| Trial ID: | L0975 |
| Source ID: | NCT00680407
|
| Associated Drug: |
Silymarin
|
| Title: |
A Multicenter, Randomized, Placebo Controlled Study to Assess the Safety and Efficacy of Orally Administered Silymarin Preparation (Legalon??) for the Treatment of Non-Cirrhotic Patients With Non-Alcoholic Steatohepatitis
|
| Acronym: |
SyNCH
|
| Status: |
Not recruiting
|
| Study Results: |
Has Results
|
| Results: |
https://clinicaltrials.gov/ct2/show/results/NCT00680407
|
| Conditions: |
Non-alcoholic Steatohepatitis
|
| Interventions: |
Other: Placebo;Drug: Silymarin 700 mg;Drug: Silymarin 420 mg
|
| Outcome Measures: |
Efficacy - Improvement by at Least 2 Points in Histology (NAS)Safety - Occurrence of a Dose-limiting Toxicity
|
| Sponsor/Collaborators: |
Madaus Inc
|
| Gender: |
All
|
| Age: |
18 Yearsnan
|
| Phases: |
Phase 2
|
| Enrollment: |
78
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
| Start Date: |
15/05/2008
|
| Completion Date: |
--
|
| Results First Posted: |
29/01/2016
|
| Last Update Posted: |
12 December 2020
|
| Locations: |
United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00680407
|
