Efficacy of the Dietary Food Supplement ALCOFILTRUM in Alleviating Alcohol Hangover Symptoms (NCT05757089) | Clinical Trial Compass
UnknownNot Applicable
Efficacy of the Dietary Food Supplement ALCOFILTRUM in Alleviating Alcohol Hangover Symptoms
Belarus60 participantsStarted 2022-03-03
Plain-language 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. 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.
Who can participate
Age range
25 Years – 45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.