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NCT01612572 Clinical Trial

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

Bronchitis Clinical Trial

Official title:
A Registry Study on Safety Surveillance of Xiyanping (a Chinese Medicine Injection) Used in China

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01612572
Other study ID # RSCMI-?
Secondary ID RSCMI- ?
Status Unknown status
Phase N/A
First received June 3, 2012
Last updated June 5, 2012
Start date January 2012
Est. completion date December 2015

Study information
Verified date June 2012
Source China Academy of Chinese Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Unknown status
Enrollment 20000
Est. completion date December 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Xiyanping injection from 2012 to 2014

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
China Academy of Chinese Medical Sciences

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with adverse events; incidence of Xiyanping'ADRs and identify factors that contributed to the occurrence of the adverse reaction The registry procedure will last 3 years only for patients using Xiyanping.
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