Safety Study of Dengzhanxixin (a Chinese Medicine Injection) Used in Hospitals in China
NCT ID: NCT01612585
Last Updated: 2012-06-11
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
30000 participants
OBSERVATIONAL
2012-04-30
2015-12-31
Brief Summary
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It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.
Dengzhanxixin is kind of Chinese Medicine injection used for treating Ischemic Stroke 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 30,000 patients.
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Detailed Description
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Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.
A registry study for Kudiezi injection safety surveillance with 30000 patients will be conducted from April.2012 to December.2014.
Eligibility criteria Patients who will use Dengzhanxixin injection in selected hospitals
Data will be collected in three aspects by three different forms as following:
Form A (green): demographic information ；Form B (pink): adverse drug events/reaction； Form C (white): extracted information from hospital information system and laboratory information system Form
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Yanming Xie
Deputy Director
Principal Investigators
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Yan M Xie, BA
Role: PRINCIPAL_INVESTIGATOR
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Other Identifiers
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RSCMI-Ⅴ
Identifier Type: -
Identifier Source: secondary_id
RSCMI-Ⅴ
Identifier Type: -
Identifier Source: org_study_id
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