A Registry Study on Reduning（a Chinese Medicine Injection）Used in Hospitals in China
NCT ID: NCT01824719
Last Updated: 2013-04-05
Study Results
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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UNKNOWN
3000 participants
OBSERVATIONAL
2013-01-31
2013-04-30
Brief Summary
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The purpose of this study is to make a event monitoring to see whether Reduning injection is safe and the characteristic and mechanism of anaphylactic reaction used Reduning injection in hospitals in China.
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Detailed Description
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In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for Reduning injection safety surveillance with 3000 patients will be conducted from Jan.2013 to Mar.2013.At the same time,Patients who have anaphylactic reaction are selected as the allergic group and not have anaphylactic reaction are selected as the control group.The proportion of allergic group and control group is 1:4.All the patients who are selected should draw blood.
Eligibility criteria Patients who will use Reduning injection in selected hospitals.
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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Allergic group
All patients who used Reduning Injection have anaphylaxis.
No interventions assigned to this group
Control group
All patients who used Reduning Injection don't have anaphylaxis.One allergic group patient should matched four control group patients.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
1 Month
80 Years
ALL
No
Sponsors
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China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Yanming Xie
Director
Principal Investigators
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Xie Y Ming
Role: PRINCIPAL_INVESTIGATOR
China Academy of Chinese Medical Sciences
Locations
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Institute of Basic Research in Clinical Medicine
Beijing, Beijing Municipality, China
Countries
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Facility Contacts
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Other Identifiers
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200907001-5-6-1
Identifier Type: -
Identifier Source: org_study_id
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