Safety Study of Dengzhanxixin (a Chinese Medicine Injection) Used in Hospitals in China
This trial is active, not recruiting.
|Conditions||ischemic stroke, coronary heart disease|
|Sponsor||China Academy of Chinese Medical Sciences|
|Collaborator||Guangdong Provincial Hospital of Traditional Chinese Medicine|
|Start date||April 2012|
|End date||December 2014|
|Trial size||30000 participants|
|Trial identifier||NCT01612585, RSCMI-Ⅴ|
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'.
Dengzhanxixin is kind of Chinese Medicine injection used for treating Ischemic Stroke 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 30,000 patients.
Number of participants with adverse events; incidence of Dengzhanxixin's 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 Dengzhanxixin
Male or female participants of any age.
Inclusion Criteria: - Patients using Dengzhanxixin injection from 2012 to 2014 Exclusion Criteria: - none
|Official title||A Registry Study on Safety Surveillance of Dengzhanxixin (a Chinese Medicine Injection) Used in China|
|Principal investigator||Yan M Xie, BA|
|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. Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study. A registry study for Kudiezi injection safety surveillance with 30000 patients will be conducted from April.2012 to December.2014. Eligibility criteria Patients who will use Dengzhanxixin injection in selected hospitals Data will be collected in three aspects by three different forms as following: Form A (green): demographic information ；Form B (pink): adverse drug events/reaction； Form C (white): extracted information from hospital information system and laboratory information system Form|
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