A Registry Study on Xiyanping(a Chinese Medicine Injection) Used in Fifty Hospitals
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Purpose
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.
| Condition |
|---|
|
Viral Pneumonia Bronchitis Infantile Diarrhea Bacillary Dysentery Virus Hepatitis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Registry Study on Safety Surveillance of Xiyanping (a Chinese Medicine Injection) Used in China |
- 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 ]
| Estimated Enrollment: | 20000 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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
Inclusion Criteria:
- Xiyanping injection from 2012 to 2014
Contacts and Locations More Information
No publications provided
| Responsible Party: | Yanming Xie, Deputy Director, China Academy of Chinese Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01612572 History of Changes |
| Other Study ID Numbers: | RSCMI-Ⅲ, RSCMI- Ⅲ |
| Study First Received: | June 3, 2012 |
| Last Updated: | June 5, 2012 |
| Health Authority: | China: State Administration of Traditional Chinese Medicine of the People's Republic of China |
Additional relevant MeSH terms:
|
Bronchitis Diarrhea Diarrhea, Infantile Dysentery Dysentery, Bacillary Hepatitis Hepatitis A Hepatitis C Pneumonia Pneumonia, Viral Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections |
Signs and Symptoms, Digestive Signs and Symptoms Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Enterobacteriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections Liver Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
ClinicalTrials.gov processed this record on May 19, 2013