A Registry Study on Safety Surveillance of Shenfu (a Chinese Medicine Injection) Used in China
试验速览
- 阶段
- 不适用
- 入组人数
- 20,000
- 主要终点
- Number of participants with adverse events; incidence of Shenfu'ADRs and identify factors that contributed to the occurrence of the adverse reaction.
研究概览
简要总结
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011.
It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.
Shenfu is kind of Chinese Medicine injection used for treating shock and coronary heart disease in many Chinese hospitals.
The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 20,000 patients.
详细描述
Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out ,because in mainland China hospitals ,Chinese Medicine Injection are used widely. Population for taking medicine characteristics,the incidence rate of ADR and other uncertain factors influence can not be found now.
A registry study for Shenfu injection safety surveillance with 20000 patients will be conducted from Jan.2012 to Dec.2015.
Eligibility criteria Patients who will use Shenfu injection in selected hospitals.
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 using Shenfu injection from 2012 to 2014
排除标准
- 未提供
结局指标
主要结局
Number of participants with adverse events; incidence of Shenfu'ADRs and identify factors that contributed to the occurrence of the adverse reaction.
时间窗: The registry procedure will last 3 years only for patients using Shenfu.
次要结局
未报告次要终点
研究者
Yanming Xie
Deputy Director
China Academy of Chinese Medical Sciences