A Registry Study on Shenqifuzheng（a Chinese Medicine Injection）Used in Hospitals in China
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in December 2012.
It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.
The purpose of this study is to make a cohort event monitoring to see whether and how Shenqifuzheng injection in hospital results in adverse events or adverse drug reactions.
研究概览
详细说明
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 Shenqifuzheng injection safety surveillance with 30000 patients will be conducted from Jan.2013 to Dec.2014.
Eligibility criteria Patients who will use Shenqifuzheng injection in selected hospitals
研究类型
注册 (预期的)
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients using Shenqifuzheng injection from 2013 to 2014
Exclusion Criteria:
- none
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of participants with adverse events; incidence of Shenqifuzheng'ADRs and identify factors that contributed to the occurrence of the adverse reaction
大体时间：to assess Shenqifuzheng's 'adverse event' and 'drug adverse reaction' during patients' hospital stay, administration information of Shenqifuzheng will be registered every day. The registry procedure will last 3 years only for patients using Shenqifuzheng
|
All patients will be measured and assessed at the time Shenqifuzheng is administered to them until they discharge.
Patients using Shenqifuzheng will be registered on a registration form including disease background, Shenqifuzheng'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 Shenqifuzheng
|
to assess Shenqifuzheng's 'adverse event' and 'drug adverse reaction' during patients' hospital stay, administration information of Shenqifuzheng will be registered every day. The registry procedure will last 3 years only for patients using Shenqifuzheng
|
合作者和调查者
调查人员
- 首席研究员：Xie M Yan、Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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