The effect of atorvastatin and L-carnitine in the treatment of nonalcoholic steatohepatitis

Phase 3

• Conditions: onalcoholic steatohepatitis (NASH).; Nonalcoholic steatohepatitis (NASH); k75.81

• Registration Number: IRCT201111204092N2
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

Inclusion Criteria: ultrasonography showing evidence of hepatic steatosis; increased AST or ALT to above 1.5 times normal; age 20-60 years old.

Exclusion Criteria

hepatitis B; hepatitis C; autoimmune hepatitis; genetic liver disease; alcohol ingestion greater than 40 gr per week; hypertension; diabetes mellitus; liver stiffness more than 7.9 KP; Not consenting to the study.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
iver 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.

Secondary Outcome Measures

Name	Time	Method
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.