Huazhi Rougan Granule as an Add-On Therapy for H. Pylori Infection With Metabolic-associated Steatohepatitis

Inclusion criteria

• Aged 18-65 years;
• Meeting the diagnostic criteria for metabolic-associated steatohepatitis (MASH) and the traditional Chinese medicine syndrome differentiation criteria for dampness-heat accumulation pattern;
• Initial treatment for H. pylori infection (positive 13C- or 14C-urea breath test);
• Signed informed consent form.

Exclusion criteria

• Individuals with fatty liver caused by chronic heart failure, malnutrition, or pregnancy; those with fatty liver syndrome in encephalopathy, abetalipoproteinemia, or localized fatty liver;
• Patients with severe fatty liver accompanied by ascites, edema, hyponatremia, hypokalemia, or other signs suggestive of cirrhosis; those with hepatitis or cirrhosis caused by viruses, drug toxicity, autoimmune diseases, or other factors;
• Individuals using hepatoprotective, enzyme-lowering, or lipid-lowering medications that may interfere with efficacy evaluation;
• Pregnant or lactating women;
• Patients with severe primary cardiovascular, renal, or other life-threatening diseases;
• Individuals with a history of cancer;
• Those positive for HCV antibody, HIV antibody, or HBsAg with detectable HBV-DNA levels;
• Individuals with a history of alcohol abuse (≥210 g/week for males or ≥140 g/week for females) or substance abuse;
• Those with known hypersensitivity to any component of the study drug;
• Participation in another clinical trial within 3 months prior to screening;
• Use of Chinese herbal medicines for the treatment of non-alcoholic simple fatty liver within 2 weeks prior to screening;
• Individuals deemed unsuitable for participation by the investigator.