Health Condition 1: E282- Polycystic ovarian syndrome
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
SRM Medical College Hospital and Research Centre