A Registry Study on Safety Surveillance of Dazhuhongjingtian (a Chinese Medicine
试验速览
- 阶段
- 不适用
- 入组人数
- 3,000
- 主要终点
- Incidence of Dazhuhongjingtian's ADRs,especially number of participants with adverse events.
研究概览
简要总结
The purpose of this study is to make a cohort event monitoring to see whether and how Dazhuhongjingtian injection in hospital results in adverse events or adverse drug reactions
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 few be found now.A registry study for Dazhuhongjingtian injection safety surveillance with 3000 patients will be conducted from June.2017 to Dec.2019.Eligibility criteria Patients who will use Dazhuhongjingtian injection in 4 selected hospitals from2017-2019.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Hour 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An anticipated sample size was caculated in this study, about
- •Patients using Dazhuhongjingtian injection from 2017 to 2019 in 4 hospitals
排除标准
- 未提供
结局指标
主要结局
Incidence of Dazhuhongjingtian's ADRs,especially number of participants with adverse events.
时间窗: The registry procedure will last about 3 years only for patients using Dazhuhongjingtian
All patients will be measured and assessed at the time Dazhuhongjingtian is administered to them until they discharge. Patients using Dazhuhongjingtian will be registered on a registration form including disease background, Dazhuhongjingtian'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 Dazhuhongjingtian.
次要结局
未报告次要终点
研究者
Yanming Xie
Deputy Director
China Academy of Chinese Medical Sciences