None listed
Conditions
Interventions
Drug : Arm1: Redoxin 420mg 2 capsules, BID (21:00 of day 0 and 08:00 of day 1) / wash out 14 days/ Placebo 420mg 2 capsules BID (21:00 pf day 14 and 08:00 of day 15)
Arm2: Placebo 420mg 2 capsules,
Sponsors
Pusan National University Korean Medicine Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy males between the ages of 19 and 39 who have experienced hangover after alcohol intake 2. Subjects with body mass index =18 and <25kg/m2 3. Subjects with the score of Alcohol Use Disorder Identification Test (AUDIT) < 11 4. Subjects who didn't drink within 7 days before recruitment 5. Subjects who defecate once daily in average 6. Subjects who signed on the written informed consent form and comply with study requirements after listening and fully understanding the details of this study.
Exclusion criteria
Exclusion criteria: 1. Subjects who have clinically significant diseases of hepatic, renal, respiratory, endocrine, genitourinary, cardiovascular, musculoskeletal system or hemato-oncologic or psychiatric diseases or history of bellows 1) uncontrolled diabetes or fast plasma glucose = 126mg/dL or typical symptoms of diabetes mellitus (polyuria, polydipsia, unexplained body weight decrease), or plasma glucose = 200 mg/dL at any time 2) active renal disease or serum creatinine = 1.4 mg/dL 3) active liver disease or alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels = 60 IU/L 4) uncontrolled hypertension or cardiac diseases of angina pectoris and myocardiac infarction 5) experience of symptoms of cardiac diseases and severe toxicity after alcohol intake 6) pancreatitis, gout, surgery of gastrointestinal tract 7) taking anti-ulcer drugs or treatment for gastric ulcer within 6 months 2. Subjects with gastrointestinal diseases that can affect the absorption of test drug (Crohn's disease, ulcer, acute or chronic pancreatitis) or gastrointestinal surgery (not for simple appendectimy) 3. Subjects with HBsAg (+) or anti-HCV ab (+) or history of hepatitis B or C 4. Subjects whose systolic blood pressure = 160 mmHg or = 100 mmHg / diastolic pressure = 95 mmHg or = 60 mmHg at the screening visit 5. Subjects with drug abuse history 6. Subjects who intake prescription drugs or herbal medication within 2 weeks prior to the first administration or who intake over-the-counter drugs or vitamins within 1 week prior to the first administration 7. Subjects who took drug metabolism inducer or inhibitor (eg barbiturate) within 1 month prior to the first administration 8. Subjects who participated other clinical trials within 3 months prior to the first administration (the end of the previous study is determined as the last day of administration). 9. Subjects who intake drugs that can affect alcohol metabolism. 10. Subjects who donate whole blood within 2 months prior to the first administration or apheresis donation within 1 month prior to the first administration or who received blood transfusion within 1 month prior to the first administration 11. Subjects with persistent alcohol consumption (> 21 units/week, 1 unit = 10 g of pure alcohol) 12. Subjects who have been diagnosed with alcoholism and received treatment 13. Subjects who are easily overcome by drink and did not drink at all 14. Subjects who did not experience hangover after drinking more than 2 bottles of soju (120 g of pure alcohol) in one time 15. Subjects who drank excessive amounts of alcohol that can affect clinical study within 7 days prior to the first administration 16. Subjects who smoked more than 1/2 pack per day within 3 months on average prior to the first administration 17. Subjects who cannot help intaking greatfruit from 48 hours prior to the first administration to the end of the study 18. Sexually active subjects who plan pregnancy or who do not use proper contraceptive methods (eg vasectomy, using condom, etc) 19. Subjects judged not eligible for this study by principal investigator or subinvestigator (physician in charge).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hangover symptom score | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood alcohol concentration (AUClast, Cmax);Blood acetaldehyde concentration (AUClast, Cmax);Alcohol concentration in breath gas;Change of gut microbiota | — |
Countries
Korea, Republic of
Contacts
Public ContactMinna Hong
Pusan National University Korean Medicine Hospital
Outcome results
None listed