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

ConditionPCOS(Insulin Resistant)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Metformin 500mg

    Drug

    Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks

  • Melatonin 3mg

    Combination product

    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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Experimental arm: Melatonin and MetforminExperimental treatment 1 intervention
Group B: Comparator arm: MetforminActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

HOMA-IR calculated by the following formula: HOMA-IR= Fasting glucose (mmol/L) x Fasting insulin mIU/ml divided by 22.5. For the present study HOMA-IR \>2.6 can be considered as insulin resistance

Time frame
Baseline to 12 weeks

Secondary outcomes

1

Change in Body Mass Index (BMI)

Body mass index is calculated by dividing the weight in kg by the height in meter square to assess obesity

Time frame
Baseline to 12 weeks
2

Change in Waist Circumference

Waist Circumference is measured in centimeter by placing a tape horizontally midway between the lower border of ribs and iliac crest on the mid axillary line.

Time frame
Baseline to 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mst.Sumyara Khatun

Lead sponsor

Bangladesh Medical University

Sponsor institution

Bangladesh Medical University

Collaborator

Source ClinicalTrials.gov
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