[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657085":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":39,"studyPopulation":25,"armGroups":40,"interventions":54,"overallOfficials":25,"centralContacts":66,"locations":72,"responsibleParty":88,"collaborators":90,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":25,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":25,"enrollmentInfo":104,"targetDuration":25,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":125,"whyStopped":25,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Hanoi Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Change in serum ALT and AST levels from baseline to Day 30","Change in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) concentrations between baseline (Day 0) and the end of treatment (Day 30). The primary efficacy analysis will compare the mean change in ALT and AST levels between the Misocholic Tab group and the placebo group.","Baseline and Day 30",[14,17,21],{"measure":15,"description":16,"timeFrame":12},"Percentage change in serum ALT and AST levels","Percentage change in serum ALT and AST concentrations from baseline to Day 30.",{"measure":18,"description":19,"timeFrame":20},"Normalization of liver enzyme levels","Proportion of participants achieving normalization of serum ALT and\u002For AST levels at Day 30.","Day 30",{"measure":22,"description":23,"timeFrame":24},"Safety and tolerability","Incidence of adverse events, serious adverse events, treatment discontinuation due to adverse events, and changes in clinical and laboratory safety parameters during the treatment period.","Baseline to Day 30",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":25,"timePerspective":25,"maskingInfo":31},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups: Misocholic Tab plus background silymarin therapy or matching placebo plus background silymarin therapy. Participants will remain in their assigned group throughout the 30-day treatment period, with no crossover between groups.","TREATMENT",{"masking":32,"maskingDescription":33,"whoMasked":34},"QUADRUPLE","Participants, care providers, investigators, and outcome assessors will be blinded to treatment allocation. The treatment allocation code will be maintained by an independent pharmacist and will be unblinded only in the event of a medical emergency or other predefined circumstances.",[35,36,37,38],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Elevated liver enzymes are among the most common abnormalities encountered in clinical practice and often reflect hepatocellular injury. Alcohol-related liver disease (ALD), drug-induced liver injury (DILI), and non-alcoholic fatty liver disease (NAFLD) are major causes of elevated serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST). Persistent elevation of liver enzymes may indicate ongoing liver injury and is associated with progression to fibrosis, cirrhosis, or liver failure if the underlying condition is not adequately controlled.\n\nCurrent management primarily consists of eliminating or controlling the underlying cause, including alcohol abstinence, withdrawal of potentially hepatotoxic medications, lifestyle modification, and supportive treatment. Although several hepatoprotective agents are used in clinical practice, evidence supporting their efficacy remains limited, and additional randomized controlled trials are needed.\n\nMisocholic Tab is a film-coated herbal medicine developed from a traditional formulation containing dried pig bile extract, artichoke extract, garlic powder, and activated charcoal. Preclinical studies have demonstrated favorable safety profiles as well as hepatoprotective, antioxidant, and anti-fibrotic effects in experimental models of alcohol-induced liver injury, drug-induced liver injury, and liver fibrosis. However, clinical evidence regarding its efficacy and safety in patients with elevated liver enzymes is currently limited.\n\nThis study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of Misocholic Tab in adult patients with mild to moderate elevation of ALT and\u002For AST associated with alcohol-related liver disease, drug-induced liver injury, or non-alcoholic fatty liver disease. Eligible participants will be randomly assigned in a 1:1 ratio to receive either Misocholic Tab or matching placebo for 30 days. Both groups will receive background therapy with silymarin according to the study protocol.\n\nThe primary efficacy endpoint is the change in serum ALT and AST levels from baseline to Day 30. Secondary endpoints include the absolute and percentage changes in liver enzyme levels, the proportion of participants achieving normalization of liver enzymes, and the assessment of safety through clinical evaluation, laboratory testing, and monitoring of adverse events.",[41,48],{"label":42,"type":43,"description":44,"interventionNames":45},"Misocholic Tab","EXPERIMENTAL","Participants will receive Misocholic Tab (1 tablet orally, three times daily after meals) for 30 days in addition to background therapy with silymarin.",[46,47],"Drug: Misocholic Tab","Drug: Silymarin (Silybum marianum)",{"label":49,"type":50,"description":51,"interventionNames":52},"Placebo","PLACEBO_COMPARATOR","Participants will receive matching placebo (1 tablet orally, three times daily after meals) for 30 days in addition to background therapy with silymarin.",[53,47],"Drug: Placebo",[55,59,62],{"type":56,"name":42,"description":57,"armGroupLabels":58,"otherNames":25},"DRUG","Film-coated herbal medicine containing dried pig bile extract, artichoke extract, garlic powder, and activated charcoal.",[42],{"type":56,"name":49,"description":60,"armGroupLabels":61,"otherNames":25},"Matching placebo identical in appearance, packaging, color, and taste to Misocholic Tab.",[49],{"type":56,"name":63,"description":64,"armGroupLabels":65,"otherNames":25},"Silymarin (Silybum marianum)","Silymarin 150 mg tablet, one tablet orally three times daily after meals for 30 days, administered as background therapy to participants in both treatment groups.",[42,49],[67],{"name":68,"role":69,"phone":70,"phoneExt":25,"email":71},"Tu Thi Thanh Nguyen, MD PhD","CONTACT","+84 902 031 192","thanhtu@hmu.edu.vn",[73],{"facility":74,"status":25,"city":75,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Hanoi Traditional Medicine General Hospital","Hanoi","10000","Vietnam","VN",{"type":80,"coordinates":81},"Point",[82,83],105.84117,21.0245,{"lat":83,"lon":82},[86],{"name":68,"role":69,"phone":25,"phoneExt":87,"email":71},"+84 902 031 19",{"type":89,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[91,93],{"name":74,"class":92},"UNKNOWN",{"name":94,"class":92},"Minh An Pharmaceutical Technology Co., Ltd.","100657085","phase-3-misocholic-tablets-for-non-viral-elevated-liver-enzymes-100657085",false,"NCT07833514","Misocholic Tablets for Non-Viral Elevated Liver Enzymes","A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Misocholic Film-Coated Tablets in Patients With Non-Viral Elevated Liver Enzymes","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Mild to moderate elevation of alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) at screening, defined as ALT and\u002For AST ≥2 to \\\u003C5 times the upper limit of normal (ULN) according to the reference range of the study laboratory.\n* Elevated liver enzymes primarily associated with one of the following conditions:\n\n  1. Alcohol-related liver disease (ALD), defined by: History of hazardous alcohol consumption for at least the previous 3 months (average ethanol intake ≥40 g\u002Fday for men or ≥20 g\u002Fday for women); Elevated ALT and\u002For AST consistent with hepatocellular liver injury; At least one supportive feature of alcohol-related liver disease (e.g., elevated GGT, AST\u002FALT ratio ≥1, hepatomegaly, right upper quadrant discomfort, or hepatic steatosis on ultrasonography); No other liver disease considered the primary cause of liver enzyme elevation.\n  2. Drug-induced liver injury (DILI), defined by: Exposure to conventional medications, herbal medicines, traditional medicines, or dietary supplements within 180 days before detection of elevated liver enzymes; A reasonable temporal relationship between exposure and liver enzyme elevation; Hepatocellular or mixed liver injury pattern with predominant ALT\u002FAST elevation; RUCAM score classified as possible or higher; No other liver disease considered the primary cause of liver enzyme elevation.\n  3. Non-alcoholic fatty liver disease (NAFLD), defined by: Evidence of hepatic steatosis on ultrasonography; Elevated ALT and\u002For AST consistent with hepatocellular liver injury; Alcohol consumption below the diagnostic threshold for alcohol-related liver disease; No other liver disease considered the primary cause of liver enzyme elevation. Willing to comply with study recommendations for management of the underlying cause, including alcohol abstinence or maximal reduction of alcohol intake when appropriate, discontinuation, substitution, or stabilization of suspected hepatotoxic medications or products when clinically feasible, and maintenance of stable background therapy throughout the study.\n* Willing to avoid the use of additional hepatoprotective drugs, herbal medicines, or dietary supplements that may significantly affect liver enzyme levels during the study unless medically required.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Evidence or reasonable suspicion of another liver disease that is considered the primary cause of elevated liver enzymes, including:\n\n  1. Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus infection (anti-HCV or HCV RNA positive);\n  2. Suspected acute viral hepatitis (including hepatitis A or E when clinically indicated);\n  3. Biliary obstruction, gallstones, biliary tract dilation, hepatic or biliary malignancy, or pancreaticobiliary disease identified by imaging;\n  4. Autoimmune liver disease, Wilson disease, hemochromatosis, alpha-1 antitrypsin deficiency, or other chronic liver diseases other than NAFLD.\n* Severe liver injury or advanced liver disease, including:\n\n  1. ALT or AST ≥5 × ULN;\n  2. Total bilirubin ≥2 × ULN or clinically significant jaundice;\n  3. INR ≥1.5 (in participants not receiving anticoagulants);\n  4. Serum albumin \\\u003C30 g\u002FL;\n  5. Platelet count \\\u003C100 × 10⁹\u002FL;\n  6. Clinical, laboratory, or imaging evidence of advanced cirrhosis or portal hypertension;\n  7. Ascites, hepatic encephalopathy, gastrointestinal bleeding related to portal hypertension, or decompensated cirrhosis;\n  8. Requirement for urgent hospitalization or specialist treatment because of liver disease.\n* Predominantly cholestatic liver injury, including ALP ≥2 × ULN or liver injury pattern considered unsuitable for evaluation of hepatocellular enzyme reduction.\n* Extrahepatic causes of elevated aminotransferases, including rhabdomyolysis, acute muscle injury, excessive recent exercise, recent myocardial infarction, severe heart failure, congestive hepatopathy, shock, or severe systemic infection.\n* Use of hepatoprotective medications, herbal medicines, or dietary supplements that may influence liver enzymes within 4 weeks before screening.\n* Inability to discontinue alcohol consumption or stabilize suspected hepatotoxic medications or products during the study.\n* Pregnant or breastfeeding women, or women planning pregnancy during the study period.\n* Known hypersensitivity to any component of Misocholic Tab.\n* Uncontrolled severe medical illness, active malignancy, or any condition that, in the opinion of the investigator, would make participation inappropriate or unsafe.\n* Participation in another interventional clinical trial.\n* Inability or unwillingness to comply with study procedures, scheduled visits, study medication, or protocol-required assessments.","ALL","18 Years",{"count":105,"type":106},60,"ESTIMATED","INTERVENTIONAL",[109],"PHASE3","Elevated liver enzymes are common laboratory abnormalities that may result from alcohol-related liver disease, drug-induced liver injury, or non-alcoholic fatty liver disease (NAFLD). Persistent elevation of liver enzymes may indicate ongoing hepatocellular injury and increase the risk of progressive liver disease. Current management primarily focuses on treating the underlying cause and providing supportive care, while evidence for effective hepatoprotective therapies remains limited.\n\nThis randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of Misocholic Tab, a film-coated herbal medicine, in adults with mild to moderate elevation of alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) associated with alcohol-related liver disease, drug-induced liver injury, or non-alcoholic fatty liver disease. Eligible participants will be randomly assigned in a 1:1 ratio to receive either Misocholic Tab or matching placebo for 30 days. Both groups will receive standard background therapy with silymarin.\n\nThe primary objective is to compare the change in serum ALT and AST levels from baseline to Day 30 between the two treatment groups. Secondary objectives include evaluating the proportion of participants whose liver enzyme levels return to the normal range and assessing the safety of Misocholic Tab through clinical evaluation, laboratory testing, and monitoring of adverse events.",[112,113,114],"Alcohol-Related Liver Disease","Drug-Induced Liver Injury","Non-alcoholic Fatty Liver Disease",[116,117,118,112,113,114,119,120,42,121,122,123,124],"Elevated Liver Enzymes","Alanine Aminotransferase","Aspartate Aminotransferase","Hepatoprotection","Herbal Medicine","Silymarin","Randomized Controlled Trial","Double-Blind Method","Placebo-Controlled Trial","NOT_YET_RECRUITING","2026-09-16",{"date":128,"type":129},"2026-09-22","ACTUAL",{"date":131,"type":106},"2026-09-15",{"date":133,"type":106},"2027-07-30",{"name":5,"class":6},1]