A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals "RSCMI-I"

Active, not recruiting

Phase N/A Results N/A

Trial Description

The purpose of this study is to make a cohort event monitoring to see whether and how Shuxuetong injection in hospital results in adverse events or adverse drug reactions.

Detailed Description

This is the first academic registry study about adverse events or adverse drug reaction for Chinese medicine injection in mainland China.
It is well known that Chinese medicine injection is just limited in mainland China, which also be accepted by China health care system.
However, more and more adverse events or adverse drug reaction have been reported in recent years in the form of case report.
In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study will be introduced in this area.
To calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study.
According to the 'rule of three', 30,000 cases need to be registered at least.

Conditions

Trial Design

  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

all inpatients used or will use Shuxuetong injection in 20 selected hospitals in mainland China

Outcomes

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

Sponsors