Overview

This trial is active, not recruiting.

Conditions coronary heart disease, angina pectoris, stroke
Sponsor China Academy of Chinese Medical Sciences
Collaborator Longhua Hospital
Start date January 2012
End date December 2014
Trial size 30000 participants
Trial identifier NCT01781676, RSCMI-Ⅷ

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Number of participants with adverse events;incidence of Kudiezi(Yueanxin)'ADRs and identify factors that contributed to the occurrence of the adverse reaction
time frame: 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.

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: Patients using Kudiezi(Yueanxin) injection from 2012 to 2014 Exclusion Criteria: none

Additional Information

Official title Registry Study Intensive Hospital Monitoring Protocol of Kudiezi Injection ( Yueanxin ) 's Clinical Safety
Principal investigator Xie Y Ming, BA
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by China Academy of Chinese Medical Sciences.