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

Nanjing Medical University

Status: Not yet enrolling

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

Treatments: Drug: Vonoprazan-amoxicillin combined with Huazhi Rougan Granule; Drug: Vonoprazan-amoxicillin combined with Huazhi Rougan Granule placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07159412

KY20250819-12

Details and patient eligibility

About

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.

Enrollment: 286 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

286 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Treatment:

Drug: Vonoprazan-amoxicillin combined with Huazhi Rougan Granule

Placebo Group

Placebo Comparator group

Treatment:

Drug: Vonoprazan-amoxicillin combined with Huazhi Rougan Granule placebo