A Registry Study of Shuxuening Injection Used in Hospitals in China "RSCMI-VII"

Active, not recruiting

Phase N/A Results N/A

Trial Description

The purpose of this study is get to know what and how Shuxuening injection in hospital results in adverse events or adverse drug reactions from a cohort event monitoring.

Detailed Description

Ginkgo leaf is major component of Shuxuening injection. Although some western countries product similar injections and use them, Shuxuening injection also regarded as Chinese medicine injection. As a TCM injection, the most important thing is how to safety use it in practice.
In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of allergic reaction.
Calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study. Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out through large sample observational study.
According to the 'rule of three', 30,000 cases need to be registered at least. The aim population is who using Shuxuening injection's during inpatient time from December 2012 to December.2014.
Data will be collected for three departments 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.

Conditions

Trial Design

  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

According to the 'rule of three', 30,000 cases need to be registered at least. The aim popution is who using Shuxuening injection's during inpatient time from December 2012 to December.2014 in more than 30 hospitals in China.

Outcomes

Type Measure Time Frame Safety Issue
Primary • Detect the incidence of Shuxuening injection's ADRs and identify factors that contributed to the occurrence of the adverse reaction to assess Shuxuening's "adverse event" and "drug adverse reaction" during patients' hospital stay, administration information of Shuxuening will be registered every day. The registry procedure will last 2 years only for patients using Shuxuening. Yes
Primary Incidence of Shuxuening injection's ADRs and factors contributed to the occurrence of the adverse reaction to assess Shuxuening's "adverse event" and "drug adverse reaction" during patients' hospital stay, administration information of Shuxuening will be registered every day. The registry procedure will last 2 years only for patients using Shuxuening. Yes

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