Safety Study of Shenmai(a Chinese Medicine Injection) Used in Hospitals in China
This trial is active, not recruiting.
|Conditions||shock, coronary heart disease|
|Sponsor||China Academy of Chinese Medical Sciences|
|Collaborator||First Teaching Hospital of Tianjin University of Traditional Chinese Medicine|
|Start date||January 2012|
|End date||December 2015|
|Trial size||30000 participants|
|Trial identifier||NCT01612611, RSCMI-Ⅵ|
The purpose of this study is to make a cohort event monitoring to see whether and how Shenmai injection in hospital results in adverse events or adverse drug reactions.
Male or female participants of any age.
Inclusion Criteria: - all inpatients use Shenmai injection in 30 selected hospitals during their hospital stay Exclusion Criteria: - none
|Official title||A Registry Study on Safety Surveillance of Shenmai (a Chinese Medicine Injection) Used in China|
|Principal investigator||Yan M Xie|
|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 shenmai injection safety surveillance with 30000 patients will be conducted from Jan.2012 to Dec.2015. Eligibility criteria Patients who will use shenmai injection in selected hospitals.|
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