Health Condition 1: F102- Alcohol dependence
Conditions
Interventions
None listed
Sponsors
MMC PHARMACEUTICALS LTD
Eligibility
Inclusion criteria
Inclusion criteria: Participants willing to be abstinent from alcohol for at least 5 days before entry into the study. Participants expected to have good social support or a family environment to ensure treatment compliance and follow-up Diagnosis as per ICD-10 criteria for alcohol dependence. Clinical institute withdrawal assessment for alcohol revised (CIWA-ar) score less than 10 Participants willing to give informed consent.
Exclusion criteria
Exclusion criteria: Participants with cirrhosis of the liver. Participants with Liver function test (LFT) values more than three times the normal values Will be excluded from the study. Participants with any chronic systemic illness or with life-threatening disease. Participants with other substance abuse/addiction. Participants with any co-morbid psychiatric disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To observe and document Drinking Behavior assessment - abstinence rate of study subjects over 30th ,60th ,90th day of BooZNil. To assess the Percentage (%) of study subjects with complete abstinence of alcohol consumption over treatment period of 12 weeks and Cumulative abstinence duration (defined as the number of days of abstinence during the treatment period). To estimate serum carbohydrate deficient transferrin over baseline and 30th ,60th and 90th day of therapy. To evaluate the effect of BooZNil in the liver function tests from baseline to 30th, 60th and 90th day of follow up.Timepoint: Baseline, 30th, 60th and 90th day of follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess scores of cravings as rated by Alcohol Craving Questionnaire (ACQ) and Obsessive-Compulsive Drinking Scale (OCDS) from baseline to 30th, 60th and 90th day of BooZNilTM treatment. To observe and assess any withdrawal symptoms and adverse events during study period. Timepoint: Baseline, 30th, 60th and 90th day of follow up. | — |
Countries
India
Contacts
Public ContactVijayakumar TM
SRM College of Pharmacy SRMIST
Outcome results
None listed