Vitamin E Versus Vitamin E Plus Pentoxiphyllin in Patients With Nonalcoholic Steatohepatitis: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Improvement in hepatocyte injury and fibrosis (NAFLD Activity Score [NAS score])
研究概览
简要总结
Nonalcoholic fatty liver disease (NAFLD) is a spectrum of hepatic pathology, ranging from simple steatosis, steatohepatitis, to cirrhosis. Nonalcoholic steatohepatitis (NASH) is a more advanced form of disease where steatosis is accompanied by hepatocyte injury as well as infiltration of inflammatory cells. Since, both vitamin E and PTX has been found to improve NASH when used alone, a combination of these two should be expected to give better results because of targeting two different pathogenetic mechanisms (cytokines amplification and oxidative stress) in NASH patients. This will be open labelled, prospective, randomized study. The diagnosis of NAFLD will be made on the basis of Ultrasonographic findings suggestive of fatty liver and presence of insulin resistance or features of metabolic syndrome. Subsequently histologic confirmation of the diagnosis of NASH will be made in all cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of NAFLD by ultrasonographic
- •Presence of Insulin resistance
- •Histological confirmation of NASH
- •Increased transaminases (>1.5 upper limit normal [ULN])
排除标准
- •Patients with alcohol > 20g/ day
- •Other known liver disease
- •Medications known to induce fatty liver
研究组 & 干预措施
Vitamin E plus Pentoxiphyllin
干预措施: Vitamin E plus Pentoxiphyllin (Drug)
Vitamin E
干预措施: Vitamin E (Drug)
结局指标
主要结局
Improvement in hepatocyte injury and fibrosis (NAFLD Activity Score [NAS score])
时间窗: Baseline and 1 year
次要结局
- Normalization of serum transaminases levels(Baseline and 1 year)
- Reduction in serum levels of proinflammatory cytokines (TNF-α and IL-6) and Malondialdehyde (MDA).(Baseline and 1 year)
- Improvement in HOMA-IR(Baseline and 1 year)
- No worsening of fibrosis(Baseline and 1 year)
