| Trial ID: | L0754 |
| Source ID: | CTRI/2019/04/018550
|
| Associated Drug: |
Silymarin
|
| Title: |
Silymarin-Choline Combination Versus Ursodeoxycholic Acid in Non-Alcoholic Fatty Liver Disease: A Randomised Double-Blind 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: Silymarin-Choline: Silymarin-Choline<br>Intervention2: Silymarin-Choline: Silymarin-Choline<br>????? Tablet Mariliv (Manufacturer: EMCEE Pharmaceuticals (P) Ltd.): A combination of Tablet Silymarin (140 mg) and Choline bitartrate (450 mg) 1
|
| Outcome Measures: |
Primary: improvement in the <br/ ><br>-elevated liver enzyme level <br/ ><br>-Liver Stiffness Measurement (by non-invasive method, Transient Elastography) <br/ ><br>-Liver Inflammation and Fibrosis Score (by Metavir Scoring System, Subject to availability of Bard Max-Core Disposable Biopsy Gun 18 G) <br/ ><br>Timepoint: Baseline and 6 months <br/ ><br>?????Secondary: <br/ ><br>-monitoring and reporting associated adverse events (if any) <br/ ><br>-medication adherence of patientsTimepoint: Baseline and 6 months
|
| Sponsor/Collaborators: |
Medical College Kolkata
|
| Gender: |
--
|
| Age: |
nannan
|
| Phases: |
Not applicable
|
| Enrollment: |
78
|
| 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:Participant and Investigator Blinded
|
| Start Date: |
10/04/2019
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
24 November 2021
|
| Locations: |
India
|
| URL: |
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=31780
|
