PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION Mohd Jafar P.G. Scholar, Dept of Moalajat.

National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore.560091

1.

Name of the candidate and address

2.

Name of the institution

National Institute of Unani Medicine, Bangalore

3.

Course of study and M.D. (Moalajat) subject 16/10/2012 (Batch: 2012 13)

4.

Date of admission

5. 6. 6.1

Therapeutic efficacy of Munzij wa Mushile Balgham and Dalk with Roghane Farfiyun in the management of Irqunnasa Title of the study (Sciatica) Brief resume of the intended work: Need of the study Sciatica is one of the commonest neuralgic pain creating difficulty and problems in activities of daily living. The lifetime incidence rate is estimated to be between 13% and 40%, 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 of research 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 disease successfully on the principles of Tanqia wa Tadeel, which translates into using Munzij wa Mushil drugs as complete regimen for the treatment of Irqunnasa. This is the high time when a comprehensive set of various modalities of treatment should be tested together as a unit of treatment. Keeping all the views in this perspective, a comprehensive protocol has been chalked out to evaluate the therapeutic efficacy of Munzij wa Mushile Balgham and Dallk with Roghane Farfiyun in the management of Irqunnasa.

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Review of Literature Sciatica 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.2 In unani system of medicine Irqunnasa is defined as the pain which starts from hip joint and descend towards foot.3 It 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 more towards the lower side of the leg according to morbid matter involved and reaches up to toes of foot.4 The etiologies are Khilte Dam ghaleez or Khilte Balgham ghaleez which get accumulated in the hip joint.5 But most of the times the cause is Khilte Balgham or a mixture of Khilte Balgham wa Safra.6 According to Ibn sina the cause lies in hip joint and sometimes in Asabe Ariza (sciatic nerve) itself.7 In the management of Irqunnasa, emphasis is given on the evacuation of causative khilt through Fasd, Nuzj wa Ishal, Hijamat, Taleeq, Qai followed by Dalk, Zimad, Takmeed, Nutool ,Tila etc.6 Hakeem Azam Khan in his book Akseere Azam described drugs for nuzj wa ishal and Dalk with Roghan Farfiyun in the management of Irqunnasa.7 Objectives of the study: To evaluate the efficacy of Munzij wa Mushile Balgham and Dalk with Roghan Farfiyun in the management of Irqunnasa. Material and Methods:

6.3

7.1 A 7.2

Source of data: OPD/IPD, NIUM Hospital, Bangalore Method of collection of data: Inclusion criteria: 1. Clinically diagnosed cases of Irqunnasa 2. Patients of Irqunnasa inflicted with Sue Mizaj Balghami 3. Both gender 4. Patients between 20 to 60 yrs of age Exclusion criteria: 1. Pregnancy, Lactation, children 2. Systemic illness e.g. cancer, liver, kidney, cardiac and pulmonary diseases 3. Spinal injury or deformity (Congenital / Acquired) 4. Any orthopedic condition of hip joint restricting gait and movement 5. Patients who fail to give consent for the trial and follow up
2

Study design: Open, clinical study Sample size: 30 patients Duration of Protocol treatment: 30 Days Follow up: 0day, 15th & 30th day Interventions: Munzije Balgham: Ingredients:7 Asalussoos (Glycyrrhiza glabra) Anisoon (Pimpinella anisum) Tukhme Karafs (Apium graveolens) Badiyan (Foeniculum vulgare) Badranjboya (Mellisa offincinalis) Mako (Solanum nigrum) Barg Shahatra (Fumeria officinalis) Suranjan (Colchicum luteum) Bekh Kibr (Capparis spinosa) Bisfaij (Polypodium vulgare) Gul Qand (Rosa damascena petals+ sugar)

5.0 gms 5.0 gms 5 .0 gms 7 .0 gms 7.0 gms 7.0 gms 7.0 gms 7.0 gms 3.0 gms 3.0 gms 36 gms

Mushile Balgham: Ingredients: 7 Sana (Cassia angustifolia) Turbud (Operculina turpethum) Zanjabeel (Zingiber officinale) Barang kabuli (Embelia rubusta) Khayar shamber (Cassia fistula)
3

7.0 gms 4.0 gms 4.0 gms 4.0 gms 48.0 gms

Shahm-e-hanzal (Citrulus colocynthis) Suranjan (Colchicum luteum) Boozidan (Pyrethrum indicum)

4.0 gms 4.0 gms 4.0 gms

Roghane Farfiyun Ingredients: 8 Suranjan (Colchicum luteum) Sonth (Zingiber officianale) Jaiphal (Myristica fragrans) Peeplamol (Piper longum) Malkangni (Celastrus peniculatus) Rai (Brassiea nigra) Farfiyun (Euphorbia resinifera) Tilon ka Tel (Sesamum indicum) Objective parameters: 1 2 3 Straight leg raising test VAS index (10 points Likerts Scale) ODI ( Oswestry Disability Index) 12.0 gms 12.0 gms 12.0 gms 12.0 gms 12.0 gms 12.0 gms 12.0 gms 720.0 ml

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 objective parameters and values shall be recorded before starting the treatment. The treatment will be started with Munzije Balgham administered 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 Farfiyun will 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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Does 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. ECG 2. X- Ray Lumbosacral region Investigation done before and after the treatment as a part of exclusion criteria and safety parameters 3. HB%, TLC, DLC, ESR 4. Liver function test 5. Kidney function test 6. Blood sugar random 7. Urine analysis

7.4

Has the ethical clearance been obtained from your institution in case of 7.3?

Approved

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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 Internal Medicine,18th edition: 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, New Delhi, 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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Signature of candidate

10

Remarks of the guide

11.

Name and Designation of guide

DR. ABDUL NASIR ANSARI READER

11.1

Signature

11.2

Co-guide

11.3

Signature

11.4 11.5

Head of department Signature

PROF. M.A.SIDDIQUI

12. 12.1

Remarks of the chairman and Director.

12.2

Signature

NATIONAL INSTITUE OF UNANI MEDICINE Kottigepalya, Magadi, Main Road, Bangalore 560091. INFORMED CONSENT FORM

Title of the study: Therapeutic efficacy of Munzij wa Mushile Balgham and Dalk with Roghane Farfiyun in the management of Irqunnasa (Sciatica) Information to the participants: The main aim of the present study is to evaluate the Efficacy of Munzij-wa-Mushil and Roghan Farfiyun in the management of Irqunnasa (Sciatica) and to provide safe, effective and economic treatment in the management of Irqunnasa. 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.

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 therapy and 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: