A Registry Study of Shujinjianyao Pill 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 Shujinjianyao Pill about four weeks ?
研究概览
简要总结
The purpose of this study is to get to know how Shujinjianyao Pill in hospital results in drug-induced liver injury or other adverse drug reactions from a cohort event monitoring as registration research.
详细描述
In order to monitor drug-induced liver injury or other adverse drug reactions of Shujinjianyao Pill in clinical real world, registry study is a suitable method in this area. Meanwhile, the investigators will use nested case-control study to find out the mechanism of drug-induced liver injury. Calculate the incidence of drug-induced liver injury or other adverse drug reactions is one of the main aims for this study. Therefore, Safety monitoring of Shujinjianyao Pill is an very important problem that needs to be done through a large sample observational study. According to the relevant regulations of the state drug administration(SDA), 3000 cases need to be registered at least. The aim population is who use Shujinjianyao Pill with normal liver function before medication from June 2018 to October 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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Patients with normal liver function before medication.
- •2.Patients suffered from Waist and knee pain or sciatica.
排除标准
- •1.Patients who are pregnant, phrenetic, and suffered from serious illness.
- •2.Patients suffered from viral hepatitis or autoimmune hepatitis or alcoholic hepatitis or hereditary metabolic hepatitis or cirrhosis or cancer of the liver.
结局指标
主要结局
Is there any abnormality in liver function test index（ALT、AST、TBil、GGT） after using Shujinjianyao Pill about four weeks ?
时间窗: After using Shujinjianyao Pill about four weeks.
The liver function test index mainly includes glutamic-pyruvic transaminase(ALT),glutamic-oxalacetic transaminase(AST), gamma-glutamyl transpeptidase(GGT) and total bilirubin(TBil). If the index is abnormal, it indicates abnormal liver function, and severe cases can lead to liver injury.
次要结局
- Is there any abnormality in blood routine examination after medication?(After using Shujinjianyao Pill around four weeks.)
- Is there any abnormality in electrocardiogram after medication?(After using Shujinjianyao Pill around four weeks.)
- Is there any abnormality in renal function test index（Bun、Cr） after medication?(After using Shujinjianyao Pill around four weeks.)
- Is there any abnormality in routine urinalysis after medication?(After using Shujinjianyao Pill around four weeks.)
研究者
Yanming Xie
Deputy director
China Academy of Chinese Medical Sciences