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PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1.

Name of the

candidate and

address

Mohd Jafar

P.G. Scholar, Dept of Moalajat.

National Institute of Unani Medicine, Kottigepalya, Magadi

Main Road, Bangalore.560091

2.

Name of the

institutionNational Institute of Unani Medicine,

Bangalore

3. Course of study and

subject

M.D. (Moalajat)

4. Date of admission 16/10/2012 (Batch: 201213)

5. Title of the study

Therapeutic efficacy ofMunzij wa Mushile Balgham andDalk

with Roghane Farfiyun in the management of Irqunnasa

(Sciatica)

6. Brief resume of the intended work:

6.1 Need of the studySciatica is one of the commonest neuralgic pain creating difficulty and problems in

activities of daily living. Thelifetimeincidence rate is estimated to be between 13% and40%,

1 which has the great potential to become chronic and intractable with major

socioeconomic implications, if left untreated.In conventional medicine, certain topical

and systemic analgesics, NSAIDs, corticosteroids etc. are the pharmacological

approaches prevalent in the management of Irqunnasa. These drugs are associated with

certain side effects; therefore, search of safe and effective regimen is the thrust area ofresearch in Unani medicine.

In recent years, preliminary research work has been carried out involving a single

modality of Ilaj bit Tadbeer, whereas, ancient physicians had treated this diseasesuccessfully on the principles of Tanqiawa Tadeel,which translates into using Munzij

wa Mushildrugs as complete regimen for the treatment of Irqunnasa. This is the high

time when a comprehensive set of various modalities of treatment should be testedtogether as a unit of treatment. Keeping all the views in this perspective, acomprehensive protocol has been chalked out to evaluate the therapeutic efficacy of

Munzij wa Mushile Balgham and Dallkwith RoghaneFarfiyun in the management of

Irqunnasa.

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6.2 Review of LiteratureSciatica

is caused by impingement of L4, L5 or S1 nerves and manifest as unilateral

neuropathic pain extending from gluteal region down the postero-lateral aspect of leg to

foot.2In unani system of medicineIrqunnasais defined as the pain which starts from hip

joint and descend towards foot.3It is a type of Wajaul Mafasil characterized by hip pain

radiating towards back of thigh up to the ankle. As it turns chronic, pain radiates moretowards the lower side of the leg according to morbid matter involved and reaches up to

toes of foot.4

The etiologies areKhilte Dam ghaleezorKhilte Balgham ghaleezwhich getaccumulated in the hip joint.

5But most of the times the cause is KhilteBalgham or a

mixture of KhilteBalghamwa Safra.6

According to Ibnsina the cause lies in hip joint

and sometimes inAsabe Ariza(sciatic nerve) itself.7

In the management ofIrqunnasa, emphasis is given on the evacuation of causativekhilt

throughFasd,Nuzj wa Ishal, Hijamat, Taleeq, Qaifollowed byDalk, Zimad,

Takmeed,

Nutool ,Tilaetc.

6Hakeem Azam Khanin his book Akseere Azamdescribed drugs for nuzj

waishalandDalkwithRoghanFarfiyunin the management of Irqunnasa.7

6.3 Objectives of the study:To evaluate the efficacy ofMunzij wa Mushile Balgham and

Dalk with Roghan Farfiyun in the management ofIrqunnasa.

7

7.1

7.2

Material and Methods:

Source of data:

OPD/IPD, NIUM Hospital, Bangalore

Method of collection of data:

Inclusion criteria:

1. Clinically diagnosed cases ofIrqunnasa2. Patients ofIrqunnasainflicted with SueMizajBalghami3. Both gender

4. Patients between 20 to 60 yrs of age

Exclusion criteria:

1. Pregnancy, Lactation, children2. Systemic illness e.g. cancer, liver, kidney, cardiac and pulmonary diseases3. Spinal injury or deformity (Congenital / Acquired)4. Any orthopedic condition of hip joint restricting gait and movement5. Patients who fail to give consent for the trial and follow up

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Study design:Open,clinicalstudy

Sample size:30 patients

Duration of Protocol treatment: 30 Days

Follow up: 0day, 15th

& 30th

day

Interventions:

Munzije Balgham:

Ingredients:7

Asalussoos (Glycyrrhizaglabra) 5.0 gms

Anisoon (Pimpinellaanisum) 5.0 gms

Tukhme Karafs (Apiumgraveolens) 5 .0 gms

Badiyan (Foeniculumvulgare) 7 .0 gms

Badranjboya (Mellisa offincinalis) 7.0 gms

Mako (Solanumnigrum) 7.0 gms

Barg Shahatra (Fumeriaofficinalis) 7.0 gms

Suranjan (Colchicumluteum) 7.0 gms

Bekh Kibr (Capparisspinosa) 3.0 gms

Bisfaij (Polypodiumvulgare) 3.0 gms

Gul Qand (Rosa damascena petals+ sugar) 36 gms

Mushi le Balgham:

Ingredients:7

Sana (Cassiaangustifolia) 7.0 gms

Turbud (Operculinaturpethum) 4.0 gms

Zanjabeel (Zingiberofficinale) 4.0 gms

Barang kabuli (Embelia rubusta) 4.0 gms

Khayar shamber (Cassiafistula) 48.0 gms

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Shahm-e-hanzal (Citruluscolocynthis) 4.0 gms


Boozidan (Pyrethrumindicum) 4.0 gms

Roghane Farf iyun

Ingredients:8


Sonth (Zingiber officianale) 12.0 gms

Jaiphal (Myristica fragrans) 12.0 gms

Peeplamol (Piper longum) 12.0 gms

Malkangni (Celastrus peniculatus) 12.0 gms

Rai (Brassiea nigra) 12.0 gms

Farfiyun (Euphorbia resinifera) 12.0 gms

Tilon ka Tel (Sesamum indicum) 720.0 ml

Objective parameters:

1

Straight leg raising test2 VAS index (10 points Likerts Scale)3 ODI ( Oswestry Disability Index)

Procedure of study: Diagnosed cases of Irqunnasa, fitting into the inclusion criteria,

shall be enrolled after obtaining their written informed consent. The enrolled patients

will be assessed as per the objectiveparameters and values shall be recorded beforestarting the treatment. The treatment will be started with Munzije Balghamadministered

in decoction form orally, with the prescribed doses, once in the morning for 15

consecutive days. On 13th and 15th

day, the ingredients of Mushile Balgham will be

mixed with those of Munzije Balgham and given in decoction form. From 16th

day

onwards, Dalk with Roghane Farfiyunwill be started on lower back and painful limb,once a day for 15 minutes for a period of 15 days. After completion of the trial, Pre and

post treatment values will be analyzed statistically to evaluate the efficacy of the

treatment.

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7.3Does the study require any

investigation Or intervention to

be conducted on the

Patients?

Investigations done only before treatment as a

part of exclusion criteria

1. ECG2. X- Ray Lumbosacral region

Investigation done before and after thetreatment as a part of exclusion criteria and

safety parameters

3. HB%, TLC, DLC, ESR4. Liver function test5. Kidney function test6. Blood sugar random7. Urine analysis

7.4 Has the ethical clearance been

obtained from your institution in case

of 7.3?

Approved

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8. List of References:

1. Prevalence Hill A.D, Oxford journals of medicine, British journal of aneasthesia,Vol. 99, issue 4, 2007: 461-473.

2. Longo Dan L. Fauci Anthony S. et al, Harrisons Principles of InternalMedicine,18

thedition: 2824-2825

3. Jurjani Ahmed Al hasan,Zakhera Kharizm Shahi, Idara Kitabush Shifa, New Delhi,vol.6,2010: 637

4. Ibn Sina,AL Qanoon, (Urdu translated by Kantoori GH),Idara Kitabush Shifa, NewDelhi, Vol.3, 2007:1120

5. Majusi Abulhasan Ali Ibne Abbas Mutatayyab,Kamilussana,Idara Kitabush Shifa,New Delhi, Vol.1, 2010:543.

6. Razi Mohammed Bin Abu Bakar Zakaria, Alhavi fit Tib, CCRUM ,New Delhi,vol.11, 2004: 76, 77, 88, 96, 99,115, 174

7. Azam Khan Hakeem Mohammad, Akseer Azam, Idara kitabush shifa, New Delhi,2011:847,848 ,841

8. Kabiruddin Hakeem Mohammad,Al Qarabadeen,CCRUM, New Delhi,2006:453

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9.Signature of candidate

10 Remarks of the guide

11. Name and Designation of guide DR. ABDUL NASIR ANSARI

READER

11.1

11.2

11.3

11.4

11.5

12.

12.1

12.2

Signature

Co-guide

Signature

Head of department PROF. M.A.SIDDIQUI

Signature

Remarks of the chairman and

Director.

Signature

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NATIONAL INSTITUE OF UNANI MEDICINE

Kottigepalya, Magadi, Main Road, Bangalore 560091.

INFORMED CONSENT FORM

Title of the study:

Therapeutic efficacy ofMunzij wa Mushile Balgham andDalk withRoghane Farfiyun in the

management ofIrqunnasa(Sciatica)

Information to the participants:

The main aim of the present study is to evaluate the Efficacy of Munzij-wa-Mushil andRoghan

Farfiyun in the management of Irqunnasa (Sciatica) and to provide safe, effective and

economic treatment in the management ofIrqunnasa. The total duration of study is 20 days.

There are no reasonably foreseeable risks or discomforts to you during the research. The

confidentiality of records identifying you will be strictly maintained and only the research

scholar or the guide will have access to your medicals records. All your blood and any sample

will be utilized only for research purpose. You may contact me for trial related queries, and you

have rights to clear all yours doubts regarding the treatment or any possible adverse reactions of

the treatment. No anticipated prorated payment shall be made to you for participating in the trial.

You are responsible for all the consequences of the treatment, either benefits or harm, on

participation in the trial. You have to answer the entire pertinent question asked by the research

scholar regarding your illness.

Undertaking by the investigator:

Your consent to participate in the above mentioned study by Mohd Jafar, P.G Scholar, Dept. of

Moalajat, NIUM, Bangalore is sought. You have the right to refuse consent or withdraw the

same during any part of the study without giving any reason. In such an event, you will continue

to receive the treatment as usual. If you have any doubts about the study, please feel free to

clarify the same. Even during the study, you are free to contact the investigator for clarification if

you desire. All the information/data collected from you will be kept in strict confidence.

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PATIENT CONSENT FORM

I................................................................................s /d/o......................

exercising my free power of choice, hereby give my consent to be included as a subject in the

clinical study Therapeutic Efficacy of Munzij-wa-Mushile Balgham and Dalk with Roghan

Farfiyun in the management of Irqunnasa (Sciatica).I understand that I may be treated with

these regimens for the disease, I am suffering from. I have

been informed to my satisfaction, by attending physician the purpose of the clinical trial and the

nature of the regimenal therapyand follow up including the laboratory investigation to monitor

and safeguard my body function.

I am also aware of my right to opt out of the trial at any time during the course of the trail

without having to give the reason for doing so. The researcher is fully authorized to publish my

identity and pictures in any form (journals,papers,magazines,books,etc.)

Signature of the patient: Signature of the attending Physician:

Date:

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