None listed
Conditions
Interventions
Dietary Supplement : All subjects will be randomized to receive test food.
Arm 1: [Oriental Raisin Tea Drink (A)] ? wash out 14 days ? Arm 2: [Oriental Raisin Tea Drink (B)] ? wash out 14 days ?
Arm
Sponsors
Global Medical Research Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects who are adult men and women between 19~40 years of age 2) Body mass index (BMI) of 18.5 to 25 kg/m2 3) Experienced a hangover after drinking alcohol 4) Subjects who agree the participation in the trial and submit informed and consent before the beginning of the trial
Exclusion criteria
Exclusion criteria: 1) Subject currently being treated for cardiovascular system (hypertension, etc.), immune system, respiratory system, endocrine system(diabetes, etc.), gastrointestinaltract/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, alcoholic metabolic disorders, cholelithiasis, pancreatitis, gout, liver disease (Carriers of hepatitis B virus and hepatitis C virus , if alcoholic liver disease, etc.) 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 5) Subject who has drunken enough alcohol within 1 week of visit 1 to interfere with the test 6) A person who usually rarely consumes alcohol or abstains from drinking less than once a month 7) 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] 8) Subject who has administered medicines and health functional foods related to liver function improvement, hangover helper within 2 weeks of visit 1 9) 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 1 10) Subject who is more than 3 times the upper limit normal AST (GOT) or ALT (GPT) of clinical institution 11) Subject who is more than 2 time the upper limit normal Creatinine of clinical trial institution 12) Subject who is TSH less than 0.1 µIU/mL or greater than 10 µIU/mL 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood alcohol concentration;Blood acetaldehyde concentration;AHS(Acute Hangover Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reaction, vital signs, clinical pathology test | — |
Countries
Korea, Republic of
Contacts
Public ContactSung-Bum Lee
Soon Chun Hyang University Hospital Bucheon
Outcome results
None listed