PCOS(Insulin Resistant)
Conditions
Keywords
Melatonin in PCOS
Brief 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.
Detailed 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.
Interventions
DRUGMetformin 500mg
Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks
COMBINATION_PRODUCTMelatonin 3mg
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
Sponsors
Bangladesh Medical University
Mst.Sumyara Khatun
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label parallel design randomized clinical trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline to 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | Baseline to 12 weeks | Body mass index is calculated by dividing the weight in kg by the height in meter square to assess obesity |
| Change in Waist Circumference | Baseline to 12 weeks | 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. |
Countries
Bangladesh
Contacts
Primary ContactMst.Sumyara Khatun, MS
Backup ContactFarzana Rahman, MBBS
Outcome results
None listed