Coronary Heart Disease, Shock
Conditions
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'. 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.
Detailed description
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.
Interventions
None listed
Sponsors
China Academy of Chinese Medical Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients using Shenfu injection from 2012 to 2014
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events; incidence of Shenfu'ADRs and identify factors that contributed to the occurrence of the adverse reaction. | The registry procedure will last 3 years only for patients using Shenfu. |
Outcome results
None listed