Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product Arm | Experimental | Participants in this arm will receive the test product, which is an alcohol alternative herbal tincture. The intervention includes taking 2 ml of the test product directly onto the tongue every evening, 1-2 hours before bedtime, for a duration of 8 weeks. |
|
| Placebo Arm | Placebo Comparator | Participants in this arm will receive a placebo. The intervention includes taking 2 ml of the placebo directly onto the tongue every evening, 1-2 hours before bedtime, for a duration of 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol Alternative Herbal Tincture (Test Product) | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvements in Sleep Quality and Mental Well-Being | 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. | Baseline, Week 2, Week 4, Week 6, and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Sleep Length and Quality | 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. | Baseline, Week 4, and Week 8 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Parallel Assignment
Not provided
Not provided
Double-blind (Participant, Investigator)
|
| Placebo | Dietary Supplement | 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). |
|
| D009422 |
| Nervous System Diseases |