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Safety Study of DanshenDuofensuanyan(a Chinese Medicine Injection)Used in Hospitals in China
Recruitment status was: Active, not recruiting
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Purpose
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 |
|---|
| Coronary Heart Disease Angina Pectoris |
| Study Type: | Observational [Patient Registry] |
| Study Design: | 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 |
- 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
| Estimated Enrollment: | 30000 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients using DanshenDuofensuanyan injection from 2013 to 2014
Exclusion Criteria:
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01814566
| Principal Investigator: | Yan M Xie, BA | 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: | NCT01814566 History of Changes |
| Other Study ID Numbers: |
2009ZX09502-030-02 |
| Study First Received: | March 14, 2013 |
| Last Updated: | May 13, 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 |
ClinicalTrials.gov processed this record on June 22, 2017