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

NCT ID: NCT01612611

Last Updated: 2012-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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

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Shock Coronary Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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a cohort using Shenmai injection

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Yanming Xie

Deputy Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yan M Xie

Role: PRINCIPAL_INVESTIGATOR

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Locations

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Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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RSCMI-Ⅵ

Identifier Type: -

Identifier Source: org_study_id

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