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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01612572
First received: June 3, 2012
Last updated: June 5, 2012
Last verified: June 2012

June 3, 2012
June 5, 2012
January 2012
December 2014   (final data collection date for primary outcome 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. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01612572 on ClinicalTrials.gov Archive Site
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A Registry Study on Xiyanping(a Chinese Medicine Injection) Used in Fifty Hospitals
A Registry Study on Safety Surveillance of Xiyanping (a Chinese Medicine Injection) Used in China

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

An anticipated sample size was caculated in this study, about 20000. Patients using Xiyanping injection from 2012 to 2014 in more than 50 hospitals

  • Viral Pneumonia
  • Bronchitis
  • Infantile Diarrhea
  • Bacillary Dysentery
  • Virus Hepatitis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20000
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Xiyanping injection from 2012 to 2014
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01612572
RSCMI-Ⅲ, RSCMI- Ⅲ
Yes
Yanming Xie, China Academy of Chinese Medical Sciences
China Academy of Chinese Medical Sciences
Not Provided
Principal Investigator: Yan M Xie, BA Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
China Academy of Chinese Medical Sciences
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP