Ignite Creation Date:
2024-05-06 @ 1:52 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04143880
Status:
UNKNOWN
Last Update Posted:
2019-11-27
First Post:
2019-10-15
Brief Title:
Progesterone in the Treatment of Acute Hemorrhagic Stroke
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
An International Multicenter Randomized Double-blind Placebo-controlled Clinical Trial of Progesterone Combined Intranasal and Intramuscular Administration in Patients With Acute Hemorrhagic Stroke
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
NOT_YET_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:
A large number of preclinical studies have confirmed that progesterone and its metabolites have strong neuroprotective effects As a neuroprotective agent progesterone has been effective in several animal models of nerve injury suggesting that the drug has a wide range of neuroprotective effects Pharmacodynamic studies have shown that some characteristic mechanisms of the action of the neurosteroid on brain injury and cerebral congestion include prevention of inflammatory reaction and cell death by inhibiting the activation of inflammatory cytokines and microglia control of angiogenic brain edema by reestablishing blood-brain barrier and regulating aquaporin-4 water transporter and cytotoxic edema by regulating Progesterone can also improve the neural dysfunction after cerebral hemorrhage promote the regeneration and repair of damaged axons activate PI3K Akt pathway to inhibit the expression of RhoA prevent the loss of Ca2 caused by excitotoxicity and improve the survival rate of neurons It was found that progesterone injection could reduce brain edema and promote the recovery of nerve function after brain injury
Detailed Description:
The purpose of this clinical trial is to further evaluate the safety and effectiveness of progesterone in the clinical application of major cerebral congestion diseases The Second Affiliated Hospital of Zhejiang University is the unit in charge of clinical research and six units participate in the multicenter randomized double-blind placebo-controlled clinical trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None