NCT01814566

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30,000 (estimated)
• Sponsor: China Academy of Chinese Medical Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Heart Disease
• Angina Pectoris

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-12-01
• Completion: 2015-12-01
• First posted: 2013-03-20
• Last updated: 2013-05-14