KCT0008927已完成Unknown
A randomized, double-blind, placebo-controlled, cross-over clinical trial to evaluate the effectiveness and safety of DA-5521 intake in alleviating hangovers
Dong-A Pharm0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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 50(Year)（—）
- 性别
- Male
入选标准
- •1) Adult male over the age of 19 and under 50
- •2) Those who have experienced hangovers after drinking
- •3) Those who have agreed to participate in the clinical trial before it starts and have signed the Informed Consent Form
排除标准
- •If any of the following exclusion criteria are met, the participant was excluded from the clinical trial :
- •1) Those who cannot consume more than 100 mL of hard liquor
- •2) Those currently under treatment for severe cardiovascular, immune system, respiratory, hepatobiliary (liver and gallbladder), renal and urinary system, neurological, musculoskeletal, mental, infectious diseases, or malignant tumors
- •3) Patients with digestive ulcers or reflux esophagitis based on the screening visit criteria
- •4) Those with a history of gastrointestinal diseases (e.g., Crohn's disease) that could affect the absorption of the test food or gastrointestinal surgeries (however, simple appendectomy or hernia surgery is excluded)
- •5) Individuals with alcohol use disorder or alcoholism based on the screening visit criteria
- •6) Those who have consumed alcohol in the past week to an extent that it may interfere with the test based on the screening visit criteria
- •7) Those continuously taking drugs believed to affect alcohol metabolism (e.g., Antabuse-class drugs), or drugs with a risk of gastrointestinal bleeding [warfarin, clopidogrel, aspirin, NSAIDs, other antipyretic analgesics, and anti-inflammatory analgesics]
- •8) Those who have taken medications or health functional foods related to liver function improvement within the past 2 weeks based on the screening visit criteria
- •9) Those who have taken drugs inducing or inhibiting drug metabolism enzymes (Barbiturates, Griseofulvin, Rifampin, Erythromycin, Isoniazid, Cimetidine, Omeprazole, etc.) within the past month (30 days) based on the screening visit criteria
- •10) Those with AST(GOT) or ALT(GPT) levels more than three times the upper normal limit of the institution
- •11) Those with Creatinine levels more than twice the upper normal limit of the institution
- •12) Those with TSH less than 0.1 µIU/mL or greater than 10 µIU/mL
- •13) Those with fasting blood sugar levels of 126 mg/dL or higher or diabetic patients receiving oral hypoglycemics or insulin
- •14) Those with uncontrolled hypertension (systolic blood pressure 160 mmHg or higher or diastolic blood pressure 100 mmHg or higher, measured after 10 minutes of rest during the clinical trial)
- •15) Those who have participated in another interventional clinical trial (including human application trials) within the past 3 months based on the screening visit criteria or plan to participate in another interventional clinical trial during the duration of this trial
- •16) Those sensitive or allergic to the ingredients of the test food
- •17) Those deemed inappropriate for the trial by the tester.
研究者
相似试验
已完成
不适用
A randomized, double-blind, placebo-controlled, crossover study on the suppressive effect of the peptide on postprandial blood glucose levelot applicableJPRN-UMIN000048002CPCC Company Limited30
已完成
1 期
A study to evaluate the prebiotic effect of Manuka Honey with Cyclopower (Trademark) capsules in healthy subjects.Gastrointestinal effect and wellnessAlternative and Complementary Medicine - Other alternative and complementary medicineOral and Gastrointestinal - Normal oral and gastrointestinal development and functionACTRN12615000857505The New Zealand Institute for Plant and Food Research20
进行中（未招募）
不适用
A study assessing the safety, tolerability and efficacy of a new medication (SER100) in patients with Isolated Systolic Hypertension (ISH) insufficiently treated with 1-3 other anti-hypertensives.MedDRA version: 14.1Level: LLTClassification code 10050591Term: Isolated systolic hypertensionSystem Organ Class: 100000004866Isolated Systolic HypertensionEUCTR2013-001227-40-HUSerodus ASA30
已完成
2 期
A randomized, double-blind, placebo-controlled, cross-over study to assess the effects of fampridine on eye movements and nerve conduction and function in patients with multiple sclerosis (MS) and a unilateral or bilateral internuclear ophthalmoplegia (INO)nerve disease10012303multiple sclerosisNL-OMON42310Centre for Human Drug Research24
进行中（未招募）
1 期
Multi-center trial in healthy subjects to investigate the effects of analgesic drugs on pain processing observed by Peripheral Nerve Excitability Testing (NET)Healthy volunteers (intended indication: pain)MedDRA version: 20.0Level: PTClassification code 10033371Term: PainSystem Organ Class: 10018065 - General disorders and administration site conditionsEUCTR2019-000942-36-ITMBERTO I - POLICLINICO DI ROMA60