Melatonin & Metformin on Clinical & Biochemical Parameters in Insulin Resistant PCOS Compared to Metformin

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorMst.Sumyara Khatun

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

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mst.Sumyara Khatun

Lead sponsor

Bangladesh Medical University

Sponsor institution

Bangladesh Medical University

Collaborator