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Huazhi Rougan Granule as an Add-On Therapy for H. Pylori Infection With Metabolic-associated Steatohepatitis
Sponsor: Nanjing First Hospital, Nanjing Medical University
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
Conditions
Interventions
Vonoprazan-amoxicillin combined with Huazhi Rougan Granule
Vonoprazan-amoxicillin dual therapy combined with Huazhi Rougan Granule
Vonoprazan-amoxicillin combined with Huazhi Rougan Granule placebo
Vonoprazan-amoxicillin dual therapy combined with Huazhi Rougan Granule placebo