Evaluation of a Fixed Combination of Herbal Extracts to Prevent Symptoms Alcohol-induced Hangovers

NCT ID: NCT04183842

Last Updated: 2019-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-04
• Study Completion Date: 2019-09-07

Brief Summary

The primary objective of the study is to test whether the tested Product LACIME Anti-hangover is effective in preventing the signs and symptoms of alcohol-induced hangover (such as headache, impaired memory, depression, anxiety, weakness, trouble sleeping and concentrating, nausea, dizziness, sleepiness, thirsty, dry mouth, sweating, sensitivity to light and sounds, vision problems) in healthy subjects.

Detailed Description

LACIME Anti-hangover is a food supplement under the form of a syrup (water/glycerin based) containing plan extracts, each one having choleretic properties.

40 healthy subjects will be tested in a randomized, double-blind, placebo-controlled, crossover trial.

The participants will have to attend the 2 phases of the study during which they will receive in a blind way a product (LACIME Anti-hangover or PLACEBO):

If a participant has received LACIME Anti-hangover for Phase 1, the same participant will receive the PLACEBO for Phase 2 and vice versa.

Inclusion Criteria:

For inclusion in the study subjects must fulfil all the following criteria:

20-30 years old healthy males and females, Body weight (kg): 60 - 80 in man and 60-70 in women, People who consume alcohol occasionally and who already have to deal with hangovers Healthy volunteers who consume alcohol regularly and moderately, Having given their free, informed and express consent in writing Co-operative, informed of the need and duration of the controls which make it possible to achieve full adherence to the protocol in place.

Exclusion Criteria:

Excluded from participating in the study:

Volunteers consuming larger amounts of alcohol (more than 2 glasses of alcohol per day) Volunteers taking medication or food supplements that may affect alcohol metabolism.

Women who are pregnant or breastfeeding or plan to become pregnant during the study Subjects with illnesses which may conflict with the investigator's interpretation, if the subject participated in the study Subject planning to change his/her lifestyle during the study (diet, physical activity, etc.) Smoker Subject participating in another study during the clinical study period.

• At the first medical visit all volunteers will be checked for illegibility, randomized, and sign written informed consent including an obligation that they will not take alcohol within the next week and come to the study site a week later at least 3 hours after the last meal.
• At the second visit, participants will attend the study site, where each will fill Hangover Severity Symptoms (HSS) form, donate blood and urine for initial analysis.

Then participants take the Product LACIME Anti-hangover or PLACEBO and after 1hour will start to consume alcohol during two hours with meal (3 sandwiches with cheese or ham) on each of the 2 study phases.

Drink consumption, the composition and sequence:

300 ml of Brandy (41% vol. alcohol) corresponding to an intake of 123 ml or 99 g of alcohol 300 ml of Champagne (13% vol. alcohol) corresponding to an intake of 40 ml or 32 g of alcohol This will ensure a 100% hangover syndrome and a total intake of 131 g of alcohol (a dose of approximately 2 g / kg).

Such a dose will provide a peak concentration after 1 hour and should allow to determine the alcohol 15 hours after absorption.

Smaller doses are usually not detectable after 10-12 hours. (Jones, 2008).

D2 test, blood sampling and urine sampling under medical control is achieved before alcohol intake.

D2 test, blood sampling and urine sampling under medical control is achieved 1h, 4h and 15h after alcohol consumption.

Conditions

Headache; Nausea; Dizziness; Sleepiness; Anxiety; Thirst

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

LACIME Anti-hangover

Combination of plant extracts under liquid form. Oral administration. Dosage 100 ml. To drink 1h00 before alcohol intake together with meal.

Group Type: EXPERIMENTAL

LACIME Anti-hangover

Intervention Type: DIETARY_SUPPLEMENT

LACIME Anti-hangover contains the following excipients:

• Purified water,
• Xanthan gum,
• Glycerin,
• Potassium sorbate (as a preservative)
• Citric acid (acidity regulator)
• Aroma (flavouring agent)

LACIME Anti-hangover contains the following plant extracts and vitamin:

• Curcuma longa rhizome extract (Curcuma),
• Panax quinquefolius extract (Ginseng panax),
• Malpighia punicifolia extract (Acerola),
• Silybum marianum extract (Milk thistle),
• Desmodium adscendens extract (Desmodium),
• Pyridoxine chlorhydrate (Vitamin B6).

Placebo

Carrot juice under liquid form. Oral administration. Dosage 100 ml. To drink 1h00 before alcohol intake together with meal.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo contains the following excipients :

• Purified water,
• Xanthan gum,
• Glycerin,
• Potassium sorbate (as a preservative)
• Citric acid (acidity regulator)
• Aroma (flavouring agent)

Placebo contains :

• Carrot juice

Interventions

LACIME Anti-hangover

LACIME Anti-hangover contains the following excipients:

• Purified water,
• Xanthan gum,
• Glycerin,
• Potassium sorbate (as a preservative)
• Citric acid (acidity regulator)
• Aroma (flavouring agent)

LACIME Anti-hangover contains the following plant extracts and vitamin:

• Curcuma longa rhizome extract (Curcuma),
• Panax quinquefolius extract (Ginseng panax),
• Malpighia punicifolia extract (Acerola),
• Silybum marianum extract (Milk thistle),
• Desmodium adscendens extract (Desmodium),
• Pyridoxine chlorhydrate (Vitamin B6).

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo contains the following excipients :

• Purified water,
• Xanthan gum,
• Glycerin,
• Potassium sorbate (as a preservative)
• Citric acid (acidity regulator)
• Aroma (flavouring agent)

Placebo contains :

• Carrot juice

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 20-30 years old healthy males,
• Body weight (kg): 60 kg - 80 kg in man,
• People who consume alcohol occasionally,
• People who already had to deal with hangovers,
• Healthy volunteers who consume alcohol regularly and moderately,
• Having given their free, informed and express consent in writing,
• Co-operative, informed of the need and duration of the controls which make it possible to achieve full adherence to the protocol in place.

Exclusion Criteria

• Volunteers consuming larger amounts of alcohol (more than 2 glasses of alcohol per day)
• Volunteers taking medication or food supplements that may affect alcohol metabolism,
• Subjects with illnesses which may conflict with the investigator's interpretation, if the subject participated in the study,
• Subject planning to change his lifestyle during the study (diet, physical activity, etc.)
• Subject participating in another study during the clinical study period.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Phytomed AB

OTHER

Sponsor Role: collaborator

Incara Lab

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander PANOSSIAN, Pr., Dr

Role: STUDY_CHAIR

Swedish Herbal Institute AB

Areg HOVHANNISYAN, PhD, Dr.Sci

Role: STUDY_DIRECTOR

Head od National Anti-Doping Organization

Artur POTOSSIAN, Dr. MD

Role: PRINCIPAL_INVESTIGATOR

CARDIOMED Family Health Center

Samvel HAYRUMYAN, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

CARDIOMED Family Health Center

Locations

Unimed Medical Center

Abovyan, Yerevan, Armenia

Countries

Armenia

References

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Reference Type: BACKGROUND

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Study Documents

Document Type: Protocol, Validation of Ethic Comitee, Informed consent form, D2 test of attention, Hangover severity scale, Randomization chart

Password will be provided by Administrator. Please ask for it at : bommelaer@shadeline.com

View Document

Other Identifiers

PM-2019-03

Identifier Type: -

Identifier Source: org_study_id