[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616597":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":28,"studyPopulation":20,"armGroups":29,"interventions":42,"overallOfficials":53,"centralContacts":60,"locations":69,"responsibleParty":90,"collaborators":94,"id":96,"slug":20,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":20,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":20,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":71,"whyStopped":20,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Bangladesh Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)","HOMA-IR calculated by the following formula:\n\nHOMA-IR= Fasting glucose (mmol\u002FL) x Fasting insulin mIU\u002Fml divided by 22.5. For the present study HOMA-IR \\>2.6 can be considered as insulin resistance","Baseline to 12 weeks",[14,17],{"measure":15,"description":16,"timeFrame":12},"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",{"measure":18,"description":19,"timeFrame":12},"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.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":24,"primaryPurpose":25,"observationalModel":20,"timePerspective":20,"maskingInfo":26},"RANDOMIZED","PARALLEL","Open label parallel design randomized clinical trial","TREATMENT",{"masking":27,"maskingDescription":20,"whoMasked":20},"NONE","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.\n\nGroup 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.\n\nGroup B:Tab. Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks.\n\nData 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.\n\nFollow 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.",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"Experimental arm: Melatonin and Metformin","EXPERIMENTAL","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",[35],"Combination Product: Melatonin 3mg",{"label":37,"type":38,"description":39,"interventionNames":40},"Comparator arm: Metformin","ACTIVE_COMPARATOR","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",[41],"Drug: Metformin 500mg",[43,48],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":20},"DRUG","Metformin 500mg","Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks",[37],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":20},"COMBINATION_PRODUCT","Melatonin 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",[31],[54,57],{"name":55,"affiliation":5,"role":56},"Jesmine Banu, MS","STUDY_CHAIR",{"name":58,"affiliation":5,"role":59},"Farzana Rahman, MBBS","PRINCIPAL_INVESTIGATOR",[61,66],{"name":62,"role":63,"phone":64,"phoneExt":20,"email":65},"Mst.Sumyara Khatun, MS","CONTACT","+8801746046581","sumirmc09@gmail.com",{"name":58,"role":63,"phone":67,"phoneExt":20,"email":68},"+8801914229346","farzana47arshi91@gmail.com",[70],{"facility":5,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"RECRUITING","Dhaka","Shahbag","1000","Bangladesh","BD",{"type":78,"coordinates":79},"Point",[80,81],90.40744,23.7104,{"lat":81,"lon":80},[84,86,87,88],{"name":85,"role":63,"phone":64,"phoneExt":20,"email":65},"Mst Sumyara Medical officer, MS",{"name":58,"role":63,"phone":67,"phoneExt":20,"email":68},{"name":58,"role":59,"phone":20,"phoneExt":20,"email":20},{"name":55,"role":89,"phone":20,"phoneExt":20,"email":20},"SUB_INVESTIGATOR",{"type":91,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Mst.Sumyara Khatun","Medical Officer",[95],{"name":5,"class":6},"100616597",false,"NCT07307677","Melatonin & Metformin on Clinical & Biochemical Parameters in Insulin Resistant PCOS Compared to Metformin","Effect of Melatonin and Metformin Combination Therapy on Clinical and Biochemical Parameters inInsulin Resistant Polycystic Ovary Syndrome Compared to Metformin Alone","Inclusion Criteria:\n\n* Diagnosed case of PCOS according to Rotterdam criteria\n* Women of age 18-35 years\n* Insulin resistance (HOMA-IR \\>2.6)\n\nExclusion Criteria:\n\n* BMI: ≤ 18.5 and ≥ 30 kg\u002Fm2\n* Uncontrolled endocrine disorders (Diabetis melitus, Hypothyroidism, Hyperprolactinemia)\n* Known case of any medical disease (Renal, hepatic or cardiac disease)\n* Any medication which would affect insulin resistance (Metformin, Myo- inositol, Pioglitazone) in last three months.\n* Hypersensitivity to melatonin.","FEMALE","18 Years","35 Years",{"count":106,"type":107},60,"ESTIMATED","INTERVENTIONAL",[110],"NA","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.\n\nGroup B:Tab. Metformin (500mg) once daily for 7days followed by twice daily for next 7 days followed by thrice daily for next 10 weeks.\n\nOutcome variables will be measured after three months, will be meticulously recorded for analysis and comparison.",[113],"PCOS(Insulin Resistant)",[115],"Melatonin in PCOS","2026-01-05",{"date":118,"type":119},"2026-01-07","ACTUAL",{"date":121,"type":119},"2025-03-11",{"date":123,"type":107},"2026-08-10",{"name":92,"class":6},1]