Trials / Not Yet Recruiting
Not Yet RecruitingNCT07159412
Huazhi Rougan Granule as an Add-On Therapy for H. Pylori Infection With Metabolic-associated Steatohepatitis
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)
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 286 (estimated)
- Sponsor
- Nanjing First Hospital, Nanjing Medical University · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2025-08-31
- Primary completion
- 2026-08-31
- Completion
- 2027-08-31
- First posted
- 2025-09-08
- Last updated
- 2025-09-08
Source: ClinicalTrials.gov record NCT07159412. Inclusion in this directory is not an endorsement.