Alcohol DrinkingNCT05757089
Efficacy of the Dietary Food Supplement ALCOFILTRUM in Alleviating Alcohol Hangover Symptoms
A study testing ALCOFILTRUM in people with Alcohol Drinking and Alcohol Intoxication, run by AVVA Pharmaceuticals Ltd. at 1 site in Belarus.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Alcohol Intoxication
- What is being tested?
- ALCOFILTRUM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelarus
- Study dates
- 3 Mar 2022to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Belarus1 site, 1 recruiting
- Recruiting
Clinical Emergency Hospital
Minsk, 220024
Olga А. Sharapova, Ph.D., +375172870001, minsk.bsmp@gmail.com
About this study
Official title: An Open-label, Randomized, Cross-over, Comparative Study of ALCOFILTRUM Dietary Food Supplement for Alleviating Alcohol Hangover Symptoms in Healthy Volunteers
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:
- Efficacy of the intervention to alleviate hangover symptoms in participants who consumed alcohol,
- Safety of intervention in participants who consuming alcohol.
Participants will take four tablets of ALCOFILTRUM dietary food supplement 30 minutes before alcohol ingestion, while the control group will intake only alcohol drink.
Read the detailed description
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.
- Conditions
- Alcohol Drinking, Alcohol Intoxication
- Being tested
- ALCOFILTRUM
- Medical subject headings
- Alcohol Drinking, Alcoholic Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALCOFILTRUMDietary supplement
ALCOFILTRUM helps alleviate alcohol hangover symptoms after a single intake for 30 minutes before alcohol consumption.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: ALCOFILTRUM |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 13 hours
Secondary outcomes (10)
Schulte test
Attention focusing and work efficiency according to Schulte test. Measurement timepoints: baseline, 1, 4, 12, 13 hours.
Measured: 13 hours
Romberg Stance test
Coordination and stability assessment in Romberg Stances. Measurement coordination and stability timepoints: baseline, 1, 4, 12, 13 hours.
Measured: 13 hours
Mini Cog test
Psychoneurological status. Measurement timepoints: baseline, 1, 4, 12, 13 hours.
Measured: 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.
Measured: 13 hours
Blood Alcohol level
Concentration of ethanol in per mille. Measurement timepoints: baseline, 1, 4, 12 hours.
Measured: 12 hours
Blood acetaldehyde level
Concentration of acetaldehyde in ng/mL. Measurement timepoints: baseline, 1, 4, 12 hours.
Measured: 12 hours
C-reactive protein level
Blood concentration of C-reactive protein in mg/L. Measurement timepoints: baseline, 4, 12 hours.
Measured: 12 hours
Bilirubin level
Blood concentrations of bilirubin and bilirubin fractions (direct and indirect) in umol/L. Measurement timepoints: baseline, 12 hours.
Measured: 12 hours
Blood Inflamatory markers
Concentrations of TNF-alpha and 8-isoprostane in pg/mL. Measurement timepoints: baseline, 4, 12 hours.
Measured: 12 hours
Liver enzyme markers
Blood concentrations of AST, ALT, ALP, GGT in u/L. Measurement timepoints: baseline, 12 hours.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start3 Mar 2022
- Primary completion30 Mar 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AVVA Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olga A. Sharapova, Ph.D., Principal investigator, City Clinical Emergency Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757089
- Sponsor's protocol ID
- ALCOFILTRUM-NIR-B-07/2021
- Status last verified
- Feb 2023
- First submitted
- 12 Jan 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Cross-over, Comparative Study of ALCOFILTRUM Dietary Food Supplement for Alleviating Alcohol Hangover Symptoms in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05757089
- Acronym / sponsor ID
- ALCOFILTRUM-NIR-B-07/2021
- Conditions
- Alcohol Drinking, Alcohol Intoxication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AVVA Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Efficacy of the intervention to alleviate hangover symptoms in participants who consumed alcohol,
- Safety of intervention in participants who consuming alcohol.
Participants will take four tablets of ALCOFILTRUM dietary food supplement 30 minutes before alcohol ingestion, while the control group will intake only alcohol drink.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALCOFILTRUM | Experimental | Dietary Supplement: ALCOFILTRUMALCOFILTRUM, 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 | – |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALCOFILTRUMALCOFILTRUM helps alleviate alcohol hangover symptoms after a single intake for 30 minutes before alcohol consumption. | Dietary supplement | ALCOFILTRUM |
Primary outcome
1-item overall hangover severity rating
Time frame: 13 hours
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.
10 secondary outcomes
Schulte test
Time frame: 13 hours
Romberg Stance test
Time frame: 13 hours
Mini Cog test
Time frame: 13 hours
Hangover Symptoms Questionnaire
Time frame: 13 hours
Blood Alcohol level
Time frame: 12 hours
Blood acetaldehyde level
Time frame: 12 hours
C-reactive protein level
Time frame: 12 hours
Bilirubin level
Time frame: 12 hours
Blood Inflamatory markers
Time frame: 12 hours
Liver enzyme markers
Time frame: 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga A. Sharapova, Ph.D. principal investigator
City Clinical Emergency Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALCOFILTRUM in people with Alcohol Drinking and Alcohol Intoxication, run by AVVA Pharmaceuticals Ltd. at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Artemiy A. Sergeev, M.D., D.Sci. (+74952690016 ext. 3017, sergeev@rnd.avvapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-item overall hangover severity rating (time frame: 13 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.