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

• Conditions: Shock; Coronary Heart Disease

• Registration Number: NCT01612533
• Lead Sponsor: China Academy of Chinese Medical Sciences

Brief 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.

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-06
• Study First Submitted: 2012-06-03
• Study First Submitted QC: 2012-06-05
• Last Update Submitted: 2012-06-05
• Study First Posted: 2012-06-06
• Last Update Posted: 2012-06-06
• Primary Completion: 2014-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

• Patients using Shenfu injection from 2012 to 2014

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events; incidence of Shenfu'ADRs and identify factors that contributed to the occurrence of the adverse reaction.	The registry procedure will last 3 years only for patients using Shenfu.