Evaluation of a Fixed Combination of Herbal Extracts to Prevent Symptoms Alcohol-induced Hangovers (NCT04183842) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of a Fixed Combination of Herbal Extracts to Prevent Symptoms Alcohol-induced Hangovers
Armenia40 participantsStarted 2019-07-04
Plain-language summary
The primary objective of the study is to test whether the tested Product LACIME Anti-hangover is effective in preventing the signs and symptoms of alcohol-induced hangover (such as headache, impaired memory, depression, anxiety, weakness, trouble sleeping and concentrating, nausea, dizziness, sleepiness, thirsty, dry mouth, sweating, sensitivity to light and sounds, vision problems) in healthy subjects.
Who can participate
Age range
20 Years – 30 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:
* 20-30 years old healthy males,
* Body weight (kg): 60 kg - 80 kg in man,
* People who consume alcohol occasionally,
* People who already had to deal with hangovers,
* Healthy volunteers who consume alcohol regularly and moderately,
* Having given their free, informed and express consent in writing,
* Co-operative, informed of the need and duration of the controls which make it possible to achieve full adherence to the protocol in place.
Exclusion Criteria:
* Volunteers consuming larger amounts of alcohol (more than 2 glasses of alcohol per day)
* Volunteers taking medication or food supplements that may affect alcohol metabolism,
* Subjects with illnesses which may conflict with the investigator's interpretation, if the subject participated in the study,
* Subject planning to change his lifestyle during the study (diet, physical activity, etc.)
* Subject participating in another study during the clinical study period.
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.
What they're measuring
1
Evaluation of the difference in Hangover Severity Scores between the activity of LACIME Anti-hangover and the activity of PLACEBO.
Timeframe: Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)