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

NCT04183842 | Completed DMC

• 1 other identifier: PM-2019-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache; Nausea; Dizziness; Sleepiness; Anxiety; Thirst

Outcome Measures

Primary Outcomes (1)

• Evaluation of the difference in Hangover Severity Scores between the activity of LACIME Anti-hangover and the activity of PLACEBO.

  Evaluation of the difference in Hangover Severity Scores between the activity of LACIME Anti-hangover and the activity of PLACEBO. The measure is the true change in self assessment scores from their baseline. 12 self assessed parameters : * Headache, * Fatigue, weakness * Thirsty * Dry mouth * Nausea * Vomiting * Trembling * Sweat * Depressed * Anxiety * Trouble Sleeping * Sensitivity to light For each of the above symptoms, the Hangover Severity Scale ranges from 0 to 4. The Scores are evaluated according to the following: * Absent=0 * Mild=1 * Moderate=2 * Severe=3 * Incapacitating=4 Self assessment is achieved: * Day 1 : 1h00 before alcohol intake (baseline) * Day 1 : Alcohol and meal intake * Day 1 : 1h00 after alcohol intake (Visit 1a) * Day 1 : 4h00 after alcohol intake (Visit 1b) * Day 1 : 15h00 after alcohol intake (Visit 1c)

  Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)

Secondary Outcomes (2)

• Evaluation of the difference in Cognitive Performance Score between the activity of LACIME Anti-hangover and the activity of PLACEBO according to "d2" psychometric test.

  Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)

• Acetaldehyde blood assay (Jones, 2008)

  Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)

Study Arms (2)

LACIME Anti-hangover

EXPERIMENTAL

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

Dietary Supplement: LACIME Anti-hangover

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

LACIME Anti-hangover 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).

LACIME Anti-hangover

Placebo 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

Placebo

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incara Lab: lead
• Phytomed AB: collaborator

Study Sites (1)

Unimed Medical Center

Abovyan, Yerevan, 0001, Armenia

Location

Related Publications (10)

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  PMID: 27515665 BACKGROUND

• Economidou D, Cippitelli A, Stopponi S, Braconi S, Clementi S, Ubaldi M, Martin-Fardon R, Weiss F, Massi M, Ciccocioppo R. Activation of brain NOP receptors attenuates acute and protracted alcohol withdrawal symptoms in the rat. Alcohol Clin Exp Res. 2011 Apr;35(4):747-55. doi: 10.1111/j.1530-0277.2010.01392.x. Epub 2011 Jan 11.

  PMID: 21223310 BACKGROUND

• Jayawardena R, Thejani T, Ranasinghe P, Fernando D, Verster JC. Interventions for treatment and/or prevention of alcohol hangover: Systematic review. Hum Psychopharmacol. 2017 Sep;32(5). doi: 10.1002/hup.2600. Epub 2017 May 31.

  PMID: 28568743 BACKGROUND

• Kim H, Kim YJ, Jeong HY, Kim JY, Choi EK, Chae SW, Kwon O. A standardized extract of the fruit of Hovenia dulcis alleviated alcohol-induced hangover in healthy subjects with heterozygous ALDH2: A randomized, controlled, crossover trial. J Ethnopharmacol. 2017 Sep 14;209:167-174. doi: 10.1016/j.jep.2017.07.028. Epub 2017 Jul 24.

  PMID: 28750942 BACKGROUND

• Lee HS, Isse T, Kawamoto T, Baik HW, Park JY, Yang M. Effect of Korean pear (Pyruspyrifolia cv. Shingo) juice on hangover severity following alcohol consumption. Food Chem Toxicol. 2013 Aug;58:101-6. doi: 10.1016/j.fct.2013.04.007. Epub 2013 Apr 13.

  PMID: 23587660 BACKGROUND

• Lee MH, Kwak JH, Jeon G, Lee JW, Seo JH, Lee HS, Lee JH. Red ginseng relieves the effects of alcohol consumption and hangover symptoms in healthy men: a randomized crossover study. Food Funct. 2014 Mar;5(3):528-34. doi: 10.1039/c3fo60481k.

  PMID: 24458173 BACKGROUND

• Pittler MH, White AR, Stevinson C, Ernst E. Effectiveness of artichoke extract in preventing alcohol-induced hangovers: a randomized controlled trial. CMAJ. 2003 Dec 9;169(12):1269-73.

  PMID: 14662662 BACKGROUND

• Robertson BM, Piasecki TM, Slutske WS, Wood PK, Sher KJ, Shiffman S, Heath AC. Validity of the hangover symptoms scale: evidence from an electronic diary study. Alcohol Clin Exp Res. 2012 Jan;36(1):171-7. doi: 10.1111/j.1530-0277.2011.01592.x. Epub 2011 Jul 18.

  PMID: 21762183 BACKGROUND

• Slutske WS, Piasecki TM, Hunt-Carter EE. Development and initial validation of the Hangover Symptoms Scale: prevalence and correlates of Hangover Symptoms in college students. Alcohol Clin Exp Res. 2003 Sep;27(9):1442-50. doi: 10.1097/01.ALC.0000085585.81711.AE.

  PMID: 14506405 BACKGROUND

• Wiese J, McPherson S, Odden MC, Shlipak MG. Effect of Opuntia ficus indica on symptoms of the alcohol hangover. Arch Intern Med. 2004 Jun 28;164(12):1334-40. doi: 10.1001/archinte.164.12.1334.

  PMID: 15226168 BACKGROUND

MeSH Terms

Conditions

Headache; Nausea; Dizziness; Sleepiness; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Sensation Disorders; Mental Disorders

Study Officials

• Alexander PANOSSIAN, Pr., Dr

  Swedish Herbal Institute AB

  STUDY CHAIR

• Areg HOVHANNISYAN, PhD, Dr.Sci

  Head od National Anti-Doping Organization

  STUDY DIRECTOR

• Artur POTOSSIAN, Dr. MD

  CARDIOMED Family Health Center

  PRINCIPAL INVESTIGATOR

• Samvel HAYRUMYAN, PhD, MD

  CARDIOMED Family Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization chart Code number for Product / Placebo distribution
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double blind, placebo controlled, crossover study.

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: December 3, 2019
• Study Start: July 4, 2019
• Primary Completion: August 26, 2019
• Study Completion: September 7, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 2 months after study completion for 6 months.
• Access Criteria: Data access is controlled by the Central Contact Person. Please contact bommelaer@shadeline.com for Password

Locations

AR (1)