A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals (RSCMI-I)
研究概览
地位
条件
详细说明
This is the first academic registry study about adverse events or adverse drug reaction for Chinese medicine injection in mainland China.
It is well known that Chinese medicine injection is just limited in mainland China, which also be accepted by China health care system.
However, more and more adverse events or adverse drug reaction have been reported in recent years in the form of case report.
In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study will be introduced in this area.
To calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study.
According to the 'rule of three', 30,000 cases need to be registered at least.
研究类型
注册 (预期的)
联系人和位置
学习地点
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Beijing
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Beijing、Beijing、中国、100700
- Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
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:
- all inpatients use Shuxuetong injection in 20 selected hospitals during their hospital stay
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Shuxuetong injection
a cohort using Shuxuetong injection
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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 |
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Number of participants with adverse events; incidence of Shuxuetong'ADRs and identify factors that contributed to the occurrence of the adverse reaction
大体时间：to assess Shuxuetong's "adverse event" and "drug adverse reaction" during patients' hospital stay, administration information of Shuxuetong will be registered every day. The registry procedure will last 3 years only for patients using Shuxuetong.
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All participants will be followed for the duration of hospital stay, an expected average of 2 weeks.Patients using Shuxuetong will be registered on a registration form including disease background, Shuxuetong'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 Shuxuetong.
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to assess Shuxuetong's "adverse event" and "drug adverse reaction" during patients' hospital stay, administration information of Shuxuetong will be registered every day. The registry procedure will last 3 years only for patients using Shuxuetong.
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合作者和调查者
调查人员
- 首席研究员：Yan M Xie、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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.