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

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ClinicalTrials.gov Identifier: NCT01612572
Recruitment Status : Unknown
Verified June 2012 by Yanming Xie, China Academy of Chinese Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : June 6, 2012
Last Update Posted : June 6, 2012
Sponsor:
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences

Brief 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.


Condition or disease
Viral Pneumonia Bronchitis Infantile Diarrhea Bacillary Dysentery Virus Hepatitis

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 : Observational
Estimated Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Registry Study on Safety Surveillance of Xiyanping (a Chinese Medicine Injection) Used in China
Study Start Date : January 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
An anticipated sample size was caculated in this study, about 20000. Patients using Xiyanping injection from 2012 to 2014 in more than 50 hospitals
Criteria

Inclusion Criteria:

  • Xiyanping injection from 2012 to 2014

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01612572


Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Investigators
Principal Investigator: Yan M Xie, BA Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

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
First Posted: June 6, 2012    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Pneumonia
Diarrhea
Bronchitis
Dysentery
Pneumonia, Viral
Diarrhea, Infantile
Dysentery, Bacillary
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Bronchial Diseases
Lung Diseases, Obstructive
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Virus Diseases
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections