Trial ID: | L0735 |
Source ID: | NCT04193982
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Associated Drug: |
Vitamin E
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Title: |
An Investigator Initiated Prospective, Four Arms Randomized Comparative Study of Efficacy and Safety of Saroglitazar, Vitamin E and Life Style Modification in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)/ Non-alcoholic Steatohepatitis (NASH)
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Acronym: |
--
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Status: |
Recruiting
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Study Results: |
No Results Available
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Results: |
--
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Conditions: |
NAFLD
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Interventions: |
Drug: Saroglitazar;Drug: Vitamin E;Drug: Combination drug;Behavioral: Lifestyle Changes
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Outcome Measures: |
Change in Non alcoholic fatty liver fibrosis score at 8week, 16week and 24week.Serum Alanine aminotransferase (ALT) changes at 6 months.;Serum triglycerides (TG) level.;Change in fibrosis on Liver Biopsy at 6 months.;Serum Aspartate aminotransferase (AST) level at 6 months.;Non alcoholic steatosis (NAS) score on liver biopsy at 6 months.;Glycosylated Hemoglobin (HbA1C) Level at 6 months.
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Sponsor/Collaborators: |
Asian Institute of Gastroenterology, India
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Gender: |
All
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Age: |
18 Years60 Years
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Phases: |
Phase 3
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Enrollment: |
250
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Study Type: |
Interventional
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Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Start Date: |
14/08/2019
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Completion Date: |
--
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Results First Posted: |
--
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Last Update Posted: |
1 February 2021
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Locations: |
India
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URL: |
https://clinicaltrials.gov/show/NCT04193982
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