None listed
Conditions
Interventions
Intervention1: NE-A01 Health Drink: 60 ml Anti Hangover Drink NE-A01 orally 15 min before consumption of social alcohol drink.
Control Intervention1: Not applicable: Not applicable
Sponsors
Naturedge Beverages Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male social drinkers between the age group of 21-35, to be considered from bars, pubs and alcohol selling outlets. 2. Should have experienced at least one hangover previously. 3. Should be able to read, write comprehend the language of the ICD and give his informed consent for participation in the trial. 4. Should have no history of alcoholism or Alcoholic abuse 5. Subjects whose blood alcohol concentration is zero at the time of enrollment. 6. Subjects with normal sleep patterns and habits.
Exclusion criteria
Exclusion criteria: 1. History of drug dependence or excessive alcohol intake on a habitual basis. 2. Subjects with psychiatric disorders. 3. Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, or any other serious medical illness. 4. Subjects with history of seizures. 5. Subjects who may be allergic to any of the natural constituents of the Investigational Product. 6. Subjects who are currently enrolled in an active investigational study or have participated in an investigational study within 30 days prior to enrollment. 7. Subjects, who in the opinion of the Investigator are not eligible for enrollment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of changes in Biochemical Evaluation from screening to end of the treatment for hangover effects like- ALDH (Acetaldehyde Dehydrogenase), Blood Aldehyde, Blood Alcohol Liver function test- ALT, AST and ALPTimepoint: Assessment of changes in Biochemical Evaluation from Baseline, after 12 hours and 24 hours of the administration of formulation. Assessment of tolerance of NE-AB01 by patients Assessment of global evaluation for overall improvement by physician and subject Baseline, after 24 hours of the formulation for hangover effects like- ALDH (Acetaldehyde Dehydrogenase), Blood Aldehyde, Blood Alcohol Liver function test- ALT, AST and ALP for baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Institute Withdrawal Assessment â?? Alcohol (CIWA-A) Modified Alcohol Hangover Severity Scale (m-AHSS) Assessment of tolerance of NE-AB01 by patients Assessment of global evaluation for overall improvement by physician and subject Timepoint: Clinical Institute Withdrawal Assessment â?? Alcohol (CIWA-A) Modified Alcohol Hangover Severity Scale (m-AHSS) Baseline, after 12 hours and 24 hours of the formulation. Assessment of tolerance of NE-AB01 by patients Assessment of global evaluation for overall improvement by physician and subject Baseline, after 24 hours of the formulation. | — |
Countries
India
Contacts
Public ContactDr Veena Deo
Naturedge Beverages Pvt. Ltd.
Outcome results
None listed