A Post -Marketing Drug Evaluation(Phase IV Clinical Trial) to Study the Safety and Efficacy of Heweizhixie Capsule in Patients With Diarrhea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- Percent of subjects with treatment Success
研究概览
简要总结
The objective of this study is to evaluate safety and efficacy of Heweizhixie Capsule in patients with diarrhea.
详细描述
The objective of this study is to evaluate safety and efficacy of Heweizhixie Capsule in patients with diarrhea.This is a Phase 4 Open Label trial, enroll 2400 patients with diarrhea Primary Outcome Measure:Percent of subjects with treatment Success
Secondary Outcome Measures:
Number of unformed stools passed per 24 h period Time (hours) from first intake to the last unformed stools Change from baseline of Leeds dyspepsia questionnaire score Percent of subjects with AE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •3 or more unformed stools in 24 hours Male and female subjects between 18 and 80 years old Signed informed consent
排除标准
- •Subjects with serum ALT more than 5ULN or serum Cr more than 442umol/L Subjects are pregnant now, likely to become pregnant Subjects, who in the opinion of the Investigator, are not suitable candidates for enrollment.
研究组 & 干预措施
Heweizhixie capsule
Heweizhixie capsule, 0.33g/#, 3 #, Tid, Oral
干预措施: Heweizhixie capsule (Drug)
结局指标
主要结局
Percent of subjects with treatment Success
时间窗: 3 days
Percent of subjects with treatment Success
次要结局
- Percent of subjects with AE(3 days)
- Number of unformed stools passed per 24 h period(per 24 h period)
- Time (hours) from first intake to the last unformed stools(3 days)
- Change from baseline of leeds dyspepsia questionnaire score(3 days)