Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT01612533
Status:
UNKNOWN
Last Update Posted:
2012-06-06
First Post:
2012-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of Shenfu (a Chinese Medicine Injection) Used in Hospitals in China
Sponsor:
China Academy of Chinese Medical Sciences
Organization:
Study Overview
Official Title:
A Registry Study on Safety Surveillance of Shenfu (a Chinese Medicine Injection) Used in China
Status:
UNKNOWN
Status Verified Date:
2012-06
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 October 2011.
It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.
Shenfu is kind of Chinese Medicine injection used for treating shock and coronary heart disease in many Chinese hospitals.
The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 20,000 patients.
It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'.
Shenfu is kind of Chinese Medicine injection used for treating shock and coronary heart disease in many Chinese hospitals.
The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 20,000 patients.
Detailed Description:
Safety surveillance on Chinese Medicine injection is an important problem that needs to be sorted out ,because in mainland China hospitals ,Chinese Medicine Injection are used widely. Population for taking medicine characteristics,the incidence rate of ADR and other uncertain factors influence can not be found now.
A registry study for Shenfu injection safety surveillance with 20000 patients will be conducted from Jan.2012 to Dec.2015.
Eligibility criteria Patients who will use Shenfu injection in selected hospitals.
A registry study for Shenfu injection safety surveillance with 20000 patients will be conducted from Jan.2012 to Dec.2015.
Eligibility criteria Patients who will use Shenfu 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?: