Clinical study of Anti Hangover Drink NE-AB01 in reducing alcohol induced hangover symptoms in adult male social drinkers.

Randomized, placebo controlled, parallel arm, clinical study to evaluate the Effectiveness, Safety and Tolerability of Anti Hangover Drink NE-AB01 in Reducing Alcohol Induced Hangover Symptoms in Adult Male Social Drinkers.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/05/019412

Enrollment

Registered

2019-05-29

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: NE-A01 Health Drink: 60 ml Anti Hangover Drink NE-A01 orally 15 min before consumption of social alcohol drink for single day. Control Intervention1: Placebo: 60 ml placebo drink orally

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: Baseline, 12 hrs and 24 hrs	—

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 subjectTimepoint: 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.	—

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 subjectTimepoint: 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.

veenadeo@hotmail.com

Outcome results