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Comparing the efficacy and safety of Baclofen and Chlordiazepoxide in Alcohol Withdrawal Syndrome.

A COMPARATIVE STUDY OF EFFICACY AND TOLERABILITY OF BACLOFEN AND CHLORDIAZEPOXIDE IN ALCOHOL WITHDRAWAL SYNDROME

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/04/003588
Enrollment
60
Registered
2013-04-26
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 10 mg: Baclofen 10 mg in following schedule TID up to 3 days, BD up to 3 days and OD up to 3 days Control Intervention1: Chlordiazepoxide 25mg: Chlordiazepoxide 25mg in followi

Sponsors

Dr VIKRAM REDDY K
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a. Subjects with alcohol dependence according to DSM-IV (TR) criteria. b. Last alcohol intake within 24 hour preceding the initiation of study. c. Willingness to give written informed consent.

Exclusion criteria

Exclusion criteria: a. Patients with known psychiatric disorders. b. Patients with known renal and cardiovascular diseases. c. Patients with known allergy to study medications. d. Patients with multi-drug abuse. e. Patients with any other substance dependence except nicotine. f. Patients with delirium tremens.

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of baclofen with chlordiazepoxide in AWS as assessed by Clinical Institute Withdrawal Assessment of Alcohol Scale Revised (CIWA-Ar score). Primary Outcome: lowering in CIWA-Ar severity scores.Timepoint: 10 days

Secondary

MeasureTime frame
Clinical Global Impression(CGI) Scales. 1.Decrease in CGI-severity scale. 2.Increase in CGI-improvement scale and 3.Change in CGI-efficacy index score according to therapeutic and side effects.Timepoint: 10 days

Countries

India

Contacts

Public ContactDr GIRISH K

KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES

drgirish_k@rediffmail.com9980911060

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026