A human trial to red ginseng complex extract on alcohol metabolism and hangover improvement

A single-dose, randomized, double-blind, placebo-controlled 2x2 cross-over design human trial to evaluate the efficacy of compounds including red ginseng complex extract on alcohol metabolism and hangover improvement

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011143

Enrollment

Registered

2025-11-12

Start date

2025-08-09

Completion date

Unknown

Last updated

2025-11-17

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 : ? Investigational Products and Dosage - Red Ginseng Complex Extract Group: Orally administered 1 capsule per dose (542 mg/day, 542 mg/dayas Red Ginseng Complex Extract) - Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: adult men and women, aged 20 to 40, who had a Body Mass Index (BMI) 18.5~25 kg/m^2 at the time of the screening visit, a tolerance of one bottle of soju, and a history of experiencing hangovers after drinking.

Exclusion criteria

Exclusion criteria: 1. Individuals with an AUDIT-K score (Alcohol Use Disorder Identification Test-Korean) exceeding 11 points. 2. Individuals who have consumed excessive amounts of alcohol that may interfere with the study within 7 days prior to the screening visit. 3. Individuals who consistently consume alcohol (exceeding 210 g/week) or cannot abstain from alcohol during the study period. 4. Individuals who have taken dietary supplements or pharmaceuticals that may affect alcohol metabolism within 1 month prior to the screening visit. 5. Individuals with alcohol metabolism disorder, alcoholism, diabetes, hypertension, gallstones, pancreatitis, gout, active tuberculosis, gastrointestinal bleeding or surgery, or renal, hepatic (such as carriers of Hepatitis B or C, or those with alcoholic liver disease), cardiac, pulmonary, gastrointestinal, or neurological diseases. 6. Individuals with hypersensitivity to alcohol, the investigational food product, or its components.Individuals who have participated in other human application trials within 1 month prior to the screening visit. 7. Women who are pregnant or breastfeeding. 8. Women of childbearing potential who do not agree to use appropriate contraceptive methods. 9. Individuals who are judged to be unsuitable for study participation by the Principal Investigator due to other reasons, including results from diagnostic laboratory tests.

Design outcomes

Primary

Measure	Time frame
Blood concentrations of alcohol and acetaldehyde;AUC (total area from zero to infinity), Cmax (peak plasma concentration), and tmax (time to reach Cmax);AHS; Acute HangoverScale;AHSS; Alcohol Hangover SeverityScale	—

Secondary

Measure	Time frame
Adverse events;Vital Sign	—

Countries

Korea, Republic of

Contacts

Public ContactJoo Jongcheon

Wonkwang University Oriental Medical Hospital, Jeonju

jcjoo2000@hanmail.net+82-63-270-1073

Outcome results