Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Reversal of hepatic encephalopathy
研究概览
简要总结
The study will be double blind with respect to rifaximin, and randomization will be performed using tables of computer-generated random numbers. All subjects will be followed up till the recovery of HE (primary end point) or 10 days whichever is earlier. In the Lactulose group (group A) patients will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passes 2-3 semisoft stools per day along with placebo . In the lactulose plus rifaximin group (group B) patients will receive cap rifaximin 400mg three times a day along with lactulose. Primary endpoints will be recovery of overt HE patients who will not recover from HE after 10 days will be continued on the same treatment. Total duration of the study is 1 year.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis
- •Age 18-80
- •Hepatic encephalopathy grade II-IV
- •Informed consent
排除标准
- •Degenerative CNS disease or major psychiatric illness
- •Serum creatinine > 1.5 mg/dl
- •Active alcohol intake <4 weeks prior to present episode
- •Others metabolic encephalopathies
- •Hepatocellular Carcinoma
- •Severe comorbidity such as CHF, Pulmonary disease, Neurological & Psychiatric problems impairing quality of life
研究组 & 干预措施
Rifaximin plus lactulose
干预措施: Rifaximin plus lactulose (Drug)
lactulose
30-60ml/day
干预措施: Lactulose (Drug)
结局指标
主要结局
Reversal of hepatic encephalopathy
时间窗: 10 days
次要结局
- Death(10 days)
- duration of hospital stay(10 days)