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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by China Academy of Chinese Medical Sciences.