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A Registry Study of Shuxuening Injection Used in Hospitals in China (RSCMI-VII)

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ClinicalTrials.gov Identifier: NCT01752946
Recruitment Status : Unknown
Verified December 2012 by Xie Yanming, China Academy of Chinese Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : December 19, 2012
Last Update Posted : December 20, 2012
Sponsor:
Collaborator:
Beijing University of Chinese Medicine
Information provided by (Responsible Party):
Xie Yanming, China Academy of Chinese Medical Sciences

Brief 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.

Condition or disease
Coronary Disease Intracranial Embolism Stroke Angina Pectoris Vasospasm

Detailed 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.


Study Type : Observational
Estimated Enrollment : 30000 participants
Time Perspective: Prospective
Official Title: A Registry Study of Shuxuening (a Chinese Medicine Injection) Used in Hospitals in China
Study Start Date : October 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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 in more than 30 hospitals in China.
Criteria

Inclusion Criteria:

  • Patients using Shuxuening injection from 2012 to 2014

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752946


Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Beijing University of Chinese Medicine
Investigators
Principal Investigator: Yan M Xie, BA Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Responsible Party: Xie Yanming, Deputy Director, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01752946     History of Changes
Other Study ID Numbers: 2009zx09502-030-07
First Posted: December 19, 2012    Key Record Dates
Last Update Posted: December 20, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Embolism
Coronary Disease
Coronary Artery Disease
Angina Pectoris
Intracranial Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Intracranial Embolism and Thrombosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Thromboembolism