| Trial ID: | L0244 |
| Source ID: | NCT02231333
|
| Associated Drug: |
SAMe
|
| Title: |
The Efficacy of S-adenosyl Methionine (SAMe) Versus Pentoxiphylline in Patients With Non-alcoholic Steatohepatitis With Fibrosis
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Steatohepatitis
|
| Interventions: |
Drug: S-adenosylmethionine (SAMe)|Drug: pentoxiphylline (PTX)
|
| Outcome Measures: |
Biochemical improvement in the form of AST/ALT|Improvement in LSM (Liver Stiffness Measurement) & CAP (Controlled Attenuation Parameter)|Metabolic response in form of anthropometry.|Fasting lipid profiles|Reduction in uric acid levels|Reduction in pro- inflammatory cytokines|Histological outcome in the form of improvement or non- progression in hepatocyte injury and fibrosis.
|
| Sponsor/Collaborators: |
Institute of Liver and Biliary Sciences, India
|
| Gender: |
All
|
| Age: |
18 Years to 70 Years ?? (Adult, Older Adult)
|
| Phases: |
Not applicable
|
| Enrollment: |
122
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
July 1, 2013
|
| Completion Date: |
July 31, 2015
|
| Results First Posted: |
--
|
| Last Update Posted: |
October 29, 2019
|
| Locations: |
Institute of Liver & Biliary Sciences, New Delhi, Delhi, India
|
| URL: |
https://ClinicalTrials.gov/show/NCT02231333
|