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:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT06994234
Eligibility Criteria:
Inclusion Criteria:
1. Meeting the diagnostic criteria for MASLD.
2. Aged between 18 and 70 years (inclusive), regardless of gender.
3. Patients voluntarily participate in this clinical study, have signed the informed consent form, and agree to comply with all study requirements, including follow-up visits, examinations, and treatments.
Exclusion Criteria:
1. Exclusion of other conditions causing liver injury, including alcoholic hepatitis, active hepatitis B or C virus infection, drug-induced hepatitis, autoimmune hepatitis, primary sclerosing cholangitis, Wilson's disease, α1-antitrypsin deficiency, liver cancer (or family history of liver cancer), etc.
2. History of medication use for more than 2 weeks within the past year that may induce hepatic steatosis or steatohepatitis (e.g., amiodarone, methotrexate, systemic glucocorticoids, tetracycline, tamoxifen, estrogen exceeding hormone replacement doses, anabolic steroids, valproic acid, or other known hepatotoxins).
3. Use of hepatoprotective drugs (including but not limited to reduced glutathione, glucurolactone, glycyrrhizin preparations, nicotinamide, bifendate, liver-protecting tablets, silymarin, polyene phosphatidylcholine, S-adenosylmethionine, ursodeoxycholic acid, vitamin E, or other herbal medicines affecting liver function) within 4 weeks prior to enrollment.
4. Presence of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or history of liver transplantation at randomization or previously, or planned liver transplantation.
5. Concurrent type 1 diabetes.
6. Severe cardiovascular, cerebrovascular, renal, or hematopoietic system diseases, as well as mood disorders (e.g., anxiety, depression) or psychiatric illnesses.
7. Patients with any type of malignancy or a history of malignancy.
8. HIV-positive status.
9. Pregnant or breastfeeding women, or subjects of childbearing potential unwilling or unable to use effective contraception from the screening period until 6 months after discontinuation of the investigational drug.
10. Participation in other interventional clinical trials within 12 weeks prior to screening.
11. Patients with unstable weight (i.e., weight loss or gain exceeding 4 kg in the past 3 months) or those with conditions preventing participation in the exercise program.
12. Other conditions deemed by the investigator as unsuitable for participation in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06994234
Study Brief:
Protocol Section:
NCT06994234