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A Study to Evaluate the Safety and Effectiveness of Berberine in Women with Polycystic Ovary Syndrome (PCOS)

Efficacy and Safety of Berberine in Polycystic Ovary Syndrome: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/107414
Enrollment
50
Registered
2026-04-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E282- Polycystic ovarian syndrome

Interventions

Intervention1: Berberine: In this study the participants in the intervention arm will receive Berberine 500mg twice daily for a duration of 12 weeks Control Intervention1: Metformin: Participants in t

Sponsors

Periswaran V
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed with PCOS by Rotterdam criteria. Not on hormonal therapy or insulin-sensitising agents for at least 3 months before enrollment. Willing to give informed consent.

Exclusion criteria

Exclusion criteria: Known diabetes mellitus (type 1 or overt type 2). Patients planning for pregnancy. Pregnancy and breastfeeding. Prior hypersensitivity to metformin or berberine. Other endocrinopathies (e.g., Cushing s syndrome, thyroid dysfunction).

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of berberine compared with metformin in polycystic ovary syndrome over 12 weeks. Evaluate and compare safety profiles, including adverse events and hormonal parameters.Timepoint: 12 weeks

Secondary

MeasureTime frame
To compare changes in body weight body mass index and waist to hip ratio between the study groups. To assess improvement in menstrual regularity and ovulatory function among participants. To compare changes in lipid and glycaemic parameters between the treatment groups. To assess medication adherence and lifestyle modifications between the treatment groupsTimepoint: 12 weeks

Countries

India

Contacts

Public ContactDr Hemanth Kumar CH

SRM Medical College Hospital and Research Centre

anuradhm@srmist.edu.in9042038136

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026