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. This 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/or 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. The 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.
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. Current 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. Misocholic 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. This 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/or 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. The 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Film-coated herbal medicine containing dried pig bile extract, artichoke extract, garlic powder, and activated charcoal.
Matching placebo identical in appearance, packaging, color, and taste to Misocholic Tab.
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.
Hanoi Traditional Medicine General Hospital
Hanoi, Hanoi, Vietnam
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.
Time frame: Baseline and Day 30
Percentage change in serum ALT and AST levels
Percentage change in serum ALT and AST concentrations from baseline to Day 30.
Time frame: Baseline and Day 30
Normalization of liver enzyme levels
Proportion of participants achieving normalization of serum ALT and/or AST levels at Day 30.
Time frame: Day 30
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.
Time frame: Baseline to Day 30
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