Health Condition 1: F102- Alcohol dependence
Conditions
Interventions
Intervention1: Chlordiazepoxide tablets: Chlordiazepoxide daily for 12 days Oral tablets
Control Intervention1: NA: NA
Sponsors
Abbott Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Males and females of more than 18 to less than 60 years Patients should be admitted in deaddiction centers after 6 hours of last alcohol use with Day 0 CIWA Ar score Patients meet criteria for mild to moderate AWS (DSM V) by the investigator Patient admitted in the deaddiction centers should be willing to give consent to participate into the trial Liver Parameters- AST or ALT less than 2 times ULN
Exclusion criteria
Exclusion criteria: Dependent on any substance other than alcohol except nicotine History of severe alcohol withdrawal complications (alcohol withdrawal seizures, epilepsy or delirium tremens) History of hepatic encephalopathy less than 1 year & other liver disease less than 6 months Received medications that may alter AWS presentation such as Antipsychotics other benzodiazepines (except rescue doses)) Known contraindications to chlordiazepoxide Pregnant or nursing females Patients with the inability or unwillingness to comply with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage reduction in AWS symptoms based on daily CIWA Ar score from baseline to day 12Timepoint: Day 0 baseline to day 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| LFT parameter before and at end of the study period Number of days required for reduction of agitation and tremors Number of minimum symptoms days Incidence of rebound symptoms (smooth withdrawal) Dropout rate Percentage of Delirium Tremens patients Outcome in mild liver dysfunction patientsTimepoint: Day 0 baseline to day 12 | — |
Countries
India
Contacts
Public ContactJawahar Nidamboor
Jagruti Rehabilitation Centre
Outcome results
None listed