An interventional study of ALCOFILTRUM in Alcohol Drinking and Alcohol Intoxication, sponsored by AVVA Pharmaceuticals Ltd.. Status unknown at 1 site in Belarus. Open to male participants aged 25 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-07.
Sponsored by AVVA Pharmaceuticals Ltd. · Not applicable, Interventional, and Prevention
The aim of this open-label, randomized, crossover, comparative pilot study is to assess efficacy and safety of the dietary food supplement ALCOFILTRUM in healthy volunteers who consume alcohol. Specifically the study will evaluate:
Participants will take four tablets of ALCOFILTRUM dietary food supplement 30 minutes before alcohol ingestion, while the control group will intake only alcohol drink.
Heavy drinking of alcoholic beverages may lead to hangover, characterized by a combination of unpleasant physical and mental symptoms that affect mood, cognition, and physical functioning. Hangover symptoms begin within several hours following drinking cessation, when a person's blood alcohol concentration (BAC) is falling, and peak when BAC is zero. The symptoms may continue for up to 24 hours thereafter. Multiple contributing factors are responsible for the development of alcohol hangover symptoms which include ethanol itself, its metabolites and congeners / fusel alcohols. The liver plays a key role in alcohol detoxification, and is therefore affected the most. Drinking large amounts of alcohol can lead to significant damage to the liver and brain cells, the reason for the need for protection.
In this open-label, randomized, cross-over, comparative pilot study investigators aim to assess efficacy and safety of the dietary food supplement ALCOFILTRUM in healthy volunteers who consume alcohol. Participants will consume an alcoholic drink (Bulbash Nano Original vodka 40%) in a dose calculated for every study subject based on ethanol 1.7g/kg body weight. The test group will take 4 tablets of ALCOFILTRUM dietary food supplement, 30 minutes before alcohol ingestion, while the control group will intake only alcohol drink. Twelve to thirteen hours after the last alcohol intake hangover symptoms will be evaluated based on questionnaires, and measurements of balance / coordination, attention and blood parameters. The findings from this study will provide important insight of a possible intervention for alleviating alcohol hangover symptoms.
701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.
This study's planned enrollment of 60 is below the median of 122 across 607 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →AVVA Pharmaceuticals Ltd. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Compared within Alcohol Drinking, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: ALCOFILTRUM
ALCOFILTRUM helps alleviate alcohol hangover symptoms after a single intake for 30 minutes before alcohol consumption.
1-item overall hangover severity rating
Intensity of hangover symptoms in 12-13 hours after alcohol intake according to 1-item overall hangover severity rating. Score range is from 0 to 10, where higher scores mean more severe hangover symptoms.
Time frame: 13 hours
Schulte test
Attention focusing and work efficiency according to Schulte test. Measurement timepoints: baseline, 1, 4, 12, 13 hours.
Time frame: 13 hours
Romberg Stance test
Coordination and stability assessment in Romberg Stances. Measurement coordination and stability timepoints: baseline, 1, 4, 12, 13 hours.
Time frame: 13 hours
Mini Cog test
Psychoneurological status. Measurement timepoints: baseline, 1, 4, 12, 13 hours.
Time frame: 13 hours
Hangover Symptoms Questionnaire
Score of Hangover Symptoms Questionnaire and frequency of hangover symptoms. Score rating from 0 to 4 for 24 diferent symptoms, where higher scores mean higher severity of the symptoms. Measurement timepoints: baseline, 1, 4, 12, 13 hours.
Time frame: 13 hours
Blood Alcohol level
Concentration of ethanol in per mille. Measurement timepoints: baseline, 1, 4, 12 hours.
Time frame: 12 hours
Blood acetaldehyde level
Concentration of acetaldehyde in ng/mL. Measurement timepoints: baseline, 1, 4, 12 hours.
Time frame: 12 hours
C-reactive protein level
Blood concentration of C-reactive protein in mg/L. Measurement timepoints: baseline, 4, 12 hours.
Time frame: 12 hours
Bilirubin level
Blood concentrations of bilirubin and bilirubin fractions (direct and indirect) in umol/L. Measurement timepoints: baseline, 12 hours.
Time frame: 12 hours
Blood Inflamatory markers
Concentrations of TNF-alpha and 8-isoprostane in pg/mL. Measurement timepoints: baseline, 4, 12 hours.
Time frame: 12 hours
Liver enzyme markers
Blood concentrations of AST, ALT, ALP, GGT in u/L. Measurement timepoints: baseline, 12 hours.
Time frame: 12 hours
Incidence of Adverse Events [Safety and Tolerability]
Incidence rate of any adverse events.
Time frame: 5 days
Incidence of Serious Adverse events [Safety and Tolerability]
Incidence rate of any serious adverse events.
Time frame: 5 days
Arterial blood pressure [Safety and Tolerability]
Level of systolic and diastolic arterial blood pressure 1; 2; 3, 4, 12, 13 hours vs. baseline.
Time frame: 13 hours
Heart rate [Safety and Tolerability]
Hear rate 1; 2; 3, 4, 12, 13 hours vs. baseline.
Time frame: 13 hours
Plan to share: No
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This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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AVVA Pharmaceuticals Ltd.