A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals

NCT ID: NCT01508403

Last Updated: 2013-05-14

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 Shuxuetong injection in hospital results in adverse events or adverse drug reactions.

Detailed Description

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This is the first academic registry study about adverse events or adverse drug reaction for Chinese medicine injection in mainland China.

It is well known that Chinese medicine injection is just limited in mainland China, which also be accepted by China health care system.

However, more and more adverse events or adverse drug reaction have been reported in recent years in the form of case report.

In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study will be introduced in this area.

To calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study.

According to the 'rule of three', 30,000 cases need to be registered at least.

Conditions

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Ischemic Stroke

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Shuxuetong injection

a cohort using Shuxuetong injection

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* all inpatients use Shuxuetong injection in 20 selected hospitals during their hospital stay
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiyuan Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role collaborator

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Yanming Xie

Deputy Director, Professor

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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2009zx09502-030

Identifier Type: -

Identifier Source: org_study_id

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