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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01406704

Enrollment

Registered

2011-08-01

Start date

2004-01-31

Completion date

2013-12-31

Last updated

2011-08-19

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

Conditions

NASH (Non-alcoholic Steato-hepatitis)

Brief 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).

Detailed 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)

Interventions

DRUGRosiglitazone

Rosiglitazone (8 mg/day)

DRUGalpha-lipoic acid

alpha-lipoic acid (1800 mg/day)

DRUGRosiglitazone/alpha-lipoic acid

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Histological evaluation	24 weeks	NASH Histological scoring system

Secondary

Measure	Time frame	Description
Biomechanical measurement	24 weeks	liver function test, insulin resistance

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026