NCT04161053招募中3 期
Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in Preventing Recurrence of Hepatic Encephalopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of encephalopathy episodes during treatment
研究概览
简要总结
Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.
详细描述
Clinical Study Evaluating the Efficacy and Safety of Nitazoxanide in preventing recurrence of Hepatic Encephalopathy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhotic patient with at least one previous episode of hepatic encephalopathy.
- •Adult Patients aging from 20 to 65 years old
排除标准
- •Active GIT bleeding.
- •Major psychiatric illness (psychosis & epilepsy).
- •Renal insufficiency (S.Cr 2mg/dl).
研究组 & 干预措施
Rifaximin
Active Comparator
550 mg Rifaximin tablets twice daily for six months.
干预措施: Rifaximin (Drug)
Nitazoxanide
Experimental
500 mg Nitazoxanide tablets twice daily for six months.
干预措施: Nitazoxanide (Drug)
结局指标
主要结局
Number of encephalopathy episodes during treatment
时间窗: 6 months
The number of encephalopathy episodes during treatment
次要结局
未报告次要终点
研究者
Sherief Abd-Elsalam
Ass. Prof. Tropical Medicine
Tanta University
研究点 (1)
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