A Clinical Study to Evaluate the Efficacy of Dietary Supplement to Alleviate Stress Versus Placeb… (NCT06672965) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Study to Evaluate the Efficacy of Dietary Supplement to Alleviate Stress Versus Placebo in Subjects with Mild to Moderate Levels of Stress
United Kingdom60 participantsStarted 2023-06-19
Plain-language summary
A single centre, double blind, placebo-controlled clinical study design in healthy subjects to evaluate the efficacy of dietary supplement to alleviate stress in subjects with mild to moderate stress
Who can participate
Age range40 Years – 45 Years
SexALL
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
✓. Must complete pre-study assessment questionnaire and have a minimum stress level score of ≥14.
✓. The subject is a healthy male or female 25-55 years of age at the time of informed consent.
✓. The subject must have a BMI of ≥18.5 and ≤30.0 kg/m2 and be willing to have their height and weight measured.
✓. No reported history of psychological or mental disorders.
✓. Free of anti-depressants/anti-anxiety/mood enhancing/recreational drugs (e.g., marijuana, THC, CBD) intake for at least 6 months prior to screening.
✓. Free of any 'over the counter' or prescribed medications except for female participants taking contraceptive pills.
✓. Agree to abstain from smoking, vaping, or using recreation drugs (e.g., marijuana, THC, CBD) during the study.
✓. Willing and able to give informed consent.
Exclusion criteria
✕. Resting systolic blood pressure above 140 mmHg or a diastolic blood pressure above 90 mmHg at baseline visit.
✕. Having taken pharmaceutical products within the last 3 months to help to relieve sleep disturbances or physiological stress.
✕. Having taken dietary supplements within the last 3 months to help relieve sleep disturbances or physiological stress.
✕
What they're measuring
1
Assessment of anxiety using Hamilton Anxiety Rating Scale (HAM-A) scale
Timeframe: 30 days
2
Assessment of depression using Hamilton Depression Rating Scale (HDRS) scale
Timeframe: 30 days
3
Assessment of perception of stress in subjects that experience moderate levels of stress using Perceived Stress Scale (PSS)