Evaluation of a Fixed Combination of Herbal Extracts to Prevent Symptoms Alcohol-induced Hangovers : A Randomized, Double Blind Placebo Controlled Crossover Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Evaluation of the difference in Hangover Severity Scores between the activity of LACIME Anti-hangover and the activity of PLACEBO.
研究概览
简要总结
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.
详细描述
LACIME Anti-hangover is a food supplement under the form of a syrup (water/glycerin based) containing plan extracts, each one having choleretic properties.
40 healthy subjects will be tested in a randomized, double-blind, placebo-controlled, crossover trial.
The participants will have to attend the 2 phases of the study during which they will receive in a blind way a product (LACIME Anti-hangover or PLACEBO):
If a participant has received LACIME Anti-hangover for Phase 1, the same participant will receive the PLACEBO for Phase 2 and vice versa.
Inclusion Criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomization chart Code number for Product / Placebo distribution
入排标准
- 年龄范围
- 20 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Evaluation of the difference in Hangover Severity Scores between the activity of LACIME Anti-hangover and the activity of PLACEBO.
时间窗: Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)
Evaluation of the difference in Hangover Severity Scores between the activity of LACIME Anti-hangover and the activity of PLACEBO. The measure is the true change in self assessment scores from their baseline. 12 self assessed parameters : * Headache, * Fatigue, weakness * Thirsty * Dry mouth * Nausea * Vomiting * Trembling * Sweat * Depressed * Anxiety * Trouble Sleeping * Sensitivity to light For each of the above symptoms, the Hangover Severity Scale ranges from 0 to 4. The Scores are evaluated according to the following: * Absent=0 * Mild=1 * Moderate=2 * Severe=3 * Incapacitating=4 Self assessment is achieved: * Day 1 : 1h00 before alcohol intake (baseline) * Day 1 : Alcohol and meal intake * Day 1 : 1h00 after alcohol intake (Visit 1a) * Day 1 : 4h00 after alcohol intake (Visit 1b) * Day 1 : 15h00 after alcohol intake (Visit 1c)
次要结局
- Evaluation of the difference in Cognitive Performance Score between the activity of LACIME Anti-hangover and the activity of PLACEBO according to "d2" psychometric test.(Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption))
- Acetaldehyde blood assay (Jones, 2008)(Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption))