Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
NCT ID:
NCT07159412
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07159412
Study Brief:
Protocol Section:
NCT07159412