A Registry Study of Runzaozhiyang Capsule Used in Clinical Real World
试验速览
- 阶段
- 不适用
- 入组人数
- 3,000
- 主要终点
- Is there any abnormality in liver function test index（ALT、AST、TBil、GGT） after using runzaozhiyang capsule around two weeks later?
研究概览
简要总结
The purpose of this study is get to know what and how Runzaozhiyang capsule in hospital results in drug-induced liver injury or adverse drug reactions from a cohort event monitoring as registration research.
详细描述
In order to improving monitoring drug-induced liver injury or adverse drug reactions of Chinese medicine containing Radix Polygoni Multiflori in clinical real world, registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of drug-induced liver injury. Calculate the incidence of drug-induced liver injury or adverse drug reactions is one of the main aims for this study. Safety surveillance on Chinese medicine containing Radix Polygoni Multiflori is an important problem that needs to be sorted out through large sample observational study. According to the relevant regulations of the CFDA, 3000 cases need to be registered at least. The aim population is who using Runzaozhiyang capsule 's with abnormal liver function before medication from June 2017 to June 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
- •Patients using Runzaozhiyang capsule 's with abnormal liver function before medication from June 2017 to June 2019.
排除标准
- 未提供
结局指标
主要结局
Is there any abnormality in liver function test index（ALT、AST、TBil、GGT） after using runzaozhiyang capsule around two weeks later?
时间窗: After using runzaozhiyang capsule around two weeks later.
Based on data from the National Center for adverse drug reactions (ADR), Chinese herbal medicine containing Polygonum multiflorum may cause liver damage, but further confirmation is needed.The liver function includes glutamic-pyruvic transaminase,glutamic-oxalacetic transaminase,GGT,TBil.
次要结局
- Is there any abnormality in renal function test index（Bun、Cr） after medication?(After using runzaozhiyang capsule around two weeks later.)
- Is there any abnormality in ECG after medication?(After using runzaozhiyang capsule around two weeks later.)
- Is there any abnormality in basic life sign（body temperature, blood pressure and pulse）？(During using runzaozhiyang capsule around two weeks.)
研究者
Yanming Xie
Deputy director
China Academy of Chinese Medical Sciences