NCT05757089

Brief Summary

The aim of this open-label, randomized, crossover, comparative pilot study is to assess efficacy and safety of the dietary food supplement ALCOFILTRUM in healthy volunteers who consume alcohol. Specifically the study will evaluate:

  • Efficacy of the intervention to alleviate hangover symptoms in participants who consumed alcohol,
  • Safety of intervention in participants who consuming alcohol. Participants will take four tablets of ALCOFILTRUM dietary food supplement 30 minutes before alcohol ingestion, while the control group will intake only alcohol drink.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

March 7, 2023

Status Verified

February 1, 2023

Enrollment Period

1.1 years

First QC Date

January 12, 2023

Last Update Submit

March 3, 2023

Conditions

Alcohol DrinkingAlcohol Intoxication

Outcome Measures

Primary Outcomes (1)

  • 1-item overall hangover severity rating

    Intensity of hangover symptoms in 12-13 hours after alcohol intake according to 1-item overall hangover severity rating. Score range is from 0 to 10, where higher scores mean more severe hangover symptoms.

    13 hours

Secondary Outcomes (10)

  • Schulte test

    13 hours

  • Romberg Stance test

    13 hours

  • Mini Cog test

    13 hours

  • Hangover Symptoms Questionnaire

    13 hours

  • Blood Alcohol level

    12 hours

  • +5 more secondary outcomes

Other Outcomes (4)

  • Incidence of Adverse Events [Safety and Tolerability]

    5 days

  • Incidence of Serious Adverse events [Safety and Tolerability]

    5 days

  • Arterial blood pressure [Safety and Tolerability]

    13 hours

  • +1 more other outcomes

Study Arms (2)

ALCOFILTRUM

EXPERIMENTAL

ALCOFILTRUM, 4 tablets in a single dose, 30 minutes prior to consumption of alcohol. Ingredients per tablet: Lignin hydrolyzed 800 mg; Glycine 150 mg; Dihydromyricetin 30 mg; Vitamin B1 30 mg.

Dietary Supplement: ALCOFILTRUM

Control

NO INTERVENTION

Interventions

ALCOFILTRUMDIETARY_SUPPLEMENT

ALCOFILTRUM helps alleviate alcohol hangover symptoms after a single intake for 30 minutes before alcohol consumption.

ALCOFILTRUM

Eligibility Criteria

Age25 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men aged from 25 to 45 years inclusive.
  • Body weight index of 18.5 to 30 kg/m2, with body weight of 60 kg to 100 kg.
  • Healthy volunteers should behave adequately, with coherent speech observed.
  • Available written Informed Consent for participation in this Study given by a healthy volunteer according to the effective laws.
  • Subjects with history of episodic intake of alcohol and episodic hangover symptoms.
  • Verified diagnosis "healthy": no chronic diseases in the history, no abnormal findings of lab tests and clinical investigations.

You may not qualify if:

  • The Investigator's decision that a healthy volunteer is to be excluded in the interests of the volunteer.
  • Any serious adverse event occurring to a healthy volunteer and associated with intake of alcohol and/or the study product.
  • A healthy volunteer refusing to collaborate with the Medical Investigator or not complying with the Study procedure.
  • A healthy volunteer was enrolled into the Study with violation of the Clinical Study Protocol.
  • Any adverse events occurring to a healthy volunteer that, in a Medical Investigator's opinion, may endanger safety of a volunteer.
  • Positive urine opioid test.
  • Positive COVID-19 Ag Rapid Test.
  • Positive blood alcohol test judging by concentration of alcohol fumes in exhaled air.
  • mg/L or higher content of alcohol fumes in exhaled air at the Screening Visit and at Visits 2, 3 prior to intake the first alcohol portion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Emergency Hospital

Minsk, 220024, Belarus

RECRUITING

MeSH Terms

Conditions

Alcohol DrinkingAlcoholic Intoxication

Condition Hierarchy (Ancestors)

Drinking BehaviorBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Olga A. Sharapova, Ph.D.

    City Clinical Emergency Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Artemiy A. Sergeev, M.D., D.Sci.

CONTACT

+74952690016sergeev@rnd.avvapharma.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2023

First Posted

March 7, 2023

Study Start

March 3, 2022

Primary Completion

March 30, 2023

Study Completion

May 30, 2023

Last Updated

March 7, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)