Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-01-25 @ 1:03 PM
Study NCT ID:
NCT01814566
Status:
UNKNOWN
Last Update Posted:
2013-05-14
First Post:
2013-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of DanshenDuofensuanyan(a Chinese Medicine Injection)Used in Hospitals in China
Sponsor:
China Academy of Chinese Medical Sciences
Organization:
Study Overview
Official Title:
Safety Study of DanshenDuofensuanyan(a Chinese Medicine Injection)Used in Hospitals in China
Status:
UNKNOWN
Status Verified Date:
2013-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: