None listed
Conditions
Interventions
Intervention1: Morning Aid: Dose : One bottle
Dosage: One bottle of Morning Aid to be consumed during the 8 drinking episodes as per the administration cycle within the treatment duration of 90 days.
Sponsors
Sipwise Beverages Private Limited
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults between the ages of 25 and 45 (both ages, all sexes inclusive) who are Social Drinker. 2. Subjects must experience atleast two hangovers per month of social drinking. 3. Subject should not have any history/diagnosis of alcoholism/alcoholic substance abuse. (Screening using SMAST) 4. Subjects must have passed the criteria set in the Screening Questionnaire 5. Subjects should be a non-smoker or must smoke 6. Subjects who are willing to abstain from use of other products not limited to home remedies, soft drinks, mocktails, medications for treating hangover symptoms for the duration of the clinical study. 7. Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period. 8. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity to the ingredients of the investigational product 2. Subjects who are on medications not limited to blood thinner that contraindication consumption of alcohol even socially. 3. Subjects with history of liver disease not limited to AFLD, cirrhosis etc. 4. Subjects with history of addiction to alcohol, smoking, and any other drug substance. 5. Subjects with history or diagnosis of psychiatric disorders 6. Subjects with history of uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc. 7. Subjects with history of seizures 8. Subjects on remission from cancer of any type less than 5 years at the time of screening 9. Subjects who have participated in a clinical study less than 1 month before screening 10. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation. 11. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 12. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Acute Hangover Scale : Total Score - GreaterThan Equal to 18 2. Morning Aid Effectiveness Questionnaire (VAS) : Highest VAS ScoreTimepoint: 1. Acute Hangover Scale : After every drinking episode 2. Morning Aid Effectiveness Questionnaire (VAS) : Visit 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Subject IP Feedback Questionnaire : Total Score of greater than equal to 20 2. Quality of Sleep VAS â?? Overall : Improvement of 10% 3. Quality of Sleep VAS â?? Highest VAS Score Timepoint: 1. Subject IP Feedback Questionnaire : Visit 3 2. Quality of Sleep VAS : After every drinking episode 3. Quality of Sleep VAS : After every drinking episode | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Raam Clinic
Outcome results
None listed