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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALCOFILTRUM | Experimental | 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. |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALCOFILTRUM | Dietary Supplement | ALCOFILTRUM helps alleviate alcohol hangover symptoms after a single intake for 30 minutes before alcohol consumption. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 13 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Schulte test | Attention focusing and work efficiency according to Schulte test. Measurement timepoints: baseline, 1, 4, 12, 13 hours. | 13 hours |
| Romberg Stance test | Coordination and stability assessment in Romberg Stances. Measurement coordination and stability timepoints: baseline, 1, 4, 12, 13 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events [Safety and Tolerability] | Incidence rate of any adverse events. | 5 days |
| Incidence of Serious Adverse events [Safety and Tolerability] | Incidence rate of any serious adverse events. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Artemiy A. Sergeev, M.D., D.Sci. | Contact | +74952690016 | 3017 | sergeev@rnd.avvapharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Olga A. Sharapova, Ph.D. | City Clinical Emergency Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Emergency Hospital | Recruiting | Minsk | 220024 | Belarus |
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| ID | Term |
|---|---|
| D000428 | Alcohol Drinking |
| D000435 | Alcoholic Intoxication |
| ID | Term |
|---|---|
| D004327 | Drinking Behavior |
| D001519 | Behavior |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
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| 13 hours |
| Mini Cog test | Psychoneurological status. Measurement timepoints: baseline, 1, 4, 12, 13 hours. | 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. | 13 hours |
| Blood Alcohol level | Concentration of ethanol in per mille. Measurement timepoints: baseline, 1, 4, 12 hours. | 12 hours |
| Blood acetaldehyde level | Concentration of acetaldehyde in ng/mL. Measurement timepoints: baseline, 1, 4, 12 hours. | 12 hours |
| C-reactive protein level | Blood concentration of C-reactive protein in mg/L. Measurement timepoints: baseline, 4, 12 hours. | 12 hours |
| Bilirubin level | Blood concentrations of bilirubin and bilirubin fractions (direct and indirect) in umol/L. Measurement timepoints: baseline, 12 hours. | 12 hours |
| Blood Inflamatory markers | Concentrations of TNF-alpha and 8-isoprostane in pg/mL. Measurement timepoints: baseline, 4, 12 hours. | 12 hours |
| Liver enzyme markers | Blood concentrations of AST, ALT, ALP, GGT in u/L. Measurement timepoints: baseline, 12 hours. | 12 hours |
| 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. | 13 hours |
| Heart rate [Safety and Tolerability] | Hear rate 1; 2; 3, 4, 12, 13 hours vs. baseline. | 13 hours |
| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |