Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH

NASH (Non-alcoholic Steato-hepatitis) Clinical Trial

Official title: Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH (Non-alcoholic Steato-hepatitis)

Status Terminated

Clinical Trial Summary

This study is to evaluate the effects of Rosiglitazone, insulin sensitizer and alpha-lipoic acid, antioxidant on patients with pathologically proved NASH (non-alcoholic steato-hepatitis).

Clinical Trial Description

Duration: 24 week-intervention Study Group: Four arms

• Control: no intervention

• Rosiglitazone: rosiglitazone (8 mg/day)

• alpha-lipoic acid: alpha-lipoic acid (1800 mg/day)

• Rosiglitazone/alpha-lipoic acid: combination of rosiglitazone (8 mg/day) and alpha-lipoic acid (1800 mg/day) ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fatty Liver
• Hepatitis
• NASH (Non-alcoholic Steato-hepatitis)

• NCT number: NCT01406704
• Study type: Interventional
• Source: Seoul St. Mary's Hospital
• Status: Terminated
• Phase: Phase 4
• Start date: January 2004
• Completion date: December 2013