Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-01-01 @ 3:17 PM
Study NCT ID:
NCT01508403
Status:
UNKNOWN
Last Update Posted:
2013-05-14
First Post:
2011-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals
Sponsor:
China Academy of Chinese Medical Sciences
Organization:
Study Overview
Official Title:
A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals
Status:
UNKNOWN
Status Verified Date:
2013-05
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:
RSCMI-I
Brief Summary:
The purpose of this study is to make a cohort event monitoring to see whether and how Shuxuetong injection in hospital results in adverse events or adverse drug reactions.
Detailed Description:
This is the first academic registry study about adverse events or adverse drug reaction for Chinese medicine injection in mainland China.
It is well known that Chinese medicine injection is just limited in mainland China, which also be accepted by China health care system.
However, more and more adverse events or adverse drug reaction have been reported in recent years in the form of case report.
In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study will be introduced in this area.
To calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study.
According to the 'rule of three', 30,000 cases need to be registered at least.
It is well known that Chinese medicine injection is just limited in mainland China, which also be accepted by China health care system.
However, more and more adverse events or adverse drug reaction have been reported in recent years in the form of case report.
In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study will be introduced in this area.
To calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study.
According to the 'rule of three', 30,000 cases need to be registered at least.
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?: