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Safety Study of DanshenDuofensuanyan(a Chinese Medicine Injection)Used in Hospitals in China

C

China Academy of Chinese Medical Sciences

Status

Unknown

Conditions

Coronary Heart Disease
Angina Pectoris

Study type

Observational

Funder types

Other

Identifiers

NCT01814566
2009ZX09502-030-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

30,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients using DanshenDuofensuanyan injection from 2013 to 2014

Exclusion criteria

  • none

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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