A trial to compare safety and efficacy of Baclofen and Diazepam in Alcohol Withdrawal Syndrome.
Phase 3
- Conditions
- Health Condition 1: null- Alcohol Withdrawal Syndrome
- Registration Number
- CTRI/2011/08/001938
- Lead Sponsor
- Dr Anshul Jhanwar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 50
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
Exclusion Criteria
1)Current diagnosis of any other substance dependence syndrome other than alcohol dependence( including nicotine & caffeine dependence).
2)Use of pharmacological agents within the last 14 days that are known to lower the seizure threshold or augment or decrease AWS.
3)H/O alcohol withdrawal seizures,epilepsy or delirium tremens.
4)Diagnosis of Schizophrenia,bipolar disorder or dementia
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The Revised Clinical Institute Withdrawal Assessment For Alcohol ( CIWA-Ar ) Score. <br/ ><br>Primary Outcome is reduction in CIWA-Ar ScoreTimepoint: 15 days
- Secondary Outcome Measures
Name Time Method Clinical Global Impression(CGI) Scale. <br/ ><br>Decrease in CGI-severity scale & Increase in CGI-improvement scaleTimepoint: 15 days