Stroke Clinical Trial
— RSCMI-VIIOfficial title:
A Registry Study of Shuxuening (a Chinese Medicine Injection) Used in Hospitals in China
The purpose of this study is get to know what and how Shuxuening injection in hospital results in adverse events or adverse drug reactions from a cohort event monitoring.
Status | Active, not recruiting |
Enrollment | 30000 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients using Shuxuening injection from 2012 to 2014 Exclusion Criteria: |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
China Academy of Chinese Medical Sciences | Beijing University of Chinese Medicine |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Shuxuening injection's ADRs and factors 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 Shuxuening will be registered on a registration form including disease background, Shuxuening's administration, and extraction information from hospital information system. When the patients occurs allergic reaction during using Shuxuening injection, it also need to collect patient's biological samples. 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 Shuxuening injection. | to assess Shuxuening's "adverse event" and "drug adverse reaction" during patients' hospital stay, administration information of Shuxuening will be registered every day. The registry procedure will last 2 years only for patients using Shuxuening. | Yes |
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