None listed
Conditions
Interventions
Intervention1: A-Hango: 500 mg of A-Hango in 100 ml water will be given to the participant one hour prior to Alcohol drink as per randomization.
Control Intervention1: Maltodextrin: 500 mg of Maltodex
Sponsors
Praras Bioscience Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject who are able to read and understand and ready to provide written informed consent. 2. Subject must be healthy adult human beings male or female between ages 25 ââ?¬â?? 65 years (2 groups - 25-45 years and 46-65 years). 3. Should have experienced at least one alcohol hangover previously as per AHSS (Alcohol Hangover Severity Score). 4. Negative pregnancy test for childbearing females 5. Subject should not consume alcohol within the last 48 hrs. 6. Having Score less than a 2 on the Short Michigan Alcohol Screening Test (SMAST). 7. Not self-reported history of counseling or treatment for substance abuse. 8. Having no sleep disorder. 9. Ready to refrain from smoking during the trial
Exclusion criteria
Exclusion criteria: 1. Subject with known hypersensitivity or intolerance to investigational product or any ingredients of the formulation. 2. Participants with acid peptic disorder, diabetes mellitus, neurological disorders, mental disorders or any other disease history which can have impact of participants as per investigator. 3. Participants showing abnormal levels in blood test parameters which are clinically significant for study participation as per Investigator (beyond �± 50% of normal range or having any clinical correlation). 4. Participants consuming certain concomitant medications which is prohibited with alcohol. 5. Participants who show hypersensitivity to alcohol. 6. A participant who the Investigator feels will not be compliant with trial requirements. 7. Subjects who have suffered any illness or who have been hospitalized within the last 4 weeks preceding the start of the study. 8. Subjects who participated in any other clinical trial or blood loss of more than 350 ml, in the past three months. 9. Subject who has difficulty with donating blood.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in ADH (Alcohol dehydrogenase) levels from blood samples: Baseline, after 1 and 5 hrs. of alcohol consumption 2. Changes in ALDH (Acetaldehyde Dehydrogenase) levels from blood samples: Baseline, after 1 and 5 hrs. of alcohol consumption 3. Changes in blood aldehyde levels: Baseline, after 1 and 5 hrs. of alcohol consumption 4. Changes in Blood Alcohol: Baseline, after 1 and 5 hrs. of alcohol consumption Timepoint: 1. Changes in ADH (Alcohol dehydrogenase) levels from blood samples: Baseline, after 1 and 5 hrs. of alcohol consumption in both periods 2. Changes in ALDH (Acetaldehyde Dehydrogenase) levels from blood samples: Baseline, after 1 and 5 hrs. of alcohol consumption in both periods 3. Changes in blood aldehyde levels: Baseline, after 1 and 5 hrs. of alcohol consumption in both periods 4. Changes in Blood Alcohol: Baseline, after 1 and 5 hrs. of alcohol consumption in both periods | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in Alcohol Hangover Symptom Severity Scale after 5 hrs. of alcohol consumption 2. The safety of the intervention by evaluating by tolerability of intervention by study subjects Timepoint: After 5 hrs of oral administration | — |
Countries
India
Contacts
Public ContactPurushotam
Auriga Research Pvt. Ltd.
Outcome results
None listed