A trial to compare safety and efficacy of Baclofen and Diazepam in Alcohol Withdrawal Syndrome

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2011
INTERVENTION: Intervention1: Baclofen, Diazepam: Baclofen 10mg BD for 5 days than OD for next 5 days. Diazepam 10mg BD for 5 days than OD for next 5 days. Intervention2: Baclofen, Diazepam: a Intervention3: Baclofen 10 mg: Baclofen 10 mg BD for 5 days followed by 10 mg OD for next 5 days Control Intervention1: Diazepam : Diazepam 10mg BD for 5 days followed by 10mg OD for next 5 days. CONDITION: Alcohol Withdrawal Syndrome PRIMARY OUTCOME: The Revised Clinical Institute Withdrawal Assessment For Alcohol ( CIWA‐Ar ) Score. ; Primary Outcome is reduction in CIWA‐Ar Score‐‐‐‐‐‐Timepoint: 15 days SECONDARY OUTCOME: Clinical Global Impression(CGI) Scale. ; Decrease in CGI‐severity scale & Increase in CGI‐improvement scale‐‐‐‐‐‐Timepoint: 15 days INCLUSION CRITERIA: 1)Meets criteria for alcohol dependence (DSM‐iv‐TR) (American Psychiatry Association‐1994) & mild to moderate alcohol withdrawal syndrome. 2)Subjects must be medically stable. 3)Have a clinical withdrawal assessment prior to study. 4)Not have any other psychiatric conditionor Psychotropic medication prior to entering the study
Epistemonikos ID: 92396896dc453bb7b220f3875b969fd6fee9b20d
First added on: Aug 22, 2024