Safety Study of Shenmai(a Chinese Medicine Injection) Used in Hospitals in China
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.
Coronary Heart Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Registry Study on Safety Surveillance of Shenmai (a Chinese Medicine Injection) Used in China|
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2015|
|a cohort using Shenmai injection|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01612611
|Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences|
|Beijing, Beijing, China, 100700|
|Principal Investigator:||Yan M Xie||Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences|