None listed
Conditions
Interventions
Dietary Supplement : Test Product : DAWN808.
• Ingredients: Yeomyeong concentrated extract (a complex extract of hazel, alder, rowan, etc.), purified water etc.
• Dosage: One can (119ml) per intake
Sponsors
Pusan National University Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adult males and females aged between 20 and 40 years old. 2. Individuals with a Body Mass Index (BMI) of 18.5 or greater and less than 25 kg/m². 3. Individuals with blood test results and vital signs within the normal range. 4. Individuals with a history of experiencing hangovers. 5. Individuals who have not consumed alcohol in the past week. 6. Individuals who have received sufficient explanation regarding the study's purpose, content, and characteristics of the test product prior to participation, and who have voluntarily decided to participate in this study and signed the informed consent form of their own free will.
Exclusion criteria
Exclusion criteria: 1. Individuals with clinically significant diseases of the liver, kidneys, nervous system, respiratory system, endocrine system, hematology/oncology, urinary system, cardiovascular system, or musculoskeletal system (including those taking non-steroidal anti-inflammatory drugs (NSAIDs) due to uncontrolled pain), or individuals with mental illness, or a history of any of the following conditions: 1) Patients with uncontrolled diabetes, or those without a history of diabetes but with an 8-hour fasting blood glucose of 126 mg/dL or higher, or those with typical symptoms of diabetes (polyuria, polydipsia, unexplained weight loss) and a random blood glucose of 200 mg/dL or higher. 2) Individuals with kidney disease or serum creatinine levels more than twice the upper limit of normal. 3) Individuals with liver disease or AST or ALT levels more than three times the upper limit of normal. 4) Patients with uncontrolled hypertension or heart conditions such as angina pectoris or myocardial infarction. 5) Individuals who have experienced severe cardiac symptoms or side effects after alcohol consumption. 6) Individuals with a history of pancreatitis, gout, or gastrointestinal surgery. 7) Individuals currently taking medication for gastric ulcers or with a history of gastric ulcer treatment within the last 6 months. 2. Individuals with a history of gastrointestinal diseases (e.g., Crohn's disease, ulcers, acute or chronic pancreatitis) or gastrointestinal surgery (excluding simple appendectomy or hernia repair) that could affect the absorption of the investigational food. 3. Individuals who are positive for HBsAg or anti-HCV Ab in serum tests, or who have a history of or current Hepatitis B or C infection. 4. Individuals with uncontrolled hypertension who, during screening, show a systolic blood pressure of = 160 mmHg or = 100 mmHg in vital signs measured in a sitting position after resting for at least 5 minutes. 5. Individuals with TSH levels less than 0.1 µIU/mL or greater than 10 µIU/mL. 6. Individuals with a history of substance abuse. 7. Individuals deemed unsuitable for participation by the investigator due to other reasons, such as taking dietary supplements or medications judged to affect alcohol metabolism. 8. Individuals who regularly consume alcohol (exceeding 21 units/week, where 1 unit = 10g of pure alcohol) or who cannot abstain from alcohol during the clinical trial period. - Examples: 1 glass of beer 5° (250mL) = 10g, 1 shot of soju 20° (50mL) = 8g, 1 glass of wine 12° (125mL) = 12g 9. Individuals with a past diagnosis and treatment for alcoholism. 10. Individuals with low alcohol tolerance who do not normally drink alcohol. 11. Individuals with high alcohol tolerance who have never experienced a hangover even after consuming more than two bottles of soju at a time. 12. Individuals who have engaged in excessive alcohol consumption within 7 days prior to the start of the study, to an extent that might interfere with the study. 13. Smokers whose average daily smoking volume exceeds 10 cigarettes in the last 3 months, and individuals who cannot adhere to smoking cessation precautions during the clinical trial period. 14. Individuals who have consumed or cannot refrain from consuming grapefruit-containing foods from 48 hours before the first dose throughout the entire clinical trial period. 15. Pregnant or lactating women. 16. Individuals who are planning a pregnancy during the study period or who are not p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood Alcohol concentration;Blood acetaldehyde concentration;Alcohol Hangover survey scale(Alcohol Hangover Severity Scale, Acute Hangover Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reaction, vital signs, Liver Function Tests, antioxidant tests | — |
Countries
Korea, Republic of
Contacts
Public ContactSeyeon Lee
Pusan National University Korean Medicine Hospital
Outcome results
None listed