NCT04479553招募中不适用
Post-marketing Safety Surveillance of Qizhi Tongluo Capsules:a Registry Study.
Zhong Wang14 个研究点 分布在 1 个国家目标入组 30,000 人开始时间: 2020年8月17日最近更新:
适应症
干预措施
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
- 30,000
- 试验地点
- 14
- 主要终点
- The incidence of adverse drug reactions (ADR) to the Qizhi Tongluo Capsules
研究概览
简要总结
This registry aims to monitor the safety of Qizhi Tongluo Capsules and to identify the potential risk factors for its adverse drug reactions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who use Qizhi Tongluo Capsules in the monitoring hospitals.
排除标准
- 未提供
研究组 & 干预措施
Qizhi Tongluo Capsules
Qizhi Tongluo Capsules will be given to the patients, and the investigators will record all the information including ADR, application of Qizhi Tongluo Capsules and the combined medications, etc.
干预措施: Qizhi Tongluo Capsules (Drug)
结局指标
主要结局
The incidence of adverse drug reactions (ADR) to the Qizhi Tongluo Capsules
时间窗: 3 years
次要结局
- The incidence of new ADRs to the Qizhi Tongluo Capsules(3 years)
- Changes in biological indicators of patients with serious adverse events(3 years)
- The incidence of serious adverse drug event (SADE) to the Qizhi Tongluo Capsules(3 years)
- The incidence of adverse drug event (ADE) to the Qizhi Tongluo Capsules(3 years)
研究者
Zhong Wang
Professor
China Academy of Chinese Medical Sciences
研究点 (14)
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