PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. / Name of the Candidate
and Address / WAJIDA TABASSUM INAMDAR
PG SCHOLAR,
DEPARTMENT OF ILMUL QABALAT WA AMRAZE NISWAN,
NATIONAL INSTITUTE OF UNANI MEDICINE, KOTTIGE PALYA, MAGADI MAIN ROAD, BANGALORE- 91.
2. / Name of the Institution / NATIONAL INSTITUTE OF UNANI MEDICINE, BANGALORE.
3. / Course of study and subject / M.S (UNANI) – ILMUL QABALAT WA AMRAZE NISWAN,
4. / Date of Admission to course / 03.11.2008
5. / Title of the Topic / “CLINICAL EVALUATION OF USRE TAMS IBTIDAEE( PRIMARY DYSMENORRHOEA) AND ITS MANAGEMENT WITH UNANI TREATMENT”
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6.3
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7.1
7.2 / Brief resume of the intended work
Need for the Study
Usre Tams (Dysmenorrhoea) means painful menstruation. (1) It is a most common gynecological complaint. (2). Usre Tams Ibtidaee (Primary dysmenorrhoea) is defined as menstrual pain that is not associated with recognized pelvic pathology, (3) and it is the commonest type of dysmenorrhoea.(4).
The incidence of dysmenorrhoea is affected by socioeconomic status, occupation, psychological makeup and age of the patient (4). It is widely prevalent with more than 70% of teenagers and 30%-50% of menstruating woman suffering from varying degree of discomfort. (5) Primary dysmenorrhoea often creates more severe symptoms than those experienced by patients with secondary dysmenorrhoea.(6) .It is responsible for the highest incidence of absenteeism resulting in loss of work hours and economic loss.(5) In addition both work and school performances are found to be poor in woman on their days with dysmenorrhoea. (7).
In conventional medicine the treatment, for this disease has its own side effects. (8). In Unani system of medicine many drugs along with regimental therapy (dry cupping) are available, which are beneficial to treat primary dysmenorrhoea. Therefore, keeping in view these facts, it has been decided to conduct a clinical trial to validate the efficacy Hulba and Hijamat bila shurt (dry cupping) scientifically, which are easily available and cost effective.
Review of literature
Unani physicians have mentioned Usre tams under Aujae reham. The various causes of Usre Tams are sue mijaz, qillate tams, insidade fame reham, sailane rehm,ghalbae akhlat ghaleez(balgham and sauda) in blood etc. (9, 10, 18).
Primary dysmenorrhoea is more frequent in nulliparous females, and reaches its maximum between the ages of 18-24. (1).It usually appears within 1-2 years of menarche. (7). Despite a predilection for younger women, dysmenorrhoea can affect any women no matter what is her age, race or parity,(6) and it has been experienced to some degree by most woman at some time in their lives. (11).
Current evidence suggests that primary dysmenorrhoea, which occurs only during ovulatory cycles is largely due to excess production and release of endometrial prostaglandin during menstruation i.e. Two to seven times more than the normal amount. A causative role of prostaglandin in dysmenorrhoea was supported with additional studies and the connection seemed complete between excess uterine prostaglandin F2 alpha, increased uterine activity, and the pain of dysmenorrhoea.(6).
Excess prostaglandin may also be responsible for hyper mobility of the gut which causes nausea, vomiting, diarrhoea. (6). The pain of primary dysmenorrhoea is labour like with supra pubic cramping, lumbosacral backache radiating down to thigh, nausea, vomiting, diarrhoea and rarely syncopal attacks. The duration of dysmenorrhoea usually lasts for 48-72 hours, starts few hours before the onset of menstrual flow (12) and its worst on 1st and 2nd day of menstrual flow. (11).
In Unani system of medicine Hijamat bila shurt (dry cupping), over the umbilicus relieves the menstrual pain especially in young girls (13), as it causes imalae mawad (diversion of fluid) from uterus (14), and Hulba is also in use since long time to relieve pain related to uterus as it have properties like Musakkin (analgesic), Mudirre haiz wa Bowl (emmenagogue, and diuretic), Dafae tashannuj (anti spasmodic), Muhallil (anti inflammatory), carminative, haematinic.(15,16,17).
On the basis of above properties Hulba and Hijamat bila shurt have been selected for the clinical evaluation in management of Usre Tams Ibtidaee.
Objectives of the study:
· To study the various aspects of Usre Tams Ibtidaee in the light of classical Unani
Literature.
· To evaluate the efficacy and safety of Hulba and Hijamat Bila Shurt the management of Primary dysmenorrhoea.
Material and Methods:
Source of Data:-
· Patients attending female OPD and IPD of National Institute of Unani Medicine Hospital, Bangalore.
Method of Collection of Data:
· By history
· By laboratory investigations.
Inclusion Criteria:
· Patients between ages of 12-30 years with regular cycle.
· Patients willing to participate in the study.
Exclusion Criteria:
· Patients with congenital anomalies of uterus, any organic pelvic pathology, membranous dysmenorrhoea.
· Patients with any systemic illness like hypertension, diabetes mellitus, Thyroid Dysfunction, cardio renal diseases and other systemic diseases.
Subjective Parameters:
· Sharp, intermittent lower abdominal pain with suprapubic cramping, Lumbosacral
backache radiating to thigh.
· Nausea, vomiting, headache, anxiety, fatigue, diarrhoea, abdominal bloating.
Objective Parameters:
· Visual Analogue Scale (for pain).
Study Design:
· Single blind, randomised standard controlled study.
Duration of Study: 1 1/2 years
Sample Size:
Total 60 patients (20 in each group)
· Group - A. Patients with test drug
· Group - B. Patients with test drug and cupping,
· Group - C. Patients with standard drug
Research Drug:
Orally:
Hulba (Trigonella foenum graecum)
Method of preparation, route of Administration and dosage
· Hulba will be powdered and 3gm orally, twice daily from 1st to 3rd day of menstruation.
Locally :
· Hijamat Bila Shurt (dry cupping) over the umbilical region. Two sittings, on 1st and 3rd day of menstruation.
Standard control:
· Mefanamic acid 500mg BD.
Duration of protocol therapy: 3 cycles
Follow up:
· Follow up during treatment: Every month after menstruation for three cycles, and one follow up after completion of treatment, for one month.
Withdrawal criteria:
· Failure to follow the protocol.
· The cases in which drug adverse reactions are noticed.
Informed consent
· Patients fulfilling the inclusion criteria mentioned above will be shown information sheet having details regarding the nature of study, and the drugs to be used. Patients will be given enough time to go through the study details mentioned in the information sheet They will be given the opportunity to ask any question & if they agree to participate in the study, they will be asked to sign the informed consent form.
Assessment of efficacy:
· By relief of clinical sign and symptoms.
· By laboratory investigations.
Assessment of safety:
· Clinical examination and by laboratory investigations.
Adverse effects documentations:
· Any adverse reaction of drugs 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. The appropriate tests will be administered to analyse the data. The confidence levels are fixed at p < 0.05 and p < 0.01 for significant differences of different treatment groups.
7.3 / Does the study require any investigations or interventions to be conducted on patients or other humans or animals? / Yes
Investigations:
Pre-test and post test
CBP(Hb%, TLC, DC, BT, CT, PT, Platelet count)
ESR
CUE
RBS
LFT
RFT
Pre-test
USG Thyroid Profile in selected cases.
7.4 / Has ethical clearance been obtained from your Institution in case of 7.3 / Applied for
8. / List of references:
1. Tindall V.R Jeffcoat’s, principles of gynaecology, 5th edition, 1987, Butterworth-Hienemann publications, p-532.
2. Saraiya B Usha, Rao A Kamini, Chatterjee Alokendu, principles and practice of obstetrics & gynecology for postgraduates, Jay pee brothers, medical publishers New Delhi, 2nd edition 2003, p-31.
3. Copeland J Larry, Text Book of Gynaecology (1993), WB Saunders Company, p: 398.
4. Khan Rashid Lateef, Five teacher’s gynaecology, 3rdedition, 2003, CBS publicationp-279.
5. Howkins and Bourne, Shaw’s Textbook of Gynaecology, 14th Edition, 2008, Churchill Livingstone, New Delhi, and p: 265.
6. Smith P Roger, Gynaecology in primary care, Williams and Wilkins’s, 1997, p-391,392.
7. Qulliyan J Edward, Zuspan P Frederick, Current Therapy in obstetrics & Gynaecology, 5th edition, 2000, W.B.Saunders company p-31, 32.
8. Tripathi K D, Essentials of medical pharmacology, Jay Pee brothers New Delhi, 5th edition, p-168,170.
9.Ibn Sina,Al Qanoon Fit Tib, Vol. II Translated by Ghulam Hussain Kantoori,
Idara e Kitab-us-Shifa, New Delhi, 2007, p-340.
10. Abu Bakr Md Bin Zakariya Razi, Kitab Alhavi, Vol IX, CCRUM, 2001, P-20.
11. Ransom B Scott, Practical strategies in obstetrics & gynaecology, W.B.Saunders company, p-41.
12. Jonathan S. Berk Novak’s Gynaecology 12 edition,1996 ,William and Wilkins’s,
p-408,410
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13. Hkm Md Kabeeruddin, Kulliyate Qanoon, Vol. I and II, Nadeem Younis Printers p-348.
14. Allama Md.Kabeeruddin, Kullyate Nafeesi vol I and II, Idara e Kitab-us-Shifa Shifa, New Delhi, p-481.
15. Hkm Md said, Hamdard Pharmacopoeia of eastern medicine Sri Sat guru Publication, 2nd edition 1970, p-46.
16.Hkm Ghulam Jeelani, Maghzanul Ilaj, Almaroof Bayaze Jeelani,vol.1,Idarae Kitabush-shifa Shifa,New Delhi,
17.Hkm Md.Kabeeruddin,Ilmul Advia Nafeesi,Aijaz Publishing House New Delhi,p-125
18. Hkm.Ajmal Khan, Haziq, Jasim Book Depot, New Delhi,1983, p-468.
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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
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12.2 / Signature