Mental Health Wellness 1NCT05757050
Mental Balance Study
A study testing Re-Focus "Verum" Tablets in people with Mental Health Wellness 1 and Work Related Stress, run by A. Vogel AG at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1, Work Related Stress
- What is being tested?
- Re-Focus "Verum" Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Mar 2023to 21 Sep 2023
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-75
Who cannot join
- • 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
- Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg). NOTE: that we must measure this in the lab using our blood pressure monitors and can only use our measurements to assess eligibility rather than home or GP readings
Show all 25Show fewer
- Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2
- Are pregnant, seeking to become pregnant or lactating
- Have learning and/or behavioural difficulties such as dyslexia or ADHD
- Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)
- Smoke tobacco or vape nicotine or use nicotine replacement products (if you have recently quit smoking or using replacements you must have stopped using them altogether for a period of 3 months before participating in this study)
- Have excessive caffeine intake (>500 mg per day). Note: This will be calculated at screening but feel free to query this with the researcher prior to attendance
- Have relevant food allergies/ intolerances/ sensitivities (Please discuss with researcher prior to attendance if you are unsure of relevance)
- Have taken antibiotics within the past 4 weeks
- Have taken dietary supplements e.g. vitamins, omega 3 fish oils etc. in the last 4 weeks (Note: participation is possible following a 4-week supplement washout prior to participating and for the duration of the study on the proviso that the supplements are taken are out of choice and are not medically prescribed or advised). Existing and consistent use of vitamin D supplements and protein shakes are permitted
- Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
- Are unable to complete all of the study assessments
- Are currently participating in other clinical or nutrition intervention studies, or have in the past 4 weeks
- Have been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months
- Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months, including a medical diagnosis of anxiety or depression.
- Suffers from frequent migraines that require medication (more than or equal to 1 per month)
- Have oral disease
- Have any known active infections
- Does not have a bank account (required for payment)
- Are non-compliant with regards treatment consumption
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, Tyne & Wear, NE1 8ST
About this study
Official title: Evaluating the Effects of the Supplement ReFocus Tablets on Stress, Cognitive Function, Sleep and Wellbeing Following 14 Days Consumption in Healthy Volunteers Reporting Subjective Stress: A Randomised, Double-blind, Placebo Controlled, Crossover Trial
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
Read the detailed description
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.
- Conditions
- Mental Health Wellness 1, Work Related Stress
- Being tested
- Re-Focus "Verum" Tablets, Re-Focus "Placebo" Tablets
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-Focus "Verum" TabletsDietary supplement
Also called Verum
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
Re-Focus "Placebo" TabletsDietary supplement
Also called Placebo
The placebo will be a matched control.
| Study group | Role | What they receive |
|---|---|---|
| Re-Focus Tablets "Verum" | Experimental | 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 Receives: Dietary Supplement: Re-Focus "Verum" Tablets; Dietary Supplement: Re-Focus "Placebo" Tablets |
| Re-Focus Tablets "Placebo" | Placebo comparator | The placebo will be a matched control Receives: Dietary Supplement: Re-Focus "Verum" Tablets; Dietary Supplement: Re-Focus "Placebo" Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Prior to (baseline) and following acute (60 minutes post-dose) of intervention
Secondary outcomes (18)
Profile of Mood States (POMS)
35-item measure, summed to create measures of vigour, tension, fatigue, depression, confusion, anger, friendliness and total mood disturbance
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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'
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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'
Measured: Prior to (baseline) and following one dose (acute) at 60 minutes post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start9 Mar 2023
- Primary completion21 Aug 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- A. Vogel AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Newcastle Upon-Tyne
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757050
- Sponsor's protocol ID
- 5'000'750-1
- Status last verified
- Feb 2026
- First submitted
- 15 Feb 2023
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pseudonymized and compiled data sheets only
Publications
Dodd F, Weishaupt R, Katumba PKM, Elcoate R, Wightman E. Effects of a Scutellaria baicalensis/Crataegus laevigata, magnesium and chromium supplement on stressed individuals: A randomised, double-blind, placebo-controlled, crossover trial. J Psychopharmacol. 2025 Dec;39(12):1420-1436. doi: 10.1177/02698811251381261. Epub 2025 Nov 5.
PubMed 41194549
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of the Supplement ReFocus Tablets on Stress, Cognitive Function, Sleep and Wellbeing Following 14 Days Consumption in Healthy Volunteers Reporting Subjective Stress: A Randomised, Double-blind, Placebo Controlled, Crossover Trial
- ClinicalTrials.gov ID
- NCT05757050
- Acronym / sponsor ID
- 5'000'750-1
- Conditions
- Mental Health Wellness 1, Work Related Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- A. Vogel AGIndustry (pharma, biotech, devices)
- Collaborators
- University of Newcastle Upon-Tyne
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 7 Mar 2023 (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 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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Re-Focus Tablets "Verum" | Experimental | Dietary Supplement: Re-Focus "Verum" Tablets, Dietary Supplement: Re-Focus "Placebo" TabletsThe 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 |
| Re-Focus Tablets "Placebo" | Placebo comparator | Dietary Supplement: Re-Focus "Verum" Tablets, Dietary Supplement: Re-Focus "Placebo" TabletsThe placebo will be a matched control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-75
Key exclusion criteria (25 listed)
- • If participant scores less 12, or less, on the Perceived Stress Scale
- 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
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 |
|---|---|---|
| Re-Focus "Verum" TabletsAlso: VerumThe 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 Tablets "Placebo", Re-Focus Tablets "Verum" |
| Re-Focus "Placebo" TabletsAlso: PlaceboThe placebo will be a matched control. | Dietary supplement | Re-Focus Tablets "Placebo", Re-Focus Tablets "Verum" |
Primary outcome
Change in Cognitive function - Cognitive domain factor score
Time frame: Prior to (baseline) and chronic (2 weeks) of intervention
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)
Change in Cognitive function - Cognitive domain factor score
Time frame: Prior to (baseline) and following acute (60 minutes post-dose) of intervention
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)
18 secondary outcomes
Profile of Mood States (POMS)
Time frame: Prior to (baseline) and following 1 and 2 weeks of intervention
Perceived Stress Scale (PSS)
Time frame: Prior to (baseline) and following 1 and 2 weeks of intervention
State-Trait Anxiety Inventory (STAI) - Trait subscale
Time frame: Prior to (baseline) and following 1 and 2 weeks of intervention
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
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)
Time frame: Prior to (baseline) and following 1 and 2 weeks of intervention
Depression, Anxiety and Stress scale (DASS-21)
Time frame: Prior to (baseline) and following 1 and 2 weeks of intervention
Visual Analogue Mood Scales (VAMS)
Time frame: Prior to (baseline) and following 1 and 2 weeks of intervention
Visual Analogue Scales (VAS)
Time frame: Prior to (baseline) and following 1 and 2 weeks of intervention
Cognitive function - Individual cognitive task score
Time frame: Prior to (baseline) and following acute (60 minutes post-dose) and chronic (2 weeks) intervention
Cognitive function - Cognitively demanding tasks
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
Time frame: Prior to (baseline) and following acute (120 minutes post-dose) and chronic (2 weeks) intervention
Physiological stress reactivity - cortisol and a-amylase
Time frame: Prior to (baseline) and following acute (120 minutes post-dose) and chronic (2 weeks) intervention
Physiological stress reactivity - Galvanised skin response (GSR)
Time frame: Prior to (baseline) and following acute (120 minutes post-dose) and chronic (2 weeks) intervention
Physiological stress reactivity - Heart rate (HR)
Time frame: Prior to (baseline) and following acute (120 minutes post-dose) and chronic (2 weeks) intervention
Cognitive function 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)
Time frame: Prior to (baseline) and following one dose (acute) at 60 minutes post-dose
Visual Analogue Scales (VAS)
Time frame: Prior to (baseline) and following one dose (acute) at 60 minutes post-dose
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 2 Mar 2026.
- Derived from this study: PubMed 41194549Dodd F, Weishaupt R, Katumba PKM, Elcoate R, Wightman E. Effects of a Scutellaria baicalensis/Crataegus laevigata, magnesium and chromium supplement on stressed individuals: A randomised, double-blind, placebo-controlled, crossover trial. J Psychopharmacol. 2025 Dec;39(12):1420-1436. doi: 10.1177/02698811251381261. Epub 2025 Nov 5.
- Individual participant dataSharing planned: No. Pseudonymized and compiled data sheets only
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Re-Focus "Verum" Tablets in people with Mental Health Wellness 1 and Work Related Stress, run by A. Vogel AG at 1 site in United Kingdom.
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 1 inclusion and 25 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 2 Mar 2026. 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 United Kingdom. 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?
Change in Cognitive function - Cognitive domain factor score (time frame: Prior to (baseline) and chronic (2 weeks) of intervention). The study lists 2 primary outcomes in all. 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 NCT05757050, which also lists 1 linked publication.
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 2 Mar 2026.