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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01508403
First received: December 20, 2011
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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.


Condition
Ischemic Stroke

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals

Resource links provided by NLM:


Further study details as provided by China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • Number of participants with adverse events; incidence of Shuxuetong'ADRs and identify factors that contributed to the occurrence of the adverse reaction [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 30000
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Shuxuetong injection
a cohort using Shuxuetong injection

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • all inpatients use Shuxuetong injection in 20 selected hospitals during their hospital stay
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508403

Locations
China, Beijing
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Beijing, Beijing, China, 100700
Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Investigators
Principal Investigator: Yan M Xie Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
  More Information

No publications provided

Responsible Party: Yanming Xie, Deputy Director, Professor, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01508403     History of Changes
Other Study ID Numbers: 2009zx09502-030
Study First Received: December 20, 2011
Last Updated: May 13, 2013
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014