Atorvastatin, L-Carnitine and Non-Alcoholic Steatohepatitis

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the present study was to compare the effects of simvastatin and L-carnitine coadministration versus simvastatin, L-Carnitine monotherapy on liver transaminases and liver elasticity in NASH patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tehran University of Medical Sciences
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• NASH diagnosed on the basis of the following criteria:

1. Imaging techniques showing evidence of hepatic steatosis

2. Increased alanine transaminase above 1.5 times normal (normal: 20 IU/L for women, 30 for men) on two occasions three months apart.

Exclusion Criteria:

• Patients with hepatitis B or C

• alanine transaminase > 300 IU/L

• Participants presenting one or more causes commonly associated with secondary NAFLD (drugs, surgical procedures, environmental toxins, or total parenteral nutrition)

• Alcohol ingestion greater than 40 gr per week

• Abnormal Lipid profile (TG>500 , LDL>160)

• Patients with hypertension, diabetes mellitus, coronary heart disease

• Fibroscan score more than 14 kp

• pregnancy, lactation

• Drug addiction

• Reynolds Risk Score > 10%

• Not consenting to the study