Safety Study of Dengzhanxixin (a Chinese Medicine Injection) Used in Hospitals in China
A Registry Study on Safety Surveillance of Dengzhanxixin (a Chinese Medicine Injection) Used in China
1 other identifier
observational
30,000
0 countries
N/A
Brief Summary
This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2012
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 3, 2012
CompletedFirst Posted
Study publicly available on registry
June 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJune 11, 2012
June 1, 2012
2.7 years
June 3, 2012
June 7, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events; incidence of Dengzhanxixin's ADRs and identify factors that contributed to the occurrence of the adverse reaction.
All patients will be measured and assessed at the time Dengzhanxixin is administered to them until they discharge. Patients using Dengzhanxixin will be registered on a registration form including disease background, Dengzhanxixin's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side effects of Dengzhanxixin.
The registry procedure will last 3 years only for patients using Dengzhanxixin
Eligibility Criteria
An anticipated sample size was caculated in this study, about 30000. Patients using Kudiezi injection from 2012 to 2014 in more than 30 hospitals
You may qualify if:
- Patients using Dengzhanxixin injection from 2012 to 2014
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yan M Xie, BA
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Director
Study Record Dates
First Submitted
June 3, 2012
First Posted
June 6, 2012
Study Start
April 1, 2012
Primary Completion
December 1, 2014
Study Completion
December 1, 2015
Last Updated
June 11, 2012
Record last verified: 2012-06