NCT01406704终止4 期
Effects of Rosiglitazone and Alpha-lipoic Acid on the Patients With Pathologically Proved NASH (Non-alcoholic Steato-hepatitis)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 26
- 主要终点
- Histological evaluation
研究概览
简要总结
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).
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patients with pathologically proved NASH (non-alcoholic steato-hepatitis)
排除标准
- •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
研究组 & 干预措施
Rosiglitazone
Experimental
Rosiglitazone (8 mg/day)
干预措施: Rosiglitazone (Drug)
alpha-lipoic acid
Experimental
alpha-lipoic acid (1800 mg/day)
干预措施: alpha-lipoic acid (Drug)
Rosiglitazone/alpha-lipoic acid
Experimental
combination of Rosiglitazone (8 mg/day) and alpha-lipoic acid (1800 mg/day)
干预措施: Rosiglitazone/alpha-lipoic acid (Drug)
结局指标
主要结局
Histological evaluation
时间窗: 24 weeks
NASH Histological scoring system
次要结局
- Biomechanical measurement(24 weeks)
研究者
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