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
  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

Resource links provided by NLM:


Further study details as provided by China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • 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)
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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  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
Pneumonia, Viral
Diarrhea, Infantile
Dysentery, Bacillary
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Virus Diseases
Pneumonia
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Dysentery
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on October 01, 2014