NCT05833932招募中不适用
Suhexiang Pill for Acute Ischemic Stroke: A Prospective Registry Study of Real-world Data
Dongzhimen Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Proportion of patients independent
研究概览
简要总结
The primary purpose of this study is to investigate the effectiveness and safety of the Suhexiang Pill for patients with acute ischemic stroke in real-world settings.
详细描述
Suhexiang Pill, a traditional Chinese patent medicine, is widely used in China for acute stroke. However, there is a lack of evidence of its efficacy and safety for acute ischemic stroke in real-world setting. This registry study will recruit 1000 patients who receive Suhexiang Pill treatment after acute ischemic stroke.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke within 7 days of symptom onset.
- •Patient who has received Suhexiang Pill treatment
- •Patient or legally authorized representative has signed informed consent.
排除标准
- •Be allergic to Suhexiang Pill
- •Known to be pregnant or breastfeeding.
- •With conditions that render outcomes or follow-up unlikely to be assessed.
结局指标
主要结局
Proportion of patients independent
时间窗: 90 days
Proportion of patients independent is defined as the modified Rankin Scale score of 0, 1, or 2.
次要结局
- National Institute of Health Stroke Scale(The change from baseline to day 10 or discharge.)
- Patient reported outcome(At day 10 or discharge.)
- Glasgow Coma Scale(The change from baseline to day 10 or discharge.)
研究者
Ying Gao
Professor
Dongzhimen Hospital, Beijing
研究点 (1)
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