NCT01612611

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

A Registry Study on Safety Surveillance of Shenmai (a Chinese Medicine Injection) Used 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

The purpose of this study is to make a cohort event monitoring to see whether and how Shenmai injection in hospital results in adverse events or adverse drug reactions.

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 shenmai injection safety surveillance with 30000 patients will be conducted from Jan.2012 to Dec.2015. Eligibility criteria Patients who will use shenmai injection in selected hospitals.

Conditions

• Shock
• Coronary Heart Disease

Timeline

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

Locations

1 site across 1 country: China