Actively Recruiting

Phase Not Applicable
Age: 18Years - 35Years
FEMALE
NCT07307677

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

Led by Mst.Sumyara Khatun · Updated on 2026-01-07

60

Participants Needed

1

Research Sites

73 weeks

Total Duration

On this page

Sponsors

M

Mst.Sumyara Khatun

Lead Sponsor

B

Bangladesh Medical University

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 35Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam criteria
  • Female aged 18 to 35 years
  • Insulin resistance with HOMA-IR greater than 2.6
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) less than or equal to 18.5 or greater than or equal to 30 kg/m2
  • Uncontrolled endocrine disorders such as diabetes mellitus, hypothyroidism, or hyperprolactinemia
  • Known medical diseases including kidney, liver, or heart conditions
  • Use of medications affecting insulin resistance (Metformin, Myo-inositol, Pioglitazone) within the last three months
  • Allergy or hypersensitivity to melatonin

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Bangladesh Medical University

Dhaka, Shahbag, Bangladesh, 1000

Actively Recruiting

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Research Team

M

Mst.Sumyara Khatun, MS

CONTACT

F

Farzana Rahman, MBBS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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