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 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT00681733
Eligibility Criteria:
Inclusion Criteria:
* Patients with biopsy proven NASH will be enrolled. Abdominal USG showing diffusely echogenic liver suggestive of fatty infiltration of liver.
* ALT \> 1.2 times the upper limit of normal for \> 6 months.(atleast three readings one month apart)
* Liver Biopsy showing steatosis affecting \>10% of hepatocytes with necroinflammatory activity, ballooning hepatocytes \&/ or fibrosis.
Exclusion Criteria:
* Alcohol intake of more than 20g/wk
* Evidence of viral/ autoimmune hepatitis
* PBC (Primary biliary cirrhosis)
* Biliary obstrution
* Wilson disease
* Haemchromatosis
* Decompensated cirrhosis
* Drug ingestion of the follwing drugs for a period of more than 4 weeks during past 6 weeks - Amiodarone, Methotrexate, Perhexiline, Glucocorticoids, Estrogens, Tamoxifen, Nifedipine, Diltiazem, Tamoxifen.
* DM Type I
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00681733
Study Brief:
Protocol Section:
NCT00681733