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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05830565
Other study ID # PIL-RIPH3-MELIM-023
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 25, 2023
Est. completion date June 25, 2023

Study information

Verified date May 2023
Source Larena SAS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Volunteers will fill out an initial questionnaire which will describe their current situation, their pathologies and current treatments, their medical history. Finally, they will complete three questionnaires on the day of their stressful event which will describe their state of stress just before taking the product, 20 minutes after taking the product; their tolerance and satisfaction with the product will be described at the end of the day.


Description:

Participants in the survey will come from a panel of volunteers. They will be contacted via an email proposing the survey accompanied by a selection questionnaire. Eligible volunteers will be called by the clinical investigation center to confirm their participation. Volunteers will fill out an initial questionnaire which will describe their current situation (sex, age, family and professional situation, cigarette consumption), their pathologies and current treatments, their medical history (disorders related to sleep, stress, anxiety, burnout, depression or other mental disorders). Finally, they will complete three questionnaires on the day of their stressful event which will describe their state of stress just before taking the product, 20 minutes after taking the product; their tolerance and satisfaction with the product will be described at the end of the day.


Recruitment information / eligibility

Status Completed
Enrollment 113
Est. completion date June 25, 2023
Est. primary completion date June 22, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult (= 18 years old) - PSS Questionnaire (Perceived Stress Scale) = 14 - Believing that they could be exposed to a stressful event in the next 2 months Exclusion Criteria: - Pregnant or breastfeeding woman - Currently taking a treatment from the following list: antihypertensives, immunosuppressants, antidepressants/barbiturates, anxiolytics, vitamin K antagonists (warfarin, acenocoumarol, fluindione), miconazole, anticonvulsants (carbamazepine, phenobarbital, phenytoin, oxcarbazepine...) and/or anti -infectious (rifampicin, rifabutin, efavirenz, nevirapine, griseofulvin) - With diabetes, autoimmune disease or hypotension - Currently taking a medication or dietary supplement that may affect mood, stress, sleep or anxiety - Currently using products containing any of the following ingredients: hawthorn, ashwagandha (Withania somnifera), bacopa monnieri, black grass, holy basil (Ocimum sanctum), fig buds, CBD, Eleutherococcus, Eschscholtzia, ginseng, griffonia, hops, oil lavender essential oil, marjoram essential oil, lavender hydrolyzate, milk protein hydrolyzate (Lactium), inositol, magnesium, lemon balm, St. John's wort, angelica orange, passionflower, rhodiola, saffron, theanine, asparagus stalk, tryptophan, valerian - Having known allergies to the ingredients of the product (theanine, rhodiola, passionflower and lavender)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Cen Experimental Dijon

Sponsors (1)

Lead Sponsor Collaborator
Larena SAS

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evolution of level of felt stress before and after product intake Change in stress VAS (visual analogue scale), minimum = 0 and maximum = 10 higher score means a worse outcome Before and 20 minutes after product intake
Secondary Percentage of stress enhancement responders Percentage of volunteers with a decrease in the VAS scale Before and 20 minutes after product intake
Secondary Evolution of level of felt stress Change in stress VAS (visual analogue scale), minimum = 0 and maximum = 10 higher score means a worse outcome stress usually felt, just before product intake, 20 minutes after product intake and before midnight
Secondary Evolution of stress-related signs before and after product intake Percentage of volunteers with a decrease in the stress-related signs VAS scales Before and 20 minutes after product intake
Secondary Percentage of stress-related signs enhancement responders Percentage of volunteers with a decrease in the stress-related signs VAS scales Before and 20 minutes after product intake
Secondary EvaluatIon of the organoleptic properties Evaluation with a Likert scale, minimum = very unpleasant and maximum = pleasant higher score means a best outcome Before midnight
Secondary satisfaction felt by volunteers Evaluation with a Likert scale, minimum = not effective and maximum = very effective higher score means a best outcome Before midnight
Secondary Adverse events Number and type of adverse events Before midnight
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