NCT01612533

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

A Registry Study on Safety Surveillance of Shenfu (a Chinese Medicine Injection) Used in China

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20,000 (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 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.

Detailed 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.

Conditions

• Shock
• Coronary Heart Disease

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-12-01
• Completion: 2015-12-01
• First posted: 2012-06-06
• Last updated: 2012-06-06