NCT01812876

A Registry Study on Shenqifuzheng（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: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in December 2012. It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'. The purpose of this study is to make a cohort event monitoring to see whether and how Shenqifuzheng injection in hospital results in adverse events or adverse drug reactions.

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. Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study. A registry study for Shenqifuzheng injection safety surveillance with 30000 patients will be conducted from Jan.2013 to Dec.2014. Eligibility criteria Patients who will use Shenqifuzheng injection in selected hospitals

Conditions

• Gastric Carcinoma
• Carcinoma of the Lungs

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-12-01
• Completion: 2015-12-01
• First posted: 2013-03-18
• Last updated: 2013-04-16