[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640120":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":45,"locations":55,"responsibleParty":74,"collaborators":31,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":31,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":58,"whyStopped":31,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Beni-Suef University","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Myo-Inositol + Folic Acid","EXPERIMENTAL","Participants receive myo-inositol 2 g twice daily combined with folic acid 200 µg twice daily for 6 months.",[13,14],"Drug: Myo-inositol","Dietary Supplement: Folic Acid",{"label":16,"type":10,"description":17,"interventionNames":18},"Myo-Inositol + Folic Acid + Alpha-Lipoic Acid","Participants receive myo-inositol 2 g twice daily and folic acid 200 µg twice daily combined with alpha-lipoic acid 600 mg once daily for 6 months.",[13,14,19],"Drug: Alpha Lipoic Acid",{"label":21,"type":10,"description":22,"interventionNames":23},"Myo-Inositol + Folic Acid + Alpha-Lipoic Acid + Metformin","Participants receive myo-inositol 2 g twice daily and folic acid 200 µg twice daily combined with alpha-lipoic acid 600 mg once daily and metformin titrated up to 1500 mg\u002Fday over 2 weeks for 6 months.",[13,14,19,24],"Drug: Metfomin",[26,32,37,41],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Myo-inositol","Myo-inositol administered orally at a dose of 2 g twice daily for 6 months.",[9,16,21],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"DIETARY_SUPPLEMENT","Folic Acid","Folic acid administered orally at a dose of 200 micrograms twice daily for 6 months.",[9,16,21],{"type":27,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"Alpha Lipoic Acid","Alpha-lipoic acid administered orally at a dose of 600 mg once daily for 6 months.",[16,21],{"type":27,"name":42,"description":43,"armGroupLabels":44,"otherNames":31},"Metfomin","Metformin administered orally starting at 500 mg once daily and titrated over two weeks to a maximum dose of 1500 mg\u002Fday (500 mg three times daily), taken after meals for 6 months.",[21],[46,51],{"name":47,"role":48,"phone":49,"phoneExt":31,"email":50},"Ahmed A Abdelkader, Lecturer Assistant","CONTACT","+201050095206","ahmed.abdelkader@hu.edu.eg",{"name":52,"role":48,"phone":53,"phoneExt":31,"email":54},"Marwa Mohsen Mahmoud, Lecturer","+201202203223","Marwa.Mohsen@pharm.bsu.edu.eg",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":31,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Faculty of Medicine, Cairo University","RECRUITING","Cairo","Cairo Governorate","Egypt","EG",{"type":64,"coordinates":65},"Point",[66,67],31.24967,30.06263,{"lat":67,"lon":66},[70],{"name":71,"role":48,"phone":72,"phoneExt":31,"email":73},"Hesham ElShaer, Professor","+0201223130881","dr.heshamelshaer@hotmail.com",{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Ahmed Abdelkader","Lecturer Assistant","100640120","phase-3-efficacy-of-alpha-lipoic-acid-combined-with-myo-inositol-in-non-diabetic-pcos-patients-100640120",false,"NCT07630779","Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol in Non-Diabetic PCOS Patients","A Randomized Controlled Trial Evaluating the Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol With or Without Metformin in Non-Diabetic Women With Polycystic Ovary Syndrome","ALA-MYO-PCOS","Inclusion Criteria:\n\n* Women aged 21 to 40 years\n* Diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam criteria\n* Not currently pregnant or lactating\n* No hormonal therapy within the last 3 months\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* \\- History of diabetes mellitus, hypertension, or thyroid disorders\n* History of cardiovascular, renal, or hepatic disease\n* Use of hormonal contraceptives or insulin sensitizers within the last 3 months\n* Known hypersensitivity or allergy to study medications (myo-inositol, alpha-lipoic acid, or metformin)\n* Non-Egyptian ethnicity","FEMALE","21 Years","40 Years",{"count":90,"type":91},180,"ESTIMATED","INTERVENTIONAL",[94],"PHASE3","This study evaluates the efficacy of alpha-lipoic acid combined with myo-inositol, with or without metformin, in improving menstrual regularity and ovulation in non-diabetic women with polycystic ovary syndrome (PCOS). The study also assesses metabolic, hormonal, and clinical outcomes.",[97],"Poly Cystic Ovary Syndrome",[99],"PCOS Myo-Inositol Alpha Lipoic Acid Metformin Insulin Resistance Ovulation","2026-06-02",{"date":102,"type":103},"2026-06-05","ACTUAL",{"date":105,"type":103},"2026-03-10",{"date":107,"type":91},"2026-12",{"name":5,"class":6},1]