| Trial ID: | L0867 |
| Source ID: | NCT02541045
|
| Associated Drug: |
Metadoxine
|
| Title: |
Clinical Trial to Evaluate the Efficacy of Metadoxine as a Therapy for Patients With Non-alcoholic Steatohepatitis
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Steatohepatitis
|
| Interventions: |
Drug: metadoxine;Other: placebo
|
| Outcome Measures: |
improvement in the degree of non-alcoholic fatty liver disease score (NAS)improvement in liver steatosis measured on a scale from 0 to 3;improvement in lobular inflammation measured on a scale from 0 to 3;improvement in ballooning measured on a scale from 0 to 2;improvement in alanine aminotransferase serum levels;improvement in aspartate aminotransferase serum levels;improvement in the degree of liver fibrosis measured on a scale from 0 to 2;to compare the occurrence of adverse effects between groups
|
| Sponsor/Collaborators: |
Hospital General de Mexico
|
| Gender: |
All
|
| Age: |
18 Years65 Years
|
| Phases: |
Phase 3
|
| Enrollment: |
108
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
| Start Date: |
31/08/2015
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
7 September 2021
|
| Locations: |
Mexico
|
| URL: |
https://clinicaltrials.gov/show/NCT02541045
|
