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

N/ANot Yet RecruitingNCT07159412

Nanjing First Hospital, Nanjing Medical University286 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

286

Conditions

Helicobacter Pylori Infection Metabolic-associated Steatohepatitis High-dose Dual Therapy

Interventions

Vonoprazan-amoxicillin combined with Huazhi Rougan GranuleDRUG

Vonoprazan-amoxicillin dual therapy combined with Huazhi Rougan Granule

Vonoprazan-amoxicillin combined with Huazhi Rougan Granule placeboDRUG

Vonoprazan-amoxicillin dual therapy combined with Huazhi Rougan Granule placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 18-65 years; 2. Meeting the diagnostic criteria for metabolic-associated steatohepatitis (MASH) and the traditional Chinese medicine syndrome differentiation criteria for dampness-heat accumulation pattern; 3. Initial treatment for H. pylori infection (positive 13C- or 14C-urea breath test); 4. Signed informed consent form. Exclusion Criteria: 1. Individuals with fatty liver caused by chronic heart failure, malnutrition, or pregnancy; those with fatty liver syndrome in encephalopathy, abetalipoproteinemia, or localized fatty liver; 2. 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; 3. Individuals using hepatoprotective, enzyme-lowering, or lipid-lowering medications that may interfere with efficacy evaluation; 4. Pregnant or lactating women; 5. Patients with severe primary cardiovascular, renal, or other life-threatening diseases; 6. Individuals with a history of cancer; 7. Those positive for HCV antibody, HIV antibody, or HBsAg with detectable HBV-DNA levels; 8. Individuals with a history of alcohol abuse (≥210 g/week for males or ≥140 g/week for females) or substance abuse; 9. Those with known hypersensitivity to any component of the study drug; 10. Participation in another clinical trial within 3 months prior to screening; 11. Use of Chinese herbal medicines for the treatment of non-alcoholic simple fatty liver within 2 weeks prior to screening; 12. Individuals deemed unsuitable for participation by the investigator.

Outcomes

Primary Outcomes

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%.

Time frame: At the end of the 12-week treatment period.