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

Seoul St. Mary's Hospital

Status and phase: Terminated; Phase 4

Conditions: NASH (Non-alcoholic Steato-hepatitis)

Treatments: Drug: Rosiglitazone/alpha-lipoic acid; Drug: alpha-lipoic acid; Drug: Rosiglitazone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01406704

KCMC-04-14

Details and patient eligibility

About

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).

Full 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)

Enrollment: 26 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 4 patient groups

Control

No Intervention group

Rosiglitazone

Experimental group

Description:

Rosiglitazone (8 mg/day)

Treatment:

Drug: Rosiglitazone

alpha-lipoic acid

Experimental group

Description:

alpha-lipoic acid (1800 mg/day)

Treatment:

Drug: alpha-lipoic acid

Rosiglitazone/alpha-lipoic acid

Experimental group

Description:

combination of Rosiglitazone (8 mg/day) and alpha-lipoic acid (1800 mg/day)

Treatment:

Drug: Rosiglitazone/alpha-lipoic acid