NCT01781676

Safety Study of Kudiezi(Yueanxin,a Chinese Medicine Injection)Used in Hospitals in China

Registry Study Intensive Hospital Monitoring Protocol of Kudiezi Injection ( Yueanxin ) 's Clinical Safety

• 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 October 2011. It was funded by China major scientific and technological specialized specialized project for 'significant new formulation of net drugs'. Kudiezi(Yueanxin) is kind of Chinese Medicine injiection used for treating corinary heart diswese、angina pectoris and stroke 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 Medincine Injection in clinical practice. Safety surveillance on Chinese Medincine injection is an important problem that needs to be sorted out through large sample observational dtudy. A registry study for Kudiezi(Yueanxin) injection safety surveillance with 30000 patients will be conducted form Jan.2012 to Dec.2015. Eligiblity crteria Patients who will use Kudiezi(Yueanxin) injection in selected hospitals. Date will be collected in four aspects by four different forms as following: Form A(blue):demographic information ;Form B(yellow):adverde drug events/reaction;Form C(white):extracted information from hodpiral information system and laboratory information system.

Conditions

• Coronary Heart Disease
• Angina Pectoris
• Stroke

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-12-01
• Completion: 2015-12-01
• First posted: 2013-02-01
• Last updated: 2013-05-14

Locations

1 site across 1 country: China