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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07320456
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-50 years, both genders eligible;
2. Meets the diagnostic criteria for NAFLD;
3. Meets the diagnostic criteria for Traditional Chinese Medicine Spleen Deficiency and Damp-Heat Syndrome;
4. Has significant risk factors: CAP≥238dB/m, Body Mass Index (BMI) ≥23 kg/m²;
5. Has not received any anti-NAFLD medication treatment in the past month;
6. Normal major organ function, including heart, kidney, and liver functions, specifically: no significant abnormalities on electrocardiogram; normal serum creatinine and urea nitrogen; normal serum bilirubin and albumin levels;
7. Has sufficient cognitive and understanding abilities to comprehend the study content and its potential risks and benefits;
8. Voluntarily participates in the study and signs an informed consent form.
Exclusion Criteria:
1. Has liver steatosis due to other definitive causes, such as alcoholic liver disease, drug-induced liver injury, viral hepatitis infections (e.g., hepatitis B, hepatitis C, etc.);
2. Has other serious liver diseases, such as autoimmune liver diseases, primary biliary cholangitis, Wilson's disease, etc.;
3. Has severe dysfunction of major organs such as the heart, kidneys, lungs, etc., such as severe heart failure (NYHA functional classification III or above), renal failure (glomerular filtration rate eGFR \< 30 mL/min/1.73m²), acute exacerbation of chronic obstructive pulmonary disease, etc.;
4. Has other serious systemic diseases, such as malignant tumors, active systemic lupus erythematosus, etc.;
5. Known allergy or intolerance to any component of the study medication;
6. Has participated in another clinical trial within the last three months;
7. Pregnant women, lactating women, or women of childbearing age who refuse to use effective contraception during the trial;
8. Has severe mental illness or behavioral disorders that may affect adherence to the study protocol;
9. Other conditions that the researcher considers unsuitable for participation in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT07320456
Study Brief:
Protocol Section:
NCT07320456