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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01814566
• Other study ID #: 2009ZX09502-030-02
• Status: Unknown status
• Phase: N/A
• First received: March 14, 2013
• Last updated: May 13, 2013
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2013
• Source: China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 30000
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients using DanshenDuofensuanyan injection from 2013 to 2014

Exclusion Criteria:

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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