Clinical Trials Logo

Clinical 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. 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


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05757050
Study type Interventional
Source A. Vogel AG
Contact
Status Enrolling by invitation
Phase N/A
Start date March 13, 2023
Completion date July 21, 2023

See also
  Status Clinical Trial Phase
Completed NCT05130944 - Feasibility of Community Psychosocial Intervention for Women N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Completed NCT05490979 - The Impact of Dyad Exercises on Well-being and Connection in Young Adults N/A
Not yet recruiting NCT05963893 - Promoting a Healthy Life Through Gender Equity
Completed NCT03849924 - Enhancing One's Sense of Self Using Self-Affirmation N/A
Active, not recruiting NCT05541653 - The IGNITE Study on Concentrated Investment in Black Neighborhoods N/A
Completed NCT03303326 - Arab American Women's Health Study N/A
Not yet recruiting NCT05542537 - Nurturing Healthy Teachers N/A
Completed NCT02785471 - Assessing Online Interventions for Men's' Mental Health and Wellbeing N/A
Completed NCT02683811 - Effectiveness of the Updated Version of the School-based Program Diario Della Salute (DDS-2) N/A
Withdrawn NCT05605028 - A Mental Health Intervention for a Community Program Called the PowerObesity N/A
Not yet recruiting NCT04537676 - Patient Empowerment Study
Recruiting NCT06324318 - Parenting in 2 Worlds Multisite Trial Phase 2
Completed NCT05455905 - Voice Biomarkers Predictive of Depression and Anxiety
Completed NCT03368014 - "Fun.Feel.Share" Lyrics-writing and Singing Show N/A
Completed NCT05109923 - Onnit Labs New Mood Supplementation in Healthy College Students N/A
Not yet recruiting NCT05825040 - Randomized Controlled Trial on Precision Mental Health N/A
Completed NCT06044363 - Satir Model for Self-esteem, Mental Health, and Family Function Among Individuals With Substance Use Disorders N/A
Not yet recruiting NCT06023342 - Examining Engagement Predictors of Health and Fitness App Uptake and Subscription in the General Population
Recruiting NCT04790162 - Heartfulness Meditation to Improve Resilience Among Health Care Students: A 90 Day Program N/A