A CLINICAL STUDY ON THE MANAGEMENT OF PRIMARY DYSMENORRHOEA (USRE TAMS IBTIDAEE) WITH A UNANI POLYHERBAL FORMULATION- AN OPEN LABEL SINGLE ARM TRIAL

A single arm study will be carried out on Usre tams Ibtidaee (primary dysmenorrhoea) with unani polyherbal formulation. Usre tams Ibtidaee (primary dysmenorrhoea) common gynecological complaint that can effect as much as 50% of the women and 10% of these women have a severe impact which makes it a major cause of absenteeism from work leading to decreased efficiency and quality of life.Primary Dysmenorrhoea is high in girls in adolescence age there are estimations suggesting that around 60% of girls of 12-17 years of age group experience some degree of menstrual cramps The prevalence is highest during 20-24 years of age.In classical Unani text Dysmenorrhoea is known as Usr-e-tams or Waja-e-rehem.Renouned unani physician A’zam Khan mentions the causes of dard-e-rahim as su’mizaj, riyah-e-ghaleez, rutubat alghaleeza (tenuous morbid matter), quruh al-rahim, buthur al-rahim, saratan al-rahim, inqilab al-rahim, shuqaq al-rahim (uterine rupture), mailan al-rahim (displacement of uterus), excessive intercourse, and postpartum period uterine pain or pain occurring during menstruation Symptoms include The cramping pain are colicky spasm of pain occurring few hours before or after the onset of menstruation peaking within first few days as menstrual flow increases felt at lower abdomen that may radiate to lower part of the thigh.In conventional medicine therapeutic options for Primary Dysmenorrhoea include Non steroidal anti-inflammatory drugs(NSAIDs) which act as prostaglandin inhibitors , Opioid Analgesics and Oral contraceptive Pills (OCPs) which act by inhibiting ovulation are the most reliable and effective treatment. NSAIDs are effective for some women but not for all as these have various adverse effects and upto 20%-25% failure rate to reduce Primary Dysmenorrhoea The treatment of Usr-e-tams in Unani system of medicine indicates the use of Mudir e Haiz , mufattih e sudad , and Dafe Tashannuj properties. Unani formulation comprising of 625mg Capsule of powder of aqueous extract of  Mur Makki(325mg), Abhal(25mg), Barg Suddab(75mg), Majeeth(75mg) taken as 2 capsules twice a day with plain water are selected as research drug. Research drug will be given 3 Days Prior to menses and 4 days during menses for 3 consecutive cycles.During the trial , efficacy of treatment will be assessed by observing changes in rating score of subjective and objective parameters. At every follow up, the subjects will be enquired about the improvement or deterioration in symptoms and recorded. After the completion Pre and Post treatment values statistically analyzed.Objective Parameters

includes Visual Analogue Scale (VAS) : VAS for pain intensity of Dysmenorrhoea , at baseline and at each follow up. 0-No pain ; 1-3 - Mild pain ; 4-6 - Moderate Pain ; 7-10 - Severe Pain.

and Verbal Multidimensional Scoring System (VMS)-The severity of Dysmenorrhoea will be assessed by a VMS. Subjective Parameters includes Associated Symptoms such as Nausea , Vomiting , headache , fatigue will be assessed

by VAS. Vertigo symptom scale was used to record Dizziness as 0- never, 1-Few times, 2- Several times, 3-Quite often, 4-Very Often During the trial ,safety of treatment will be assessed by LFT ,KFT Will be carried out at baseline and visit 3

patient that will be included using following criteria i.e  Patients in age group of 14-28 years of age.,Patient with VAS Score of 4 to 10.Unmarried.Patient able to participate in the study and ready to follow the instructions and signed the

informed consent..Patient will be WITHDRAWL if they Failure to follow the Protocol and investigator instruction. or  in Any serious or adverse reaction or event