[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metabolic-dysfunction-associated-fatty-liver-disease-mafld\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metabolic-dysfunction-associated-fatty-liver-disease-mafld":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"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":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100643834","phase-2-linzhi-jianghuang-fufang-huoxue-anshen-capsule-for-non-alcoholic-fatty-liver-100643834",false,"NCT07637006","Linzhi Jianghuang Fufang Huoxue Anshen Capsule for Non-alcoholic Fatty Liver","The Efficacy and Safety of Linzhi Jianghuang Fufang Huoxue Anshen Capsule for Non-alcoholic Fatty Liver: a Randomized, Double-blinded, Placebo-controlled Trial","LJF","Inclusion Criteria:\n\n* 1\\) Age between 18 and 65 years (inclusive);\n* 2\\) Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) ≥ 10%;\n* 3\\) Liver stiffness measured by transient elastography \\\u003C 7.3 kPa;\n* 4\\) Presence of one or more metabolic risk factors: a. Fasting plasma glucose ≥ 6.1 mmol\u002FL, or 2-hour postprandial glucose ≥ 7.8 mmol\u002FL, or HbA1c ≥ 5.7%, or a history of type 2 diabetes, or HOMA-IR ≥ 2.5; b. Arterial blood pressure ≥ 130\u002F85 mmHg, or receiving antihypertensive medication; c. Fasting serum triglycerides ≥ 1.7 mmol\u002FL;\n* 5\\) Diagnosis of NAFLD with Phlegm-Stasis Obstructing Collateral pattern according to Traditional Chinese Medicine (TCM) criteria, formulated based on the \"Consensus Opinion on Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Non-alcoholic Fatty Liver Disease (2017)\": Primary Symptoms: a. Intercostal stabbing or dull pain; b. Palpable abdominal mass (hypochondriac mass); c. Dark or dull complexion; d. Obesity. Secondary Symptoms: a. Epigastric and chest fullness and oppression; b. Expectoration of sputum; c. Poor appetite and aversion to greasy food; d. Heavy sensation in the limbs. Tongue and Pulse: Dark red tongue with ecchymosis, enlarged tongue body with teeth marks, greasy coating; wiry, slippery, or hesitant pulse. Diagnosis can be established with the presence of at least 2 primary symptoms and 1 or 2 secondary symptoms, in conjunction with the tongue and pulse presentation.\n* 6\\) Understand the trial content thoroughly and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* 1\\) Excessive alcohol intake (converted pure alcohol \\> 210 g per week for men, \\> 140 g per week for women), or an Alcohol Use Disorder Identification Test (AUDIT) score ≥ 8;\n* 2\\) Other liver diseases (e.g., alcoholic hepatitis, viral hepatitis, drug-induced liver disease, Wilson's disease, autoimmune liver disease, etc.), or a history of liver transplantation or liver resection;\n* 3\\) Presence of severe concurrent diseases affecting the heart, brain, hematopoietic system, immune system, or kidneys (BUN \\> 1.5 × ULN, Cr \\> ULN);\n* 4\\) Presence of other endocrine system disorders, such as hyperthyroidism, Cushing's syndrome, etc.;\n* 5\\) History of malignancy that has not been in complete remission for more than 5 years;\n* 6\\) Hepatic decompensation (total bilirubin, platelet count, prothrombin time, albumin \\> ULN; ALT or AST \\> 2 × ULN), presence of ascites, varices, or a history of hepatic encephalopathy;\n* 7\\) Poorly controlled severe hypertension, defined as systolic blood pressure ≥ 180 mmHg and\u002For diastolic blood pressure ≥ 110 mmHg;\n* 8\\) Insulin-dependent diabetes mellitus (e.g., type 1 diabetes mellitus, or current use of insulin), or non-insulin-dependent diabetes mellitus with poor glycemic control (HbA1c ≥ 9.5%), or diabetic acute complications, or diabetes with severe chronic complications;\n* 9\\) Use of medications that may cause hepatic steatosis or steatohepatitis (e.g., tamoxifen, amiodarone, glucocorticoids, tetracyclines, methotrexate, valproate, salicylates, estrogens) or potentially hepatotoxic drugs for 2 consecutive weeks or more within the past year;\n* 10\\) Current use or use within the past 3 months of GLP-1 receptor agonists;\n* 11\\) Adjustment of hypoglycemic, antihypertensive, or lipid-lowering medications within the past 3 months (e.g., adding or discontinuing medication, dose change, or irregular use);\n* 12\\) Regular use of hepatoprotective drugs or vitamin E within the past month;\n* 13\\) History of bariatric surgery within the past year, or body weight change \\> 5% within the past 3 months;\n* 14\\) History of surgery within the past month;\n* 15\\) Coagulation abnormalities, or current use of medications or foods with anticoagulant effects (e.g., aspirin, warfarin, Panax notoginseng, safflower, Angelica sinensis, peach kernel, etc.);\n* 16\\) Concomitant psychiatric or psychological disorders, or substance\u002Fdrug abuse;\n* 17\\) Known allergic constitution, or known allergy to any component of LJF;\n* 18\\) Participation in another clinical trial within the past month;\n* 19\\) Contraindications for MRI examination, such as claustrophobia or presence of metallic implants;\n* 20\\) Individuals of childbearing potential (male or female) with fertility plans; pregnant or lactating women.","ALL","18 Years","65 Years",{"count":21,"type":22},180,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a randomized, double-blinded, placebo-controlled clinical trial aimed at evaluating the efficacy and safety of Linzhi Jianghuang Fufang Huoxue Anshen Capsule (LJF) for non-alcoholic fatty liver.",[28],"Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)",[30,31,32,33,34],"Non-alcoholic fatty liver","Traditional Chinese medicine","Non-alcoholic fatty liver disease","Metabolic dysfunction-associated fatty liver disease","Linzhi Jianghuang Fufang Huoxue Anshen Capsule","NOT_YET_RECRUITING","2026-06-07",{"date":38,"type":39},"2026-06-09","ACTUAL",{"date":41,"type":22},"2026-09",{"date":43,"type":22},"2029-01",{"name":45,"class":46},"Hong Kong Baptist University","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":68,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},"100598184","gepaktiv-vs-udca-and-ademetionine-in-mafld-with-hepatomegaly-100598184","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)",{"count":56,"type":22},90,[58],"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",[28,61,62,63,64,65,66,67],"Hepatomegaly","Nonalcoholic Fatty Liver (NAFL)","Nonalcoholic Fatty Liver Disease (NAFLD)","Fatty Liver","Fatty Liver, Alcoholic","Fatty Liver, Nonalcoholic","Fatty Liver Disease",[61,69,70,71,72,73,74,75,76,77,64],"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":81,"type":39},"2025-07-23",{"date":83,"type":39},"2025-06-19",{"date":85,"type":22},"2025-08",{"name":87,"class":46},"Phenomen Pharma",1,"Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD)"]