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

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ClinicalTrials.gov Identifier: NCT01814566
Recruitment Status : Unknown
Verified March 2013 by Yanming Xie, China Academy of Chinese Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : March 20, 2013
Last Update Posted : May 14, 2013
Sponsor:
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in January 2013.

It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.

DanshenDuofensuanyan is kind of Chinese Medicine injection used for treating coronary heart disease and angina pectoris in many Chinese hospitals.

The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.


Condition or disease
Coronary Heart Disease Angina Pectoris

Detailed Description:

It is very common that Chinese Medicine Injection used in hospitals in mainland China. However safety problems rose in recent years. There could be many uncertain factors influence Chinese Medicine Injection in clinical practice.

In order to ensure the safety of public drug use and lower drug-induced risks, a registry study for DanshenDuofensuanyan injection safety surveillance with 30000 patients will be conducted from Jan.2013 to Dec.2015.

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


Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 14 Days
Official Title: Safety Study of DanshenDuofensuanyan(a Chinese Medicine Injection)Used in Hospitals in China
Study Start Date : January 2013
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of participants with adverse events; incidence of DanshenDuofensuanyan'adverse drug reaction（ADRs）and identify factors that contributed to the occurrence of the adverse reaction [ Time Frame: to assess DanshenDuofensuanyan's 'adverse event' and 'drug adverse reaction' during patients' hospital stay. The registry procedure will last 2 years only for patients using DanshenDuofensuanyan ]
    All patients will be measured and assessed at the time DanshenDuofensuanyan is administered to them until they discharge. Patients using DanshenDuofensuanyan will be registered on a registration form including disease background, DanshenDuofensuanyan'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 DanshenDuofensuanyan.


Biospecimen Retention:   None Retained
Eligibility criteria Patients who will use DanshenDuofensuanyan injection in selected hospitals.

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
An anticipated sample size was caculated in this study, about 30000 Patients using DanshenDuofensuanyan injection from 2013 to 2014 in more than 20 hospitals
Criteria

Inclusion Criteria:

  • Patients using DanshenDuofensuanyan injection from 2013 to 2014

Exclusion Criteria:

Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01814566


Sponsors and Collaborators
China Academy of Chinese Medical Sciences
Investigators
Principal Investigator: Yan M Xie, BA Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Yanming Xie, Deputy Director, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01814566     History of Changes
Other Study ID Numbers: 2009ZX09502-030-02
First Posted: March 20, 2013    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Angina Pectoris
Cardiovascular Diseases
Vascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms