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 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT05804305
Eligibility Criteria:
Inclusion Criteria:
1. Patients between age 25 and 64 years
2. Patients having NAFLD as evident by a radiologic test like ultrasound/fibroscan/CT scan etc.
3. ALT level of 1.5 times ULN
4. If already known case of NAFLD, then patient should be on stable doses of Vitamin E, oral hypoglycemics or anti-lipidemic drugs, with no change in medication during 6 months prior to recruitment.
Exclusion Criteria:
1. Patients with age less than 18 yrs or more than 80 yrs,
2. Women of childbearing age
3. Clinically significant acute or chronic liver disease unrelated to NAFLD
4. Evidence of hepatitis B and C
5. Evidence of primary biliary cirrhosis, primary sclerosing cholangitis, or biliary obstruction
6. Autoimmune hepatitis
7. Drug-induced steatohepatitis (ingestion of drugs known to produce hepatic steatosis including corticosteroids, high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months)
8. Any cardiovascular event or evidence of active CVS disease
9. Type 1 Diabetes
10. Those consuming alcohol of over 20 grams/day for males and 10 grams/day for females
11. Severe end-organ damage
12. Human immunodeficiency virus (HIV) infection
13. Compensated and decompensated cirrhosis
14. Patients with uncontrolled diabetes
15. Mental instability or incompetence
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
64 Years
Study:
NCT05804305
Study Brief:
Protocol Section:
NCT05804305