| Trial ID: | L0716 |
| Source ID: | CTRI/2019/12/022339
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| Associated Drug: |
Saroglitazar Magnesium
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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 Non alcoholic fatty liver disease (NAFLD)/ Non-alcoholic Steatohepatitis (NASH).
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
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| Interventions: |
Intervention1: Saroglitazar Magnesium: Patients randomly assigned to this group will receive Saroglitazar Magnesium 4 mg tablet orally once daily for 24 weeks.<br>Intervention2: Vitamin E: Patients randomly assigned to this group will receive Vitamin E or
|
| Outcome Measures: |
1. Change in NAFLD fibrosis score at 8week, 16week and 24week. <br/ ><br>2. Compare the overall efficacy of patients with NAFLD/ NASH treated with Saroglitazar magnesium, vitamin E and Saroglitazar magnesium with Vitamin E and Life style modifications alone. <br/ ><br>3. Determine the safety profile of these regimens in those patients.Timepoint: 2 month, 4 month, 6 month1. Serum alanine aminotransferase (ALT) & aspartate aminotransferase (AST) level. <br/ ><br>2. Serum triglycerides (TG) level, high-density lipoprotein (HDL), low density lipoprotein (LDL) & fasting plasma glucose (FPG)/glycosylated haemoglobin (HbA1c). <br/ ><br>3. Liver Biopsy at 24week in selected patients.Timepoint: 2 month, 4 month, 6 month
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| Sponsor/Collaborators: |
Asian Institute of Gastroenterology
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| Gender: |
--
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| Age: |
nannan
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| Phases: |
Phase 3/Phase 4
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| Enrollment: |
200
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| Study Type: |
Interventional
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| Study Designs: |
Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
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| Start Date: |
12/12/2019
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
24 November 2021
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| Locations: |
India
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| URL: |
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=37575
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