A Pilot Study On The Efficacy Of Unani Management In Endometriosis (Batan-E-Rehmiyat) With Chronic Pelvic Pain And Dysmenorrhea.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 6
- Locations
- 1
Study Overview
Brief Summary
A pilot interventional study is planned to evaluate the efficacy and safety of a Unani therapeutic regimen in the management of endometriosis Batana e Rehmiyat with special reference to chronic pelvic pain and dysmenorrhea. Endometriosis is a chronic estrogen dependent inflammatory disorder characterized by the presence of endometrial like tissue outside the uterine cavity, commonly affecting the ovaries, pelvic peritoneum and uterosacral ligaments, leading to symptoms such as chronic pelvic pain, dysmenorrhea, dyspareunia, infertility and reduced quality of life. Conventional management mainly includes hormonal therapy, analgesics and surgical interventions which often provide only temporary symptomatic relief and are associated with recurrence and adverse effects. In the Unani system of medicine the clinical presentation of endometriosis corresponds to Batana e Rehmiyat and conditions described under Waram al Rahim and Tashannuj al Rahim which arise due to derangement of temperament Su e Mizaj and accumulation of morbid humours Ghair Tabayi Akhlat in the uterus.
The present open label pilot interventional study will be conducted in the Department of Qabalat wa Amraz e Niswan at A and U Tibbia College and Hospital. A total of six women aged 18 to 45 years with clinically and radiologically confirmed endometriosis will be included in the study. The intervention will consist of Unani medicinal therapy including Majoon Dabeedul Ward 10 g twice daily and Arq e Birinjasif 20 ml twice daily for a duration of three months. The primary outcome will be reduction in pelvic pain and dysmenorrhea assessed using the Visual Analogue Scale and dysmenorrhea severity score. Secondary outcomes will include assessment of menstrual parameters such as cycle regularity, duration and amount of menstrual flow, improvement in quality of life using a WHOQOL BREF based questionnaire, patient satisfaction and safety evaluation through clinical monitoring and laboratory investigations including complete blood count at baseline and at the end of the study. Baseline evaluation, monthly follow up and final assessment after three months of treatment will be performed. The study aims to assess feasibility, preliminary efficacy and safety of the Unani regimen and to generate preliminary evidence for further larger clinical studies in the management of endometriosis.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Women aged 18–45 years,Diagnosed cases of endometriosis confirmed by USG or MRI,Complaints of dysmenorrhea and/or chronic pelvic pain,No hormonal or surgical treatment for endometriosis in the last three months,Willingness to participate and provide informed consent.
Exclusion Criteria
- •patient fails to follow instructions.
Investigators
Dr AYSHA RAZA
A and U Tibbia College and Hospital
