Effect of Melatonin and Metformin Combination Therapy on Clinical and Biochemical Parameters inInsulin Resistant Polycystic Ovary Syndrome Compared to Metformin Alone
Status: Recruiting
Location: See location...
Intervention Type: Combination product, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: f
View:
• Diagnosed case of PCOS according to Rotterdam criteria
• Women of age 18-35 years
• Insulin resistance (HOMA-IR \>2.6)
Locations
Other Locations
Bangladesh
Bangladesh Medical University
RECRUITING
Dhaka
Contact Information
Primary
Mst.Sumyara Khatun, MS
sumirmc09@gmail.com
+8801746046581
Backup
Farzana Rahman, MBBS
farzana47arshi91@gmail.com
+8801914229346
Time Frame
Start Date: 2025-03-11
Estimated Completion Date: 2026-08-10
Participants
Target number of participants: 60
Treatments
Experimental: Experimental arm: Melatonin and Metformin
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
Active_comparator: Comparator arm: Metformin
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
Related Therapeutic Areas
Sponsors
Collaborators: Bangladesh Medical University
Leads: Mst.Sumyara Khatun