[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628740":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":37,"locations":38,"responsibleParty":55,"collaborators":57,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":37,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":37,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":37,"overallStatus":79,"whyStopped":37,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Liaquat University of Medical & Health Sciences","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Berberine Phytosome (Inositol-Naïve)","EXPERIMENTAL","Participants receive berberine phytosome supplementation (550 mg once daily) for 12 weeks in women who have not previously taken inositol. Participants also receive lifestyle advice including dietary guidance and encouragement of regular physical activity.",[13,14],"Dietary Supplement: Berberine Phytosome (Sophy®)","Behavioral: Lifestyle Advice",{"label":16,"type":10,"description":17,"interventionNames":18},"Berberine Phytosome + Inositol","Participants who have been taking inositol (myo-inositol or D-chiro-inositol) for at least three months receive berberine phytosome supplementation (550 mg once daily) for 12 weeks in addition to ongoing lifestyle advice including dietary guidance and regular physical activity.",[13,14],{"label":20,"type":21,"description":22,"interventionNames":23},"Lifestyle Advice Only (Control)","ACTIVE_COMPARATOR","Participants receive lifestyle advice including dietary guidance and recommendations for increased physical activity without berberine phytosome supplementation during the 12-week study period.",[14],[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DIETARY_SUPPLEMENT","Berberine Phytosome (Sophy®)","Berberine phytosome administered orally at a dose of 550 mg once daily for 12 weeks. The formulation used in this study is Sophy® (PharmExtracta S.p.A., Italy), a nutraceutical preparation containing berberine designed to improve bioavailability.",[9,16],[31],"Sophy® (PharmExtracta S.p.A., Italy)",{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"BEHAVIORAL","Lifestyle Advice","Participants receive standardized lifestyle advice including dietary recommendations based on a Mediterranean diet and encouragement of regular physical activity such as brisk walking or cycling for approximately 30 minutes, three to five times per week.",[9,16,20],null,[39],{"facility":40,"status":37,"city":41,"state":37,"zip":37,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"University of Urbino Carlo Bo","Urbino","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],12.63633,43.72621,{"lat":48,"lon":47},[51],{"name":52,"role":53,"phone":37,"phoneExt":37,"email":54},"Prof. Davide, Sisti, PhD","CONTACT","davide.sisti@uniurb.it",{"type":56,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR",[58],{"name":59,"class":6},"University of Urbino \"Carlo Bo\"","100628740","berberine-phytosome-for-signs-and-symptoms-of-polycystic-ovary-syndrome-pcos-100628740",false,"NCT07465575","Berberine Phytosome for Signs and Symptoms of Polycystic Ovary Syndrome (PCOS)","Effectiveness of Berberine Phytosome in Improving Signs and Symptoms of Polycystic Ovary Syndrome (PCOS): A Multicentre, Randomized, Controlled Trial","Inclusion Criteria:\n\n* Women aged 18-40 years\n* Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam criteria\n* Body mass index (BMI) ≥ 25 kg\u002Fm²\n* Evidence of insulin resistance (HOMA-IR above normal range)\n* Willingness to follow lifestyle recommendations including dietary advice and physical activity\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Use of insulin-sensitizing drugs (e.g., metformin) within the previous 3 months\n* Current hormonal therapy including oral contraceptives or anti-androgens\n* Diagnosis of diabetes mellitus\n* Known liver, renal, cardiovascular, or endocrine diseases other than PCOS\n* Use of berberine-containing supplements within the previous 3 months\n* Known hypersensitivity to berberine or related compounds","FEMALE","18 Years","40 Years",{"count":71,"type":72},150,"ESTIMATED","INTERVENTIONAL",[75],"NA","This multicenter, randomized, controlled clinical trial aims to evaluate the effectiveness of berberine phytosome supplementation in improving signs and symptoms associated with polycystic ovary syndrome (PCOS). Women presenting with clinical features suggestive of PCOS, including hirsutism, acne, menstrual irregularities, and overweight, will be enrolled.\n\nParticipants will be randomly assigned to one of three groups: (1) berberine phytosome supplementation in women not previously taking inositol, (2) berberine phytosome supplementation in women already taking inositol for at least three months, or (3) a control group receiving lifestyle advice without supplementation. The intervention will consist of berberine phytosome 550 mg once daily for 12 weeks.\n\nThe study will evaluate changes in clinical manifestations associated with hyperandrogenism and metabolic dysfunction, including hirsutism, acne severity, body mass index, and metabolic parameters. The results will provide evidence on the potential role of berberine phytosome supplementation in improving clinical manifestations related to PCOS.",[78],"Polycystic Ovary Syndrome","NOT_YET_RECRUITING","2026-03-16",{"date":82,"type":83},"2026-03-19","ACTUAL",{"date":80,"type":72},{"date":86,"type":72},"2027-03-31",{"name":5,"class":6},1]