Overview

This trial is active, not recruiting.

Conditions coronary heart disease, angina pectoris
Sponsor China Academy of Chinese Medical Sciences
Start date January 2013
End date December 2014
Trial size 30000 participants
Trial identifier NCT01814566, 2009ZX09502-030-02

Summary

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in January 2013.

It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.

DanshenDuofensuanyan is kind of Chinese Medicine injection used for treating coronary heart disease and angina pectoris 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.

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 DanshenDuofensuanyan'adverse drug reaction(ADRs)and identify factors that contributed to the occurrence of the adverse reaction
time frame: to assess DanshenDuofensuanyan's 'adverse event' and 'drug adverse reaction' during patients' hospital stay. The registry procedure will last 2 years only for patients using DanshenDuofensuanyan

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients using DanshenDuofensuanyan injection from 2013 to 2014 Exclusion Criteria: - none

Additional Information

Official title Safety Study of DanshenDuofensuanyan(a Chinese Medicine Injection)Used in Hospitals in China
Principal investigator Yan M Xie, BA
Description 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. In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for DanshenDuofensuanyan injection safety surveillance with 30000 patients will be conducted from Jan.2013 to Dec.2015. Eligibility criteria Patients who will use DanshenDuofensuanyan injection in selected hospitals.
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by China Academy of Chinese Medical Sciences.