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

Mst.Sumyara Khatun

Status: Enrolling

Conditions: PCOS(Insulin Resistant)

Treatments: Combination Product: Melatonin 3mg; Drug: Metformin 500mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07307677

5498

Details and patient eligibility

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.

Full description

After obtaining approval of the Institutional Review Board (IRB), this randomized controlled trial will be conducted at Bangabandhu Sheikh Mujib Medical University (BSMMU). Already diagnosed patients of polycystic ovary syndrome with subfertility with HOMA-IR >2.6 attending in the OPD of Reproductive Endocrinology and Infertility department at BSMMU will be the study population. Women with PCOS fulfilling inclusion and exclusion criteria will be explained in details regarding the objectives, rationality, procedure and potential benefits of the study. The patients will be counselled regarding the drugs and side effects and Informed written consent will be obtained before enrollment.Random allocation will be done using serially numbered closed opaque envelopes. Eligible women will be randomly allocated into two groups:experimental group: A and control group: B. Each group will be contained 30 selected patients.

Group A:Tab. Melatonin (3mg) 3 tablet once daily at night for 12 weeks with Tab. Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks.

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.

Data will be collected through interviews, physical examinations and laboratory investigations. Prior to commencement of treatment, full assessments including demographic and clinical information and the result of baseline investigations will be undertaken.

Follow up: Participants will come after one month to assess compliance with the regimen and monitor for any potential side effects. A third visit will be scheduled at the end of the third month for a comprehensive assessment. Any adverse events experienced by participants will be carefully noted and documented throughout the study duration. Outcome variables will be measured after three months, will be meticulously recorded for analysis and comparison.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Experimental arm: Melatonin and Metformin

Experimental group

Description:

Participants will receive 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:

Combination Product: Melatonin 3mg

Comparator arm: Metformin

Active Comparator group

Description:

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

Treatment:

Drug: Metformin 500mg