Overview

This trial is active, not recruiting.

Conditions shock, coronary heart disease
Sponsor China Academy of Chinese Medical Sciences
Start date January 2012
End date December 2014
Trial size 20000 participants
Trial identifier NCT01612533, RSCMI-IV

Summary

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'.

Shenfu is kind of Chinese Medicine injection used for treating shock 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 20,000 patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Number of participants with adverse events; incidence of Shenfu'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 Shenfu.

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients using Shenfu injection from 2012 to 2014

Additional Information

Official title A Registry Study on Safety Surveillance of Shenfu (a Chinese Medicine Injection) Used in China
Principal investigator Yan M Xie, BA
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 Shenfu injection safety surveillance with 20000 patients will be conducted from Jan.2012 to Dec.2015. Eligibility criteria Patients who will use Shenfu 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.