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 |

Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
---|---|---|---|---|---|---|---|
D321 | Saroglitazar | Chemical drug | DB13115 | PPARA agonist; PPARG agonist | Antidiabetic drug | Approved in India | Details |
D020 | Atorvastatin | Chemical drug | DB01076 | DPP4 inhibitor; AHR agonist; HDAC2 inhibitor; NR1I3 ligand | Enhance lipid metabolism | Under clinical trials | Details |
D094 | Cysteamine | Chemical drug | DB00847 | GSS stimulant | Renal drug | Under clinical trials | Details |
D095 | Cysteamine bitartrate | Chemical drug | DB00847 | -- | -- | Under clinical trials | Details |
D157 | Glucophage | Chemical drug | DB00331 | -- | -- | Under clinical trials | Details |
D225 | Metformin | Chemical drug | DB00331 | PRKAB1 inducer activator; ETEDH inhibitor; GPD1 inhibitor | Improve insulin resistance | Under clinical trials | Details |
D298 | Ranolazine | Chemical drug | DB00243 | -- | -- | Under clinical trials | Details |
D328 | Serine | Chemical drug | DB00133 | SRR | Improve insulin resistance | Under clinical trials | Details |