[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598184":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":41,"locations":47,"responsibleParty":70,"collaborators":31,"id":72,"slug":31,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":31,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":98,"overallStatus":50,"whyStopped":31,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Phenomen Pharma","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 2 (n=30)","ACTIVE_COMPARATOR","Group 2 (n=30): UDCA 10-15 mg\u002Fkg\u002Fday;",[13],"Drug: UDCA (Ursodeoxycholic acid)",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 3 (n=30)","Group 3 (n=30): Ademetionine 800-1600 mg\u002Fday.",[18],"Drug: Ademetionine",{"label":20,"type":21,"description":22,"interventionNames":23},"Group 1 (n=30)","EXPERIMENTAL","Participants receive dietary supplement 'Gepaktiv' (2 capsules × 3 times\u002Fday, 60 minutes before meals",[24],"Combination Product: Dietary supplement \"Gepaktiv\"",[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"COMBINATION_PRODUCT","Dietary supplement \"Gepaktiv\"","Dietary supplement \"Gepaktiv\" 60 minutes before meals 2 capsules × 3 times\u002Fday",[20],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"DRUG","UDCA (Ursodeoxycholic acid)","UDCA 10-15 mg\u002Fkg\u002Fday",[9],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"Ademetionine","Ademetionine 800-1600 mg\u002Fday.",[15],[42],{"name":43,"role":44,"phone":45,"phoneExt":31,"email":46},"Evgeniy Chesnokov, MD, Professor","CONTACT","+79091846111","e.v.chesnokov@mail.ru",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Tyumen State Medical University","RECRUITING","Tyumen","Tyumen Oblast","625000","Russia",{"type":56,"coordinates":57},"Point",[58,59],65.52722,57.15222,{"lat":59,"lon":58},[62,66,67],{"name":63,"role":44,"phone":64,"phoneExt":31,"email":65},"Irina Nagibina","89123872991","irina.nagibina@mail.ru",{"name":31,"role":44,"phone":45,"phoneExt":31,"email":46},{"name":68,"role":69,"phone":31,"phoneExt":31,"email":31},"Evgeniy Chesnokov, MD, professor","PRINCIPAL_INVESTIGATOR",{"type":71,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100598184",false,"NCT07068191","Gepaktiv vs UDCA and Ademetionine in MAFLD With Hepatomegaly","Randomized Comparative Clinical Study of the Dietary Supplement \"Gepaktiv\" (International Name: Phenomenon) in Comparison With Ursodeoxycholic Acid (UDCA) and Ademetionine in Patients With Metabolic Associated Fatty Liver Disease (MAFLD) and Hepatomegaly","HEPACT","Inclusion Criteria:\n\n* Age 18 to 65 years\n* Confirmed diagnosis of metabolic-associated fatty liver disease (MAFLD)\n* Hepatomegaly confirmed by ultrasound (≥3 cm craniocaudal liver enlargement)\n* ALT level between 90-150 U\u002FL\n* Steatosis ≥260 dB\u002Fm by FibroScan (CAP)\n* Fibrosis ≥11 kPa by transient elastography (FibroScan)\n* Ability to comply with study procedures\n* Signed informed consent\n\nExclusion Criteria:\n\n* Liver cirrhosis or hepatocellular carcinoma\n* Pregnancy or lactation\n* Known allergy to any of the study medications or supplement components\n* Gallstones or biliary obstruction\n* Shrunken liver on imaging\n* Hepatic cysts (simple liver cysts\u002Fbiliary cysts)\n* Liver nodules (focal liver lesions)","ALL","18 Years","65 Years",{"count":83,"type":84},90,"ESTIMATED","INTERVENTIONAL",[87],"NA","This study compares the effectiveness of the dietary supplement Gepaktiv with standard medications (UDCA and Ademetionine) in patients with fatty liver disease (MAFLD) and liver enlargement (hepatomegaly).\n\nKey points:\n\n* Participants will receive either Gepaktiv, UDCA, or Ademetionine for 15 days\n* Doctors will monitor liver health through blood tests and ultrasound scans\n* The study will check if Gepaktiv helps improve liver function as effectively as standard treatments.\n\nMain measurements:\n\n* Changes in liver enzyme levels (ALT, AST)\n* Reduction in liver size\n* Improvement in fat accumulation (steatosis) measured by FibroScan This research may provide evidence for a new natural option to support liver health.Data analysis will be done by an independent biostatistics",[90,91,92,93,94,95,96,97],"Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)","Hepatomegaly","Nonalcoholic Fatty Liver (NAFL)","Nonalcoholic Fatty Liver Disease (NAFLD)","Fatty Liver","Fatty Liver, Alcoholic","Fatty Liver, Nonalcoholic","Fatty Liver Disease",[91,99,100,101,102,103,104,105,106,107,94],"Gepaktiv","Metabolic dysfunction-associated fatty liver disease (MAFLD)","metabolic dysfunction-associated steatotic liver disease (MASLD)","Nonalcoholic fatty liver disease (NAFLD)","liver diseases","Nonalcoholic fatty liver (NAFL)","Liver","Liver steatosis","Dietary supplements","2025-07-19",{"date":110,"type":111},"2025-07-23","ACTUAL",{"date":113,"type":111},"2025-06-19",{"date":115,"type":84},"2025-08",{"name":5,"class":6},1]