Bronchitis Clinical Trial
Official title:
A Registry Study on Safety Surveillance of Xiyanping (a Chinese Medicine Injection) Used in China
Verified date | June 2012 |
Source | China Academy of Chinese Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
China Academy of Chinese Medical Sciences |
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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