Health Condition 1: E282- Polycystic ovarian syndrome
Conditions
Interventions
Intervention1: Saroglitazar and metformin: Saroglitazar 4 mg
Metformin 500 mg BD daily for 6 months
Control Intervention1: Metformin: Metformin 500 mg BD daily for 6 months
Sponsors
HARYANA STATE COUNCIL FOR SCIENCE INNOVATION AND TECHNOLOGY
Eligibility
Inclusion criteria
Inclusion criteria: (i) females with 18-45 years age; (ii) diagnosed with PCOS as per Rotterdam revised 2003 criteria; and (iii) willing to give written consent.
Exclusion criteria
Exclusion criteria: (i) pregnancy or lactation; (ii) current or recent (within last 3 months) intake of drugs affecting insulin sensitivity or ovulatory function; (iii) presence of comorbidity such as diabetes mellitus, thyroid dysfunction, hyperprolactinemia, androgen-secreting neo?plasms and Cushing?s syndrome; (iv) current or recent (3 months prior) partici?pation in any other interventional study; and (v) known allergy to study drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum sex hormone binding globulin (SHBG) levelsTimepoint: 6 months from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in clinical efficacy endpoints (anthropometry, hirsutism score, menstrual cycles regularity)Timepoint: 6 months from baseline;Change in metabolic efficacy end points (lipid profile, fasting plasma glucose, HOMA-IR index, metabolic syndrome)Timepoint: 6 months from baseline;Change in gonadal efficacy end points (ovarian function, circulating androgens)Timepoint: 6 months from baseline;Change in hepatic steatosis grading on transabdominal ultrasoundTimepoint: 6 months from baseline;Any derangement in serum biochemical (renal and liver function tests) and haematological (blood counts) parametersTimepoint: 6 months from baseline;Change in WHO-QOLBREF questionnaire scoreTimepoint: 6 months from baseline | — |
Countries
India
Contacts
Public ContactNiti Mittal
PGIMS, Rohtak
Outcome results
None listed