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A Clinical Trial for the Evaluation of the Efficacy and Safety of Dr.Lac KAYOU on Alcohol metabolism and Hangover Improvement

A Randomized, Double-Blind, Crossover, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Dr.Lac KAYOU on Alcohol metabolism and Hangover Improvement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0011228
Enrollment
34
Registered
2025-11-27
Start date
2025-03-26
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : All subjects will be randomized to receive test product. Arm 1: [Test raw material(Dr. Lac KAYOU)] ? wash out 7 days ? [Control raw material(Placebo)] Arm 2: [Control raw materia

Sponsors

Luxbiome Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy adults aged 20 to 40 who drink alcohol. 2. Individuals with a Body Mass Index (BMI) of 18.5 to 25 kg/m2. 3. Individuals who have experienced a hangover in the past. 4. Individuals who have consumed alcohol equivalent to 450 mL of Chamisul Original 20% (9 shots). 5. Individuals whose blood test results and vital signs are within the normal range. 6. Individuals who voluntarily signed their consent to this study.

Exclusion criteria

Exclusion criteria: 1. Excessive drinking or alcohol consumption in the past week. 2. Participation in a human clinical trial within the past month. 3. Taking dietary supplements or medications that may affect alcohol metabolism. 4. Individuals with alcohol metabolism disorders, diabetes, hypertension, gallstones, pancreatitis, gout, active tuberculosis, gastrointestinal bleeding or surgery, or kidney/liver disease (including hepatitis B/C carriers or alcoholic liver disease), or those with heart, lung, gastrointestinal, or neurological disorders. 5. Pregnant or breastfeeding women. 6. Individuals with serum creatinine =1.4 mg/dL or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =60 IU/L on pre-screening tests 7. Individuals who typically consume little to no alcohol (once a month or less) or abstain from alcohol entirely. 8. Even if a test subject showed no health abnormalities in the pre-test examination, the tester may immediately exclude them from the test before or during the test if the tester determines that continuing the test is unsafe due to the subject's physical/mental state, such as complaining of dizziness before or during the test, or suddenly expressing psychological fear regarding blood collection.

Design outcomes

Primary

MeasureTime frame
Blood alcohol concentrations;Blood acetaldehyde concentrations;Blood indicators;Hangover Symptoms Survey(Acute Hangover Scale(AHS), Alcohol Hangover Severity Scale(AHSS)

Secondary

MeasureTime frame
Blood alcohol concentration measured using a breathalyzer

Countries

Korea, Republic of

Contacts

Public ContactDain Lee

Chung-Ang Univerisity Hospital

n.leedain@gmail.com+82-2-6299-1397

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026