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Role of Baclofen and topiramate in alcoholism

Not Applicable
Completed
Conditions
Health Condition 1: null- Alcohol Dependence Syndrome
Registration Number
CTRI/2016/01/006525
Lead Sponsor
Government Medical College Hospital GMCH
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
60
Inclusion Criteria

a)age 18-65 years

b) males

c) patients meeting diagnostic criteria for alcohol dependence as per ICD-10 classification

Exclusion Criteria

a) Presence of serious physical illness such as renal dysfunction, seizure disorder, cardiac disease (as assessed by thorough physical examination ,past history and routine laboratory screening) b) Presence of another current co-existing major psychiatric disorder c) Presence of another current drug abuse except nicotine and caffeine d) Patients with history of hypersensitivity reaction with these drugs in past e) Patient not willing to consent.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Craving by Obsessive and Compulsive Drinking Scale (OCDS), Motivation by Readiness to Change Questionnaire, withdrawal symptoms by CIWA-Ar, Side effects of drugs using checklistTimepoint: At Week 1,2,3,4,6,8,10 and 12
Secondary Outcome Measures
NameTimeMethod
Craving by Obsessive and Compulsive Drinking Scale (OCDS) and Visual Analogue scale (VAS),Quality of life by WHO QOL-Bref, Field Trial Version(Hindi version),Hemogram, SERFT, LFT, side effects checklistTimepoint: baseline,week 4,8,12
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