This study employed a double-blind, randomized, placebo-controlled design. Eligible treatment-naïve patients with Helicobacter pylori (Hp) infection complicated by metabolic-associated steatohepatitis (MASH) (dampness-heat accumulation syndrome) were enrolled and randomly assigned to either the experimental group or the placebo control group. Both groups received a 2-week Hp eradication regimen consisting of vonoprazan (20 mg twice daily) and amoxicillin (1000 mg three times daily). The experimental group additionally received active Huazhi Rougan Granule (taken orally three times daily, one sachet each time, with a 6-day medication followed by a 1-day drug holiday per cycle), while the placebo control group received an identical matching placebo on the same schedule. The study aims to evaluate the synergistic therapeutic efficacy of Huazhi Rougan Granule in combination with the vonoprazan-amoxicillin dual therapy.
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.
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;
Parallel
Vonoprazan-amoxicillin combined with Huazhi Rougan Granule
DrugVonoprazan-amoxicillin dual therapy combined with Huazhi Rougan Granule
Vonoprazan-amoxicillin combined with Huazhi Rougan Granule placebo
DrugVonoprazan-amoxicillin dual therapy combined with Huazhi Rougan Granule placebo
Helicobacter pylori eradication rate
Patients must undergo a follow-up 13C-urea breath test (13C-UBT) after treatment completion to determine eradication success. A DOB value \< 4‱ is considered indicative of successful eradication. The eradication rate is calculated as follows: (number of successfully eradicated patients in each group / total number of patients in that group) × 100.00%.
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