Status:
COMPLETED
The Efficacy of S-adenosyl Methionine (SAMe) Versus Pentoxiphylline in Patients With Non-alcoholic Steatohepatitis With Fibrosis
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Non-alcoholic Steatohepatitis
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Nonalcoholic fatty liver disease is one the most commonly encountered conditions in a daily outpatient Hepatology clinic. Secondly our country is the diabetic capital of the world and so the incidence...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2015
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT02231333
Start Date
July 1 2013
End Date
July 31 2015
Last Update
October 29 2019
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070