[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Phenomen Pharma\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":58},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":36,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":5},"100598184","gepaktiv-vs-udca-and-ademetionine-in-mafld-with-hepatomegaly-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":21,"type":22},90,"ESTIMATED","INTERVENTIONAL",[25],"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",[28,29,30,31,32,33,34,35],"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",[29,37,38,39,40,41,42,43,44,45,32],"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","RECRUITING","2025-07-19",{"date":49,"type":50},"2025-07-23","ACTUAL",{"date":52,"type":50},"2025-06-19",{"date":54,"type":22},"2025-08",{"name":56,"class":57},"Phenomen Pharma","OTHER",""]