Who is sponsoring RSCMI-VII?

RSCMI-VII is sponsored by China Academy of Chinese Medical Sciences.

What condition does RSCMI-VII study?

RSCMI-VII studies Coronary Disease, Intracranial Embolism, Stroke, Angina Pectoris, Vasospasm.

What is the status of RSCMI-VII?

RSCMI-VII is currently UNKNOWN.

Last reviewed 2012-12-19 · How we verify

A Registry Study of Shuxuening (a Chinese Medicine Injection) Used in Hospitals in China (RSCMI-VII)

NCT01752946 UNKNOWN

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.

Details

Lead sponsor	China Academy of Chinese Medical Sciences
Status	UNKNOWN
Enrolment	30000
Start date	2012-10
Completion	2015-12

Conditions

Coronary Disease
Intracranial Embolism
Stroke
Angina Pectoris
Vasospasm

Primary outcomes

Incidence of Shuxuening injection's ADRs and factors contributed to the occurrence of the adverse reaction — 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.
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.