None listed
Conditions
Interventions
Dietary Supplement : Open-label, comparative study, human application test : study as follows for each phase
Study subjects: single group 40 subjects
Phase 1: alcohol alone,
Phase 2: Alcohol + kis lip
Sponsors
Kyung Hee University Hosipital at Gangdong
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy adult males aged 25 to 45 at the time of the screening test 2) Those who are over 45 kg and are within ± 20% of the ideal body weight. * Ideal body weight = (height cm – 100) x 0.9 3) Those who have more than 1 bottle of soju and have experienced hangover 4) A person who, after receiving sufficient explanation for this human application test, voluntarily decides to participate and agrees in writing to observe the precautions
Exclusion criteria
Exclusion criteria: 1) Those who show symptoms of acute disease 28 days before the start of the test (injection of human body test food) 2) A person with a history (e.g., inflammatory gastrointestinal disease, gastric or duodenal ulcer, gastrointestinal treatment, and liver disease) that can affect the absorption, distribution, metabolism and excretion of food for human applications. 3) A person with clinically significant gastrointestinal tract, cardiovascular system, respiratory system, kidney, endocrine system, haematological, digestive system, central nervous system, mental illness, or malignant tumor 4) A person who is deemed unfit for the study through a medical examination within 28 days of the initiation of a test (injection of food for human body testing) (inclusion of diseases, physical examination, clinical pathological examination, etc.) 5) Has or is currently active with a history of gastric or duodenal ulcers in the past a man with a gastric ulcer 6) In a laboratory test or vital signs, a person who shows any of the following results: a. AST (SGOT) or ALT (SGPT) > Twice the normal range limit b. Total bilirubin > Twice the upper normal range limit 7) A person with clinically significant allergic diseases (except minor allergic rhinitis that does not require administration) 8) Anyone who is hypersensitive to alcohol or has a history of alcoholism. 9) Those who participated in other clinical studies within 60 days of the commencement of testing (injection of food for human body testing) as subjects of study 10) Those who take drugs that induce and inhibit metabolic enzymes, such as barbital drugs, within 30 days prior to the start of the test (injection of food for human body testing) or within 10 days (injection of food for human body testing) or within five times the half-life of those who take drugs that will affect human testing 11) Systolic blood pressure > 140 mmHg, relaxed blood pressure >90 mmHg or higher 12) Those with increased guide pressure or who suffer from or suffer from glaucoma, urinary fluid, etc. 13) A person who has been eating an abnormal diet that may affect absorption, distribution, metabolism and excretion of alcohol or functional food. 14) Those who cannot eat standard meals provided by Kang Dong Kyung Hee University Hospital 15) A person who gives full blood within 60 days of the start of the test (injecting human body test food) or a person who gives component blood within 30 days of the start of the test 16) Continuous caffeine (Caffeine >5 cups/day), drinking (Alcohol >30g/day) or smoking or excessive smokers (cigarette >10/day) 17) A person who determines that the tester is unfit to participate in the human testing due to other reasons, including laboratory test results. 18) Person who cannot read letters or whose ability is limited (illiterate)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| measurement of blood alcohol concentration;measurement of blood acetaldehyde concentration;Survey | — |
Secondary
| Measure | Time frame |
|---|---|
| Effects of genetic variation on blood alcohol, acetaldehyde and hangover improvers | — |
Countries
Korea, Republic of
Contacts
Public Contactjunghwa lee
Kyung Hee University Hospital at Gangdong
Outcome results
None listed