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S.N.lnstitute of Ayurvedie Studie» & Research. fluthur, Kollam ~/

Professor. Dept. of Rasasarra and Bhaishajy« Kalpana, ALN Rao Memorial Ayurvcdic Medical College, Koppa. DIS- Chikkamnuglore

To evaluate the clinical efficacy of Sila Sindooradi Vari on PCOS.

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PRINCIPAL FEATURES OF POLY CYSTIC OVARIAN SYNDROME • Hyper Androgenism -1 lirsuitism, acne,

obesity, menstrual irregularity and infertility, • Insulin Resistence - Increased blood glucose

levels and insulin levels. In Ayurveda - PCOS is an anukta disease, but

11 rs correlated with some of the Vimshathi Yoni vyapada. AJMS AND OBJECTIVES

Vyadhis and Medovriddhi Vikaras. So I have chosen Poly Cystic Ovarian disease, which can be explained as Amajanya and Meclho Vriddhi Vikara.

Poly Cystic Ovarian Syndrome is one of the common non communicable Female disease, occurrence of which is stepping up among the scenario. Important demographic and economic changes are occurring in India. Increased migration from villages to cities, so increased urbanization and mechanization that caused adverse life style changes. nutritional imbalance, physical inactivity and stress. These changes resulted in increased risk of Diabetes. Hypertension, Menstrual disorders like PCOS etc in developing countries.

Poly Cystic Ovarian Syndrome is defined as multiple, small, peripheral follicles associated with clinical and metabolic features.

INTRODUCTION Ayurveda is the ancient medical science

which provides comprehensive model or holistic health care for achieving health and harmony to an individual on physical, mental and spiritual aspects.

Rasa sastra is considered as an advanced branch of Ayurvcdic system of medication. which deals with Mercury, metals and minerals.

Rasa chikiisa is more effective among other treatments like herbal and surgical treatments. known as Daivi chikitsa - by its qualities.

Though Rasa dravyas are toxic substances. it acts like nectar - after proper sodhana and marana processes i.e. purification and size reduction processes.

Arsenic preparations are more effective even in minute doses. It acts as aphrodisiac and eradicates bacterial and viral infections.

Koopi pakwa is one of the Rasa preparation. in which the medicine is prepared in glass bottle. in order to enhance the potency of Mercu 1 y by ino eased proportions or Gandhaka jarana,

Sila Sindoor Ras is one of the Koopi pakwa preparation, contains Parada. Candhaka and Manasila.

The available Rasa Sastre literature will not be accepted by rhis modern world until we prove it with clinical evidences. Hence I felt that Clinical evaluation of Sila Sindoor is needed.

According lo Rasa Tantra Sarva Siddha Prayoga Sangraha, Sita Sindoor is effective in Arna janya

CLINICAL EVALUATION OF SILASINDOORADI VAT! ON POLYCYSTIC OVARIAN DISEASE

Or. B. I. Mathapati

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,~ S.~.lnstitute of Ayurvedic Studies&. Research. Puthur, Kollam

l Decreased sex hormone binding globulin

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In PCOS cysts are actually nor cysts, bur are immature follicles. Physiologically - Around 20 follicles mature each month and only a single follicle is ovulated. If a mature follicle doesnor become adorninat follicle. it preabsorbed into the ovary. In PCOS this reabsorption does not occur . Higher GnRH- Increase LH/FSI I ratio. Lh is responsible for steroidogenesis (androgens). producing androsrenadoinc and testosterone. FSH is responsible for converting androgens into oestrogens i.e. Oestradiol. oestrone, oestriol. Oestrogens are bound to albumin - 30°u, Sex Hormone binding Globulin - 69°0 and I'~ is biologically active. Increased GnRH

l Increased LH/FSI I ratio stimulates

l Ovary to produce

l Excessive testosterone

• PATHOPHYSIOLOGY

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Anovulation resulting in irregular menstruation. amenorrhoea, ovulation related infertility, poly cystic ovaries. Excessive Androgenic I Iorrnones - resulting Acne & Hirsuitism. Insulin Resistence - often associated with obesity. Type 2 diabetes. I Iigh cholesterol levels.

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syndrome, Ovarian hypenhecosis, sclerocysuc ovarian syndrome, Iunct ional ovarian hyper androgenism.

THE PRJNCJPAL FEATURES

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PCOS is the most common female Endocrine disorder; IL is a complex, heterogeneous disorder of uncertain etiology, Genes. environment. poor dietary choices and physical inactivity contributes co PCOS. PCOS produces symptoms at reproductive age 1e .. 12 - 45 years. Synonyms: PCOD. Stein Leventhal

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Vipaka Kalu Karma Vamya, Saraka, Lekhana

It is very effective in Swasa Kasa. Medoroga, Kushta, Visarpa, Kanthamala and Rakta Vikaras .. It is very effective in medo rogas by its Katu, Lekhana and Kaphaghua pro pen ies. h does Arna pachana which is located in arnasaya by its Saraka and Snigdha gunas. DISEASE REVIEW - MODERN ASPECT

Guru, Ushna Cuna

• Preparation of Vati: HY adding equal quanriry of Satapushpachooma and trituration with Varuna rwak Kashaya

SILA SINDOORA RASA It is a Koopipakwa Rasayana, prepared mainly

with Parada. Candhaka and Manahsila. Manahsila is the main ingredient and has the properties: -

Ras a Tikca

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• Name of the Drug: Sita Sindooradi \'ali Reference: Rasa Tantra Sarva Siddha Prayoga Sangraha Ingredients: Parada. Candhaka, Manahsila in 2:2: I ratio. Method of Preparation: Koopi pakwa vidhana by Bahirdhoorna technique Time of preparation: 48 Hrs

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• To provide safe. economical, non-surgical, non-hormonal and side effect free multi model management or PCOS, the present study has been selected and designed.

DRUG REVIEW

Quarterly Medical Journal July- September 2016

S, '-.lnslitUIC or A) urvedic Studies & Research, Puthur, Kollam ~ (>

• r reparation of Sila Sincloor Vati includes 2 main steps. I repararion of Silasindoor Rasa by Koopipakwa V1Cl11ana for 48 Hrs 111 Bahirdhurna technique.

2. Preparauon or Vati (capsule) - by adding

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• So. when \g111mandya and Amarva are corrected, there will be proper metabolism. The Insulin will be absorbed and utilized - decreased glucose levels - raised liver SHBC. - decreased formation of free Androgens and Oestrogens - decreased PCOD

rHARMACEUllCAL STUDY

MANAGEMEl\T

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• TI1e modem anology of Pradushrartava rs PCOD. In PCOD we find ohgomenorrhoea or amenorrhoea with anovulation. Development and rupture of follicles is improper. 011c to Amatva, there ts no paka of follicles to gel ruptured. Due to Dhatwagni Mandya - Improper production of enzymes and Pormones will rake place.

• Due to Amarva. the dhatupadhaiu are nor properly formed and Arna circulates in the body. hampering proper absorption.

Aparhyaahara Vihara Sevana-+ Arna --+ Insulin is not utilized properly - Hvper insulinemia __,. inhibits SHl~G - Increased free androgens and oestroaens=-« PCOlJ • Here 111 PCOD. there is I Ivper lnsulinacrnia

alonawuh raised blood glucose levels as insulin is nor utilized. may be due to Amartavam.

• This increased Insulin. inhibits formation of SI !BG (Sex 1 lormone Binding Globulin) lrom uver. thus mcrcasmg free Androgens and Oestrogens. uh imately leading to PCOO.

CONCEPT OF AGNI ANO AMA IN PRADUSI ITA AARTAVA Will I SPECIAL REFERENCE TO PCOO

Rasa dushti is caused by Arna. which is in the result of Agnimandya. Agnimandya - Apakwa aadya Rasa - Arna - Saarna Rasa - Pradushtartava.

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I lvper androgerusrn Sapraja vandhyarva Vvana. Apana Vavu dushti Sthoulya, \'dtak.ipha Samyukta Waist Hip ratio disproportion Medoja granthi Pradushta artava means "utkarshena vaikalvarn" - abnorrnahrv in excess. Aartava dushri: 'Vara puta slesnma kunapagrandu poori poova kshccna rnootra purcesha rerasha prajopadane 114.1 samarrho bhavaruhi' All the Anhava dushus are caused by Rasa dusht i. <b Rajas is the upadharu of Rasa dhatu

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• udavartmi • Pradara

• Anarrava/Nastartava

• Viphala aarrava dushn • Aartava kshava

NEAREST AYURVEDIC TERMINOLOGY

• Anovulatory menstrual cycles • Oligomenorrhoca • Amenorrhoea • Dy~me11011 hea • vlenorrhagia • I lyperandrogenisrn • rnfertilitv • PCOD wuh Insulin resistance • Obesitv

Poly cystic ova: y

t\YURVEDIC CONCEfYf

PCOS ASSOCIATED SYMfYTOMS

Increased free andro~cns- Hyper androgeuisrn with free back mechanism again raised l.H1FSH ratio

! Decreased follicle growth

! Multiple small follicles

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7 ~~ ~ S.N.lnslitule of Ayurvcdk Studies & Research, Puthur, Kellam

The commonly used history taking procedure and Ayurvedic parameters are merged into the proforma and laboratory reports are also included within. Drug: Sila Sindooracli Vari •

CASE SHEET/HISTORY TAKlNG

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Total 8 subjective parameters are adopted as follows - Dysmenorrhoca, Oligorncnorrhoea, Hypomenorrhoea. Menorrhagia depending on duration of the cycle and amount of bleeding. Acne, I lirsuitism and BMI. Total 3 objective parameters are adopted as follows. No of immatuere follicles in ovaries. serum cholesterol nd 2nd hr value of Glucose Tolerance Test.

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FOR Tl-IE ASSESSMENT OF Tl-IE EFFECT OF Tl-IE DRUG

• • Nausea • Vomitting • Abdominal pain

Loss appetite Diarrhea

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EXCLUSION CRJTERIA • Pelvic Inflammatory Disease • Tuberculosis • Underweight SIDE EFFECT CRITERIA

• Informed written consent. • •

• Menstrual abnormalities Clinical manifestation of 1 typer androgenisrn such as excessive hair growth (Hirsuitism) and raised incidence of Ac11e. Multiple small peripheral follicles . Normal Serum Prolaciin .

• INCLUSION CRITERIA

as<;e~:-. the effects of Sil.: Siudoo: adi Val i on PCOD patients.

• Material and methods: - For this clinical study 30 patients are selected on the basis of poly cystic ovaries confirmed through UILra Sono Gram from the P. G. 0. P. D unit of Rasa Sasira ol Or. A. L. Govt. Ayurvcdic Hospital, after duly complying the norms of selection and exclusi on criteria.

• Title of the study: - Hvaluation of clinical efficacy of Sila Sindooradi Vati on Poly Cystic Ovarian Disease. The aim of this study is to

CLINICAL STUDY • •

Removal of Kacha-kupi from the sand . Breaki ng process of bottle . Separation of final product and storage.

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POST-I I EATING Pl IASE It includes: -

Self-cooling phase.

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Heating procedure and temperature pattern . Clearing the neck or the bottle (Chalan a) Paka-pariksha (Examination or proper Paka) . Mudrana (Sealing) procedure . Valuka apasarana . Tivragni I Intense heat .

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A. Collection and identification of raw material.

H. Processing I Sodhana of raw material. C:. Kajjali preparation. D. Bhavana I Trituration. E. Enwrapping the bottle (Kapadamirri}. I~ Filling of bhavita Khajjali in kupi/

bottle. G. Preparing the Bhatti. H. Placing the kupi in Valuka Yantra, HEATING PHASE It includes: -

Fw <1ny Koopipakwa preparation step by step heating procedure is viral. Hence it is divided into 3 phases. I. Pre - heating phase 2. I Ieating phase 3. Post heating phase PRE HEATING PHASE - INCLUDES

Satapushpa Choorna <111cl Lrit111 ill inn with Varuna twak Kashaya, filling in to capsules after dried completely.

KOOPIPAKWA PROCESS

Quarterly Medical Journal July - Sept em her 20 I ri

,,,.,_..._ S.N.lnstitute of A) urvedic Studies & Research, Puthur, Kellam ~'dt

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No Response Poor Response

Fair Response Good Response

7% 7% ~

RESULTS OF OVERALL PARAMETERS

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STATISTICAL i\NALYSIS OF OVERALL PARA \1ETERS

The mean difference on overall parameters 1~

highly significum (<0.001) on the assessment a Iler I st month. 2nd month and al-,o Jrd month or treat­ menl. when compared with Student's "I" tcs:

Ir Cnrl••Jrnl & ~) GU S 0 0 j 0

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Showing results on overall parameters

Good Response > 75°0

Fair Response 51-75°11

Poor Response 26 - 50°"

No Response < 25"o

Normal Grade 0 () - ._

Mild Grade 1 "' .) ,_

Moderate Grade 2 5 -- Severe Grade 3 10

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• • Route of Administration: Oral

Dose: One capsule of250 mg. twice ii day after meals with Honey as Anupana. Method of study: Single blind test. Criteria for assessment: Assessment is done alter 15 days ro check fot side effects.

• Once in I month-3 rimes for assessing results. The parameters have given grading & scoring

basing on severity of the symptom for the statisrical analysis.

Quarterlv Medh'al Journal July - September 2016

9 ,~ S.;>i.l nslil ult/ of.'\) urvedlc Sin dies & Research, Puthur, Koll am

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• Hence early diagnosis, close long term follow up and screening for diabetes and cardiovascular diseases are warranted. An opportunity exists for preventive therapy which should improve the reproductive, metabolic and cardiovascular risks. l.ifestyle modification, including weight reducing diet and exercise is mandatory as <1

first line therapy in PCOS subjects. In Ayurvedic literature. we don't find any direct reference or correlation for the PCOS. Bue some of the clinical conditions and symptoms explained under the bending of Yonivyapat and Artava dushti. Where lunctional menstrual disorders are dealt Gm be compared with PCOS. On screening and summanzmg various opinions and classifications mentioned by different authors of Ayurvcdic classics in their respective works, PCOS can also be explained in terms of Pradushtaarrava.

Rasa Sastra is a branch of learning Ayurvedic Pharmaceutics by dealing with metals. minerals certain poisonous herbs. Ir is developed under nucleus of Mercury. which is considered as essence of C11l metals and minerals due to its cmalgarnating

• It is extremely important because PCOS is now thought lO increase metabolic and cardiovascular risks.

These risks are strongly linked to i11s11li11 resistence which results in; Obesity. Impaired glucose intolerance. Type 2 Diabetes rncllitus and Hypertension, cardiovascular disease. significantly increased risk of myocardial infarction. lipid abnormalities and impaired librinolysis. PREVENTION

DISCUSSION The Polycystic Ovary Sv11dro111e (PCOS) is

an extremely common disorder. IL occui s i11 6~. 1 o 10°., of women of reproductive age. It is a complex multi system disorder causing dvslunct iou of l interrelated axes - Metabolic, SI eroidogeruc and Reproductive . COMPLICATIONS • Increased risk for endometrial cancer.

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I 2 ) 4 \. ' 1 11 ~ 10 II I) I) 14 IS 14 U I It 10

IMPROVEMENT OF OLIOMENORRHOEA

"' uo IOI llt 100

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REDUCTION OF POLY CYSTJC OVARIES

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PARAMETER \VJSE RELIEF ON BEFORE TRf.AT'VlENT AND AFTER TREATME.~T

Quarterly Medical Journal .July- September :!OJ 6

S.N.ln~lilulc or ) Uri edir Studk~ & Research, Puthur, Kollam ~ IO

I. Ashianga I lridaya Sarccra Sthana 2. Ashtanga Hridaya Uthara Sthana 3. Rasa Ihantra Sarva Siddha Prayoga Samhita 4. Rasa karna Samuchchayarn 5. Ayurvediya Rasasastra (Prof Siddhi "\,111dan

Mishra) 6. Text Hook of Gynaecology

BIRl.IOGRAPHY:

pm amerers: Oligomenorrhoea, I lvpornenot rhoea, Dysmcnori hoea, Acne vulgaris and PCO (Nn. of follicles). lb effect is marked ()11 Scrum Cholesterol lewis and BMI on the completion of the study. This could be attributed co the Likt.1 rasa, ushna guna, lekh.ma, mcdohara, kaphahara and saraka properties of the ingredients that go into the forrnulauon of SiluSindcoradi Vari. The presence of Varu11;1 in the formulation has stgruficantly contributed to the reduction in the Sile and no or the follicles, because of its anti-inflamrnarorv and anti-tumor artivirv The Satapushpa might have worked with its deepana property. However the eflect oft he drug m mitigating the Insuhn resist.mce and impi oved effective glucose utilization by the nssue could not be established due to the smaller sample of the studyand also the shorter duration of the study. CONCLUSION

8 subjective parameters and 3 obiecuve parnmetcrs are select eel and scoring has been given for each p.11 ameter, with rota I no. of scoring ts I 00 for severe g1 .ide of the parameter. Star 1st ical analysis of eyeball results shows that the effect of the dnig is highly significant, but on Hirsuitisrn. Sr. glucose are not significant. It could be clue co less duration of treatment. There was merger adverse drug reaction which could be immediately taken care by giving Kooshmanda Swarasa as Anupana and 1 educing the dose for lcw days. This drug exerted good response in 2 (6.66~.) patients. fair response in 17 (56.G7~) patients. poor response in 9 (30°.,) pal ients and no response in 2 (6.6 7"o} patients. It c<111 be concluded Sila Sindooradi Vati is effective in Poly Cystic Ovarian Syndrome. And it may need the increased duration of the treat menr,

quality, (Rasaua; sarva dhaumaam rasa ityahhidheevmhe}. It b considered as <111 advanced branch of Avurvedic mediation dealing with metals and mineral'> m prevention and l 1 catrnent of diseases. The medicines of Ras.i Shastra r;-111 be prepared in different methods. Koopi pakwa Rasavana is one of the popular and unique method of preparauon because of its sushrnatya (Nano particle size). Drug reach the target organ easily lo exet t quick and eflect rve result.

Sil a Sindoor Rasa. the selected d 1 ug for the prevent study is one of the popular Koopipakwa Yogd\. Ihe popularity of this drug is Cl edited to its abroad specu um of activity. In wide range of cluucal conditions with lirtle alterations in tho dosage and Anup.111<1. The composition. Bhavana dravyas and also time of preparation differs with till' disease. it is used for .111d also I he reference drawn. The drug for the present study is prepm ed as J)l'I the textual spcuficarions of Rasa Tantra Sarva Sidclha Prayoga Sangraha.

30 pat rents were randomly select ed from the r. C.. 0. P. D unit of Rasa Sasrra of D1. A. L. Govt. Ayurvedic Hospital. after duly complying the norms of selection and exclusion crirci ia.

Total 8 subjective parameters me adopted as follows - Dysmenorrhoca, Ollgomcnorrhoen, Hvpomcnorrhoea, Menorrhagia depending 011 duration of the cycle and amount of bleeding. Arne, llirsuiusm and BMI. Total 3 objective parameters are adopted c1S follows. No of immature follicles in ovaries, scrum cholesterol and 2nd hr value of Glucose lolct ance Test. The drug Sila Smdocra Rasa was administered in dose of250 mg. two times in a day. A single blind clinical study was conducted for a total period or90 days With periodical assessment of the parameters every 30 clays. Results after 3 months of treatment on individual parameters have been analyzed.

The mean diffe1 ence on overall paramet e1 s is highly significanr I <0.00 I) on the assessment aft Cl I Sl month. 2nd month and also 3rd monl h or treatment, when compared with Student's "t" test. Of the I I parameters included for the study, the drug has shown highly significant efficacv on five

Q11e1rll!I'~\' 1\ lcdica! Journal .J11h - September 20 I (i