- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01612572
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.
Study Overview
Status
Detailed 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.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Xiyanping injection from 2012 to 2014
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
The registry procedure will last 3 years only for patients using Xiyanping.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia
- Lung Diseases
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Bronchial Diseases
- Gastroenteritis
- Intestinal Diseases
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Lung Diseases, Obstructive
- Enterobacteriaceae Infections
- Diarrhea
- Pneumonia, Viral
- Dysentery, Bacillary
- Bronchitis
- Dysentery
- Diarrhea, Infantile
Other Study ID Numbers
- RSCMI-Ⅲ
- RSCMI- Ⅲ
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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