About this trial
Women with polycystic ovary syndrome with HOMA-IR \>2.6 fulfilling inclusion and exclusion criteria will be randomly allocated into two groups:experimental group: A (Melatonin 3mg and Metformin 500mg) and control group: B (Metformin 500mg). Each group will be contained 30 selected patients.
Group B:Tab. Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks.
Outcome variables will be measured after three months, will be meticulously recorded for analysis and comparison.
Eligibility criteria
Qualifiers
Diagnosed case of PCOS according to Rotterdam criteria
Women of age 18-35 years
Insulin resistance (HOMA-IR >2.6)
Disqualifiers
BMI: ≤ 18.5 and ≥ 30 kg/m2
Uncontrolled endocrine disorders (Diabetis melitus, Hypothyroidism, Hyperprolactinemia)
Known case of any medical disease (Renal, hepatic or cardiac disease)
Any medication which would affect insulin resistance (Metformin, Myo- inositol, Pioglitazone) in last three months.
Trial design
Treatments tested in this trial
- Metformin 500mg
- Melatonin 3mg
Treatment groups
Sponsors and collaborators
Mst.Sumyara Khatun
Lead sponsor
Bangladesh Medical University
Sponsor institution
Bangladesh Medical University
Collaborator