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

NCT01508403 | Unknown DMC

• 1 other identifier: 2009zx09502-030
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Shuxuetong injection

a cohort using Shuxuetong injection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all inpatients used or will use Shuxuetong injection in 20 selected hospitals in mainland China

You may qualify if:

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

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead
• Xiyuan Hospital of China Academy of Chinese Medical Sciences: collaborator

Study Sites (1)

Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100700, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yan M Xie

  Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director, Professor

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: January 12, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: May 14, 2013

Record last verified: 2013-05

Locations

CN (1)