Status:
NOT_YET_RECRUITING
Huazhi Rougan Granule as an Add-On Therapy for H. Pylori Infection With Metabolic-associated Steatohepatitis
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Helicobacter Pylori Infection
Metabolic-associated Steatohepatitis
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Aged 18-65 years;
- Meeting the diagnostic criteria for metabolic-associated steatohepatitis (MASH) and the traditional Chinese medicine syndrome differentiation criteria for dampness-heat accumulation pattern;
- Initial treatment for H. pylori infection (positive 13C- or 14C-urea breath test);
- Signed informed consent form.
Exclusion
- Individuals with fatty liver caused by chronic heart failure, malnutrition, or pregnancy; those with fatty liver syndrome in encephalopathy, abetalipoproteinemia, or localized fatty liver;
- 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;
- Individuals using hepatoprotective, enzyme-lowering, or lipid-lowering medications that may interfere with efficacy evaluation;
- Pregnant or lactating women;
- Patients with severe primary cardiovascular, renal, or other life-threatening diseases;
- Individuals with a history of cancer;
- Those positive for HCV antibody, HIV antibody, or HBsAg with detectable HBV-DNA levels;
- Individuals with a history of alcohol abuse (≥210 g/week for males or ≥140 g/week for females) or substance abuse;
- Those with known hypersensitivity to any component of the study drug;
- Participation in another clinical trial within 3 months prior to screening;
- Use of Chinese herbal medicines for the treatment of non-alcoholic simple fatty liver within 2 weeks prior to screening;
- Individuals deemed unsuitable for participation by the investigator.
Key Trial Info
Start Date :
August 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT07159412
Start Date
August 31 2025
End Date
August 31 2027
Last Update
September 8 2025
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