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Misocholic Tablets for Non-Viral Elevated Liver Enzymes

ConditionsAlcohol-Related Liver DiseaseDrug-Induced Liver InjuryNon-alcoholic Fatty Liver Disease
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHanoi Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years or older.

Mild to moderate elevation of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) at screening, defined as ALT and/or AST ≥2 to <5 times the upper limit of normal (ULN) according to the reference range of the study laboratory.

Alcohol-related liver disease (ALD), defined by: History of hazardous alcohol consumption for at least the previous 3 months (average ethanol intake ≥40 g/day for men or ≥20 g/day for women); Elevated ALT and/or AST consistent with hepatocellular liver injury; At least one supportive feature of alcohol-related liver disease (e.g., elevated GGT, AST/ALT ratio ≥1, hepatomegaly, right upper quadrant discomfort, or hepatic steatosis on ultrasonography); No other liver disease considered the primary cause of liver enzyme elevation.

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/AST elevation; RUCAM score classified as possible or higher; No other liver disease considered the primary cause of liver enzyme elevation.

Disqualifiers

Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus infection (anti-HCV or HCV RNA positive);

Suspected acute viral hepatitis (including hepatitis A or E when clinically indicated);

Biliary obstruction, gallstones, biliary tract dilation, hepatic or biliary malignancy, or pancreaticobiliary disease identified by imaging;

Autoimmune liver disease, Wilson disease, hemochromatosis, alpha-1 antitrypsin deficiency, or other chronic liver diseases other than NAFLD.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Misocholic Tab

    Drug

    Film-coated herbal medicine containing dried pig bile extract, artichoke extract, garlic powder, and activated charcoal.

  • Placebo

    Drug

    Matching placebo identical in appearance, packaging, color, and taste to Misocholic Tab.

  • Silymarin (Silybum marianum)

    Drug

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Misocholic TabExperimental treatment 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Normalization of liver enzyme levels

Proportion of participants achieving normalization of serum ALT and/or AST levels at Day 30.

Time frame
Day 30
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hanoi Medical University

Lead sponsor

Hanoi Traditional Medicine General Hospital

Collaborator

Minh An Pharmaceutical Technology Co., Ltd.

Collaborator

Source ClinicalTrials.gov

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