Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427980
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-20
Brief Title:
Efficacy and Safety of Chinese Herbal HuoXue LiShui Formula for Chronic Subdural Hematoma
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
Efficacy and Safety of Chinese Herbal HuoXue LiShui Formula for Chronic Subdural Hematoma a A Prospective Randomized Double-blinded Placebo-controlled Multicenter Trail
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
CHARM
Brief Summary:
A prospective randomised double-blind placebo-controlled multicentre trial was designed to compare the the incidence of hematoma progression requiring operation or hematoma recurrence requiring re-operation and improves clinical outcomes at 24 weeks in patients with CSDH of treatment in the HXLS and placebo groups
Detailed Description:
The CHARM trial is a prospective randomized double-blinded placebo-controlled multicenter clinical study The trial aims to investigate the efficacy of the Chinese herbal formula HXLS as an addition to a primary conservative treatment of CSDH in an effort to prevent surgery The investigators hypothesize that compared with placebo the Chinese herbal formula HXLS reduce incidence of hematoma progression requiring operation or hematoma recurrence requiring re-operation and improves clinical outcomes at 24 weeks in patients with CSDH Consequently the defined null hypothesis will be that there is no difference between the groups In total 160 patients will be randomly assigned to the HXLS group and the placebo group at a 11 ratio
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?:
None
Is an FDA AA801 Violation?:
None