None listed
Conditions
Interventions
Intervention1: Anti Hangover Drink 25 ml: A herbal drink containing natural plant extracts intended to minimise or nullify alcohol induced hangover symptoms.
This treatment arm will receive IP, at th
Sponsors
Ms Plant Lipids Private Limited
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male social drinkers between the age group of 21-35, to be considered from bars, pubs and alcohol selling outlets. 2. Should have experienced atleast one hangover previously. 3. Should be able to read, write comprehend the language of the ICD and give his informed consent for participation in the trial. 4. Subjects with full comprehension and ability to understand the purpose and the nature of trial 5. Should be a non smoker. 6. Should have no history of alcoholism or Alcoholic abuse (SMAST) 7. Subjects with normal baseline laboratory parameters. 8. Subjects who are willing to stay at the trial site during the trial period. 9. Subjects whose blood alcohol / breath alcohol concentration is zero at the time of enrollment. 10. Subjects with normal sleep patterns and habits.
Exclusion criteria
Exclusion criteria: 1. History of drug dependence or excessive alcohol intake on a habitual basis of more than two units of alcoholic beverages. 2. Subjects with psychiatric disorders as evaluated by the modified Suicide Behaviors Questionnaire. 3. Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, or any other serious medical illness. 4. Subjects with history of seizures. 5. Subjects who maybe allergic to any of the natural constituents of the Investigational Product. 6. Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrollment. 7. Subjects, who in the opinion of the Investigator are not eligible for enrollment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: 1. Objective Assessment: Clinical Institute Withdrawal Assessment â?? Alcohol (CIWA-A): 0-9 Score 2. Subjective Assessment: Modified Alcohol Hangover Severity Scale (m-AHSS) : 0-14 Score Safety: 1. Development of adverse reactions due to the usage of the investigational product or consumption of alcohol. 2. Severe Withdrawal symptoms (score of 20 in CIWA-A) 3. Safety Laboratory Investigations.Timepoint: 1. CIWA-A: TWO TIMES: Once at Baseline before consumption of alcohol and once the morning after waking up. 2. m-AHSS : TWO TIMES: Once at Baseline before consumption of alcohol and once the morning after waking up. 3. Safety Laboratory Investigations â?? TWO TIMES: During Screening and at end of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: 1. Objective Assessment: Clinical Institute Withdrawal Assessment â?? Alcohol (CIWA-A): 10-19 Score 2. Subjective Assessment: Modified Alcohol Hangover Severity Scale (m-AHSS) : 15-28 Score Timepoint: 1. CIWA-A: TWO TIMES: Once at Baseline before consumption of alcohol and once the morning after waking up. 2. m-AHSS: TWO TIMES: Once at Baseline before consumption of alcohol and once the morning after waking up. | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Raam Poly Clinic
Outcome results
None listed