Proforma for Registration of Subjects for Dissertation

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. Name of the Candidate HINA REHMAN and Address P G SCHOLAR, DEPARTMENT OF ILMUL QABALAT WA AMRAZE NISWAN, NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGAE PALYA, MAGADI MAIN ROAD. BANGALORE- 91. 2. Name of the Institution NATIONAL INSTITUTE OF UNANI MEDICINE, BANGALORE.

3. Course of study and M.S (UNANI) – ILMUL QABALAT WA AMRAZE subject NISWAN.

4. Date of Admission to 03-11-2010 course 5. Title of the Topic EFFICACY OF REWAND CHINI (Rheum emodi) IN THE MANAGEMENT OF PRIMARY DYSMENORRHOEA

6. Brief resume of the intended work

6.1 Need for the Study: Dysmenorrhoea is a common gynaecological disorder that affects more than 50% of menstruating women in the age group of 18-25 years.1 It is the common cause of school absenteeism among adolescent girls resulting in loss of work hours and economic loss.1,2 The incidence of primary dysmenorrhoea with incapacitation of work is about 5- 10%.3, 4 The incidence of primary dysmenorrhoea is affected by social status, occupation and age.3 It is widely prevalent in more than 70% of teenagers suffering from varying degree of discomfort. Its prevalence is higher amongst the intelligent and sensitive working women.1 The treatment of dysmenorrhoea in conventional medicine is use of NSAIDS and hormonal pills which have got their own side-effects. In Unani systems of medicine, several drugs have been mentioned under the heading of musakkin, mudir haiz, mufatteh sudad. Considering this fact, it has been decided to conduct the clinical trial to evaluate the efficacy of Rewand chini in the management of primary dysmenorrhoea.

6.2 Review of literature: Primary dysmenorrhoea is referred as painful menstruation without any demonstrable pelvic pathology.1,3,4 Pain is related to dysrhythmic uterine contraction and uterine hypoxia. It is mainly confined to the adolescent.4 Primary dysmenorrhoea is unusual in the absence of ovulatory cycles.5 Symptoms of primary dysmenorrhoea include a colicky abdominal pain localised to midline or lower quadrants, with radiation 2

often noted to lower back and legs. Accompanying symptoms may include nausea, vomiting, headache, anxiety, fatigue, diarrhoea and rarely syncopal episodes.5,6 Ibn sina has mentioned that any obstruction in the flow of menstruation may cause usre tams; backache prior to menstruation is due to involvement of uterus.7 Usre tams is caused by ghaleez khoon. During menstruation rehm undergoes forceful contraction to expel the ghaleez khoon resulting in pain.8 In usre tams menstrual blood is expelled out in lesser amount.9 It is associated with nausea, restlessness, headache, low grade fever etc. All these symptoms appears prior to menstruation.9,10 If such type of pain occurs during menstruation, mudir haiz drugs are recommended which open the blood vessels and makes blood lateef and hence induces menstruation, ultimately it relieves the pain.11,12 Rewand chini has been selected for the trial as it has got mudir haiz, musakkin, muhalil warm, kasire riyah, mufatteh suddad properties.13,14 It helps in easy flow of menstruation and relieve the pain.

6. 3 Objectives of the study:  To evaluate the efficacy of Rewand chini in the management of primary dysmenorrhoea.

7 MATERIAL METHODS

7.1 Source of Data: Patients attending the female OPD and IPD, Department of Ilmul Qabalat wa Amraze Niswan, NIUM, Bangalore.

7.2 Method of Collection of data:  History taking.

Selection Criteria: Patients of primary dysmenorrhoea clinically assessed will be included in the study after obtaining their voluntary consent.

Inclusion Criteria:  Unmarried patients in the age group of 15-25 years.  Patients with regular menstrual cycle.  Patients with painful menstruation.

Exclusion Criteria: Patients with  Irregular menstrual cycle.  Organic pelvic pathology.  Systemic illness.  Allergic/sensitive to NSAIDs.  Married patients.

Subjective parameters:  Painful menstruation associated with nausea, vomiting, diarrhoea, giddiness & headache.

Objective parameters:  Visual Analogue scale (VAS) score for the assessment of pain.

Study design Randomized single blind standard controlled study.

Sample size:  Total patients 60.  Test group – 30 Patients.  Control group – 30 Patients.

Duration of the study: One and half year.

Duration of the Protocol therapy: 3 consecutive cycles.

For Test Group: 10,12,14,15 Rewand chini (Rheum emodi) - 2.5gm.

For control group: Mefenamic acid.

Method of preparation:  For test group: Powder of Rewand chini in capsule form.  For control group: Powder of Mefenamic acid in capsule form. Misri will be given for the both the groups separately.

Dosage and Duration:  For test group: 2.5gm in two divided doses, 2 days prior to menstruation & 3days during menstruation.  For control group: Mefenamic acid 250mg TID, after meal for the same duration.

Route of Administration Orally.

Follow UP:  During treatment: before and after every menstrual cycle.  After treatment: once in a month for three consecutive cycles.

Withdrawal Criteria:  Failure to protocol therapy.  The case in which adverse reaction is noticed.

Informed Consent: Patient’s fulfilling the inclusion criteria mentioned above will be given the information sheet having details regarding the nature of study and the procedure to be used. Patients will be given enough time to go through the study details mentioned in the information sheet. They will be given an opportunity to ask any question and if they agree to participate in the study, they will be asked to sign the informed consent form.

Assessment of the efficacy:  Reduction in VAS score.

Assessment of the safety:  Clinical symptoms.  Adverse drug reaction.  Investigations.

Adverse effects documentation: Any adverse reaction of the drug will be documented.

Documentation: The record will be submitted to the department after completion of study.

Statistical Analysis: The statistical analysis will be restricted to those patients who will complete the study. Analysis of the data will be made by appropriate statistical test.

Does the study require any investigations or interventions to be conducted on 7.3 patients or humans or animals? Yes,

Investigations: 1. Complete blood picture with ESR. 2. Random blood sugar. 3. Complete urine examination. 4. Blood urea, serum creatinine & uric acid. 5. SGOT, SGPT, alkaline phosphatase. 6. Pelvic scan. 7. Thyroid profile.

Has ethical clearance been obtained from your Institution in case of 7.3? 7.4 Yes.

List of references; 8 1. Padubidri VG, Daftary SN. Shaw’s Textbook of Gynaecology. 14th ed. New Delhi: Elsevier; 2008: 265. 2. Moore TR, Reiter RC, Rebar RW, Baker VV. Gynecology & Obstetrics. A Longitudinal Approach. New York: Churchill Livingstone; 1993: 773-775. 3. Kumar P, Malhotra N. Jeffcoate’s Principles of Gynaecology.7th ed. New Delhi: Jaypee Brother Publishers (P) Ltd; 2008: 617,618. 4. Dutta DC. Text book of Gynecology. 4th ed. Calcutta: New Central Book Agency; 2003: 46,168.

5. Copeland LJ. Textbook of Gynecology. Pennsylvania: W.B Saunders Company; 1993: 398. 6. Berek JS. Novak’s Gynaecology. 12th ed. Maryland: Williams & Wilkins; 1996: 408, 410. 7. Ibn Sina. Al Qanoon Fil Tib. (Urdu trans.By Kantoori G H). New Delhi: Idarae Kitabul Shifa; 2010: 447-448, 1096, 1118. 8. Khan A. Biyaze Ajmal. New Delhi: Ejaz Publication; 1995: 137. 9. Khan A. Haziq.1st ed. Karachi: Madina Publishing Company; 1983: 467-469. 10. Gelani G. Maghzanul Ilaj. Vol II. New Delhi: Idarae Kitabul Shifa; 2007: 645,646. 11. Ibn Rushd. Kitabul Kulliyat. New Delhi: CCRUM; 1987: 226. 12. Khan A. Al Akseer. Vol II (Urdu trans.By Kabeeruddin). New Delhi: Ejaz Publication; 2003: 1325, 1326. 13. Anonymous. The Unani Pharmacopeia of India. Part I, Vol II, New Delhi: CCRUM; 2007: 91, 92. 14. Ghani N R. Khazainul advia. New Delhi: Idarae Kitabul Shifa; 752, 753. 15. Arzani A. Qarabadeen Qadri. New Delhi: Ejaz Publication; 1998: 367,368.

9 Signature of the Candidate

10. Remarks of the Guide

11 Name & Designation of

11.1 Guide

11.2 Signature

11.3 Co- Guide

11.4 Signature

11.5 Head of Department

11.6 Signature

12 Remarks of the Chairman & 12.1 Principal

12.2 Signature

National Institute Of Unani Medicine Kottigapalya, Magadi Main Road, Bangalore-560091

Informed Consent Form

Title of the study : Efficacy of research drug in the management of primary dysmenorrhoea.

Information to the participant: Dysmenorrhoea is a common gynaecological disorder that affects more than 50% of menstruating women in the age group of 18-25 years. It is the common cause of school absenteeism among adolescent girls resulting in loss of work hours and economic loss. The incidence of primary dysmenorrhoea with incapacitation of work is about 5-10%. Primary dysmenorrhoea is referred as painful menstruation without any demonstrable pelvic pathology. Primary dysmenorrhoea may be associated with nausea, vomiting, headache, anxiety, fatigue, diarrhoea and rarely syncopal episodes. This may lead to loss of work and ultimately affects the quality of life.

The main aim of the present study is to evaluate the efficacy of research drug in the patients of primary dysmenorrhoea. Research drug will be given 2 days prior to menstruation and 3 days during the menstruation. Assessment will be done at monthly interval for 3 consecutive cycles. The study requires the necessary laboratory investigation to evaluate any drug reactions on the body. The present test drug may relieve pain by its emmenogogue, analgesic and deobstruent action.

Undertaking by the investigator: Your consent to participate in the above mentioned study by Hina Rehman, P.G.Scholar, Department of Ilmul Qabalat wa Amraze Niswan, 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, the study does not put any financial burden on you. If you have any doubt 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 confidential.

Patient consent form

I------exercising my free power of choice, here by given my consent to be included as a subject in the evaluation of a disease with investigation. I have been informed to my satisfaction, by the attending physician regarding the purpose of the study, the type of the investigation and follow up including the laboratory investigations to evaluate the cause of disease and to rule out systemic diseases. I am also aware of my right to opt out of the trial at any time during the course of the trial without having to give the reasons for doing so.

------Signature of the P.G. Scholar, Signature of the Patient. Hina Rehman, NIUM, Bangalore-91, Phone no. 9481777409.

Guide: Dr Wajeeha Begum, Lecturer, Department of Ilmul Qabalat wa Amraze Niswan. NIUM, Bangalore-91.

Date: ------Place: ------