Skip to content

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

Baclofen in the treatment of Alcohol Withdrawal Syndrome : A comparative study vs Diazepam

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2011/08/001938
Enrollment
50
Registered
2011-08-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Alcohol Withdrawal Syndrome

Interventions

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: Baclo

Sponsors

Dr Anshul Jhanwar
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The Revised Clinical Institute Withdrawal Assessment For Alcohol ( CIWA-Ar ) Score. Primary Outcome is reduction in CIWA-Ar ScoreTimepoint: 15 days

Secondary

MeasureTime frame
Clinical Global Impression(CGI) Scale. Decrease in CGI-severity scale & Increase in CGI-improvement scaleTimepoint: 15 days

Countries

India

Contacts

Public ContactDr Ashutosh Chourishi

R.D.Gardi Medical College

dr_chourishi@yahoo.co.in9893005655

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026