Safety Study of Dengzhanxixin (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'.
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.
Coronary Heart Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||A Registry Study on Safety Surveillance of Dengzhanxixin (a Chinese Medicine Injection) Used in China|
- 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 ] [ Designated as safety issue: Yes ]All patients will be measured and assessed at the time Dengzhanxixin is administered to them until they discharge. Patients using Dengzhanxixin will be registered on a registration form including disease background, Dengzhanxixin's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side effects of Dengzhanxixin.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612585
|Principal Investigator:||Yan M Xie, BA||Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences|