A Stratified Randomized, Double-Blind, Crossover, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of SKH on Hangover Improvement
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0009581
- Lead Sponsor
- Bundang CHA General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
1) Subjects who are adult men and women between 19~40 years of age
2) BMI of visit 1, is placed on 18.0 kg/m2~25 kg/m2
3) Experienced a hangover after drinking alcohol
4) A person whose ALDH2 genotype is wild or heterogeneous
5) Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial.
1) Subject currently being treated for cardiovascular system (hypertension, etc.), immune system, respiratory system, endocrine system (diabetes, etc.), gastrointestinal tract/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, psychotropic, infectious diseases, and malignant tumors
2) Patients with peptic ulcer and reflux esophagitis based on visit 1
3) Subject who has a history of gastrointestinal diseases (e.g., Crohn's disease) or gastrointestinal surgeries (except for simple appendectomy or hernia surgery) that may affect the absorption of food for clinical trials
4) Alcohol use disorder or alcoholics as of visit 1
5) Subject who has drunken enough alcohol within 1 week of visit 1 to interfere with the test
6) Subject who has constantly administered drugs (such as antabuse-based drugs) or dietary supplements that are likely to affect alcohol metabolism, or drugs that pose a risk of gastrointestinal bleeding [warfarin, clopidogrel, aspirin, NSAIDs, and other antipyretic and anti-inflammatory drugs]
7) Subject who has administered medicines and health functional foods related to liver function improvement within 2 weeks of visit 2
8) Subject who has administered drugs that induce and inhibit drug metabolism enzymes (Barbiturates, Griseofulvin, Rifampin, Erythromycin, Isoniazid, Cimetidine, Omeprazole, etc.) within 1 month (30 days) based on visit 2
9) Subject who has administered antibiotics and intestinal control drugs within two weeks on the basis of visit 2
10) Subject who has ingested probiotics, prebiotics, and lactic acid bacteria products continuously (more than 4 times a week) within 2 weeks based on visit 2
11) Subject who is more than 2 time the upper limit normal Creatinine of clinical trial institution
12) Subject who is more than 3 times the upper limit normal AST (GOT) or ALT (GPT) of clinical institution
13) Anyone who is pregnant or breastfeeding or has a pregnancy plan for the duration of the test
14) Anyone who has participated or planned to participate in other clinical trials within the past one month
15) Subject who is sensitive or has an allergic reaction to food for human application testing
16) Anyone who is found to be inadequate by the tester for other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Alcohol, Acetaldehyde concentration in blood and Dynamics parameters (dense by time, Cmax, AUC)
- Secondary Outcome Measures
Name Time Method Alcohol, Acetaldehyde concentration in blood and Dynamics parameters(Tmax), AHS (Acute Hangover Scale), Time required to reach 0.03% or less of alcohol level in the blood