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

• Conditions: Shock; Coronary Heart Disease

• Registration Number: NCT01612611
• Lead Sponsor: China Academy of Chinese Medical Sciences

Brief 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.

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
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30000

Inclusion Criteria

• all inpatients use Shenmai injection in 30 selected hospitals during their hospital stay

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Exclusion Criteria

• none

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China