Overview

This trial is active, not recruiting.

Conditions viral pneumonia, bronchitis, infantile diarrhea, bacillary dysentery, virus hepatitis
Sponsor China Academy of Chinese Medical Sciences
Start date January 2012
End date December 2014
Trial size 20000 participants
Trial identifier NCT01612572, RSCMI- Ⅲ, RSCMI-Ⅲ

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
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.

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Xiyanping injection from 2012 to 2014

Additional Information

Official title A Registry Study on Safety Surveillance of Xiyanping (a Chinese Medicine Injection) Used in China
Principal investigator Yan M Xie, BA
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by China Academy of Chinese Medical Sciences.