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

Phase 4TerminatedNCT01406704

Seoul St. Mary's Hospital26 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

NASH (Non-alcoholic Steato-hepatitis)

Interventions

RosiglitazoneDRUG

Rosiglitazone (8 mg/day)

alpha-lipoic acidDRUG

alpha-lipoic acid (1800 mg/day)

Rosiglitazone/alpha-lipoic acidDRUG

combination of Rosiglitazone (8 mg/day) and Thioctic acid (1800 mg/day)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * the patients with pathologically proved NASH (non-alcoholic steato-hepatitis) Exclusion Criteria: * alcohol consumption \> 20g/day * viral hepatitis B and C * autoimmune hepatitis * Wilson's disease * hemochromatosis * alpha-1 antitrypsin deficiency * breast-feeding or pregnant females * subjects planning to become pregnant * severe comorbid medical conditions (such as severe cardiac, pulmonary, renal or psychological problems) * those not consenting for the study

Outcomes

Primary Outcomes

Histological evaluation

NASH Histological scoring system

Time frame: 24 weeks

Secondary Outcomes

Biomechanical measurement

liver function test, insulin resistance

Time frame: 24 weeks

Data from ClinicalTrials.gov

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