A Registry Study of Shuxuening Injection Used in Hospitals in China

Stroke Clinical Trial

— RSCMI-VII  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01752946
• Other study ID #: 2009zx09502-030-07
• Status: Active, not recruiting
• Phase: N/A
• First received: December 15, 2012
• Last updated: December 19, 2012
• Start date: October 2012
• Est. completion date: December 2015

Study information

• Verified date: December 2012
• Source: China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30000
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients using Shuxuening injection from 2012 to 2014

Exclusion Criteria:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Intracranial Embolism
• Stroke
• Vasospasm

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	Beijing University of Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Shuxuening injection's ADRs and factors contributed to the occurrence of the adverse reaction	All participants will be followed for the duration of hospital stay, an expected average of 2 weeks. Patients using Shuxuening will be registered on a registration form including disease background, Shuxuening's administration, and extraction information from hospital information system. When the patients occurs allergic reaction during using Shuxuening injection, it also need to collect patient's biological samples. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side-effects of Shuxuening injection.	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