None listed
Conditions
Interventions
Intervention1: Hydron Alkaline Ionised Water (HAIW): Subject will be asked to consume HAIW as and even required for 15 days.
Control Intervention1: Packaged Drinking water: Subject will be asked to co
Sponsors
Hydron Alkaline Aqua Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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 2. Participants willing to sign inform consent form 3. A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period
Exclusion criteria
Exclusion criteria: 1. 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 2. Pregnant or planning to become pregnant, nursing mothers, 3. 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. 4. Subjects with abnormal creatinine (two times the standard upper limit), aspartate aminotransferase (AST), or alanine transaminase (ALT) (three times the standard upper limit) levels. 5. Participants who participated in other interventional clinical trials within 1 month or planned to participate in other interventional clinical trials 6. Participants sensitive or allergic to alkaline water 7. Participants with known history of hepatitis B and or C, diabetes mellitus, hypertension, cancer 8. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of Alcohol Hangover Severity Scale (AHSS)Timepoint: Screening visit (up to 3 days), Baseline visit (Day 0), telephonic follow ups and Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Global assessment for overall change by investigator and by participant 2. Assessment of tolerability of study products by assessing adverse events and Adverse drug reactions 3. Assessment of adverse events and vitals Timepoint: Screening visit (up to 3 days), Baseline visit (Day 0), telephonic follow ups and Day 15 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed