| Trial ID: | L0970 |
| Source ID: | NCT00820651
|
| Associated Drug: |
Diamel
|
| Title: |
Efficacy and Safety of Diamel, a Nutritional Supplement, in Patients With Nonalcoholic Steatohepatitis. A Randomized and Double Blind Controlled Study
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis;Insulin Resistance
|
| Interventions: |
Dietary Supplement: Diamel;Other: Placebo and lifestyle counseling
|
| Outcome Measures: |
The histological improvement (steatosis, necro-inflammatory activity and fibrosis) at 52 weeks (end of the treatment) as compared with pre-treatment liver biopsy.Insulinresistance levels (HOMA-IR) at 52 weeks (end of the treatment), Aminotransferase levels at 52 weeks (end of the treatment), Body weight, Body Mass Index and waist circumference at 52 weeks (end of the treatment)
|
| Sponsor/Collaborators: |
Catalysis SL
|
| Gender: |
All
|
| Age: |
18 Years70 Years
|
| Phases: |
Phase 3
|
| Enrollment: |
158
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
|
| Start Date: |
09/01/2009
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
19 February 2015
|
| Locations: |
Cuba
|
| URL: |
http://clinicaltrials.gov/show/NCT00820651
|
