A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals (RSCMI-I)
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals|
- Number of participants with adverse events; incidence of Shuxuetong'ADRs and identify factors that contributed to the occurrence of the adverse reaction [ Time Frame: to assess Shuxuetong's "adverse event" and "drug adverse reaction" during patients' hospital stay, administration information of Shuxuetong will be registered every day. The registry procedure will last 3 years only for patients using Shuxuetong. ] [ Designated as safety issue: Yes ]All participants will be followed for the duration of hospital stay, an expected average of 2 weeks.Patients using Shuxuetong will be registered on a registration form including disease background, Shuxuetong'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 Shuxuetong.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
a cohort using Shuxuetong injection
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508403
|Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences|
|Beijing, Beijing, China, 100700|
|Principal Investigator:||Yan M Xie||Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences|