NCT02604654已完成4 期
Phase IV Clinical Trial of Yiqitongluo Granule in the Treatment of Stroke With Qi-deficiency and Blood-stasis Syndrome
Yi Yang0 个研究点目标入组 2,197 人开始时间: 2015年12月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,197
- 主要终点
- Safety of Yiqitongluo for stroke measured by laboratory index
研究概览
简要总结
The purpose of the prospective study is to evaluate the effectiveness and safety of Yiqitongluo granule in the treatment of stroke with qi-deficiency and blood-stasis in more than sixy hospitals all over China.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mild and moderate ischemic stroke patient with 4-25 NIHSS score
- •stable patients within 1 week to 3 months
- •sign informed consent before study
排除标准
- •CT shows cerebral hemorrhage disease: such as hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, and subarachnoid hemorrhage
- •severe disturbance of consciousness
- •dysphagia
- •hemorrhagic diathesis
- •patient with malignant tumor whose expected lifetime is less than 3 months
- •allergic constitution
- •gestation period, lactation period, woman with the possibility or plan of pregnancy
- •those who participated in other clinical trials within 3 months or taking part in other clinical trials
研究组 & 干预措施
Yiqitongluo group
Experimental
Yiqitongluo granule 12g each time, 3 times a daily for 4 weeks.
干预措施: Yiqitongluo granule (Drug)
结局指标
主要结局
Safety of Yiqitongluo for stroke measured by laboratory index
时间窗: change from baseline laboratory index at 28(±7) days
次要结局
- Effect of Yiqitongluo for stroke with mRS(90(±7) days)
- Effect of Yiqitongluo for stroke with BI(28(±7) days)
- Effect of Yiqitongluo for stroke with EQ-5D(28(±7) days)
- Effect of Yiqitongluo for stroke with syndrome of traditional Chinese medicine(28(±7) days)
- Effect of Yiqitongluo for stroke with NIHSS(28(±7) days)
研究者
Yi Yang
Associated Dean of First Hospital of Jilin University
The First Hospital of Jilin University
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