HeadacheLACIMENCT04183842
Evaluation of a Fixed Combination of Herbal Extracts to Prevent Symptoms Alcohol-induced Hangovers
A study testing LACIME Anti-hangover in people with Headache and Nausea, run by Incara Lab at 1 site in Armenia.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- What is being tested?
- LACIME Anti-hangover
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteArmenia
- Study dates
- 4 Jul 2019to 7 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Fixed Combination of Herbal Extracts to Prevent Symptoms Alcohol-induced Hangovers : A Randomized, Double Blind Placebo Controlled Crossover Study.
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.
Read the 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.
- Being tested
- LACIME Anti-hangover, Placebo
- Medical subject headings
- Headache, Nausea, Dizziness, Sleepiness, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LACIME Anti-hangoverDietary 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).
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
The test "d2" consists of identifying and marking the letters "d" accompanied by two dashes only in the middle of other annoying characters.
The test "d2" is an array containing 14 lines of 47 characters which must all be checked.
The recorded figures are :
- correctly identifyed characters,
- omissions,
- confusions,
- total number of errors.
Three indices, reveal the evolution of the concentration:
- Concentration Performance (error-corrected processing rate)
- Speed of treatment
- Fluctuation Rate (precision in treatment and accuracy)
Changes of psychometric parameters are evaluated by d2 test at:
- 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)
Measured: Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)
Acetaldehyde blood assay (Jones, 2008)
Alcohol is mainly metabolized by hepatic oxydation by NADH / NAD+ enzymatic route.
Ingestion of Alcohol provoques an increase in the ratio NADH / NAD+ which disrupts all the other metabolic pathways in equilibrium with this coenzyme.
In the first stage of hepatic metabolism, the enzyme dehydrogenase converts alcohol into Acetaldehyde, a very toxic substance that has effects on the entire body.
Acetaldehyde is a choice marker to evaluate the level of alcoholic intoxication whenever it is an acute, massive or chronic absorption.
Titration of blood concentration of Acetaldehyde in mg/l
Changes of blood parameters from baseline are evaluated at:
- 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)
Measured: Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start4 Jul 2019
- Primary completion26 Aug 2019
- Study completion7 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double blind, placebo controlled, crossover study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incara Lab
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Phytomed AB
- Responsible party
- Sponsor
- Investigators
- Alexander PANOSSIAN, Pr., Dr, Study chair, Swedish Herbal Institute ABAreg HOVHANNISYAN, PhD, Dr.Sci, Study director, Head od National Anti-Doping OrganizationArtur POTOSSIAN, Dr. MD, Principal investigator, CARDIOMED Family Health CenterSamvel HAYRUMYAN, PhD, MD, Principal investigator, CARDIOMED Family Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04183842
- Sponsor's protocol ID
- PM-2019-03
- Acronym
- LACIME
- Status last verified
- Nov 2019
- First submitted
- 16 Oct 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Aziz AM, Brothers S, Sartor G, Holm L, Heilig M, Wahlestedt C, Thorsell A. The nociceptin/orphanin FQ receptor agonist SR-8993 as a candidate therapeutic for alcohol use disorders: validation in rat models. Psychopharmacology (Berl). 2016 Oct;233(19-20):3553-63. doi: 10.1007/s00213-016-4385-8. Epub 2016 Aug 11.
PubMed 27515665Economidou 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.
PubMed 21223310Jayawardena 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.
PubMed 28568743Kim 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.
PubMed 28750942Lee 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.
PubMed 23587660Lee 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.
PubMed 24458173Pittler 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.
PubMed 14662662Robertson 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.
PubMed 21762183Slutske 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.
PubMed 14506405Wiese 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.
PubMed 15226168
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Fixed Combination of Herbal Extracts to Prevent Symptoms Alcohol-induced Hangovers : A Randomized, Double Blind Placebo Controlled Crossover Study.
- ClinicalTrials.gov ID
- NCT04183842
- Acronym / sponsor ID
- LACIME / PM-2019-03
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Incara LabIndustry (pharma, biotech, devices)
- Collaborators
- Phytomed AB
- Study start
- 4 Jul 2019 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 7 Sep 2019 (actual)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double blind, placebo controlled, crossover study.
| Arm | Type | Receives |
|---|---|---|
| LACIME Anti-hangover | Experimental | Dietary Supplement: LACIME Anti-hangoverCombination of plant extracts under liquid form. Oral administration. Dosage 100 ml. To drink 1h00 before alcohol intake together with meal. |
| Placebo | Placebo comparator | Other: PlaceboCarrot juice under liquid form. Oral administration. Dosage 100 ml. To drink 1h00 before alcohol intake together with meal. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LACIME Anti-hangoverLACIME 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). | Dietary supplement | LACIME Anti-hangover |
| PlaceboPlacebo 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 | Other | Placebo |
Primary outcome
Evaluation of the difference in Hangover Severity Scores between the activity of LACIME Anti-hangover and the activity of PLACEBO.
Time frame: Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)
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)
2 secondary outcomes
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.
Time frame: Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)
Acetaldehyde blood assay (Jones, 2008)
Time frame: Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Background: PubMed 27515665Aziz AM, Brothers S, Sartor G, Holm L, Heilig M, Wahlestedt C, Thorsell A. The nociceptin/orphanin FQ receptor agonist SR-8993 as a candidate therapeutic for alcohol use disorders: validation in rat models. Psychopharmacology (Berl). 2016 Oct;233(19-20):3553-63. doi: 10.1007/s00213-016-4385-8. Epub 2016 Aug 11.
- Background: PubMed 21223310Economidou 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.
- Background: PubMed 28568743Jayawardena 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.
- Background: PubMed 28750942Kim 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.
- Background: PubMed 23587660Lee 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.
- Background: PubMed 24458173Lee 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.
- Background: PubMed 14662662Pittler 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.
- Background: PubMed 21762183Robertson 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.
- Background: PubMed 14506405Slutske 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.
- Background: PubMed 15226168Wiese 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander PANOSSIAN, Pr., Dr study chair
Swedish Herbal Institute AB
Areg HOVHANNISYAN, PhD, Dr.Sci study director
Head od National Anti-Doping Organization
Artur POTOSSIAN, Dr. MD principal investigator
CARDIOMED Family Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LACIME Anti-hangover in people with Headache and Nausea, run by Incara Lab at 1 site in Armenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the difference in Hangover Severity Scores between the activity of LACIME Anti-hangover and the activity of PLACEBO. (time frame: Total duration 2 days (Total=16h00: From 1h00 before alcohol intake until 15h after alcohol consumption)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04183842, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.