Clinical Trial Details

Trial ID: L0742
Source ID: CTRI/2019/06/019592
Associated Drug: Saroglitazar
Title: Comparative Effectiveness of Ranolazine and Saroglitazar on Non-Alcoholic Fatty Liver Disease in Patients with Diabetic Dyslipidemia: A Randomized controlled open label trial
Acronym: --
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications
Interventions: Intervention1: Ranolazine: 500mg OD Oral for 12 months<br>Intervention2: Saroglitazar: 4mg OD Oral 12 months<br>Control Intervention1: Metformin<br><br>Atorvastatin: 500mg BD oral 12 months<br><br>10mg OD oral 12 months<br>
Outcome Measures: -Change from baseline serum AST, ALT, and GGT, HOMA-IR, HBA1c, BMI, Albumin, Total bilirubin, Triglycerides, Total cholesterol, HDL LDL, miRNA-122. <br/ ><br>-Variation in liver fat content as measured byFatty liver index and Liver accumulation product, NAFLD fibrosis score, Hepatic steatosis index, NAFLD Fat score. <br/ ><br>-Changes in liver fibrosis. <br/ ><br>Timepoint: 0, 90th day, 180th day, 270th day and 360th dayADR monitoring during study periodTimepoint: 0, 90th day, 180th day, 270th day and 360th day
Sponsor/Collaborators: Self
Gender: --
Age: nannan
Phases: Phase 4
Enrollment: 270
Study Type: Interventional
Study Designs: Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
Start Date: 10/06/2019
Completion Date: --
Results First Posted: --
Last Update Posted: 24 November 2021
Locations: India
URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=34149