CTRI/2022/03/041489
Completed
Phase 2
A pilot study to evaluate the safety and efficacy of Gunmakudori Mezhugu (GKM) in the management of Garpa vayu (PCOS) in the women of reproductive age.
Central Council for Research in Siddha0 sites34 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Central Council for Research in Siddha
- Enrollment
- 34
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Age limit 18 years to 45 years.
- •2\.PCOS women diagnosed by Rotterdam criteria.
- •3\.Presence with Oligomenorrhea or Amenorrhea after negative screening pregnancy test.
- •4\.Hyperandrogenism clinically Hirsutism, Biochemically elevated serum testosterone concentrations.
- •5\.Polycystic ovaries.
Exclusion Criteria
- •1\.Age younger than 18 or older than 45
- •2\.Hyperandrogenism due to other reasons including hyperprolactinemia, thyroid diseases, congenital adrenal hyperplasia, Cushing syndrome etc.
- •3\.Subjects with metabolic, endocrinal disorders and psychiatric illnesses.
- •4\.Not associated with any organic reproductive system abnormalities.
- •5\.Current or previous (within the last 3 months) use of oral contraceptives.
- •6\.Pregnant or suspected to be pregnant.
Outcomes
Primary Outcomes
Not specified
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