This trial is active, not recruiting.

Conditions coronary disease, intracranial embolism, stroke, angina pectoris, vasospasm
Sponsor China Academy of Chinese Medical Sciences
Collaborator Beijing University of Chinese Medicine
Start date October 2012
End date December 2015
Trial size 30000 participants
Trial identifier NCT01752946, 2009zx09502-030-07


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Incidence of Shuxuening injection's ADRs and factors contributed to the occurrence of the adverse reaction
time frame: 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.

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title A Registry Study of Shuxuening (a Chinese Medicine Injection) Used in Hospitals in China
Principal investigator Yan M Xie, BA
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by China Academy of Chinese Medical Sciences.