None listed
Conditions
Interventions
Dietary Supplement : 1) Test Product(Complex Extract of Fermented Rice Bran and Cabbage and Hovenia Dulcis Extract)
- Consumption Method: Consume 2 bottles and 1 sachet simultaneously
- Duration: sing
Sponsors
Dong-A Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Adult men and women over the age of 19 and under 40 (2) Those who have experienced hangovers after drinking (3) Those with a body mass index (BMI) of 18 to 25 kg / m2 (4) Those who have agreed to participate in the clinical trial before it starts and have signed the Informed Consent Form
Exclusion criteria
Exclusion criteria: (1) Those who has a clinically significant hypersensitivity reaction or has a history of alcohol, human application test products, or ingredients (2) Those who have taken drugs (e.g., barbiturates, griseofulvin, rifampin, erythromycin, isoniazid, cimetidine, omeprazole, etc.) or foods (e.g., grapefruit-containing products) known to induce or inhibit drug-metabolizing enzymes within 4 weeks before the screening date and subject enrollment (3) Those who have taken Antabuse-class drugs or other products deemed to potentially affect alcohol metabolism within 4 weeks before the screening date and subject enrollment (4) Those with a result of **Homozygote type (ALDH22/2) or AA in the ALDH2 genetic trait test (5) Those who typically consume little to no alcohol or are habitual abstainers (6) Those who have taken medications with a risk of gastrointestinal bleeding (e.g., warfarin, clopidogrel, aspirin, NSAIDs, antipyretics, analgesics), antibiotics, probiotics, hormonal agents, or herbal medicines continuously within 4 weeks before the screening date and subject enrollment (intermittent use of antibiotics, NSAIDs, antipyretics, and analgesics for transient treatment purposes may be permitted at the investigator's discretion) (7) Those who have consumed dietary supplements that may affect liver function (e.g., licorice extract, milk thistle [silymarin], etc.) within 2 weeks before the screening date and subject enrollment (8) Those who have engaged in significant alcohol consumption that may interfere with the study within 1 week before the screening date and subject enrollment (9) Those undergoing treatment for clinically significant conditions such as liver or biliary diseases, kidney disorders, neurological or brain disorders, respiratory diseases, endocrine disorders, hematological disorders, urological diseases, cardiovascular or cerebrovascular diseases, immune disorders, musculoskeletal disorders, malignancies, metabolic disorders, or psychiatric illnesses (10) Those with a history of gastrointestinal diseases that could affect the absorption, distribution, metabolism, or excretion of the investigational product (e.g., Crohn's disease) or a history of gastrointestinal surgery (simple appendectomy or hernia surgery is excluded) (11) Those who have received antipsychotic drug treatment within 8 weeks before the screening date (12) Those with a history of or current alcohol use disorder (13) Those showing the following results in clinical laboratory tests: ? AST or ALT: Greater than 3 times the upper limit of the reference range. ? Serum creatinine: = 2.0 mg/dL. (14) Those with thyroid function test results (TSH) of = 0.1 µIU/mL or = 10 µIU/mL. (15) Pregnant or breastfeeding women, or women planning to become pregnant during the study period (16) Those who have participated in another clinical trial or human application study within 12 weeks before the screening date, or who plan to participate in another clinical or human application study during the trial period (17) Those deemed unsuitable for study participation by the principal investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alcohol in the blood after alcohol consumption;AHS(Acute Hangover Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Hangover symptom: Vomiting | — |
Countries
Korea, Republic of
Contacts
Public ContactHui-Yeon Jang
Jeonbuk National University Hospital
Outcome results
None listed