[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650506":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":48,"locations":56,"responsibleParty":71,"collaborators":33,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":33,"eligibilityCriteria":78,"healthyVolunteers":75,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":33,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":59,"whyStopped":33,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Khyber Medical University Peshawar","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Orlistat + Standard Lifestyle Advice","EXPERIMENTAL","Participants will receive oral Orlistat capsules twice daily between lunch and dinner for 3 months in addition to standard lifestyle advice, including a healthy diet, regular physical activity, walking or cycling for at least 30 minutes daily, and other lifestyle modifications.",[13,14],"Drug: Orlistat","Behavioral: Standard Lifestyle Advice",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo + Standard Lifestyle Advice","PLACEBO_COMPARATOR","Participants will receive matching placebo capsules twice daily for 3 months together with the same standard lifestyle advice, including a healthy diet, regular physical activity, walking or cycling for at least 30 minutes daily, and other lifestyle modifications",[20,14],"Drug: Placebo",[22,29,34],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Orlistat","Oral Orlistat capsules administered twice daily between lunch and dinner for 3 months as an adjunct to the recommended care plan for women with polycystic ovary syndrome (PCOS). Participants will also receive standard lifestyle advice, including a healthy diet, regular physical activity, walking, and cycling.",[9],[28],"Oral Orlistat capsules",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Placebo","Matching placebo capsules administered twice daily for 3 months in addition to standard lifestyle advice, including a healthy diet, regular physical activity, walking, and cycling, for women with polycystic ovary syndrome (PCOS).",[16],null,{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"BEHAVIORAL","Standard Lifestyle Advice","Participants will receive standardized lifestyle advice, including maintaining a healthy diet, engaging in regular physical activity, and performing at least 30 minutes of walking or cycling daily throughout the 3-month study period.",[9,16],[40],"Lifestyle Modification",[42,46],{"name":43,"affiliation":44,"role":45},"Prof Dr Ruqqiya Sultana, MBBS","Khyber Medical Univeristy Peshawar","PRINCIPAL_INVESTIGATOR",{"name":47,"affiliation":44,"role":45},"Dr Noman Arif, PhD",[49,53],{"name":43,"role":50,"phone":51,"phoneExt":33,"email":52},"CONTACT","+92 314 5014992","ruqqia_sultana@yahoo.com",{"name":47,"role":50,"phone":54,"phoneExt":33,"email":55},"+92 345 3059391","nomanarif@kmu.edu.pk",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":33,"country":62,"countryCode":63,"cosmosGeoPoint":33,"geoPoint":33,"contacts":64},"Ayub Teaching Hospital","RECRUITING","Abbottābād","Khyber Pakhtunkhwa","Pakistan","PK",[65,67],{"name":66,"role":50,"phone":51,"phoneExt":33,"email":52},"Dr. Ruqqiya Sultana, MBBS",{"name":68,"role":50,"phone":69,"phoneExt":33,"email":70},"Dr Syed Muhammad Shabbir Ali Naqvi, PhD*","+923460113227","coordinator.ctu@kmu.edu.pk",{"type":72,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100650506","effect-of-orlistat-on-metabolic-and-hormonal-features-in-women-with-polycystic-ovary-syndrome-pcos-a-randomized-controlled-clinical-trial-100650506",false,"NCT07747909","Effect of Orlistat on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS): a Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Females aged 18-45 years.\n* Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam Criteria (presence of any two of the following):\n* Oligomenorrhea or amenorrhea.\n* Clinical or biochemical hyperandrogenism.\n* Polycystic ovaries on ultrasonography.\n* Body mass index (BMI) between 18.5 and 35 kg\u002Fm² (Asian criteria).\n\nExclusion Criteria:\n\n* Current or recent use of oral contraceptives, ovulation induction medications, anti-obesity medications, cholesterol-lowering medications, or other therapies\u002Fsupplements known to affect insulin physiology or androgen metabolism (e.g., inositols, curcumin, lipoic acid, cinnamon, gymnemic, or other botanical extracts).\n* Women undergoing in vitro fertilization (IVF) treatment.\n* Known congenital adrenal hyperplasia, thyroid disorders, hyperprolactinemia, or diabetes mellitus.\n* Presence of severe renal or liver disease.\n* Menopausal, pregnant, or breastfeeding women.\n* Anti-Müllerian Hormone (AMH) \\\u003C 0.7 ng\u002FmL.","FEMALE","18 Years","45 Years",{"count":83,"type":84},120,"ESTIMATED","INTERVENTIONAL",[87],"NA","This randomized controlled clinical trial aims to evaluate the effect of orlistat on the metabolic and hormonal features of women with polycystic ovary syndrome (PCOS). Eligible women diagnosed with PCOS according to the Rotterdam criteria will be randomly assigned to receive either orlistat plus standard lifestyle advice or placebo plus standard lifestyle advice for three months. The study will assess the effect of orlistat on hormonal parameters, glucose metabolism, lipid profile, liver function, anthropometric measures, non-alcoholic fatty liver disease, and quality of life to determine its effectiveness as an adjunctive treatment for women with PCOS.",[90],"Polycystic Ovary Syndrome",[92,24,93,94],"PCOS","Lifestyle Intervention","Quality of Life","2026-07-31",{"date":97,"type":98},"2026-08-05","ACTUAL",{"date":100,"type":98},"2026-01-01",{"date":102,"type":84},"2026-09-15",{"name":5,"class":6},1]