A clinical trial to study the effect of the Siddha medicine in patients having Poly cystic ovarian syndrome (PCOS)
Phase 2
Not yet recruiting
- Conditions
- Polycystic ovarian syndrome,
- Registration Number
- CTRI/2020/09/027580
- Lead Sponsor
- Government Siddha Medical college
- Brief Summary
This is a single Non randomized open clinical trial to study the safety and efficacy of Siddha medicine Thumattikkai mezhugu. The medicine is given 130mg once in a morning during menstrual cycle for 3days (3 consecutive cycles). Clinical trail is conducted after conducting Pre clinical toxicity study. During the trial all the study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
- subjects within 15.
- 35 years Both Unmarried and married women Amenorrhoea Irregular menstruation Oligomenorrhoea Polycystic ovary in ultra sound ( unilateral/ bilateral).
Exclusion Criteria
H/O Hypothyroidism/ Hyperthyroidism H/O Pituitary/ adrenal disorders H/O Hemorrhagic cyst H/O Chocolate cyst H/O Tuberculosis of the ovary and uterus.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome is mainly assessed by regulation of menstrual cycle regulation of ovulation disappearance / reduction in the size or number of the cyst 3 days (3 consecutive cycles)
- Secondary Outcome Measures
Name Time Method Secondary outcome is assessed by comparing the hormonal levels reduction in size of cyst before and after treatment 3 days ( 3 consecutive cycles)
Trial Locations
- Locations (1)
Arignar Anna Government Hospital of Indian Medicine
🇮🇳Chennai, TAMIL NADU, India
Arignar Anna Government Hospital of Indian Medicine🇮🇳Chennai, TAMIL NADU, IndiaDr Abisha RPrincipal investigator8825794303abishahepzhi@gmail.com