Efficacy and Safety of Nerve Growth Factor or Edaravone on Alcohol-induced Brain Injury
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Treatments:
Edaravone Ethanol Mitogens Thiamine Vitamin B Complex Vitamins