Safety Study of Kudiezi(Yueanxin,a Chinese Medicine Injection)Used in Hospitals in China

Active, not recruiting

Phase N/A Results N/A

Trial Description

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 disweseŃÇüangina 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.

Detailed Description

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.

Conditions

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

An anticpcipated sample size was caculated in this study,about 30000.Patients using Kudiezi injection from 2012 to 2014 in more than 20 hospital.

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of participants with adverse events;incidence of Kudiezi(Yueanxin)'ADRs and identify factors that contributed to the occurrence of the adverse reaction to assess Kudiezi(Yueanxin)'s 'adverse event' and 'drug adverse reaction' during patients' hospital stay,administration information of Kudiezi will be registered every day.The registry procedure will last 3 years only for patients using Kudiezi. Yes

Sponsors