In routine practice cretin Purvarupa are noted

1 Karnakandu

2 Karnagurutwa

3 Alpa karnashoola

4 Discomfort in ear

Rupa

1 Karnashoola

2 Karnakandu

3 Karnasrava

4 karnabadhirya

5 Cotton wool like or wet newspaper like grayish brown or black colored mass

is seen

6 External auditory canal skin appears edematous and red

Upashaya and Anupashaya

Appropriate application of Aushadhi Ahara and Vihara when produces relief in

the symptom is called as Upashaya and when aggravates the symptoms is

called Anaupashaya There is not any reference available in the classics about

the Upashaya and Anupashaya of karnasrava

Sadhyasadhyata

Sushruta has not mentioned specially the Sadhyasadhyata of Karnarogas But

Vagbhata has mentioned Karnasrava as a Sadhyavyadhi[69]

Sadhysadhyatagives the clear picture of prognosis of the disease It depends

on many factors like nature of disease severity of disease Vaya Prakriti Bala

of the patient etc

Page | 48

Upadrava of Karnasrava

In Samhita there is no reference available regarding the Upadrava of

Karnasrava

Samanya Chikitsa ndash

The common treatment principle for all Karnaroga is Ghritapana Use of

Rasayana Bhrahmacharya Avyayama Shirasnana and Atibhashaya

सामरय कणवरोगष घतपान रसयनम

अवयायमो शशराःसतनान बरमहचयवम कतपरनम

स उ२१३

Ghratapana - Ghrita is a Yogavahi and follow Sanskara in addition to these

acquired properties and capable of retaining its own properties So Ghritapana

is effective in Karnasrava

Rasayana - Rasayana represent the basic approach of Ayurveda which

comprise preventive promotive and curative aspect of health

Brahmacharyaapalana -It is like Sadvrittapalana and is equals to Rasayana

effect

Vyayama - It leads to vitiation if Vatas a Karna is a Sthana of vata and

exercise causes Kshayaj Samprapti hence it is important to avoid exercise in

Karnasrava

Shirasnana- In Shirasnana water enters in external acoustic canal it changes

the PH of meatus skin from acid to alkali which favors the growth of pathogens

Atibhashya - Excessive speaking causes Vata Prakopa and Vatapraokopa is

basic Samprapti for Karnasrava as the preventive aspect avoidance of

excessive speaking is necessary

Page | 49

Ghritapana Rasayana and Brahmacharyapalana should be followed for

preservation of dhatu Samyata and restriction of vitiation of Vata Vayayama

Shirasnana and Atibhashaya should be avoided in Karnasrava to protect the

Siras from the affliction of Vata and Kapha

Vishesha Chikitsa ndash

The general treatment principle of Karnasrava described in classics is closely

related to Dushtavrana Chikitsa

शशरोवरचन च ए िपन परण तरा

परमाजवन िान च ीकषय ीकषय़ाचारत [70]

स उ २१४०

कणवसततरा ोददत कयावत पततकशमकणवयो [71]

ाउ १८३५

उपददि च सततरोत साय परात वपचततवशि परमजय

य अगर मदन सघत गगलना ा िपतयतपा मिना परयत [72]

असउ २२४२४३

In addition to that Shirovirechana Karnadhoopana Karnapurana

karnapramarjana Karnadhavana are also indicated

Page | 50

Treatment is also mentioned for Karnasrava

1 Karnaprakshalana Yoga - with Aargawadadi Gana Kashaya and Surasadi

Gana Kashaya [73]

2 Avachurnana Yoga ndash with Aargawadadi Gana Churna and Surasadi Gana

Churna[74]

3 Karnapoorna Yoga ndash

bull Rasanjana Laksha with Sarjachoorna[75]

bull Panchkashaya with Kapittha swarasa and Madhu[76]

bull Jambu AmrapallavShivalaKshuodra Mahavriksha and Madhuki all are

taken in equal quantity and Kalka is prepared and 4 times Taila is taken

and 16 parts of Kwatha is added and Taila Paka is done[77]

bull Sarjatwak Choorna with Karpashiphalarasa and Madhu[78]

bull Abhaya LodraTindukaSamanga(Manjista) Kwatha of this Dravyas mixed

with Madhu and Kapittha Rasa[79]

bull Yogratnakara mention the following drugs for Karnapoorana-

a Samudraphena Churna[80]

b Jambwambpatra Yoga

4 Karnadhoopana Yoga ndash

bull Dhoopana with Churna of Bilvapatra Haridra Palandu[81]

bull Vartak Dhoopana [82]

5 Internal Medications-

bull Rasnadi Guggula [83]

bull Triphala Guggula [84]

bull Sarivadi Vati [85]

bull Gandhaka Rasayana [86]

Page | 51

According to Vagbhata-

Ear should be cleaned with the Pichu and Varti followed by Guggula Dhoopana

and then Karnapoorana with Madhu Followed by Avachurnanana with

Sukshmachootana of Surasadigana

Pathyaapathya ndash Pathya and Apathy mentioned for Samanya Karnaroga is

recommended in Karnasrava also

पथय[87]

सतदो वरको मन नसतय िमाः शशरावयिाः

गोिमाः शालयो मदगााः याशच परतन हवाः 80

लाो मयरो हररणानदसततततरो नकककिाः

पिोल शशगर ातावक सतनषराण कदठललकम

रसायनातन सवणण बरमहचयवमिाषणाम |

उपयकत यरादोषशमद कणावमय दहतम ||81||

िापर २१

Aharaja Upacharaja

bull Godhuma bull Vamana

bull Shala bull Virechana

bull Mudga bull Nasya

bull Yava bull Dhoomapana

bull Puranagitra bull Kavala

bull Lava Harina Tittiramamsa

Page | 52

अपथय[88]

दरत काटठ शशरसतनान वययाम शलटमल गर

कणडयन तषारशच कणवरोगी पररतपयजत

िापर २१

Viharaja

bull Patola ShigruVartaka bull Bhramacharaya

bull Sunishannaka bull Avyayama

bull Katthlika bull Aakthanam

bull All types of Rasayana bull Upacharaja

bull Vamana

Apathyas

bull Abhishyandakara Aharas

bull Shirasnana

bull Karna kandooyana

bull Tushara sevana

bull Guru Kaphakaraka Aaharas

bull Dantdhavana

Page | 53

OTOMYCOSIS

Definition-

Otomycosis is a superficial acute sub-acute or chronic infection of external

ear canal It is mostly unilateral It is characterized by inflammation purities

and scaling Otomycosis is a common condition encountered in ENT practice

more in chronic and persistent ear infection

The Fungal infections are not communicable in the usual sense but the

humans become an accidental host by their introduction into tissue trauma

The virulence factors favoring colonization of fungus in human host are yet to

be identified Ability of the fungus to grow at 37 C and elaboration of a variety

of enzymes and toxins are speculated to contribute to virulence Only 100 to

150 species are generally recognized as a cause of disease in humans[89]

Prevalence-

Otomycosis is a word wide in distribution and in various record stated that 5

to 20 of all cases of infective otitis externa Otomycosis prevalent is more in

warm and humid climates It is one of the commonest manifestations in India

during rainy season It occurs mostly in humid atmosphere otitis externa due

to fungal infection may resembles the desquamative form of diffuse infective

otitis externa The incidence in temperature climates has increased in

proportion to the use of topical antibiotics which have a medium sterilized of

other organism in which the fungus may flourish

Page | 54

Predisposing factors- [90]

1 Environmental factors such as climate contagious and polluting hygiene

more frequently during rainy season as the humidity increases

2 Individual susceptibility ndashGeneral Immunological status of the Individual

eg HIV infection Radiotherapy chemotherapy Diabetes mellitus

3 Self-inflicted trauma that is use of pins to clean the itching ear or use of ear

bud to clean the wax

4 Wide spread of topical antibiotics steroid preparations which have medium

sterilized of other organism in which the fungus may grow

5 Failure of defense mechanism in External auditory canal

6 During swimming or head bath water enters in External acoustic canal

causes quantitative and qualitative change in ear wax It causes change in pH

7 Long term use of hearing aids

Pathophysiology ndash

The life cycle of the average mold encountered in the ear may be reckoned

as two weeks and flare ups may be anticipated at such intervals Swimming is

held responsible for infection in many cases The sequence sequence of

pathogenic changes produced by molds in the external ear is as follows ndash

1 Implantation of the organism in external ear

2 Growth of organism follows the rate depending on condition of temperature

moisture or preexisting irritation

3 Invasion of epithelium occurs with attendant itching and discomfort which

may be quite severe

Page | 55

4 Exfoliation of epithelium occurs as nature attempts to overcome the

infection by casting off upper most cells

5 Denudation occurs from exfoliation as the top layers of epithelium are cast

off and the canal becomes filled with debris

6 Superficial ulceration and lizematoid dermatitis results if the pathologic

process goes for enough The changes do not always proceed through the

entire sequence sometimes the molds produce changes of the mildest

imaginable character which may be overlooked[91]

Clinical features -

Symptoms-

1 Irritation and itching ndash Irritation is mostly found when the infective

organism is aspergillus niger There is sensation of discomfort which is more

diffuse in the ear canal then localized in the deeper part Candida infection

causes marked itching In external ear it is intense and worse at night

2 Discharge through ear- Intermittent scanty colorless discharge through

ear Mucus being a fungal metabolic product appears as discharge Excessive

discharge is associated with mixed infection

3 Pain and discomfort ndash Mild to severe pain in the ear occasionally Mostly

seen in cases where ear is infected with Aspergillus flavus mixed infection

with gram negative organism or mixed infection with candida and aspergillus

Headache is sometimes associated with pain

4 Deafness- Varying degree of mild to moderate conductive deafness

5 A sensation of fullness in ear

6 Tinnitus 7 Vertigo

Page | 56

Signs ndash

1 The external acoustic meatus may contain a mass formed of epithelial

debris exudates cerumen and fungus

2 Erythematous external canal

Fungal appearance

A Niger - The color of the mass which is usually grey or black is mainly

determined by the type of fungus concerned Its appearance is like wet

newspaper or blotting paper or a cotton wool It has a peculiar musty odor In

this infection fruiting heads may be seen as black specks in the debris

Occasionally as inactive form occurs in which the canal is lined by mold giving

a fluffy appearance due to the presence of tiny mycelia

Candida ndash Candida infections generally show as white deposits on magenta

colored skin when the debris is removed it rapidly recovers in 24 hrs

The underlying canal skin is often inflamed and granular due to invasion by

fungal mycelia and be seen in all cases In rare cases excoriation and

ulceration with marked extensive shedding of the epithelium and deep

ulceration can be seen usually associated with a flavus and with pathogenic

bacteria[92]

Otoscope Appearance

1 Aspergillus Niger ndash Black headed

2 Aspergillus Fumigators ndash pale blue or green

3 Candida Albicans ndash White- or cream-colored deposits

Page | 57

4 Auricle is normal in most cases In severe cases small ulceration with crust

formation may be present on lateral surface

5 Tympanic Membrane

In most cases it is normal with normal mobility and normal hearing In a few

cases the surface of the tympanic membrane is congested and scaly There is

erosion or ulceration of the external epithelial layer and the membrane itself

may be edematous

Diagnosis

1 Above mentioned symptoms and signs

2 In the stage at which patient with otitis externa usually first present

themselves mycelia threads conidiophors not visible to naked eye may

sometimes be identified with the microscope

3 Confirmed by culture

Page | 58

Fig7 Aspergillus Niger Fig8 Candida Albicans

Fig9 Aspergillus Fumigators Fig 10 Wet Paper like appearance

Page | 59

Treatment

1 Antibiotic or steroid drops should be discontinued if they are being instilled

since long time

2 Removal of fungal mass epithelial debris and discharge from the external

canal or mastoid cavity repeatedly and thoroughly by forcepa or suction or

syringing or cautiously blow a stream of air into the canal through a fine

cannula and dry thoroughly by swabbing liquid petroleum on swab used in

cleaning the ear lessens the burning sensation when metacresy acetate is to

be employed in the subsequent treatment

Furuncle is developed as a complication if there is no gentleness in cleaning

Cleansing may have to be delayed until local sensitiveness is lessened which

can usually be accomplished within twenty-four hours If there is excessive

epithelial debris along with otomycosis then metacresyl acetate which is a

keratolytic in introduction into the external auditory canal on cotton wick and

is allowed to remain for twenty-four hours After twenty-four hours the cotton

wick is removed at which time the canal can usually be cleansed with little

discomfort as the medication is also anesthetic The epithelium of the canal

was white from contact with the drug The top layer was detached and this

epithelial debris can be easily wiped away The wick is reinserted and wet with

metacresyl acetate

The treatment is employed for three to four days in succession and then a

bland application is substituted Icthyol iodine is of value at this stage Iodine

ointment 2 in combination with Tannic acid 2 is also an excellent local

application following cresatin treatment

Next one of the fungicides may be applied

Page | 60

1 Nystin Effective for candida infection but less active against aspergillus

group Nystatin in boric powder consisting of 100000units of nystatingm of

powder 3 times week for 3 weeks

2 Clotrimazole Available as 11 cream or drops or lotions Phenyl

(zchlorophenyl) 1 ndash imidazole ndash methane is a chlorinated trityl imidazol 1

effective against candida and dermatophytes and for aspergilli infection

3 Amphotericin B Available as cream and as 3 solution and 015 drops

for topical application Very effective for candida infection can be fungistatic

or fungicidal

4 Econazole Available as solution (Econazole nitrate) and as cream (1)

Broad spectrum ndash more effective for Aspergillus Also active against some

gram-positive bacteria (Staphylococci and Streptococci and Dermatophytes)

5 Miconazole Highly effective against dermatophytes and candida infections

used as a 21 cream applied once or twice a day for 10 days

6 Gentian violet 21 Available as drops (recently some evidence of

carcinogenicity) Discolors the ear canal and this interfere with clinical

examination

Other topical antifungal agents are ketoconazole Natamycin Tolciclat Bifonas

zole Fenticonzole Oxiconazole Tioconazole ciclopiroxolomine Tolnafate

Haloprogin Flucytosine Acetic acid Whit field ointment selenium sulfide

undcyclenic acid triacetin etc

Page | 61

Minimal length of treatment

A month of drug treatment is usually required because the antifungal agents

used are not sporicidal and it is necessary that the period of treatment covers

germination time It may be advisable to give short gaps in the period of

treatment to ensure all spores have germinated before deciding to terminate

therapy

Prevention

Accomplished by strict attention to the predisposing causes

1 Water should be prevented from entering the ear

2 Avoidance of external ear trauma

3 Use of alcohol medicated or plain in the ears after swimming mercuric

cyanide (15000) in ethyl alcohol (70) is a satisfactory liquid to use

Ear stoppers do no good unless their use is followed by some antiseptic in the

canal Divers exposed to water for long periods of time may also use acidic

alcohol

4 During Summer months with their high humidity special efforts are needed

to maintain ear dry 5 Indiscriminate use of topical antibiotics steroid

preparations should be avoided

Page | 62

DRUG REVIEW

1 GUGGULA

Fig11 - Guggula

Historical review of Guggula [93]

bull Atharvaveda one of the well-known Vedas of Hindus The earliest

reference given by Atharvaveda medicinal and therapeutic properties of

Guggula Guggula has long history of use in Ayurveda

bull Acharya Charaka Sushruta and Vagbhata describe detail regarding the

actions uses and indication as well as the variety of Guggula

Page | 63

bull Various Nighantus (Medical lexicons) were written between 12th and 14th

centuries AD was based on the Ayurvedic literature also describes

Guggula

bull The explanation of word Guggula is that Gunjo Vyadhegurdti Rakshati

which means to relief against different diseases

bull Guggula is the best medicine because it develops through the rays of

hot sun on specific circumstances

bull Guggula has an aromatic odor

गगलो कणवदौगवररधय िपन शरटठमछयत[94]

स उ २२११२

Latin name- Commiphora mukul

Family ndash Burseraceae

Rasa- Tikta Katu

Guna ndash Laghu Rukshasukshma vishada sara

Veerya ndash Ushna

Vipaka ndash Katu

Action- Rasayana Lekhana

Doshaghanta - Tridoshhara

Page | 64

Chemical composition [95]

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Oleoresin-Z-Guggulsterone E-Guggulsterone

Gum- guggulignans 1 and 2 guggula Tetrols mukulol allylcembrol c

27

Guggulusterol 1 2 ans 3 Z and E ndash guggulusterol

Volatile oils- Phenol eugenol cuminic aldehyde-2 pinine Limonene and

Sesquiterpines

Parts Used ndash Gum oleoresin

Guggula purity test

1 Yellowish brown emulsion is obtained when Guggula is triturated with

water

2 An ethereal solution of the drug attains reddish colour when treated

with br2 vapors and purple colour when moistened with nitric acid

Biochemical action ndash Antiseptic Anti-inflammatory Disinfectant Diuretic

Immunostimulant stimulating expectorant Ant suppurative Antipyretic

Enhance phagocytosis

Karma- Rasayana cardiovascular disease

Page | 65

2 AGARU-

Fig 12 Agaru

Historical review of Agaru [96]

bull The word Agaru literally means the one which is the heaviest and no

aromatic wood is heavier than it Since thousands of years Agaru lsquoThe

wood of Godrsquo has been used for multiple purpose like commercial

medicinal spiritual aromatic historical

bull The medicinal use of Agaru have been recorded in many pieces of India

Greek Roman Chinese Middle eastern and European since ancient times

bull Acharya Charaka used Agaru and pest of Rasna to counteract the effect of

cold in Agraya Dravyas

bull Acharya Sushruta used Agaru as a Dhoopana Dravya along with Guggula

Ral and Shoma in the treatment of Karnasweda and Vrana

Page | 66

Types-

bull Dhanwantsri Nighantu describes Kaleyaka as a type of Agaru

bull Sodhala Nighantu describes three types of Agaru ndash Agaru Krishna

Agaru Kakatunda Agaru

bull Raj Nighantu describes five types of Agaru ndash Krishna Agaru Kasht

Agaru Daha Agaru Mangalya Agaru and Agurusaar

bull Arthashasstra describes three Agaru wood product

1 Jongaka ndash Black or variegated black in colour and having variegated

spots

2 Dongaka ndash Black in color

3 Parasamudraka- Black in colour and smells like Navamallika

अगर उटण कि तपछय ततकत ततकषण च वपततलम

लघ कणाविरोगघन शीत ात कफपरणत

िापर २१ [97]

Family- Thymelaccensis

Latin name- Aquilaria agallocha

Guna- Laghu Ruksha Tikshan

Rasa- Katu Tikta

Vipaka ndash Katu

Virya ndash Ushna

Karma- Sheetaprasasmana Vranaorasadan Tvachya Pittavardhaka

Shirovirechana Mangalya Sugandhik and Rochaka in properties [100]

Krishna Agaru karma- Katu Tikta rasa Ushna Sheeta when applied externally

and Pittahara when taken orally

Page | 67

Chemical Constituents -

Agaru hardwood is rich in essential oil resins alkaloids saponins Steroids

terpenoids tannins flavonoids and phenolic compound Agaru wood

predominantly contains 2-[-2-phenylethy]-4H-chromen-4-one derivatives and

sesquiterpenes Agaru oil contains selinene dihydroselinene agarnol b-

agarofuran vetispira-2(11)valerianol dihydrokaranone and tetradecanoic

acids[99]

Part Used ndash

Heartwood- Dark resinous wood which is formed when the plant becomes

infected with a type of fungus (ascomycetous mold) Species of Aspergillus

fusarium and penicillium are reported to be associated with the development

of infection Prior to infection the heartwood is odorless relatively light and

pale colored however as the infection progresses the tree produces a dark

aromatic resin in the heartwood The infected resin in response to the attack

which results in accumulation of a very dense dark resin in the heartwood

The infected resin embedded wood is known as Agarwood Infection is more

common on the trunk roots and the area when branches divide The formation

of Agarwood starts when the tree attains the age of 20 years On an average

approximately 30 ml oil is extracted from 100 kg of infected Agarwood[98]

Qualities of best Agaru-

It should be black in color

It should be extremely heavy and aromatic

It should be oily in appearance and test

It should be sink in water

It should burn easily with bright flame with a bright flame giving off a pleasant

smell

Page | 68

3 MADANA

Fig 13 MADANA

Madana consist of dried fruit of Xeromphis spinosa It is a deciduous thorny

shrub or a small tree reaching a high up to 9 m and girth about a meter

branches numerous thick and horizontal found in sub-Himalayan tracts[101]

मदनो मिरनदसततकतो ीयोटणो लखनो लघ

ानदरतिदवििीहर परततशयायवरणारतक

रि कटठकफ़ानाहशोथगलमवरणापह[102]

िा पर १६० १६1

Page | 69

Latin name-Randia dumetorum

Familly ndash Rubiaceae

Rasa - Madhura Tikta

Guna-Laghu Ruksha

Virya- Ushna

Vipaka ndash Katu

Karma- Vamana and Lekhana

Chemical Composition-

Essential Oil Valerianic acid Saponin tannin resin [103]

Page | 70

YAWA [104]

Fig 14 Yawa

1 In Samhitakala Aacharya Charaka Acharya Sushruta explain detail about

medicinal properties of Yawa

2The use of Yawa in Aaharya Dravya mainly described by Dhanwantari

Nighantu Raj Nighantu Bhavprakash Nighantu[105]

Macroscopic Description-

Fruit a caryopsis elliptical oblong Ovoid and tapering at both ends smooth

about 1cm long and 02- 03cm wide dorsally compressed and flattened on

the sides with a shallow longitudinal furrow 3-5 ridges having shallow

depression between them grains tightly enclosed and adhering the lemma

and palea pale greenish yellow odor not distinct taste sweetish acrid

Page | 71

Latin Name ndash Hordenum vulgare

Family- Poaceae

Rasa- Kashaya Madhura

Virya- Sita

Vipaka- Katu

Karma- Vatakrt Pittahara Kaphahara Medahara Balya Visrya

SthairyakaraLekhana

Page | 72

PROCEDURE REVIEW [105]

In Ayurvedic classics there are many references regarding Dhoopana Dravya

Dhoopana is administering Dhuma with the help of Dhoopana Dravya

In Kashyapa Samhita there are 40 types of Dhoopana advised for children

Anesthesia (Mohajananam Dhoopa) is also mentioned For this Dhoopana the

drug used were herbs hairs of animals legs horns old cloths of Buddhist

monks

From the references available regarding Dhoopana we can understand that

Karna can be protected from maggots (krimi) Bactria (Rakshogna) lice etc

References clearly indicate the analgesic and disinfectant effect of Dhoopana

Karma Dhoopana is mentioned for Dushta Vrana Chikitsa It reduces Vedana

Srava Pootigandha of Dushtavrana It also helps in Vranaropana

Dushtavrana Chikitsa is mentioned in the treatment of Karnasrava[106]

Origin of Dhoopana-

In ancient period children of sages were constantly harassed by the

Rakshasas Hence the sages approached lord Agni for shelter Agni in turn

gave them Dhoopana Dravya and asked sages to use the Dhoopana for

protection against Rakshasas bhutas pishachas

Classification of Dhoopana

1 It is classified into Dhupa Anudhupa Pratidhupa

2 On the basis of Origin it is classified into Jangama and Sthavara

Selection of Guggula for Dhoopana

Page | 73

bull Guggul is a best Vatahara

bull It is Krimighana

bull It contains Oleoresin

bull In Ashtang Hrudaya Guggula Dhoopana mentioned for Karnasrava

Selection of Agaru for Dhoopana

bull Agaru is Laghu Ruksha Katu Tikshna

bull Vranaorasadan Tvachya

bull It should burn easily with bright flame with a bright flame giving off a

pleasant smell

Karna Dhoopana Indication

1 Karnaarava

2 Putikarna

3 Krimikarna

4Vataj Karnashula

Contraindications

Especially for Karnadhoopan contraindication is not mentioned in classic texts

But Dhoopana is contraindicated in Pittaj vaydhi Sharad and Grishma Rutu

Page | 74

MATERIAL AND METHOD

Page | 75

For randomize comparative clinical trial to study the effect of Agaruwadi

Karnadhoopana and Guggula Karnadhoopana in Karnasrava following material

and method were required

Source of data

Patient irrespective of gender occupation religion social economic status

signs and symptoms of classical features of Karnasrava (Otomycosis) selected

from the OPD of Shalakyatantra department

Materials ndash

1Patients

2 Drugs-Agaruwadi Dhoopana

Guggula Dhoopana

3Torch

4Otoscope

5 Tuning fork

6Jobson horn probe

7Cotton

8Case record form

DRUG

Group A Trial Group

1Churana of Agaru Yawa Madan

2Ghrita

3Jala

Group B Control Group

1Googula Churna

Page | 76

Properties of Drug

Table no 1 Properties of Drug

Drug

Family

Rasa Veerya Vipaka Effect

on

Dosha

Guna Karma

Agaru

(Aquilegria

Agallocha)

Thymelaca

ceae

Katu

Tikta

Ushna Katu KV Laghu

Ruksha

Tikshna

Shitaprashamana

Shothahara

Vedanasthapak

Durghandhihara

Madan

(Randia

spinosa)

Rubiaceace

Kashaya

Madhur

Tikat

Katu

Ushna Katu KV Ruksha

Laghu

Vatakaphaghana

Shothahara

Vedanasthapak

Vranashodhak

Yawa

Poaceae

Hordeum

Vulgare

Kashaya

Madhur

Sheeta Madhur KP Ruksha

Laghu

Vataghana

Vernashodhana

Raktshodhaka

Guggula

Commiphora

Mukul

Burseracea

e

Tikta

Kashaya

Anushna Katu VPK Laghu

Ruksha

Shothahara

Vedanasthapaka

Kandughna

Ghrita Madhura Sheet Madhur VK Snigdha Vataghana

Shothahara

Vedanasthapaka

Page | 77

METHODOLOGY

SELECTION CRITERIA

1)INCLUSION CRITERIA

1 Patients having signs and symptoms of Karnasrava (Otomycosis) ie करणशल

( pain ) करणकणड ( Itching ) करणसतराव ( Discharge )बाधिरण ( conductive Loss of

hearing )

2 Patient from age group 19 to 70 years

3 Any Gender

2)EXCLUSION CRITERIA

1 Patients suffering from any systemic disease like DM TB HTN

2 Chronic suppurative otitis media (CSOM)

3 Acute supportive otitis media (ASOM)

3 Perforation of Tympanic membrane

4 Chronic otitis media

3)WITHDRAWAL CRITERIA

1If patient develops any adverse effect such as irritation pain burning

sensation in ear loss of hearing and such patients was withdrawn from trial

and receive prompt appropriate medical attention

2If patient shows aggravation in symptoms

3If patient refuses to continue with the treatment

Page | 78

STUDY SETTING

Types of study - Randomized Clinical comparative Trial

Place of work - OPD of Shalakyatantra

Duration of study - 18 months

Study Population - Patients of Karnasrava in Shalakyatantra OPD

SAMPLE SIZE CALCULATION

Sampling Method ndash Purposive sampling followed by random allocation in two

groups

Sample size calculation-

n = z2 p (1-p)

d2

Were

n = sample size

P = prevalence of disease=10

z = standard normal variable ie 196

d = error ie005

desired Sample Size would be

n = Z2 P(1-P)d2

= (196)2x (0021) x(0979)(005)2

= 34

Visiting ENT OPD (ShalakyaTantra) and IPD (ShalakyaTantra) 21 = 34

n raquo34

So one group includes 34patients

Page | 79

Sampling Method

Total 68 patient of Karnasrava are selected by Purposive sampling followed by

random allocation in two groups Written informed consent is taken prior to

commencement of trial They are divided in 2 groups

Group A (Trial Group) 34 patients treated with Agaruwadi Dhoopana for 7

days

Dose 5 minutes twice in a day

Group B (Control Group) 34 patients treated with Guggula Dhoopana for 7

days

Dose 5 minutes twice in a day

STUDY DESIGN ndash

Open labeled Randomized Comparative Clinical trial

STUDY DESIGN

Screening of patient

Inclusion criteria satisfied Exclusion criteria

Initial assessment Excluded

Counseling of patient Treated accordingly

Patient selection by Simple Random Sampling Method

Page | 80

68 Patients were divided in two groups lsquoArsquo and lsquoBrsquo

Trial group A-34 patients were given

Agaruwadi Dhoopana

Control group B- 34 patients were

given Guggul Dhoopana

Informed written consent

Treatment was given for 7 days

Assessment on 1st 4th and 7th day

Post assessments follow up on 15th day

Observation

Data Collection

Statistical analysis of data

Conclusion

Page | 81

(A) Agaruwadi Varti for group A (Trial group)

Table no 2

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

B) Guggula Varti for group B (Control group)

SOP of it is same as above Agaruwadi Varti

Table no 3

Drug Guggula Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose Two times a day

Duration 7 days

FOLLOW UP

For both groups follow ups were done on 1st 4th and 7th and post

assessment follow up15th day

EXAMINATIONS

Torch for Local examination of ear

Otoscope examination

Tuning fork Test

Page | 82

OBSERVATION TABLE

Table no 4

Sr no Subjective criteria Day 1 Day 4 Day 7 Day 15

1 करणशल

(pain)

2 करणकणड

(Itching)

3 करणसतराव (Discharge )

4 बाधिरण (Conductive Deafness)

OBSERVATIONS

a) करणशल (Pain) -

0 - Absent

1 ndash Present

b) करणकणड (Itching) -

0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

Page | 83

c) करणसतराव (Discharge)

0- Absent

1- Mild -Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाधिरण (conductive Loss of hearing)

0 - Absent

1- Present

Observations were carried out before and after completion of treatment and

during each follow up After observations the data collected and presented in

the form of graphs charts and table

Page | 84

TRIAL DRUG

Authentication and standardization of raw drug material done After

authentication and standardizing of raw drug material Agaruwadi Varti was

prepared by Varti as explained in Ayurvedic classics

Method of Varti preparations

Panchavidh Kashaya Kalpana that is five method of pharmaceutical

preparation constitutes the fundamental process of Ayurvedic pharmaceutics

which is well explained in Sushrut Samhita Varti Kalpana is one among them

which can be included in Kalka Kalpana

तीररसतरपतपतीनामपरककव तीत [106]

स डलहण शरच 151

Medicines are powered triturated and given the Varti shape that is like wick

of lamp so it is called as Varti Kalpana

Drug content Agaru Madan Yawa

Route of Administration Local

Dose Two times a day

Duration 7 days

Page | 85

Methodology

Standard operating procedure (SOP) of Agaruwadi Varti

Agaruwadi Varti is prepared according to the classical text

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization was done as recommended in pharmacy procedure The

raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 mixed together in

equal quantity to make Agaruwadi churn

Quantity of each churn is 4 grams all are mixed when the Varti get dry total

weight of Varti was 10gram

STEP 4 - Agaruwadi churn triturated with appropriate quantity of water or

Ghrita and prepared Varti in GMP Certified Ayurvedic pharmacy Standard

aseptic precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Varti was packed in sterile air packed container

STEP 6 - Agaruwadi Dhoopana was given with the help of Dhoopana yantra

Authentication and Standardization of raw drug of Agaruwadi Varti was done

Sterilization was done as recommended in pharmacy procedure Sterile

preparation packed in sterile container of suitable size Under all aseptic

precaution Karnadhoopana given to infected ear

Page | 86

Containers for packaging and their sterilization-

Sterilization of the containers for storing Varties was done by Ethylene Oxide

(Eto) method

Ethylene Oxide (Eto) procedure-

It includes exposure of materials to ethylene oxide gas under vacuum in a

sealed chamber It consists of four primary variables

1Gas Concentration

2Humidity

3Temperature

4 Time

EtO gas is an alkylating agent which disturbs the DNA of microorganism

preventing them from reproducing It penetrates the breathable packaging

and sterilizes all the accessible surface of the product to render products

sterility by alkylation of essentials proteins for cell reproduction

Most Eto sterilization methods involves three different stages These can be

separated into three different on the size or number of devices to treat

1Preconditioning stage-

First products are passed through a preconditioning phase to make

microorganism grow The batch load goes through a well time under a

controlled environment of temperature and humidity

2Sterilizer stage-

Performed using process phase specially designed to provide the required level

of EtO exposure to assure sterility for a device or family of devices

3Degasser Aerration stage-

Finally products need to go through a degassing phase to remove any residual

particles of Eto The batch load goes over well time under a temperature-

controlled environment

The sterile containers were then used to store Agaruwadi Varti and handed to

patients included in the study

Page | 87

Packing of Agaruwadi Varti

The ETO sterilize plastic container were used for packing of Agaruwadi Varti

Varti was filled into these sterilize containers (7 in each) In an aseptic

environment plugging and capping was done under aseptic precautions In this

way packing of Agaruwadi Varti done These Varti were given to patient and

advise to take two times a day under all hygienic precautions

History and Examination

bull Proper history and presenting complains was recorded on case record form

bull Ear examination with otoscope was done during initial assessment and each

follow up

bull Otoscopic examination was done during initial assessment and each follow

up

bull Systemic Examination that is Blood Pressure Temperature Respiration

rate Pulse was recorded on case record form

Page | 88

Raw material

Fig14 यव चरण Fig15 मदनफळ चरण

Fig16 अगर चरण Fig17 गगगळ चरण

Page | 89

Preparation of Agaruwadi Varti

Fig18 Preparation of Agaruwadi Varti

Fig19 अगरवादी वरती

Page | 90

Fig20 Instruments used for examination of Karnasrava

Fig19 Karnadhoopana Yantra

Page | 91

Karnadhoopana Procedure

Fig 22 Karnadhoopana Procedure

Page | 92

OBSERVATIONS AND RESULTS

Page | 93

BASED ON DRUGS

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 94

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

AUTHENTICATION CERTIFICATE

Page | 95

BASED ON STASTICIAL ANALYSIS OF DEMOGRAPHIC DATA

68 patients of Karnasrava ndash Otomycosis

Table no 5

No of Patients Total

Group A Group B

Registered 38 37 75

Completed 34 34 68

Discontinue 04 03 07

Total 68 patients were enrolled in study 38 patients registered in group A

amongst them 34 patients completed the treatment and04 patients

discontinued the treatment However in group B 37 patients completed the

treatment and 03 patients discontinued the treatment out of 37 registered

patients

Hence the total number of patients registered in the present study was 75

and out of which 68 patients were discontinued the treatment So they

dropped out from the study While 68 patients were successfully completed

the treatment So observations and result of 68 patients were given below

Here we are going to discuss the statistical analysis of the data obtained in

the form of master chart that was prepared in accordance with the data

collected from the patients that had been included in the study The purpose

of statistical analysis was to analyzed the relation between age gender

occupation diet addiction and education

Page | 96

1 Age wise distribution of patients

Table no 6

In trial group 10 (29412) patients were from age group 18-25 years 14

(41176) patients were from age group 25-35 years 8 (23529) patients

were from age group 35-45 years and 2 (58824) patients were from age

group 45-60 yearsIn control group 6 (17647) patients were from age group

18-25 years 14 (41176) patients were from age group 25-35 years 7

(20588) patients were from age group 35-45 years and 7 (20588)

patients were from age group 45-60 years

Fig 23 Age wise distribution of patients

0

2

4

6

8

10

12

14

15 -25 25-35 35-45 45-60

10

14

8

2

6

14

7 7

Age Distribution

Trial Group N Control Group N

Age Distribution

Trial Group Control Group

N N

18 -25 10 29412 6 17647

25-35 14 41176 14 41176

35-45 8 23529 7 20588

45-60 2 58824 7 20588

Total 34 100 34 100

Page | 97

1 Gender wise distribution of patients

Table no 7

Sex

Trial Group Control Group

N N

Female 23 67647 15 44118

Male 11 32353 19 55882

Total 34 100 34 100

In trial group 23 (67647) patients were female and 11 (32353) patients

were male

In Control group 15 (44118) patients were female and 19 (55882)

patients were male

Fig 24 Gender wise distribution of patients

0

5

10

15

20

25

N N

TRIAL GROUP CONTROL GROUP

23

15

11

19

Gender

Female Male

Page | 98

2 Education wise distribution of patients

Table no 8

Education

Trial Group Control Group

N N

Illiterate 4 11765 3 88235

SSC 4 11765 3 88235

HSC 8 23529 9 26471

Graduation 16 47059 10 29412

Primary 1 29412 3 88235

Post-Graduation 1 29412 6 17647

Total 34 100 34 100

In trial group 4 (11765) patients were illiterate 4 (11765) patients were

SSC educated 8 (23529) patients were HSC educated 16 (47059)

patients were graduated 1 (29412) patients were primary educated and

1(29412) patients were post graduated

In control grou 3 (88235) patients were illiterate 3 (88235) patients

were SSC educated 9 (26471) patients were HSC educated 10 (29412)

patients were graduated 3 (88235) patients were primary educated and

6 (17647) patients were post graduated

Page | 99

Fig 25 Education wise distribution of patients

0

2

4

6

8

10

12

14

16

ILLITERATE SSC HSC GRADUATION PRIMARY POST GRADUATION

4 4

8

16

1 1

3 3

910

3

6

Education

Trial Group N Control Group N

Page | 100

3 Occupation wise distribution of patients

Table no 9

Occupation

Trial Group Control Group

N N

Accountant 1 294 2 588

Housewife 11 3235 8 2353

Engineer 1 294 1 294

Job 1 294 4 1176

Labor 1 294 3 882

Mess 1 294 0 000

Naturotherapyst 1 294 0 000

Pharma 1 294 0 000

Shopkeeper 4 1176 2 588

Singer 1 294 0 000

Student 8 2353 4 1176

Tailor 1 294 1 294

Teacher 1 294 1 294

Worker 1 294 3 882

Farmer 0 000 1 294

Lab Tech 0 000 1 294

Page | 101

Daily Collection 0 000 1 294

Fruit seller 0 000 1 294

Bus Driver 0 000 1 294

Total 34 10000 34 10000

In trial group 11 (3235 ) were housewife 8(2353) were students

4(1176) were shopkeeper 1(294) was accountant 1(294) was

engineer 1(294) was doing job 1(294)was labour 1(294) was

catering 1(294) was Naturotherapyst 1(294) was Pharma 1(294)

was Singer 1(294) was Tailor 1(294) was Teacher and 1(294) was

worker

In Control group 8 (2353)were housewife 4(1176) were students

2(588) were shopkeeper 2(588) was accountant 1(294) was

engineer 4( 1176) was doing job 3(882)was labor 1(294) was

Farmer 1(294) was Lab tech 1(294) was Daily collection 1(294)

was Tailor 1(294) was Teacher and 3(882) was worker 1(294) was

Fruit seller and 1(294) Bus driver

Fig 26 Education wise distribution of patients

0

2

4

6

8

10

12

1

11

1 1 1 1 1 1

4

1

8

1 1 10 0 0 0 0

2

8

1

43

0 0 02

0

4

1 13

1 1 1 1 1

Occupation

Trial Group N Control Group N

Page | 102

4 Religion wise distribution of patients

Table no 10

Religion

Trial Group Control Group

N N

Hindu 31 9118 33 9706

Muslim 3 882 1 294

Total 34 10000 34 10000

In trial group 31 (9118) patients were Hindu and 3 (882) patients were

Muslim

In control group 33 (9706) patients were Hindu and 1 (294) patient

were Muslim

Fig 27 Religion wise distribution of patients

0

5

10

15

20

25

30

35

N N

TRIAL GROUP CONTROL GROUP

3133

31

Religion

Hindu Muslim

Page | 103

5 Diet wise distribution of patients

Table no 11

Diet

Trial Group Control Group

N N

Veg 14 4118 20 5882

Non-Veg 20 5882 14 4118

Total 34 10000 34 10000

In trial group 14 (4118) patients were vegetarian and 20 (5882)

patients were Non vegetarian

In control group 20 (5882) patients were vegetarian and 14 (4118)

patients were Non-Veg

Fig 28 Diet wise distribution of patients

0

5

10

15

20

N N

TRIAL GROUP CONTROL GROUP

14

2020

14

Diet

Veg Non Veg

Page | 104

6 Addiction wise distribution of patients

Table no 12

Addiction

Trial Group Control Group

N N

None 30 8824 27 7941

Alcohol 2 588 0 000

Tobacco 1 294 2 588

Mishri 0 000 1 294

Smoking 1 294 4 1176

Total 34 10000 34 10000

In trial group 30 (8824) patients have no addiction 2 (588) patients

have addiction of alcohol 1 (294) patients have addiction of Tobacco 0

(0) patients have addiction of Mishri and 1 (294) patients have addiction

of smoking

In control group 27 (7941) patients have no addiction 0 (0) patients

have addiction of alcohol 2 (588) patients have addiction of Tobacco 1

(294) patients have addiction of Mishri and 11 (1176) patients have

addiction of smoking

Page | 105

Fig 29 Addiction wise distribution of patients

0

5

10

15

20

25

30

NONE ALCOHOL TOBACCO MISHRI SMOKING

30

21

01

27

0

21

4

Addiction

Trial Group N Control Group N

Page | 106

Statistical Analysis and Results

Effect of study on Karnashoola-

Table no 13

Karnashoola

Group A Group B

BT AT BT AT

N N N N

Grade 2 0 000 0 000 0 000 0 000

Grade 1 30 10000 7 2333 32 10667 5 1667

Grade 0 4 1333 27 9000 2 667 29 9667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 30 Effect of study on Karnashoola

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

30

7

32

54

27

2

29

Karnashoola

Grade 2 Grade 1 Grade 0

Page | 107

Table no 14

Karnashoola Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 088 100 033 006

969 2829E-

08 7667 HS

AT 021 000 041 007

Group

B

BT 094 100 024 004

1037 7103E-

11 8438 HS

AT 015 000 036 007

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 31

000010020030040050060070080090100

BT AT BT AT

GROUP A GROUP B

088

021

094

015

Karnashoola

Mean

Page | 108

Table no 15

Karnashoola

Mean SD Effect

Group

A

Group

B Trial Control Trial Control

Day 1 088 094 033 024 000 000

Day 3 065 071 049 046 2667 2500

Day 5 024 038 043 049 7333 5938

Day 14 021 015 041 036 7667 8438

000

010

020

030

040

050

060

070

080

090

100

Day 1 Day 3 Day 5 Day 14

Karnashoola

Mean Group A Mean Group B

Page | 109

Table no 16

Karnashoola N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3250 110500

510000 275 Control group 34 3650 124100

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 110

Effect of study on Karnakandu

Table no 17

Karnakandu

Group A Group B

BT AT BT AT

N N N N

Grade 3 7 2333 0 000 4 1333 0 000

Grade 2 18 6000 0 000 18 6000 0 000

Grade 1 7 2333 7 2333 10 3333 15 5000

Grade 0 2 667 27 9000 2 667 19 6333

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 32 Effect of study on Karnakandu

0

5

10

15

20

25

30

N N N N

BT AT BT AT

GROUP A GROUP B

7

0

4

0

18

0

18

0

7 7

10

15

2

27

2

19

karnakandu

Grade 3 Grade 2 Grade 1 Grade 0

Page | 111

Table no 18

Karnakandu Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 188 200 081 015

1091 3119E-

10 8906 HS

AT 021 000 041 007

Group

B

BT 171 200 076 014

1032 4746E-

09 7414 HS

AT 044 000 050 009

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Page | 112

Fig 33

Table no 19

Karnakandu

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 188 171 081 076 000 000

Day 3 126 118 057 058 3281 3103

Day 5 071 074 046 051 6250 5690

Day 14 021 044 041 050 8906 7414

000

020

040

060

080

100

120

140

160

180

200

BT AT BT AT

GROUP A GROUP B

188

021

171

044

Karnakandu

Mean

Page | 113

Table no 20

Karnakandu N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 4051 137750

373500 006 Control group 34 2849 96850

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is less than

005 Hence we conclude that there is significant difference between Trial

Group and Control Group

000

020

040

060

080

100

120

140

160

180

200

Day 1 Day 3 Day 5 Day 14

Karnakandu

Mean Group A Mean Group B

Page | 114

Effect of study on Karnasrava

Table no 21

Karnasrava

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 11 3667 0 000 8 2667 0 000

Grade 1 23 7667 3 1000 26 8667 2 667

Grade 0 0 000 31 10333 0 000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 34

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 0

11

0

8

0

23

3

26

20

31

0

32

Karnasrava

Grade 3 Grade 2 Grade 1 Grade 0

Page | 115

Table no 22

Karnasrava Mean Median SD SE Wilcoxon

W P-Value

Effect Result

Group

A

BT 132 100 047 009

1122 4356E-

13 9333 HS

AT 009 000 029 005

Group

B

BT 124 100 043 008

1130 9364E-

14 9524 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 35

000

020

040

060

080

100

120

140

BT AT BT AT

GROUP A GROUP B

132

009

124

006

Karnasrava

Mean

Page | 116

Table no 23

Karnasrava

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 132 124 047 043 000 000

Day 3 100 100 025 025 2444 1905

Day 5 047 038 051 049 6444 6905

Day 14 009 006 029 024 9333 9524

000

020

040

060

080

100

120

140

Day 1 Day 3 Day 5 Day 14

Karnasrava

Mean Group A Mean Group B

Page | 117

Table no 24

Karnasrava N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3535 120200

549000 655 Control

group 34 3365 114400

Total 68

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Page | 118

Effect of study on Karnabadhirya

Table no 25

Karn

Badhirya

Group A Group B

BT AT BT AT

N N N N

Grade 3 0 000 0 000 0 000 0 000

Grade 2 0 000 0 000 0 000 0 000

Grade 1 13 4333 0 000 16 5333 2 667

Grade 0 21 7000 34 11333 18 6000 32 10667

TOTAL 34 11333 30 10000 34 11333 34 11333

Fig 36

0

5

10

15

20

25

30

35

N N N N

BT AT BT AT

GROUP A GROUP B

0 0 0 00 0 0 0

13

0

16

2

21

34

18

32

Karnabadhirya

Grade 3 Grade 2 Grade 1 Grade 0

Page | 119

Table no 26

Karn

Badhirya Mean Median SD SE

Wilcoxon

W P-Value

Effect Result

Group

A

BT 038 000 049 009

799 7173E-

05 10000 HS

AT 000 000 000 000

Group

B

BT 047 000 051 009

816 0000138 8750 HS

AT 006 000 024 004

Since observations are on ordinal scale (gradations) we have used Wilcoxon

signed Rank Test to test efficacy in Trial Group and Control Group From above

table we can observe that P-Value for Trial Group and Control Group is less

than 0001 Hence we conclude that effect observed in Trial Group and Control

Group is highly significant

Fig 38

000

005

010

015

020

025

030

035

040

045

050

BT AT BT AT

GROUP A GROUP B

038

000

047

006

Karnbadhirya

Mean

Page | 120

Table no 27

Karn

Badhirya

Mean SD Effect

Group A Group B Trial Control Trial Control

Day 1 038 047 049 051 000 000

Day 3 009 006 029 024 7692 8750

Day 5 003 006 017 024 9231 8750

Day 14 000 006 000 024 10000 8750

000

005

010

015

020

025

030

035

040

045

050

Day 1 Day 3 Day 5 Day 14

Karn Badhirya

Mean Group A Mean Group B

Page | 121

Table no 28

Karn

Badhirya N

Mean

Rank

Sum of

Ranks

Mann-

Whitney U

Asymp Sig

(2-tailed)

Trial group 34 3400 115600

561000 806 Control

group 34 3500 119000

Total 68

Page | 122

COMPARISION BETWEEN GROUP A AND GROUP B

We have used Mann Whitney U-Test for comparison between Trial Group and

Control Group From above table we can observe that P-Value is greater than

005 Hence we conclude that there is no significant difference between Trial

Group and Control Group

Table no 29

Overall Effect

Trial Group Control Group

N N

Marked Improvement 21 6176 16 4706

Moderate Improvement 8 2353 13 3824

Mild Improvement 4 1176 5 1471

No Change 1 2941 0 0

TOTAL 34 100 34 100

Fig 39

0

5

10

15

20

25

MARKED IMPROVEMENT

MODERATE IMPROVEMENT

MILD IMPROVEMENT NO CHANGE

21

8

41

1613

5

0

Overall Effect

Trial Group N Control Group N

Page | 123

DISCUSSION

Page | 124

Discussion is nothing but the logical reasoning of observations In

every research work discussion part is very important because it brings into

light about the logical analysis which are helpful in filling the research gap in

the scientific world

The discussion is categorized into following ways for the ease of

understanding

1 Discussion on selection of topic

2 Discussion on review of literature

3 Discussion on drugs their mode of action on the disease mode of action

of Karnadhoopana

4 Discussion on observation and results

1 Discussion on selection of topic

Otomycosis is commonly encountered in day-to-day practice Majority

of Indian people affected with this pathology This disease commonly

manifests in developing countries low socio-economic standard and lack

of hygiene Now a days due to busy lifestyle people are not able to follow

the proper instruction of care of ear which may be responsible for the

recurrent nature of disease So for the management of this we use

Karnadhoopana with the help of Agaruwadi Varti Dhoopana is simple

easy cost-effective procedure which can be done even at OPD levelso

for the disease Karnasrava we selected Karna Dhoopana as therapeutic

procedure Karnadhoopana was done with Agaruwadi Varti and Guggula

Varti which was very effective for treatment

Page | 125

2 Discussion on review of literature

Karnasrava is one such disease among 28 Karnarogas mentioned by

Acharya Sushruta in the chapter named Karna Roga Vigyana Acharya

Charaka included Karnasrava as symptom under the four types of

Karnarogas due to vitiation of different doshas Acharya Vagbhata has

not described Karnasrava separately It is a fact that systemic

description of Karnarogas is available in all the ancients of pus from a

Vata afflicted ear may results from head injury or immersion in water

Karnasrava is a clinical entity which can be correlated with Otomycosis

Karnasrava is explained as symptom as well as a disease in Ayurveda

Nidana- Karnasrava occur due to Samanya Nidana and Vishesh Nidana

Vishesh Nidana like Shirobhighata Nimmajato jale Mithyayoga of Shashtra

The exact pathology behind Karnasrava is not understood clearly

Purvarupa ndash No specific Purvarupa are found for Karnasrava in classical

literature Acharya Madhukara describe Purvarupa as expression of

Rupa(lakshana) with less intensity that is less intensity itching sound in ear

may considered as Purvarupa of Lakshana

Samprapti- Aacharya Sushruta not explained the Samprapti of Karnasrava

separately and we must consider the general Samprapti of Karnaroga Due to

various aetiologias as cited above ear afflicted by Vata dosha causes Twak

Rakta Mamsa dushti results in Karnasrava According to Acharya Sushruta

Vata-Kapha dose is dominance in Karnasrava

Page | 126

Nidan

Nija Agantuja

Vata ndash kapha prakopak nidana Shirobhighata Nimmajato-jale

Mithya yoga of Shastra

Vata- kapha Prakopaka(Chaya prakopak) Vata-kapha prakopaka

( Achay prakopak)

Twak Rakta Mamsa dushti

Karnasrava

Page | 127

Chikitsa

The curative aspect and this must be done simultaneously giving due

importance to Nidan Parivarjana that is preventive measures So Nidan

Parivarjana that is avoidance of causative factors like Jalkrida Mithyayogen

shashtrasya Karnakandu Shirasnan Pratishaya is the first step in combating

the disease and form the part of line of treatment

Above Samprapti helps us to proceed towards the treatment of Karnasrava

The main protocol of treatment is removal of fungus and wound management

which include various measures to keep area day clean clear of microbes and

providing ideal condition for healing

Samany Chikitsa- Acharya Sushruta described general treatment for

Karnaroga as Snehapana (Drinking ghee) Rasayana (Rejuvenation therapy)

Bhramacharya Avoid excessive speaking Avoidance of physical exercise and

head bath

Vishesha Chikitsa ndash Acharya Sushruta mentioned some procedures in the

treatment of Karnasrava which is Shirovirechana Karnadhoopana

Karnapurana Karanpramarjana Dhavan Avachurnana Karnapurana Above

various procedures described in Ayurveda for management of fungus growth

in ear discharging ear fulfill these requirements of wound management

Page | 128

Discussion on observation and Result

Out of 68 patients 34 patients included for the trial The incidence of

Karnasrava is observed in trial and control groups

The statistical analysis provided the following data

AGE

Trial group- Maximum no of patients that is 14 (41176) patients were from

age group 25-35 years followed by 29412 patients were from age group

18-25 years 23529patients were from age group 35-45 years and

58824 patients were from age group 45-60 years

Control group - Maximum no of patients that is 14 (41176) patients were

from age group 25-35 years followed by 20588 patients were from age

group 35-45 years and 20588 patients were from age group 45-60 years

17647 patients were from age group 15-25 years

The maximum no of cases of Karnasrava found in age group between 25 to

35 years The reason behind this is repeated use of ear bud or emersed water

in ear More use of earphone or working more in cold environment

GENDER

Trial group ndash A higher prevalence seen in females 6764 and 3235 in

males

Control group - A higher prevalence seen in males 5588 and 4411 in

females

Females and males both are prone to disease

Page | 129

EDUCATION

Trial group-It is observed that amongst 34 patients maximum ie16

(47059) patients were graduated 8 (23529) patients were HSC

educated 4 (11765) patients were SSC educated 4 (11765) patients

were illiterate 1 (29412) patient were primary educated and 1(29412)

patient were post graduated

Control group- It is observed that 10 (29412) patients were graduated 9

(26471) patients were HSC educated 6 (17647) patients were post

graduated 3 (88235) patients were SSC educated 3 (88235) patients

were primary educated3 (88235) patients were illiterate

There is no direct relation between education and Otomycosis

RELIGION

Trial group- The incidence of patients of Hindu religion are 9118 and Muslim

religion are 882

Control group- The incidence of patients of Hindu religion are 9706 and

Muslim religion are 294

There is no probable explanation for this maximum number of patients in

Hindu religion it depends upon the patients attend the hospital and

community residing there

Page | 130

DIET

Trial group It was found that maximum ie5882 patients were taking

mixed diet while 4118 were taking vegetarian diet

Control group It was found that maximum ie5882 were taking

vegetarian diet while 4118 patients were taking mixed diet

The dietary habit of person is based on choice availability and religious

customs of the person

ADDICTION-

Trial group- It was found that maximum ie 30 (8824) patients have no

addiction 2 (588) patients have addiction of alcohol 1 (294) patients

have addiction of Tobacco 1 (294) patients have addiction of smoking and

0 (0) patients have addiction of Mishri

Control group - It was found that maximum ie 27 (7941) patients have

no addiction 4(1176) patients have addiction of smoking 2 (588)

patients have addiction of Tobacco 1 (294) patients have addiction of

Mishri and 0 (0) patients have addiction of alcohol

Very few patients were addicted to Alcohol Smoking Tobacco and Mishri

These factors can be taken as provoking factors for Otomycosis

Page | 131

Discussion based on probable Mode of action of Karnadhoopana

In Ayurveda classics Karna Dhoopana is therapeutic procedure explain for

Karnasrava Dhoopana is administration of Dhooma (Fumes) with the help of

Dhoopan Dravya References indicates that analgesic and disinfectant effect

of Dhoopana karma and mention for Dushta Vrana Chikitsa It reduces

Vedana Srava amp also does Vrana Ropana action

Various Dhoopanas and Dhoopan Dravas for different element in various

Samhitas of Ayurveda but there is a lacuna of availability of reference

regarding how to do it and method of procedure Matra Kala Contraindication

etc

Currently simple modified way of Karnadhoopana according to Yukti Praman

and experience but there is lac of standardization

Karnadhoopana is one among the topical Bahiparimajan type of treatment

Karna Parmarjana is procedure of cleaning ear with the help of cotton or gauze

piece soaked in honey

Page | 132

Dhoopan

The fumes coming out on burning Agaruwadi Varti

Administrated directly into external ear canal

Causes vasodilation

Due to this increase blood supply in external ear canal

It helps in absorption of drug

Fumes dries up Srava and bring the analgesic effect

Karnagata Kapha amp Avrut Vata Dosha Shaman

Decrease in signs and symptoms like karnasrava Karnshool Karnabadhirya amp

Karnandu

Page | 133

3 Discussion based on probable mode of action of Agaruwadi

Dhoopana

Agaru ndash

I Agaru is a fragrant tree aroma is a result of fungal pathogenesis when the

wood of tree is contaminated by fungi at wounds it develops scrap filled

with resin and turn out to be aroma Medicinal use of Agaru have been

recorded in ancient medicinal science in in inflammatory disease and some

infective disease

II Acharya Charaka has referred to Agaru as an Ushna dravya despite having

Tikta Rasa Ashtang Samgraha used Agaru as Dhupana Dravya along with

Madan and Yawa in Karnasrava Nighantu recommended is use as a

Dhoopana

III In various Samhitas and Nighantus Agaru described as Tikta Snighdha

Sheetaprashamana Vranaprasadana Tvachya Due to these properties

Agaru is used in the treatment of Karna-Akashi Roga and Dushta Vrana

Shodhaka

IV Agaru is reported to have Antimicrobial Analgesic Antioxidants

Antihistaminic and anxiolytic properties Its Antihistaminic property gives

relief from itching which is cardinal feature of Otomycosis Due to Katu

Ushna Tikta Guna improves blood circulation Bheda stage develop It is

Niram Awastha of Dosha Karnagata kapha and vata get decrease and

symptoms like karnashoolakarnasrava get decrease Agaru also have a

Antioxidant properties

V Chemically Agaru Contain 2-(2-Phenylethyl) Chromones Terpenoids

Flavonoids

VI Natural Agarwood had inhibitive activities towards Staphylococcus Aures

The chloroform extract of Agarwood prolongs the pain threshold[108]

Page | 134

Madan

I Madanphala have therapeutic properties like Anti-inflammatory

Antiallergic Analgesic and Wound healing

II It is Useful in treatment of disease like Shotha (inflammation) Vidradhi

(Abscess) Pratishaya (Common cold) Kushta(Skin disease)

III Extract of Madanphala mainly contain Glcosides Tritorpenct

Glycosides Saponin

IV Saponin glycosides are act as fire extinguisher This property is helpful

for vartiIt also act as a detergent which clean the surface of fungus

V Tritorpenct act as a anti-inflammatory antimicrobial and

immunomodulator compound Interaction of glycosides with sterol

causes disturbance of selective permeability in plasmic membraneso

exudates and discharge get decrease

VI Pharmacological activity [109]

Antibacterial Activity The preliminary antibacterial activity of Methanolic

extract of Randia D lam was done on some standard and wild pathogenic

strains The inhibition of the bacterial growth was more pronounced on E coli

as compared to the other tested organism This shows the antibacterial action

of Randia D secondary infection can prevent

Anti-Allergic Activity In Ayurveda Randia D Extract and its fraction of milk

induced leukocytosis and eosinophilia in mice

Anti-Inflammatory Activity The crude methanol extract of fruit of Randia D

effectively reduced the carrageenin induced oedema in hind paw of the rats

significant reduction in granular tissue formation was recorded This activity

seems to be significant at various acute phases of inflammation and om

formation of granular tissue This proves action of Madanaphala in shopa

(inflammation)

Page | 135

Analgesic Activity Analgesic activity was tested in mice weighing between 20-

250 with six number of animals in each group Methanlic extract of fruit Randia

d give analgesic activity in both models This proves its Shoolanashaka (pain

killer) action

Immunomodulatory Activity Randia D has immunostimulant activity and

chloroform fraction which strongly affected immune system seems to be

bioactive fraction of this plant

The overall effect of Agaru Mandanphala Yawa having Anti-inflammatory

Antiseptic Antimicrobial Property Active ingredient shows these properties

Agaru Yawa Madanphala

Vatakaphaghna

Act as

Vranashodhak

Vedanasthapaka

Sheetaprashamana

Shothara

Avarana of Vata get decrease so helps to Shaman of Vata dosha

Karnakandu Karnashoola Karnasrava

Prashamana

Page | 136

This fact can be taken into consideration and probably acknowledge that

Karnadhoopana with Agaruwadi Varti had not leave any residue in the ear

Removal of fibrin keratinocyte migration and in growth of epithelial tissue

plays a major role in healing It is technique of fumigation of ear with the

smoke of anti-infective drug In Karnadhoopana Sthanik Swedana increase the

blood supply and helps in absorption of the drug reduce Karnakandu amp

Karnshoola associated with infection

Page | 137

SUMMARY AND CONCLUSION

Page | 138

The dissertation entitled randomize comparative clinical trial to study the

effect of Agaruwadi Karnadhoopan and Guggula Karnadhoopan In Karnasrava

wsr to Otomycosis

The dissertation is divided into fallowing parts

Introduction

Review of literature

Ayurvedic review

Modern Review

Drug review

Procedure review

Material and Method

Observation and result

Discussion

Summary and conclusion

bull INTRODUCTION

It includes importance of Shalakyatantra in Sushrut Samhita Charka

Samhita And Ashtang Samgraha

Common and specific causes of Karnasrava

Karnasrava is a clinical entity which can be corelate with Otomycosis

In Ashtang Samgraha stated the procedure like Karnadhoopana with

Agaru Yawa Madanphala in Karnasrava

Page | 139

bull REVIEW OF LITERATURE

1 Ayurvedic review

2 Modern review

3 Drug review

Ayurvedic review-

It includes Rachana-Sharir and Kriya-Sharir of Karna detail description of

Karnaroga and its types Karnaroga Samanya hetu Poorvaroopa Rupa

Samprapti Upadrava Pathya-Apathya of Karnasrava Vishesh Nidan and

Chikitsa of Karnasrava Detail description of Karnadhoopana according to

various Acharays have been mentioned

Modern review-

It includes anatomy and physiology of Ear brief anatomy of ear anatomy of

External middle and Internal ear Detail description of the disease

Otomycosis mechanism of fungal infection in external canal pathophysiology

investigations diagnosis and management

Drug review-

Detail description of Agaru Yawa Madan Guggula and its synonyms

Ayurvedic properties Karma uses Pharmacological action and their

pharmacodynamic properties

Page | 140

MATERIAL AND METHOD

It includes description regarding materials required for the study Preparation

of Agaruwadi Varti its Standardization Sterilization and packaging

Plan of study

1 Total 68 patients completed the treatment Age criteria was kept

between 18-60 years Patient selection was done by done by simple

random sampling method and divided into two groups A (Trial) and

Group B (Control) 34 patients in each group

2 Patients in Group A were treated with Karnadhoopana with Agaruwadi

Varti for 7 days two times in a day while patients in Group B were treated

with Karnadhoopana with Guggula for 7 days two times in a day

3 Clinical examination done during each follow up ie 0th 4rd 7th and

observation were recorded

Page | 141

OBSERVATIONS AND RESULTS

Page | 142

1 It was observed that higher incidence of disease Karnasrava ie

Otomycosis found in age group 25-35 years

2 Disease otomycosis was equal in both male and female

3 The trial group there was significant relief in Karnakandu (8906)

Karnasrava(9333) Karnashoola(7667) and karnabadhirya(100)

4 In control group there was significant relief in Karnakandu (7414)

Karnasrava(9524) Karnashoola(8438) and

karnabadhirya(8750)

Page | 143

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Page | 144

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BIBILOGRAPHY

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Page | 158

ANNEXURE

Page | 159

ANNEXURE- 1

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

CASE RECORD FORM

RESEARCH PROFORMA FOR MS (AYU) DESSERTATION

DEPARTMENT OF SHALAKYATANTRA

NAME -

ADDRESS -

GENDER - AGE - OCCUPATION-

RELIGION - EDUCATION - MARITAL STATUS-

OPD IPD NO-

DATE OF ADMISSIONCOMMESEMENT-

DATE OF DISCHARGECOMPLITION-

DATE OF COUNSELLING-

TEL NO-

CHIEF COMPLAINTS-

PAST MEDICAL AND SURGICAL HISTORY-

TREATMENT HISTORY-

FAMILY HISTORY-

Page | 160

PERSONAL HISTORY-

a) Ahar(Diet)

b) Vihar

c) History of addiction

GENERAL EXAMINATION

PULSE - MIN BP - mm of hg

TEMP - 0F RR - MIN

ASHATAVIDHA PARIKSHANA

Nadi- Mutra- Mala-

Jivha- Shabda- Sparsha-

Drik- Aakruti-

SYSTEMIC EXAMINATION

RS ndash

CNS-

CVS ndash

Page | 161

LOCAL EXAMINATION (KARNA PARIKSHAN)

OBSERVATION TABLE FOR SUBJECTIVE CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching )

RIGHT EAR LEFT EAR

KARNASHASHUKULI

KARNAPUTRAK

KARNAPALI

KARNAKUHARA -

SRAVA

GANDH

VARNA

SWARUPA

KARNAPATALA (TM)

Page | 162

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

Hearing Test

1Renne Test ndash

2 Weber Test -

Examination of Ear-

Pathological Investigation-

Other Examination-

Nidan Panchak-

1Hetu-

2Purvarup-

3Rupa-

4Upashayanupashaya-

5Samprapti

Signature of Guide Signature of Doctor(Researcher)

Page | 163

ANNEXURE 12

PREPARTION OF DRUG

Standard Operating Procedure (SOP) of Agaruwadi Dhoopana Varti

STEP 1 - Agaru Madan and Yawa these raw drugs were purchased from

authentic source

STEP 2 - Sterilization were done as recommended in pharmacy procedure

The raw drugs were authentified and standardize from certified lab

STEP 3 - Powder of above drugs having mesh size of 100 were mixed together

in equal quantity to make Agaruwadi churn

STEP 4 - Agaruwadi churn were triturated with appropriate quantity of water

and prepared Varti in GMP Certified Ayurvedic pharmacy Standard aseptic

precaution was taken during preparation of Varti

STEP 5 - Agaruwadi Dhoopana Varti was packed in sterile air packed

container

STEP 6 - Agaruwadi Dhoopan was given with the help of Dhoopan yantra

TREATMENT DETAIL-

Purvakarma -

1 The patient is asked to sit comfortably on chair having sufficient light and

less amount of dust

2 The EAC is cleaned thoroughly by Pichu Varti (cotton swab) to remove the

discharge and other debris

Pradhankarma -

1 The patient is asked to relax completely on the chair

Page | 164

2 Fumes are passed to the ear with Dhoopana Yantra

3 Dhoopana yantra is funnel shaped and its one end will keep the ear covered

for the passage of Dhooma into the ear canal and other end where Agaruwadi

Dhoopana Varti were placed which produces fumes

4 This Dhoopana was given for 5 min

Pashchat karma -

1 The patient were advised to avoid cold refrigerated food drinks cold water

bath cold wind fog and prevent water from entering the ear

(A) Agaruwadi Dhoopana Varti

B) Guggula Dhoopana Varti SOP of it is same as above Agaruwadi Dhoopana

Varti

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Drug Agaruwadi Varti

Route of administration Local

Kriyakalpa Karna Dhoopana

Dose two times a day

Duration 7 days

Page | 165

ANNEXURE 21

INFORMED CONSENT DOCUMENT

Study Title

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

Introduction

- You are invited to take part in a research study RANDOMSIED COMPARATIVE

CLINICAL TRIAL TO STUDY THE EFFECT OF AGARUWADI DHOOPANA AND

GUGGULA DHOOPANA IN KARNASRAVA

- Before you decide it is important for you to understand why the

research is being done and what it will involve

- Please take time to read the following information carefully and discuss

it with friends relatives and your doctor if you wish

- Ask us if there is anything that is not clear or if you would like more

information

Purpose amp Nature of Study

- In this research project by examine you and ldquoKarnasravardquo (Otomycosis)

disease were treated

- In the part of treatment Agaruwadi Dhoopana or Guggula Dhoopan were

given

- Dhoopana means medicated drug fumes were given in ear with the help of

Dhoopan Yantra

Page | 166

- Treatment was given for 7 days

Study Duration

7days

Participation

- Your participation is entirely voluntary

- If you do decide to take part you were given this information sheet to keep

and be asked to sign a informed consent form

- If you decide to take part you are still free to withdraw at any time and

without giving a reason This will not affect the standard of current or future

medical care you may receive

Confidentiality

- All information which is collected about you during the research were

kept strictly confidential

- Any information about you which is collected from the center will have

your identity in the form of a code number so that it will remain confidential

Benefits Of Study

- The results obtained from this study would be helpful for providing better

quality of treatment amp other essential facilities for Karnasrava (Discharge)

patients

- You will get clinical benefit from the study

Page | 167

Risks Of Study

- In this treatment there are few chances of Irritation of Ear Nose and

congestion at EAC if any of these happens then treatment were given

Results Of Study

- If the Results obtained are profitable then they may get published

without disclosing your details

Signature of patient

Date

Time

Phone no of Researcher

Page | 168

रण मादहती पतरक

सशोिनाच शीषवक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE

EFFECT OF AGARUWADI DHOOPANA AND GUGGULA DHOOPANA

IN KARNASRAVA

परसतताना

- आपणास या सशोिनातपमक अभयासात सहिागी होणय़ाच आाहन करणयात यत आह

- सशोिनातील सहिाग तननदशचत करणयापी सशोिनाच उददश समजन घया

- खालील मादहती काळजीपवक ाचा आणण आशयक ािलयास आपलया डॉकिराशी कका

दहतशरचतकाशी चचाव करा

- काही सददिता असलयास कका आणखी मादहती ही असलयास आमछयाशी चचाव करा

सशोिनाच उददीटि सतरप

- सदर सशोिन परकलपामरधय आपलयाला तपासणी करन कणवसरा या वयाशरिची शरचककतपसा दणयात

यणार आह

- सदर वयाशरिची शरचककतपसा महणन आपणास अगरादी िपन कका गगल िपन

दणयात यणार आह

- सदर औषि आपणास 7 ददस घयायाच आह

Page | 169

कालािी

- 7 ददस

सहिाग

- आपला सहिाग हा पणवपण ऎनदछिक आह

- आपला सहिाग तननदशचत असलयास आपणास ही मादहती पतरतरका दणयात यईल आपणास यातील

समती पतरकार सही कराी लागल

- सहिाग तननदशचत असनही आपण कोणतपयाही ळस कोणतही कारण न दता माघार घ शकता

याचा आपलया दयकीय सविर कोणताही पररणाम होणार नाही

गोपनीयता

- सशोिना दरमयान गोळा कलली आपलया वषयाची सव मादहती गोपनीय ठणयात यईल

- आपली यनदकतक मादहती साकततक सतरपात गोपनीय ठणयात यईल

सशोिनाच फ़ायद

- सशोिनाच तनटकषव कणवसरा बाशरित रणाछया दयकीय इतर सविाचा दजाव सिारणयास

फायदशीर ठरतील

सशोिनातील जोणखम

- य़ा शरचककतपसमरधय कान दखण डॊळय़ातन नाकातन पाणी य़ण नाकात जळजळण डोक जड

होण ही लिण ददस शकतात यापकी लिण तनमावण झालयास तपयाची शरचककतपसा कली जाईल

Page | 170

सशोिनाच तनटकषव

सशोिनाच तनटकषव फ़ायदशीर ठरलयास आपली मादहती गोपनीय ठन परकाशशत करणय़ात यईल

रण सतािरी-

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

Page | 171

ANNEXURE 31

INFORMED CONSENT FORM

Patient OPD no __________

Subjectrsquos Identifier

Date of Birth Age Gender

I _____________________________________ age___________ years

exercising my free power of choice hereby give my consent to be included

as a participant in the clinical study entitled

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

1 I confirm that I have read have been read and understood the information

sheet for the above study and can ask questions

2 I understand that my participation in the study is voluntary and that I am

free to withdraw at any time without giving any reason without affecting my

medical care or legal rights

3 I understand that the Ethics Committee members investigators and study

doctors will not need my permission to look at my health records both in

respect of the current study and any further research that may be conducted

in relation to it even if I withdraw from the trial I agree to his access

However I understand that my identity will not be revealed in information

released to third parties or published

4I agree not to restrict the use of any data or results that arisefrom this study

provided such a use only for scientific purpose

5 I agree to take part in the above study

Page | 172

signature with Date-

Left hand thumb impression

Name amp signature of the witness ndash

Name amp signature of the student ndash

Page | 173

ANNEXURE 32

समतीपतरक

RANDOMSIED COMPARATIVE CLINICAL TRIAL TO STUDY THE EFFECT OF

AGARUWADI DHOOPANA AND GUGGULA DHOOPANA IN KARNASRAVA

वयकतीच य

ददनाक जरमददनाक

1) मी ह तननदशचत कररत आह ककसदर सशोिन परकलपाबाबतची सपणव मदहती मी ाचली असनमला ती

समजली आहतपयाबददल मला परशन वचारणयाची पणव मिा आह सदर मादहतीन माझ समािान झाल

आह

2) मी सदर सशोिनातन माझया मजीनसार किीही बाहर पड शकतो या माझया अशरिकाराची मला कलपना

आह

3) माझी दयककय मादहती तपासणयाची कागदपतर कळ सशोिनाकररता ापरली जाणार आहत याची

मला मादहती आहसदर सशोिन परकलपातील सबशरित घिकाना माझी दयककय मादहती पाहणयाची मी

समती दत आहतरावप या सदिावतील माझी ओळख दशववणारी मादहती कोणासही ददली जाणार नाहीयाची

मला कलपना दणयात आली आह

4) सदर अभयासातन शमळणारी मादहती अरा तनटकषव कळ शासततरीय हतसाठी ापरल जाणयासाठी माझी

समती आह

5) रील अभयासात सहिागी होणयास माझी समती आह

रण सतािरी-

Page | 174

ददनाक-

ळ-

सशोिकाचा दररधतन िमाक

ASSESSMENT CRITERIA

Sr no Subjective

criteria

Day 1 Day 4 Day 7 Day 15

1 कणवशल

(pain)

2 कणवकणड

(Itching)

3 कणवसततरा

(Discharge

)

4 बाशरियव

(conductiv

e

Deafness)

a) कणवशल ( pain )- 0 - Absent

1 ndash Present

Page | 175

b) कणवकणड (Itching)- 0 - Absent

1 - Mild- Intermittent or occasionally

2 - Moderate-frequently

3 - Severe-continuous

c) कणवसततरा ( Discharge )

0- Absent

1-Mild- Scanty secretion near Tympanic membrane Brownish Blackish

White

2 - Moderate - secretion irrigating in ear canal BrownishBlackishwhite

3- Severe - secretion coming out of ear canal BrownishBlackishwhite

d) बाशरियव ( conductive Loss of hearing )

0 - Present

1 - Absent

Page | 176

Page | 177

Page | 178

Page | 179

Page | 180

CERTIFICATE OF ANALYSIS OF AGARUWADI VARTI

Page | 181

CERTIFICATE OF ANALYSIS OF GUGGULA VARTI

Page | 182

AUTHENTIFICATION CERTIFICATE