KCT0003683招募中未知
The Efficacy and safety of Hwangryunhaedok-tang on Hangover and study of changes in gut microbiota composition
Pusan National University Korean Medicine Hospital0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 39(Year)（—）
- 性别
- Male
入选标准
- •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.
排除标准
- •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).
研究者
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