Melatonin & Metformin on Clinical & Biochemical Parameters in Insulin Resistant PCOS Compared to Metformin
Recruiting · NCT07307677 · Interventional (participants receive a specific treatment) · Lead sponsor: Mst.Sumyara Khatun
View the official record on ClinicalTrials.gov →Interventions studied
Melatonin 3mgMetformin 500mg
What this trial is about
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.
Who can take part
Age range
18 Years to 35 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Diagnosed case of PCOS according to Rotterdam criteria
- Women of age 18-35 years
- Insulin resistance (HOMA-IR \>2.6)
Exclusion criteria
- 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.
Where it is running
1 location listed.
- Bangladesh Medical University - Dhaka, Shahbag, Bangladesh