Ignite Creation Date:
2024-05-06 @ 1:14 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03968042
Status:
UNKNOWN
Last Update Posted:
2020-10-27
First Post:
2019-05-28
Brief Title:
Efficacy and Safety of Nerve Growth Factor or Edaravone on Alcohol-induced Brain Injury
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
Efficacy and Safety of Nerve Growth Factor or Edaravone on Alcohol-induced Brain Injury
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
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:
Alcohol is one of most common harmful substance and alcohol intake brings great burden on health worldwide Excess alcohol intake may lead to alcohol-related brain injuries and cognitive impairment Although both nerve growth factor and antioxidative treatment were effective to relieve alcohol-related injuries in central nervous system in the preclinical studies there is no relevant clinical trial about their efficacy and safety on patients Since nerve growth factor and one of the antioxidative medication edaravone have been used in some neural diseases in clinical trials we tend to evaluate the efficacy and safety of nerve growth factor or edaravone on alcohol-induced brain injuries The study is a randomized-controlled study and the patients will be assigned into one of the following three groups randomly 1 regular treatment combination of vitamin B1 B6 C E and mecobalamine with nerve growth factor for 2 weeks and subsequently regular treatment for 6 months 2 regular treatment RT with edaravone for 2 weeks and subsequently RT for 6 months 3 RT alone for 6 months The patients will be followed up for 6 months Cognitive functions recurrence of alcohol dependence duration of abstention alcohol intake craving for alcohol and other psychological assessments will be recorded and compared among the 3 treatment groups and the efficacy of nerve growth factor or edaravone will be evaluated in our study
Detailed Description:
None
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