None listed
Conditions
Interventions
Intervention1: Venerg-UTM: Each tablet contains multiple plant extracts.
Control Intervention1: Placebo: The placebo product contains 4 g of Nutraceuticals grade excipients tablet.
Sponsors
Synthite Industries Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Male or Female aged 21-40 years 2. Subjects are able and agrees to drink alcohol 3. Subjects willing to comply to study procedure and sign written informed consent 4. Healthy subjects, who self-reports not to have any history of concomitant medication or illness and the subjects, who are not on any medication. 5. Psychologically stable subjects 6. Subjects having normal sleep patterns.
Exclusion criteria
Exclusion criteria: 1. Subjects, who have had experienced illness apart from hangover after alcohol consumption. 2. Subjects on any kind of medications 3. Subjects undergoing treatment for any condition 4. History of chronic smoking, alcoholism, psychiatric disorders, drug abuse or dependence, or regular use of psychoactive drugs 5. Breast feeding women 6. Pregnant women 7. Subject planning to conceive. 8. Subjects participating in another clinical trial or subjects participated in any clinical trial within last 6 months. 9. Any condition that in the opinion of the investigator does not justify the subjectâ??s inclusion for the study. 10. Subjects who have consumed alcohol within past 24 hours. 11. Subjects donâ??t have any chronic liver and kidneys disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To check, if the unit dose of 1 tablet (4g) in 250 ml water is sufficient to treat the hangover. 2. To check effect of IP on Serum Alcohol (Ethanol) concentration at baseline and EOT 3. To check the consumption time of the IP Summary of change: The pre-established Aldehyde dehydrogenase test has been replaced with Serum alcohol(ethanol) test as per the direction of the Sponsor. Timepoint: 1 Day | — |
Secondary
| Measure | Time frame |
|---|---|
| Understanding the hangover effect and associated symptom/disordersTimepoint: 1 Day | — |
Countries
India
Contacts
Public ContactSubham Dutta
Synthite Industries Pvt Ltd
Outcome results
None listed