| Trial ID: | L0659 |
| Source ID: | IRCT201111204092N2
|
| Associated Drug: |
L-carnitine
|
| Title: |
Comparison of effectiveness of L-carnitine, atorvastatin, L-carnitine+atorvastatin, and placebo on liver enzyme levels and liver stiffness of subjects with nonalcoholic steatohepatitis
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic steatohepatitis (NASH). <br>Nonalcoholic steatohepatitis (NASH);k75.81;Nonalcoholic steatohepatitis (NASH)
|
| Interventions: |
Intervention 1: Atorvastatin 20 mg daily for 12 months. Intervention 2: L-carnitine 1 gr daily for 12 months. Intervention 3: Atorvastatin 20 mg and L-carnitine 1 gr daily for 12 months. Intervention 4: Placebo daily for 12 months.;Treatment - Drugs;Treat
|
| Outcome Measures: |
Liver stiffness. Timepoint: years 0 and 1. Method of measurement: FibroScan.;Liver enzymes (AST and ALT). Timepoint: months 0, 1, 3, 6, 9, and 12. Method of measurement: Elisa.Muscular cramps. Timepoint: months 1, 3, 6, 9, 12. Method of measurement: Questionnaire.;Nausea. Timepoint: months 1, 3, 6, 9, 12. Method of measurement: Questionnaire.;Dyspepsia. Timepoint: months 1, 3, 6, 9, 12. Method of measurement: Questionnaire.;Compliance. Timepoint: months 1, 3, 6, 9, 12. Method of measurement: Questionnaire.
|
| Sponsor/Collaborators: |
Tehran University of Medical Sciences
|
| Gender: |
All
|
| Age: |
20 years60 years
|
| Phases: |
Phase 3
|
| Enrollment: |
440
|
| Study Type: |
interventional
|
| Study Designs: |
Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment.
|
| Start Date: |
25/02/2012
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
22 February 2018
|
| Locations: |
Iran (Islamic Republic of)
|
| URL: |
http://en.irct.ir/trial/4284
|
