Melatonin & Metformin on Clinical & Biochemical Parameters in Insulin Resistant PCOS Compared to Metformin
Effect of Melatonin and Metformin Combination Therapy on Clinical and Biochemical Parameters inInsulin Resistant Polycystic Ovary Syndrome Compared to Metformin Alone
Mst.Sumyara Khatun
60 participants
Mar 11, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria3
- Diagnosed case of PCOS according to Rotterdam criteria
- Women of age 18-35 years
- Insulin resistance (HOMA-IR >2.6)
Exclusion Criteria5
- 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.
- Hypersensitivity to melatonin.
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Interventions
Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks
Melatonin (3mg) 3 tablet single dose at night for 12 weeks and Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks
Locations(1)
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NCT07307677