KCT0009581已完成Unknown
A Stratified Randomized, Double-Blind, Crossover, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of SKH on Hangover Improvement
Bundang CHA General Hospital0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 40(Year)（—）
- 性别
- All
入选标准
- •1) Subjects who are adult men and women between 19~40 years of age
- •2) BMI of visit 1, is placed on 18.0 kg/m2~25 kg/m2
- •3) Experienced a hangover after drinking alcohol
- •4) A person whose ALDH2 genotype is wild or heterogeneous
- •5) Subjects who agree the particpation in the trial and submit informed and consent before the beginning of the trial.
排除标准
- •1) Subject currently being treated for cardiovascular system (hypertension, etc.), immune system, respiratory system, endocrine system (diabetes, etc.), gastrointestinal tract/liver and biliary system, kidney and urinary system, nervous system, musculoskeletal system, psychotropic, infectious diseases, and malignant tumors
- •2) Patients with peptic ulcer and reflux esophagitis based on visit 1
- •3) Subject who has a history of gastrointestinal diseases (e.g., Crohn's disease) or gastrointestinal surgeries (except for simple appendectomy or hernia surgery) that may affect the absorption of food for clinical trials
- •4) Alcohol use disorder or alcoholics as of visit 1
- •5) Subject who has drunken enough alcohol within 1 week of visit 1 to interfere with the test
- •6) Subject who has constantly administered drugs (such as antabuse-based drugs) or dietary supplements that are likely to affect alcohol metabolism, or drugs that pose a risk of gastrointestinal bleeding [warfarin, clopidogrel, aspirin, NSAIDs, and other antipyretic and anti-inflammatory drugs]
- •7) Subject who has administered medicines and health functional foods related to liver function improvement within 2 weeks of visit 2
- •8) Subject who has administered drugs that induce and inhibit drug metabolism enzymes (Barbiturates, Griseofulvin, Rifampin, Erythromycin, Isoniazid, Cimetidine, Omeprazole, etc.) within 1 month (30 days) based on visit 2
- •9) Subject who has administered antibiotics and intestinal control drugs within two weeks on the basis of visit 2
- •10) Subject who has ingested probiotics, prebiotics, and lactic acid bacteria products continuously (more than 4 times a week) within 2 weeks based on visit 2
- •11) Subject who is more than 2 time the upper limit normal Creatinine of clinical trial institution
- •12) Subject who is more than 3 times the upper limit normal AST (GOT) or ALT (GPT) of clinical institution
- •13) Anyone who is pregnant or breastfeeding or has a pregnancy plan for the duration of the test
- •14) Anyone who has participated or planned to participate in other clinical trials within the past one month
- •15) Subject who is sensitive or has an allergic reaction to food for human application testing
- •16) Anyone who is found to be inadequate by the tester for other reasons
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