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

Comparison of effectiveness of L-carnitine, atorvastatin, L-carnitine+atorvastatin, and placebo on liver enzyme levels and liver stiffness of subjects with nonalcoholic steatohepatitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201111204092N2

Enrollment

440

Registered

2012-02-25

Start date

2012-04-03

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic steatohepatitis (NASH). 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

Treatment - Drugs

Placebo

Atorvastatin 20 mg daily for 12 months

L-carnitine 1 gr daily for 12 months

Atorvastatin 20 mg and L-carnitine 1 gr daily for 12 months

Placebo daily for 12 months

Eligibility

Sex/Gender

All

Age

20 Years to 60 Years

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahin Merat

Tehran University of Medical Sciences

merat@tums.ac.ir+98 21 8241 5111

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026