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CompletedNCT03909906Updated Mar 3, 2020

Chronic Effects of Euphytose® on Psychological and Physiological Measures of Stress

An interventional study of Euphytose® and Placebo Oral Tablet in Mood, sponsored by Northumbria University. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-03.

Sponsored by Northumbria University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The aim of this study is to assess the chronic effects (14 days) of Euphytose® on psychological state, physiological stress responses and any resulting changes in gut microflora communities as compared to placebo.

Read the detailed description

The aim of the proposed study is to assess the effects of chronic (14 days) supplementation with Euphytose® on psychological state with regards perceived stress and overall mood as well as psychological and physiological stress responses during a laboratory stressor. The trial will employ the Observed Multitasking Stressor (OMS), with psychological state and physiological responses assessed before and after its completion. The main mood/psychological stressor assessment will take place pre-treatment and following 14 days of treatment. Stool samples will also be collected from participants in order to assess changes in gut microflora communities at visits 1 and 2.

02

Conditions studied

  • Mood

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Keywords

  • cognition
  • anxiety
  • herbal supplements
03

In context

Anxiety Disorders

5,065 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.

This study's enrollment of 31 is below the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.

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Lead sponsor

Northumbria University is the lead sponsor of 160 studies on the registry; 22 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 18-65 years
  • In good physical health
  • Subjects agree to abstain throughout the trial from all dietary supplements (note: protein shakes and garlic supplements are allowed)
  • Body Mass Index above 18 kg/m2 and below 35 kg/m2
  • Subjects are, in the opinion of the investigator, willing to participate in all scheduled visits and to adhere to all study procedures
  • Subjects accept to refrain from alcohol intake 24 hours prior to Testing Visits 1-4
  • Subjects do not have a current diagnosis of a significant medical condition which may interfere with the subject's ability to perform assessments and successfully completes training
  • Subjects provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial and understood and accepts these
  • Have a bank account (required for payment)

Exclusion criteria

Exclusion Criteria:

  • Have any pre-existing medical condition/illness? NOTE: the exceptions to this are controlled (medicated) arthritis, asthma, high cholesterol and reflux-related conditions
  • Event (personal or professional) likely to have impacted the subject's emotional and/ or psychological state within the last 8 weeks (for example but not restricted to: change of professional function/situation, death of a family member, divorce, surgery, accident, etc.)
  • Event (personal or professional) likely to affect the subject's emotional, psychological or hormonal state planned during the next 8 weeks, including vaccination, important medical exam etc.
  • Smoking or the use of any nicotine replacement products e.g. vaping, gum, patches (smoking within the last 3 months)
  • Blood pressure >159/99 millimeters of mercury (mmHg)
  • Excessive use of caffeine (> 500 mg caffeine per day) from all dietary sources
  • Current intake of pharmaceuticals (excluding contraception and arthritis, cholesterol and reflux-related hormone replacement treatments (for female participants) where symptoms are stable and medications do not contraindicate the study outcomes and inhalers used as required)
  • Have taken antibiotics within the last 4 weeks
  • Any known active infections
  • Have a recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as more than 60g (men) / 40g (women) pure alcohol per day (7 / 5.5 units)
  • A history of neurological or psychiatric diseases excluding anxiety or depression
  • A diagnosis/treatment for a psychiatric disorder within the past 12 months (including anxiety or depression)
  • A history of significant head trauma
  • Have sleep disturbances and/or are taking sleep aid medication
  • Have learning difficulties or dyslexia
  • Have visual impairment that cannot be corrected with glasses or contact lenses (including colour blindness)
  • Have frequent migraines that require medication (more than or equal to 1 per month)
  • Not proficient in English equivalent to International English Language Testing System (IELTS) band 6 or above
  • Are pregnant, trying to get pregnant or breast feeding
  • Have any health condition that would prevent fulfillment of the study requirements
  • Any condition which may interfere with the subjects ability to perform assessments
  • Are employed in a job that includes night shift work
  • Have no access to the internet (including via smartphone)
  • Are unable to perform the computerized tests during training to the established acceptable levels for participation in this type of study.
  • Have habitually used supplements, within the last month (defined as more than 3 consecutive days or 4 days in total)
  • Participation in another clinical trial within 30 days prior to screening
  • Any history of hypersensitivity to the investigational product or its active or inactive constituents or any food allergy or intolerance
  • Non-compliant in terms of treatment consumption
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
31 participants (actual)

Study arms

  • Active comparator
    Euphytose®

    Euphytose® 2 tablets 3 times per day for 14 days

    Drug: Euphytose®

  • Placebo comparator
    Placebo

    Matched placebo 2 tablets, 3 times per day for 14 days

    Drug: Placebo Oral Tablet

Interventions

  • DrugEuphytose®

    (50mg Valeriana officinalis L., 40mg Passiflora incarnate L., 10mg Crataegus sp., 10mg Ballota nigra L.)

  • DrugPlacebo Oral Tablet

    Placebo comparator

06

What researchers measure

Primary outcomes

  1. Chronic treatment effects on anxiety following a psychological stressor

    Ratings of anxiety as defined by the Stait Trait Anxiety Inventory (STAI) - State subscale

    Time frame: Following 14 days treatment

Secondary outcomes

  1. Chronic (14 days) treatment effects on general anxiety

    Ratings of anxiety as defined by the Stait Trait Anxiety Inventory (STAI) - Trait subscale

    Time frame: Following 14 days treatment

  2. Chronic (14 days) treatment effects on general psychological health

    Ratings of general psychological health as defined by the General Health Questionnaire (GHQ-12)

    Time frame: Following 14 days treatment

  3. Chronic (14 Days) treatment effects on stress

    Ratings of stress as defined by the Perceived Stress Scale (PSS) (Total score 0-40)

    Time frame: Following 14 days treatment

  4. Chronic (14 days) treatment effects on psychological distress

    Ratings of stress as defined by the Profile of Mood States (POMS)

    Time frame: Following 14 days treatment

  5. Chronic (14 days) treatment effects on subjective mood as assessed by visual analogue scales following a psychological stressor

    Ratings of mood (scored along a 100mm line)

    Time frame: Following 14 days treatment, measures immediately before, after and at 30, 60 and 90 minutes following a psychological stressor

  6. Chronic (14 days) treatment effects on subjective ratings of stress as assessed by visual analogue scales following a psychological stressor

    Ratings of stress (scored along a 100mm line)

    Time frame: Following 14 days treatment, measures immediately before, after and at 30, 60 and 90 minutes following a psychological stressor

  7. Chronic (14 days) treatment effects on physiological stress responses

    Measuring readings of galvanic skin response to determine response to psychological stressor

    Time frame: Measures taken following 14 days treatment prior to and during a psychological stressor

  8. Chronic (14 days) treatment effects on physiological stress responses

    Measuring readings of heart rate response to determine response to psychological stressor

    Time frame: Measures taken following 14 days treatment prior to and during a psychological stressor

  9. Chronic (14 days) treatment effects on other physiological stress responses

    Measuring salivary cortisol and a-amylase to determine response to psychological stressor

    Time frame: Following 14 days treatment, measures taken at baseline, immediately before, after and then at 15, 30, 60 and 90 minutes following a psychological stressor

  10. Chronic (14 days) treatment effects on gut microbiota

    Measuring changes in gut microflora communities

    Time frame: Following 14 days treatment

  11. Chronic (14 days) treatment effects on cognitive performance during psychological stressor

    Tasks include serial 3s, serial 7s, serial 17s, tracking task

    Time frame: Following 14 days treatment

  12. 7 days treatment effects on cognitive performance

    Tasks include simple reaction time, digit vigilance, stroop, Rapid Visual Information Processing (RVIP), peg and ball tasks

    Time frame: Following 7 days treatment

  13. 13 days treatment effects on cognitive performance

    Tasks include simple reaction time, digit vigilance, stroop, RVIP, peg and ball tasks

    Time frame: Following 13 days treatment

  14. 7 days treatment effects on subjective ratings of mood as assessed by visual analogue scales

    Ratings of mood (scored along a 100mm line)

    Time frame: Following 7 days treatment

  15. 13 days treatment effects on subjective ratings of mood as assessed by visual analogue scales

    Ratings of mood (scored along a 100mm line)

    Time frame: Following 13 days treatment

  16. 7 days treatment effects on subjective ratings of stress as assessed by visual analogue scales

    Ratings of stress (scored along a 100mm line)

    Time frame: Following 7 days treatment

  17. 13 days treatment effects on subjective ratings of stress as assessed by visual analogue scales

    Ratings of stress (scored along a 100mm line)

    Time frame: Following 13 days treatment

  18. 7 days treatment effects on stress

    Ratings of stress as defined by the Perceived Stress Scale (PSS) (Total score 0-40)

    Time frame: Following 7 days treatment

  19. 13 days treatment effects on stress

    Ratings of stress as defined by the Perceived Stress Scale (PSS) (Total score 0-40)

    Time frame: Following 13 days treatment

  20. 7 days treatment effects on sedation

    Ratings of subjective drowsiness as as defined by the Karolinska Sleepiness Scale (KSS) (Total score 1-10)

    Time frame: Following 7 days treatment

  21. 13 days treatment effects on sedation

    Ratings of subjective drowsiness as as defined by the Karolinska Sleepiness Scale (KSS)(Total score 1-10)

    Time frame: Following 13 days treatment

07

Study locations

1 site
  • Brain performance and nutrition research centre, Northumbria university
    Newcastle upon Tyne, Tyne and Wear NE1 8ST, United Kingdom
08

References and documents

Publications

  • Dodd F, Kennedy D, Wightman E, Khan J, Patan M, Elcoate R, Jackson P. The chronic effects of a combination of herbal extracts (Euphytose(R)) on psychological mood state and response to a laboratory stressor: A randomised, placebo-controlled, double blind study in healthy humans. J Psychopharmacol. 2022 Nov;36(11):1243-1256. doi: 10.1177/02698811221112933. Epub 2022 Jul 23. PubMed 35875924 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2019 to primary completion in Dec 2019, 8 months.

Of 2,720 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's 8 months is below that.

Counting every sponsor, half of 2,789 studies reached it within 12 months; a quarter within 5 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 4, 2019
First posted
Apr 10, 2019
StartActual
Apr 3, 2019
Primary completionActual
Dec 18, 2019
CompletionActual
Dec 18, 2019
Last update
Mar 3, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03909906
Lead sponsor
Northumbria University
Collaborators
Bayer
Responsible party
Philippa Jackson (Senior Lecturer, Northumbria University) — Principal investigator
First posted
Apr 10, 2019
Start date
Apr 3, 2019
Primary completion
Dec 18, 2019
Completion
Dec 18, 2019
Last update
Mar 3, 2020

Study contacts

Philippa Jackson, Dr
principal investigator · Study Principal Investigator

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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