A Randomized, Controlled, Double Blind clinical study to evaluate use of Hydron Alkaline Ionised Water (HAIW) in healthy participants with Alcohol Hangover
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Assessment of Alcohol Hangover Severity Scale (AHSS)
研究概览
简要总结
It is a randomized, controlled, double blind clinical study to evaluate use of Hydron Alkaline Ionised Water (HAIW) in healthy participants with Alcohol Hangover. The study will be carried out at 3 to 4 centres in India. As per computer generated randomization list, subjects will be randomized either to HAIW Group or Packaged Drinking Water in 1:1 ratio. Subject will be asked to consume either HAIW or Packaged Drinking water as and even required for 15 days. The primary objectives of the study will be to assess subjects on Alcohol Hangover Severity Scale (AHSS). The secondary objectives of the study will be to assess global assessment for overall change by investigator and by participant, tolerability of study products by assessing adverse events /Adverse drug reactions and adverse events and vitals on screening visit (up to 3 days), Baseline visit (Day 0), telephonic follow ups and Day 15
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Literate healthy male and female participants self-reporting to be moderate drinkers of alcohol, which is approximated to usual drinking occasions (corresponding to 2 to 5 or 3 to 7 alcoholic drinks for a 70 kg female and male, respectively, over a 2 to 3 h period) and having any of the symptoms of hangover of mild to moderate severity
- •Participants willing to sign inform consent form
- •A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period.
排除标准
- •Subjects being treated for cardiovascular (high blood pressure), immune, respiratory, endocrine (diabetes), gastrointestinal, liver, biliary tract, kidney and urinary, nervous, and musculoskeletal system, psychiatric, infectious, and thyroid diseases, malignant tumors, or a history of peptic ulcer, reflux esophagitis, or gastrointestinal surgery
- •Pregnant or planning to become pregnant, nursing mothers,
- •Subjects with alcohol use disorder, alcoholism, substance abuse, or were taking an anti-abuse drug or warfarin, clopidogrel, aspirin, or non-steroidal anti-inflammatory drugs.
- •Subjects with abnormal creatinine (two times the standard upper limit), aspartate aminotransferase (AST), or alanine transaminase (ALT) (three times the standard upper limit) levels.
- •Participants who participated in other interventional clinical trials within 1 month or planned to participate in other interventional clinical trials
- •Participants sensitive or allergic to alkaline water
- •Participants with known history of hepatitis B and or C, diabetes mellitus, hypertension, cancer
- •Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his her participation in, and completion of the protocol.
结局指标
主要结局
Assessment of Alcohol Hangover Severity Scale (AHSS)
时间窗: Screening visit (up to 3 days), Baseline visit (Day 0), telephonic follow ups and Day 15
次要结局
- 1. Global assessment for overall change by investigator and by participant(2. Assessment of tolerability of study products by assessing adverse events and)
研究者
Dr Ksheetij Kothari
Shivam Multispecialty & Accident Care Centre Pvt. Ltd.