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NOT YET RECRUITING
NCT07159412
NA

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

Sponsor: Nanjing First Hospital, Nanjing Medical University

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Huazhi Rougan Granule Combined With High-Dose Dual Therapy for Helicobacter Pylori Infection Complicated With Metabolic-associated Steatohepatitis (Dampness-Heat Accumulation Syndrome)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

286

Start Date

2025-08-31

Completion Date

2027-08-31

Last Updated

2025-09-08

Healthy Volunteers

No

Interventions

DRUG

Vonoprazan-amoxicillin combined with Huazhi Rougan Granule

Vonoprazan-amoxicillin dual therapy combined with Huazhi Rougan Granule

DRUG

Vonoprazan-amoxicillin combined with Huazhi Rougan Granule placebo

Vonoprazan-amoxicillin dual therapy combined with Huazhi Rougan Granule placebo