Efficacy of the Dietary Food Supplement ALCOFILTRUM in Alleviating Alcohol Hangover Symptoms
Alcohol Drinking, Alcohol Intoxication
About this trial
This is an interventional prevention trial for Alcohol Drinking
Eligibility Criteria
Inclusion Criteria: Healthy men aged from 25 to 45 years inclusive. Body weight index of 18.5 to 30 kg/m2, with body weight of 60 kg to 100 kg. Healthy volunteers should behave adequately, with coherent speech observed. Available written Informed Consent for participation in this Study given by a healthy volunteer according to the effective laws. Subjects with history of episodic intake of alcohol and episodic hangover symptoms. Verified diagnosis "healthy": no chronic diseases in the history, no abnormal findings of lab tests and clinical investigations. Exclusion Criteria: The Investigator's decision that a healthy volunteer is to be excluded in the interests of the volunteer. Any serious adverse event occurring to a healthy volunteer and associated with intake of alcohol and/or the study product. A healthy volunteer refusing to collaborate with the Medical Investigator or not complying with the Study procedure. A healthy volunteer was enrolled into the Study with violation of the Clinical Study Protocol. Any adverse events occurring to a healthy volunteer that, in a Medical Investigator's opinion, may endanger safety of a volunteer. Positive urine opioid test. Positive COVID-19 Ag Rapid Test. Positive blood alcohol test judging by concentration of alcohol fumes in exhaled air. 0.15 mg/L or higher content of alcohol fumes in exhaled air at the Screening Visit and at Visits 2, 3 prior to intake the first alcohol portion.
Sites / Locations
- Clinical Emergency HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
ALCOFILTRUM
Control
ALCOFILTRUM, 4 tablets in a single dose, 30 minutes prior to consumption of alcohol. Ingredients per tablet: Lignin hydrolyzed 800 mg; Glycine 150 mg; Dihydromyricetin 30 mg; Vitamin B1 30 mg.