A Registry Study of Shuxuening Injection Used in Hospitals in China

A Registry Study of Shuxuening (a Chinese Medicine Injection) Used in Hospitals in China

Sponsors

Lead Sponsor: China Academy of Chinese Medical Sciences

Collaborator: Beijing University of Chinese Medicine

Source China Academy of Chinese Medical Sciences
Brief Summary

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.

Overall Status Unknown status
Start Date 2012-10-01
Completion Date 2015-12-01
Primary Completion Date 2015-12-01
Study Type Observational
Primary Outcome
Measure Time Frame
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.
Enrollment 30000
Condition
Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

Inclusion Criteria: - Patients using Shuxuening injection from 2012 to 2014 Exclusion Criteria: - none

Gender:

All

Minimum Age:

N/A

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Yan M Xie, BA Principal Investigator Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Verification Date

2012-12-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: China Academy of Chinese Medical Sciences

Investigator Full Name: Xie Yanming

Investigator Title: Deputy Director

Has Expanded Access No
Condition Browse
Acronym RSCMI-VII
Study Design Info

Time Perspective: Prospective

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