Mental Balance Study (NCT05757050) | Clinical Trial Compass
CompletedNot Applicable
Mental Balance Study
United Kingdom36 participantsStarted 2023-03-09
Plain-language 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. 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18-75
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
* 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
* 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 participatin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Cognitive function - Cognitive domain factor score
Timeframe: Prior to (baseline) and chronic (2 weeks) of intervention
2
Change in Cognitive function - Cognitive domain factor score
Timeframe: Prior to (baseline) and following acute (60 minutes post-dose) of intervention