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Safety Study of Shenmai(a Chinese Medicine Injection) Used in Hospitals in China

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01612611
Recruitment Status : Unknown
Verified June 2012 by Yanming Xie, China Academy of Chinese Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : June 6, 2012
Last Update Posted : June 6, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to make a cohort event monitoring to see whether and how Shenmai injection in hospital results in adverse events or adverse drug reactions.

Condition or disease
Shock Coronary Heart Disease

Detailed Description:

Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out ,because in mainland China hospitals ,Chinese Medicine Injection are used widely. Population for taking medicine characteristics,the incidence rate of ADR and other uncertain factors influence can not be found now.

A registry study for shenmai injection safety surveillance with 30000 patients will be conducted from Jan.2012 to Dec.2015.

Eligibility criteria Patients who will use shenmai injection in selected hospitals.


Study Design

Study Type : Observational
Estimated Enrollment : 30000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Registry Study on Safety Surveillance of Shenmai (a Chinese Medicine Injection) Used in China
Study Start Date : January 2012
Estimated Study Completion Date : December 2015
Groups and Cohorts

Group/Cohort
a cohort using Shenmai injection


Outcome Measures

Eligibility Criteria

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
all inpatients used Shenmai injection in 30 selected hospitals in mainland China
Criteria

Inclusion Criteria:

  • all inpatients use Shenmai injection in 30 selected hospitals during their hospital stay

Exclusion Criteria:

Contacts and Locations

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): NCT01612611


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
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Investigators
Principal Investigator: Yan M Xie Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
More Information

Responsible Party: Yanming Xie, Deputy Director, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01612611     History of Changes
Other Study ID Numbers: RSCMI-Ⅵ
First Posted: June 6, 2012    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases