Health Condition 1: F10- Alcohol related disorders
Conditions
Interventions
Intervention1: Withania sominfera: Aqueous extract of Withania somnifera given in the dosage form of tablet
Tablet Withania somnifera 250 mg two tablets before bedtime for 90 days.
Control Interventi
Sponsors
Multi-disciplinary Research Unit - GSMC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Be diagnosed with alcohol use disorder (AUD) as per DSM (Diagnostic and Statistical Manual of Mental Disorders)-5 by one consultant psychiatrist working in the department of psychiatry, KEMH. 2. have age not less than 18 years and not more than 50 years. 3. Be treatment-naïve OR have not taken any drug or behavioural treatment for alcohol abuse in the preceding 6 weeks. 4. Have undergone medical detoxication (using a benzodiazepine) during the screening phase (prior to randomization) as per routine psychiatry OPD practices. 5. Be abstinent from alcohol at least 7 days prior to randomization. 6. Be able to give informed consent and is willing to come for regular follow-ups (as mentioned in the table of assessments) for three months after recruitment in the study.
Exclusion criteria
Exclusion criteria: 1. Have current (past 12 months) dependence on any psychoactive substance other than alcohol, including sedatives and hypnotics, as defined by DSM-5 criteria. 2. Have been hospitalized in the last one year, for alcohol intoxication delirium, alcohol withdrawal delirium, alcohol-induced persisting dementia or amnestic disorder, or have had an alcohol withdrawal seizure, alcohol-induced psychotic disorder with a primary diagnosis of AUD or a history of any seizure disorder. 3. Have severe AUD as ascertained by a score above 30 in Severity of Alcohol dependence questionnaire (SADQ). 4. Risk for significant withdrawal based on a Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) score higher than 9. 5. Have participated in any behavioural and/or pharmacological intervention research for treatment of other substance abuse disorder (other than alcohol) within 3 months prior to signing the informed consent. 6. Have any of the following, based on DSM-5 criteria a. Current or lifetime diagnosis of psychotic disorders, b. Current bipolar disorder, c. Current major depressive episode, d. Current (past 3 months) eating disorder (anorexia or bulimia), or e. Within past year diagnosis of panic disorder with or without agoraphobia. Note: Participants diagnosed with psychiatric disorders not specifically excluded above may be included at the discretion of the PI as long as the concurrent treatment for the comorbid psychiatric condition does not compromise the study integrity by virtue of its type, duration, or intensity. 7. Have clinically significant abnormal laboratory values, including investigations suggestive of steatohepatitis: elevation of liver enzymes (AST, ALT) 5-fold above the upper limit of normal (ULN) 8. Have abnormal ECG having clinical implications in view of the investigator or any serious or unstable medical illness or any potentially life-threatening or progressive medical condition other than addiction that may compromise participant safety or study conduct. 9. Known history of diabetes 10. History of hypertension, dyslipidaemia or any other cardiovascular disease or systemic medical illness requiring life-long therapy 11. Refuse consent to participate 12. Planning to move or relocate/ not available to follow-up over 3 months. 13. Patient taking background benzodiazepine therapy for any reason 14. Patients taking herbal or any other medicines from complementary, alternative, traditional systems in last one month and also not willing to avoid these medicines during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference between the Withania somnifera and placebo groups on the alcohol craving in response to ACQ-SF-R at EOS.Timepoint: Difference between the Withania somnifera and placebo groups on the alcohol craving in response to ACQ-SF-R at EOS. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Withania somnifera on reduction of alcohol consumption, abstinence, mood (using self-reported questionnaires)Timepoint: 0, 30, 60, 90 days | — |
Countries
India
Contacts
Public ContactDr Padmaja Marathe
Seth GS Medical College and KEM Hospital
Outcome results
None listed