A Registry Study on Safety Surveillance of Dazhuhongjingtian (a Chinese Medicine Injection) Used in China
1 other identifier
observational
3,000
0 countries
N/A
Brief Summary
The purpose of this study is to make a cohort event monitoring to see whether and how Dazhuhongjingtian injection in hospital results in adverse events or adverse drug reactions
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2017
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2017
CompletedFirst Posted
Study publicly available on registry
June 16, 2017
CompletedStudy Start
First participant enrolled
June 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedJune 20, 2017
June 1, 2017
1 month
June 14, 2017
June 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Dazhuhongjingtian's ADRs,especially number of participants with adverse events.
All patients will be measured and assessed at the time Dazhuhongjingtian is administered to them until they discharge. Patients using Dazhuhongjingtian will be registered on a registration form including disease background, Dazhuhongjingtian'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 Dazhuhongjingtian.
The registry procedure will last about 3 years only for patients using Dazhuhongjingtian
Interventions
All patients will be measured and assessed at the time Dazhuhongjingtian Injection is administered to them until they discharge. Patients using Dazhuhongjingtian Injection will be registered on a registration form including disease background, Dazhuhongjingtian Injection'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 Dazhuhongjingtian Injection.
Eligibility Criteria
An anticipated sample size was caculated in this study, about 3000. Patients using Dazhuhongjingtian injection from 2017 to 2019 in 4 hospitals
You may qualify if:
- \- An anticipated sample size was caculated in this study, about 3000. Patients using Dazhuhongjingtian injection from 2017 to 2019 in 4 hospitals
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yan Ming Xie, BA
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Director
Study Record Dates
First Submitted
June 14, 2017
First Posted
June 16, 2017
Study Start
June 19, 2017
Primary Completion
July 19, 2017
Study Completion
December 31, 2019
Last Updated
June 20, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will share