None listed
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female participants aged between 20 to 50 years, with BMI 18.5 to 25 kg per m2. 2.Participants with previous history of social alcohol consumption and hangover symptom score (HSS) greater than 5. 3.Participants who used to drink alcohol regularly or more than once in a month(social drinking, but not alcohol abuse) and are willing and able to comply with the alcohol consumption, blood withdrawal requirements and overnight stay as per the study requirements. 4.Participants judged by the Investigator to be in general good health based on medical history and laboratory investigations. 5.Participants understand the study procedures and sign informed consent forms to participate in the study. 6.Women of child bearing potential and men with partners of child bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Note: A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria a. Has not undergone a hysterectomy or bilateral oophorectomy or b. Has not attained menopause (Women not menstruating for at least 12 consecutive months). 7. Male participants who are willing to refrain from donating sperm from first admission to the study until 90 days after the study completion.
Exclusion criteria
Exclusion criteria: 1.Excessive drinking or alcohol intake in the past one week. 2.Participants who have participated in a any other clinical trial within last 1 month. 3.Known history of alcohol abuse or dependency or drug abuse that would limit ability to comprehend or follow instructions related to informed consent, treatment instructions or study procedures. 4. Any other conditions (physical, psychological, social or uncontrolled dietary measures) that can interfere with the participant s compliance to the study in the opinion of the Investigator. 5. Participantive sleep duration of less than 3 hours in the night before every study period. 6. Participants taking any dietary supplements or medications within last 1month that may affect alcohol metabolism as per Investigator s discreation. 7. Participants with known clinically significant disorders like Alcohol metabolism disorders, diabetes, hypertension, cholelithiasis, pancreatitis, gout, active tuberculosis, Gastrointestinal bleeding, kidney or liver disease (hepatitis B or C carriers, alcoholic Liver disease, etc.), heart, lung, gastrointestinal, nervous system disease or any other chronic disorder that can interfere with the study conduct in the opinion of the Investigator. 8. Participants with known history or present condition of allergic response to any of the ingredients in the investigational product. 9. Pregnant as assessed by UPT and History of Amenorrhea and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy outcome: Blood alcohol and acetaldehyde levels Secondary efficacy outcomes: -Assessment of Acute Hangover Scale (AHS) -Acute Hangover Severity Scale (AHSS) - Clinical assessment of Alcohol Hangover Symptoms Timepoint: Primary efficacy outcome time points: Pre alcohol,0hr,0.25hr,0.5hr,1 hr,2hr,4hr,6hr and 15hr. Secondary efficacy outcome time points: 15th hours | — |
Secondary
| Measure | Time frame |
|---|---|
| -Assessment of Acute Hangover Scale (AHS) -Acute Hangover Severity Scale (AHSS) -Clinical assessment of Alcohol Hangover Symptoms -Safety evaluation through Laboratory Investigations. -Incidence of adverse events Timepoint: Day0, Day 1 & Day 2 15th Hour. | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
Himalaya Wellness Company
Outcome results
None listed