An interventional study of Re-Focus "Verum" Tablets and Re-Focus "Placebo" Tablets in Mental Health Wellness 1 and Work Related Stress, sponsored by A. Vogel AG. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by A. Vogel AG · Not applicable, Interventional, and Treatment
The proposed design is a randomised, double-blind, controlled, crossover intervention assessing the effects of an active intervention, containing Scutellaria baicalensis and Crataegus, versus placebo, on stress, cognition, sleep and wellbeing in healthy human volunteers. Outcome measures will be assessed acutely on day 1 and following 14 days of supplement consumption. Some interim outcome measures will also be assessed throughout the supplementation period to monitor sub-chronic changes
Participants will attend the laboratory on 5 occasions. The first visit will take place on day -2 (this is a minimum period and can take place a maximum of 14 days prior to the baseline lab visit. A training refresher will take place if 14 days is exceeded) and represents an in-person screening and training visit. (This takes place following an earlier telephone pre-screen where participants will confirm that they meet the study inclusion criteria, and not any of the exclusion criteria (performed separately, this refines the lab-based screening/training visit).) Here participants will provide written, informed consent, complete demographic and anthropometric measurements (BMI \& WHR) and be trained on the COMPASS cognitive tasks and study questionnaires.
If progressed through training/screening, participants will then return to the lab, on day 1, to complete their baseline lab visit for arm 1. This will take place at approximately 10:00 am, with participants having consumed their normal breakfast no later than 8:30 am that morning. Participants will first complete the PROM questionnaires and a baseline GSR reading (including a day-baseline saliva sample) will also be taken during this time. For the next 50 minutes, participants will complete the pre-dose COMPASS cognitive task battery and, after a short break, participants will complete the pre-dose OMS. At approximately 11:50 am, participants will consume their full daily treatment dose (2 tablets) along with a standardised lunch of a white bread cheese sandwich, packet of ready salted crisps, and a custard pot. After an hour-long 'absorption' period, participants will complete the post-dose COMPASS cognitive tasks and OMS and the testing day will be completed at approximately 2:30 pm.
Before leaving the lab, participants will be provided with their 14 (+/- the additional doses required for compliance and in case of delayed return for the chronic visit) days-worth of treatment, alongside a treatment diary to note down the time of treatment consumption each day. (The number of returned tablets on day 15, alongside reference to this treatment diary, will serve as the study compliance measures.) Participants will be advised to adhere to the following dosing regimen for each day going forward; 1 tablet in the morning, 1 in the evening, to be consumed 1 hour away from meals. On day 7 (+/- 2 days), participants will complete the PROM questionnaires, via survey, at home.
Participants will return to the lab on day 15 (+/- 2 days), following 14 full days of treatment, for the chronic lab visit for arm 1, and repeat the same procedure as day 1. A minimum 14-day washout period (with a maximum of 28 days) will then commence.
On day 30, participants will return to the lab for the baseline visit for arm 2 and repeat the same procedure as the acute arm 1 for visit. During the interim period, treatment will be consumed in the same way and, half-way through the dosing period (day 36 (+/- 2 days)) participants will complete the PROM questionnaires, via survey, at home.
On day 44 (+/- 2 days) participants will return to the lab for the chronic lab visit for arm 2, their final visit, which will be identical to the arm 1 chronic lab visit, with the exception that participants will be debriefed at the end of their visit and participant payment arranged. Here, participants will also be asked which treatment order they believed themselves to be on.
Please see figure 3 for the overall trial diagram and figure 4 for the procedure within the acute and chronic testing sessions.
235 studies on the registry are indexed under Occupational Stress; 63 are open to participants now.
This study's enrollment of 36 is below the median of 89 across 167 interventional studies indexed under Occupational Stress.
Browse Occupational Stress studies →A. Vogel AG is the lead sponsor of 15 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
If participant scores less 12, or less, on the Perceived Stress Scale
Have any pre-existing medical condition/illness which will impact taking part in the study
* NOTE: the explicit exceptions to this are controlled hyper/hypothyroidism, hay fever, high cholesterol and reflux-related conditions
Are currently taking prescription medications
*NOTE: the explicit exceptions to this are contraceptive treatments for female participants, thyroid medications, topical skin treatments and those medications used in the treatment of high cholesterol and reflux-related conditions; and those taken 'as needed' in the treatment of asthma and hay fever
The active intervention contains Scutellaria baicalensis (400 mg) and Crataegus (40 mg) and is in the form of a chewable tablet with a blood-orange flavour
Dietary Supplement: Re-Focus "Verum" Tablets · Dietary Supplement: Re-Focus "Placebo" Tablets
The placebo will be a matched control
Dietary Supplement: Re-Focus "Verum" Tablets · Dietary Supplement: Re-Focus "Placebo" Tablets
The active intervention contains Scutellaria baicalensis (400 mg) and Crataegus (40 mg) and is in the form of a chewable tablet with a blood-orange flavour
Also known as: Verum
The placebo will be a matched control.
Also known as: Placebo
Change in Cognitive function - Cognitive domain factor score
Speed of attention, accuracy of attention, speed of memory, accuracy of working memory, and accuracy of episodic memory measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University)
Time frame: Prior to (baseline) and chronic (2 weeks) of intervention
Change in Cognitive function - Cognitive domain factor score
Speed of attention, accuracy of attention, speed of memory, accuracy of working memory, and accuracy of episodic memory measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University)
Time frame: Prior to (baseline) and following acute (60 minutes post-dose) of intervention
Profile of Mood States (POMS)
35-item measure, summed to create measures of vigour, tension, fatigue, depression, confusion, anger, friendliness and total mood disturbance
Time frame: Prior to (baseline) and following 1 and 2 weeks of intervention
Perceived Stress Scale (PSS)
10-item measure, summed to create a single value with higher scores indicating higher levels of stress
Time frame: Prior to (baseline) and following 1 and 2 weeks of intervention
State-Trait Anxiety Inventory (STAI) - Trait subscale
20 item measure, summed to create a measure of trait anxiety
Time frame: Prior to (baseline) and following 1 and 2 weeks of intervention
World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF)
World Health Organisation Quality of Life Questionnaire (WHOQOL-BREF)
Time frame: Prior to (baseline) and following 1 and 2 weeks of intervention
Subjective sleep continuity
Perceived sleep continuity as assessed by subjective sleep diary (measuring: Sleep latency, time in bed, number of awakenings, wake after sleep onset, total sleep time, sleep efficiency, nocturnal physical tension, nocturnal psychological tension, sleep enjoyment and feelings of restedness)
Time frame: Prior to (baseline) and following 1 and 2 weeks of intervention
Subjective sleep via Patient-Reported Outcome Measurement, Information System Sleep Disturbance scale (PROMIS-SD)
8-item measure, summed to create a single value with higher scores indicating higher levels of sleep disturbance
Time frame: Prior to (baseline) and following 1 and 2 weeks of intervention
Depression, Anxiety and Stress scale (DASS-21)
21 item measure, summed to create 3 component scores; depression, anxiety and stress.
Time frame: Prior to (baseline) and following 1 and 2 weeks of intervention
Visual Analogue Mood Scales (VAMS)
18 visual analogue scales scored along a 100 mm line, combined to give an average score on 3 factors: Alertness, Tranquillity and Stress
Time frame: Prior to (baseline) and following 1 and 2 weeks of intervention
Visual Analogue Scales (VAS)
Visual analogue scales scored along a 100 mm line, including 'relaxed', 'stress', 'anxious', 'calm'
Time frame: Prior to (baseline) and following 1 and 2 weeks of intervention
Cognitive function - Individual cognitive task score
Individual tasks include the following: Immediate word recall, numeric working memory, choice reaction time, Corsi blocks, Peg and ball, delayed word recall, delayed word recognition, delayed name to face recall, delayed picture recognition measured by COMPASS, Northumbria University
Time frame: Prior to (baseline) and following acute (60 minutes post-dose) and chronic (2 weeks) intervention
Cognitive function - Cognitively demanding tasks
Cognitive function and mental fatigue during extended performance of cognitively demanding tasks (Cognitive Demand Battery, comprising serial 3s subtractions, serial 7s subtractions, rapid visual information processing task, and mental fatigue scale, repeated 3 times). Measured COMPASS, Northumbria University
Time frame: Prior to (baseline) and following acute (60 minutes post-dose) and chronic (2 weeks) intervention
Subjective stress reactivity - State-Trait Anxiety Inventory (STAI), State subscale
20 item measure, summed to create a measure of subjective state anxiety. Measured as response to psychological stressor
Time frame: Prior to (baseline) and following acute (120 minutes post-dose) and chronic (2 weeks) intervention
Physiological stress reactivity - cortisol and a-amylase
Measuring salivary cortisol and a-amylase to determine response to psychological stressor
Time frame: Prior to (baseline) and following acute (120 minutes post-dose) and chronic (2 weeks) intervention
Physiological stress reactivity - Galvanised skin response (GSR)
Measuring galvanised skin response to psychological stressor
Time frame: Prior to (baseline) and following acute (120 minutes post-dose) and chronic (2 weeks) intervention
Physiological stress reactivity - Heart rate (HR)
Measuring heart rate in response to psychological stressor
Time frame: Prior to (baseline) and following acute (120 minutes post-dose) and chronic (2 weeks) intervention
Cognitive function during psychological stressor
Individual tasks include the following: serial 3s subtractions, serial 7s subtractions, serial 17s subtractions and a tracking task during psychological stressor
Time frame: Prior to (baseline) and following acute (120 minutes post-dose) and chronic (2 weeks) intervention
Visual Analogue Mood Scales (VAMS)
18 visual analogue scales scored along a 100 mm line, combined to give an average score on 3 factors: Alertness, Tranquillity and Stress
Time frame: Prior to (baseline) and following one dose (acute) at 60 minutes post-dose
Visual Analogue Scales (VAS)
Visual analogue scales scored along a 100 mm line, including 'relaxed' 'stress' 'anxious' 'calm'
Time frame: Prior to (baseline) and following one dose (acute) at 60 minutes post-dose
Plan to share: No — Pseudonymized and compiled data sheets only
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A. Vogel AG