This trial is active, not recruiting.

Condition ischemic stroke
Sponsor China Academy of Chinese Medical Sciences
Collaborator Xiyuan Hospital of China Academy of Chinese Medical Sciences
Start date January 2012
End date December 2014
Trial size 30000 participants
Trial identifier NCT01508403, 2009zx09502-030


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective prospective
a cohort using Shuxuetong injection

Primary Outcomes

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.

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - all inpatients use Shuxuetong injection in 20 selected hospitals during their hospital stay

Additional Information

Official title A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals
Principal investigator Yan M Xie
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by China Academy of Chinese Medical Sciences.