NCT01508403|UnknownDMC
A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals
RSCMI-I
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RSCMI-I
Sponsor study identifier
observational
30,000
1 country
1
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 20, 2011
Actual (reported)January 2012
Date type not reportedThis date has not been verified as actual or estimated.
January 12, 2012
Actual (reported)December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Number of participants with adverse events; incidence of Shuxuetong'ADRs and identify factors that contributed to the occurrence of the adverse reaction
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.
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.
a cohort using Shuxuetong injection
all inpatients used or will use Shuxuetong injection in 20 selected hospitals in mainland China
Contact the study team to confirm eligibility.
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100700, China
Yan M Xie
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
First Submitted
December 20, 2011
First Posted
January 12, 2012
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Estimated (date passed)Phase ⅡStudy of Pinocembrin Injection to Treat Ischemic Stroke
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 14, 2013
Record last verified: 2013-05
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