| Trial ID: | L0706 |
| Source ID: | CTRI/2020/02/023250
|
| Associated Drug: |
Remogliflozin
|
| Title: |
Efficacy and Safety of Remogliflozin on Non-alcoholic fatty liver disease in diabetic patients on background Metformin therapy-A Randomized Controlled Clinical Trial
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
|
| Interventions: |
Intervention1: Tablet Remogliflozin Etabonate: Dose 100 mg<br>Twice daily<br>Oral route<br>6 week duration<br>Intervention2: Tablet Metformin: Dose 500 mg<br>Twice daily<br>Oral route<br>6 weeks duration<br>Control Intervention1: NIL: NIL<br>Control Inter
|
| Outcome Measures: |
Aspartate transaminase <br/ ><br>Alanine TransaminaseTimepoint: 0 week and 6 weeks <br/ ><br>0 week and 6 weeksAdverse drug reactionsTimepoint: 6 weeks;Body weightTimepoint: 0 week and 6 weeks;Fasting blood glucoseTimepoint: 0 week and 6 weeks
|
| Sponsor/Collaborators: |
Kshirsagar Shivani Prakash
|
| Gender: |
--
|
| Age: |
nannan
|
| Phases: |
Phase 3
|
| Enrollment: |
60
|
| Study Type: |
Interventional
|
| Study Designs: |
Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded
|
| Start Date: |
11/02/2020
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
24 November 2021
|
| Locations: |
India
|
| URL: |
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=39836
|
