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 @ 2:48 AM
Ignite Modification Date:
2025-12-25 @ 2:48 AM
NCT ID:
NCT02231333
Eligibility Criteria:
Inclusion Criteria:
* Age 18 to 70 years
* Persistently abnormal ALT \>1.2 times upper limit of normal
* Histological evidence of NASH (Non alcoholic Steatohepatitis) on liver biopsy. The minimal criteria for diagnosis of NASH included the presence of lobular inflammation and fibrosis up to stage 3 as per Burnt stating.
Exclusion Criteria:
* Alcohol intake of more than 40gm / week with features suggestive chronic liver disease .
* Other known cause of chronic liver disease like Hepatitis B,C, autoimmune liver disease, Wilson's disease, alpha 1 antitrypsin deficiency and hemochromatosis, primary biliary cirrhosis, PSC (Primary Sclerosis Cholangitis).
* Patient on Medication like estrogens, amiodarone, MTx, tamoxifen, ATT (Antitubercular Treatment)
* Pregnancy or lactation
* Hypersensitivity to methylxanthines (e.g., caffeine, theophylline,)
* Recent retinal/cerebral hemorrhage
* Acute myocardial infarction or severe cardiac arrhythmias.
* Impaired renal function.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02231333
Study Brief:
Protocol Section:
NCT02231333