A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals

Ischemic Stroke Clinical Trial

— RSCMI-I  

Official title:

A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01508403
• Other study ID #: 2009zx09502-030
• Status: Active, not recruiting
• Phase: N/A
• First received: December 20, 2011
• Last updated: May 13, 2013
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: May 2013
• 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 to make a cohort event monitoring to see whether and how Shuxuetong injection in hospital results in adverse events or adverse drug reactions.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30000
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all inpatients use Shuxuetong injection in 20 selected hospitals during their hospital stay

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Ischemic Stroke

Locations

Country	Name	City	State
China	Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	Xiyuan Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	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	All participants will be followed for the duration of hospital stay, an expected average of 2 weeks.Patients using Shuxuetong will be registered on a registration form including disease background, Shuxuetong's administration, and extraction information from hospital information system. 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 Shuxuetong.	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