Anxiety, Stress
Conditions
Keywords
Sleep Quality, Sleep Tracker, Relaxation, Herbal Tincture
Brief summary
This is a virtual randomized placebo-controlled double-blind trial lasting eight weeks. The trial will assess the effects of a test product on improving sleep quality, promoting a sense of calm, and reducing feelings of stress and anxiety, using a sleep tracker and subject-specific questionnaires. The study involves 80 participants who experience sleep issues and feelings associated with stress and anxiety.
Interventions
DIETARY_SUPPLEMENTAlcohol Alternative Herbal Tincture (Test Product)
The test product contains organic vegetable glycerin, distilled water, organic elderberries, organic bilberries, organic beetroot juice powder, organic California poppy (whole plant), organic tart cherry, organic hawthorn berries, organic blue vervain (aerial parts), organic ceylon cinnamon bark, organic black pepper fruit, and L-theanine.
DIETARY_SUPPLEMENTPlacebo
The placebo is designed to match the test product in appearance and taste but does not contain the active herbal ingredients. Participants will take 2 ml of the placebo directly onto the tongue every evening, 1-2 hours before bedtime, for a duration of 8 weeks. The placebo contains organic vegetable glycerin, distilled water, organic beet juice powder, organic tart cherries, organic ceylon cinnamon chips, and natural green food coloring (derived from spirulina and turmeric).
Sponsors
Citruslabs
Apothekary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind (Participant, Investigator)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Aged 21-65 years * Male or female * Good general health * Experience daily feelings of stress and anxiety within the past two weeks * Experience daily problems with sleeping, reduced energy levels, and fatigue over the past two weeks * Have used alcohol products to help relax or sleep within the past two weeks * Experience tension in the body within the past two weeks * Experience problems with relaxing in the evening within the past two weeks * Willing to abstain from alcohol for the duration of the study * Willing to maintain stable use of other herbal supplements, over-the-counter medications, or prescriptions during the study
Exclusion criteria
* Chronic health conditions, including oncological and psychiatric disorders * Taking SSRIs, sedative, or blood pressure-lowering medications * Pregnant, breastfeeding, or planning to conceive within the next three months * Currently enrolled or planning to enroll in another research trial over the next eight weeks * History of substance abuse * Known serious allergic reactions requiring an Epi-Pen
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvements in Sleep Quality and Mental Well-Being | Baseline, Week 2, Week 4, Week 6, and Week 8 | Changes in sleep quality, mental well-being, stress, and feelings of anxiety will be assessed using self-assessment questionnaires. Participants will complete these questionnaires at specified intervals throughout the study to evaluate the effectiveness of the herbal tincture compared to the placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Sleep Length and Quality | Baseline, Week 4, and Week 8 | Changes in sleep length and quality will be monitored using a Fitbit sleep tracker. The sleep tracker will collect data on various sleep parameters, including total sleep time and sleep stages, to assess the impact of the herbal tincture compared to the placebo. |
Countries
United States
Outcome results
None listed