Safety Study of Shenfu (a Chinese Medicine Injection) Used in Hospitals 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'.
Shenfu is kind of Chinese Medicine injection used for treating shock and coronary heart disease 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.
Coronary Heart Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Registry Study on Safety Surveillance of Shenfu (a Chinese Medicine Injection) Used in China|
- Number of participants with adverse events; incidence of Shenfu'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 Shenfu. ] [ Designated as safety issue: Yes ]
|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)|
Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out ,because in mainland China hospitals ,Chinese Medicine Injection are used widely. Population for taking medicine characteristics,the incidence rate of ADR and other uncertain factors influence can not be found now.
A registry study for Shenfu injection safety surveillance with 20000 patients will be conducted from Jan.2012 to Dec.2015.
Eligibility criteria Patients who will use Shenfu injection in selected hospitals.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612533
|Principal Investigator:||Yan M Xie, BA||Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences|