The Efficacy and safety of Hwangryunhaedok-tang on Hangover and study of changes in gut microbiota compositio
- Conditions
- Not Applicable
- Registration Number
- KCT0003683
- Lead Sponsor
- Pusan National University Korean Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 40
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.
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).
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hangover symptom score
- Secondary Outcome Measures
Name Time Method Blood alcohol concentration (AUClast, Cmax);Blood acetaldehyde concentration (AUClast, Cmax);Alcohol concentration in breath gas;Change of gut microbiota