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临床试验/NCT02239237
NCT02239237已完成不适用

Post-marketing Safety Surveillance of Compound Kuh-seng Injection: a Registry Study

Zhong Wang29 个研究点 分布在 1 个国家目标入组 30,283 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30,283
试验地点
29
主要终点
The incidence of severe adverse reactions (SAR) to the Compound Kuh-seng Injection

研究概览

简要总结

This registry aims to monitor the safety of Compound Kuh-seng Injection and to identify the potential risk factors for the adverse drug reactions. Compound Kuh-seng Injection is a kind of natural compound injection extracted from herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who use Compound Kushen Injection in the monitoring hospitals

排除标准

  • 未提供

研究组 & 干预措施

Compound Kuh-seng Injection

Compound Kuh-seng Injection will be given to the patients, and the investigators will record all the information including ADR, application of Compound Kuh-seng Injection and the combined medications, etc.

干预措施: Compound Kuh-seng Injection (Drug)

结局指标

主要结局

The incidence of severe adverse reactions (SAR) to the Compound Kuh-seng Injection

时间窗: 2 years

次要结局

  • The incidence of anaphylactic reaction to Compound Kuh-seng Injection(2 years)
  • The incidence of new ADRs to Compound Kuh-seng Injection(2 years)
  • The incidence of new SARs to Compound Kuh-seng Injection(2 years)
  • The incidence of adverse drug reactions (ADR) to Compound Kuh-seng Injection(2 years)

研究者

发起方
Zhong Wang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhong Wang

Dr

China Academy of Chinese Medical Sciences

研究点 (29)

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