A Registry Study on Safety Surveillance of Dengzhanxixin (a Chinese Medicine Injection) Used in China
试验速览
- 阶段
- 不适用
- 入组人数
- 30,000
- 主要终点
- Number of participants with adverse events; incidence of Dengzhanxixin's 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'.
Dengzhanxixin is kind of Chinese Medicine injection used for treating Ischemic Stroke 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 30,000 patients.
详细描述
It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.
Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.
A registry study for Kudiezi injection safety surveillance with 30000 patients will be conducted from April.2012 to December.2014.
Eligibility criteria Patients who will use Dengzhanxixin injection in selected hospitals
Data will be collected in three aspects by three different forms as following:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients using Dengzhanxixin 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 Dengzhanxixin's 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 Dengzhanxixin
All patients will be measured and assessed at the time Dengzhanxixin is administered to them until they discharge. Patients using Dengzhanxixin will be registered on a registration form including disease background, Dengzhanxixin's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side effects of Dengzhanxixin.
次要结局
未报告次要终点
研究者
Yanming Xie
Deputy Director
China Academy of Chinese Medical Sciences