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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01814566
First received: March 14, 2013
Last updated: May 13, 2013
Last verified: March 2013

March 14, 2013
May 13, 2013
January 2013
December 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01814566 on ClinicalTrials.gov Archive Site
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Safety Study of DanshenDuofensuanyan(a Chinese Medicine Injection)Used in Hospitals in China
Safety Study of DanshenDuofensuanyan(a Chinese Medicine Injection)Used in Hospitals in China

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.

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
14 Days
Retention:   None Retained
Description:

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

Non-Probability Sample

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

  • Coronary Heart Disease
  • Angina Pectoris
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30000
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients using DanshenDuofensuanyan injection from 2013 to 2014

Exclusion Criteria:

  • none
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01814566
2009ZX09502-030-02
Yes
Yanming Xie, China Academy of Chinese Medical Sciences
China Academy of Chinese Medical Sciences
Not Provided
Principal Investigator: Yan M Xie, BA Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
China Academy of Chinese Medical Sciences
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP