A Registry Study on Xiyanping(a Chinese Medicine Injection) Used in Fifty Hospitals

Overview

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011. It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'. Xiyanping is kind of Chinese Medicine injection used for treating viral pneumonia 、bronchitis、amygdalitis、infantile diarrhea、bacillary dysentery 、virus hepatitis、and Children acute hot diseases in many Chinese hospitals. The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 20,000 patients.

Full Title of Study: “A Registry Study on Safety Surveillance of Xiyanping (a Chinese Medicine Injection) Used in China”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2014

Detailed Description

It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice. In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for Xiyanping injection safety surveillance with 20000 patients will be conducted from Jan.2012 to Dec.2015. Eligibility criteria Patients who will use Xiyanping injection in selected hospitals.

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with adverse events; incidence of Xiyanping’ADRs and identify factors that contributed to the occurrence of the adverse reaction
    • Time Frame: The registry procedure will last 3 years only for patients using Xiyanping.

Participating in This Clinical Trial

Inclusion Criteria

  • Xiyanping injection from 2012 to 2014

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • China Academy of Chinese Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yanming Xie, Deputy Director – China Academy of Chinese Medical Sciences
  • Overall Official(s)
    • Yan M Xie, BA, Principal Investigator, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

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