Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 7:45 AM
Study NCT ID:
NCT02559960
Status:
SUSPENDED
Last Update Posted:
2021-04-08
First Post:
2015-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-marketing Safety Surveillance of Breviscapine Powder-Injection : a Registry Study
Sponsor:
Zhong Wang
Organization:
Study Overview
Official Title:
Post-marketing Safety Surveillance of Breviscapine Powder-Injection : a Registry Study
Status:
SUSPENDED
Status Verified Date:
2021-04
Last Known Status:
None
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 registry aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions.
Detailed Description:
Breviscapine Powder-Injection is a kind of natural compound injection with high purity of Scutellarin-Na (over 98%). It's a popular drug for ischemic diseases, as cerebral ischemic stroke, coronary heart disease or angor pectoris. However, more and more case reports about the adverse drug events of Chinese medicine injections extracted from Dengzhanhua (herba erigernotis) (Breviscapine is one of the most common compounds in it) have been reported in recent 10 years. Therefore, this registry of Breviscapine Powder-Injection aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions.
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?: