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

NCT ID: NCT07159412

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2027-08-31

Brief Summary

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.

Conditions

Helicobacter Pylori Infection; Metabolic-associated Steatohepatitis; High-dose Dual Therapy; Huazhi Rougan Granule

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

Group Type: EXPERIMENTAL

Vonoprazan-amoxicillin combined with Huazhi Rougan Granule

Intervention Type: DRUG

Vonoprazan-amoxicillin dual therapy combined with Huazhi Rougan Granule

Placebo Group

Group Type: PLACEBO_COMPARATOR

Vonoprazan-amoxicillin combined with Huazhi Rougan Granule placebo

Intervention Type: DRUG

Vonoprazan-amoxicillin dual therapy combined with Huazhi Rougan Granule placebo

Interventions

Vonoprazan-amoxicillin combined with Huazhi Rougan Granule

Vonoprazan-amoxicillin dual therapy combined with Huazhi Rougan Granule

Intervention Type: DRUG

Vonoprazan-amoxicillin combined with Huazhi Rougan Granule placebo

Vonoprazan-amoxicillin dual therapy combined with Huazhi Rougan Granule placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Wanli Liu

Role: CONTACT

18951768998@163.com

18951768998

Other Identifiers

KY20250819-12

Identifier Type: -

Identifier Source: org_study_id