An interventional study of S-adenosylmethionine (SAMe) and pentoxiphylline (PTX) in Non-alcoholic Steatohepatitis, sponsored by Institute of Liver and Biliary Sciences, India. Completed at 1 site in India. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-10-29.
Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment
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 of NAFLD (Non Alcoholic Fatty Liver Disease) is expected to rise in the future. It is a spectrum of hepatic pathology, ranging from simple steatosis, steatohepatitis, to cirrhosis. Nonalcoholic steatohepatitis (NASH) is a more advanced form of disease where steatosis is accompanied by hepatocyte injury as well as infiltration of inflammatory cells. Approximately 10-20% of patients with NASH may progress to cirrhosis. NASH is felt to be a major etiology of cryptogenic cirrhosis. Around 6230 human studies out of which 49 RCTs have been done till date to define the appropriate treatment of nonalcoholic steatohepatitis. However, still a controversy and no recommended treatment available till date. Recently published PIVENS trial has shown that Vitamin E has proven benefit in NASH. Other trials have also shown that pentoxiphylline has shown benefit in the form of histological improvement and biochemical improvement in the form of liver enzymes. Role of SAMe has been studied in alcoholic liver disease and showed to improve in both biochemical and histological features. However the usefulness of SAMe in NAFLD is not known till now. Hence this study has been designed.
1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.
This study's enrollment of 122 is above the median of 60 across 1,003 interventional studies indexed under Fatty Liver.
Browse Fatty Liver studies →Institute of Liver and Biliary Sciences, India is the lead sponsor of 296 studies on the registry; 84 are open to participants now.
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Exclusion Criteria:
Drug: S-adenosylmethionine (SAMe)
Drug: pentoxiphylline (PTX)
Biochemical improvement in the form of AST/ALT
Time frame: 1 Years
Improvement in LSM (Liver Stiffness Measurement) & CAP (Controlled Attenuation Parameter)
Time frame: 1 years
Metabolic response in form of anthropometry.
metabolic response in form of anthropometry (BMI, waist circumference).
Time frame: 1 Years
Fasting lipid profiles
Time frame: 1 Years
Reduction in uric acid levels
Time frame: 1 Years
Reduction in pro- inflammatory cytokines
Time frame: 1 Years
Histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis.
Time frame: 1 years
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Institute of Liver and Biliary Sciences, India