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Clinical Trials/CTRI/2022/03/041489
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.

Registry
who.int
Start Date
TBD
End Date
August 16, 2023
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Central Council for Research in Siddha

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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