Stroke Clinical Trial
Official title:
Registry Study Intensive Hospital Monitoring Protocol of Kudiezi Injection ( Yueanxin ) 's Clinical Safety
This study was advocated by institute of Basic Research in Clinical Medicine,China Academy
of Chinese Medical Sciences in October 2011.
It was funded by China major scientific and technological specialized specialized project
for 'significant new formulation of net drugs'.
Kudiezi(Yueanxin) is kind of Chinese Medicine injiection used for treating corinary heart
diswese、angina pectoris and stroke in many Chinese hospitals.
The purpose of this study is to determine adverse drug events or adverse drug reaction in
large sample size 30,000 patients.
It is very common that Chinese Medicine Injection used in hospitals in mainland
China.However safety problems rose in recent years.There could be many uncertain factors
influence Chinese Medincine Injection in clinical practice.
Safety surveillance on Chinese Medincine injection is an important problem that needs to be
sorted out through large sample observational dtudy.
A registry study for Kudiezi(Yueanxin) injection safety surveillance with 30000 patients
will be conducted form Jan.2012 to Dec.2015.
Eligiblity crteria Patients who will use Kudiezi(Yueanxin) injection in selected hospitals.
Date will be collected in four aspects by four different forms as following:
Form A(blue):demographic information ;Form B(yellow):adverde drug events/reaction;Form
C(white):extracted information from hodpiral information system and laboratory information
system.
;
Observational Model: Cohort, Time Perspective: Prospective
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