Safety Study of Dengzhanxixin (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 project for 'significant new formulation of new drugs'.
Dengzhanxixin is kind of Chinese Medicine injection used for treating Ischemic Stroke and coronary heart disease 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 Medicine Injection in clinical practice.
Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.
A registry study for Kudiezi injection safety surveillance with 30000 patients will be conducted from April.2012 to December.2014.
Eligibility criteria Patients who will use Dengzhanxixin injection in selected hospitals
Data will be collected in three aspects by three different forms as following:
Form A (green): demographic information ;Form B (pink): adverse drug events/reaction; Form C (white): extracted information from hospital information system and laboratory information system Form

Conditions

Trial Design

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

Trial Population

An anticipated sample size was caculated in this study, about 30000. Patients using Kudiezi injection from 2012 to 2014 in more than 30 hospitals

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of participants with adverse events; incidence of Dengzhanxixin's ADRs and identify factors that contributed to the occurrence of the adverse reaction. The registry procedure will last 3 years only for patients using Dengzhanxixin Yes

Sponsors