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A randomized, double-blinded, placebo-controlled study assessing the impact of health and wellness products on feeling of anxiety, stress, and other health outcomes
This is a randomized, double-blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.
Eligible participants will (1) endorse a desire for less anxiety or stress, (2) indicate an interest in taking a health and wellness product to potentially help their feelings of anxiety or stress, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.
Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Control 1 | Placebo Comparator | Calm Product Form 1 - control |
|
| Active Product 1.1 | Experimental | Calm Product Form 1 - active product 1 |
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| Active Product 1.2 | Experimental | Calm Product Form 1 - active product 2 |
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| Active Product 1.3 | Experimental | Calm Product Form 1 - active product 3 |
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| Placebo Control 2 | Placebo Comparator | Calm Product Form 2 - control |
|
| Active Product 2.1 | Experimental | Calm Product Form 2 - active product 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calm Active Study Product 1.1 Usage | Dietary Supplement | Participants will use their Radicle Calm Active Study Product 1.1 as directed for a period of 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in feelings of anxiety | Mean difference in feelings of anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in stress | Mean difference in stress score as assessed by National Institutes of Health (NIH) Toolbox Perceived Stress Survey (scale 10-50; where lower scores correspond to less stress) | 6 weeks |
| Change in cognitive function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily K. Pauli, PharmD | Radicle Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radicle Science, Inc | Del Mar | California | 92014 | United States |
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| Label | URL |
|---|---|
| Radicle Science, Inc | View source |
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Data will not be shared with researchers outside of Radicle Collaborators on this study.
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Participants will be stratified based on gender at birth then randomized to one of the study arms
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The investigator is blinded to the participants' study product assignment. Participants are blinded to the study product they are assigned.
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| Placebo Control 3 | Placebo Comparator | Calm Product Form 3 - control |
|
| Active Product 3.1 | Experimental | Calm Product Form 3 - active product 1 |
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| Placebo Control 4 | Placebo Comparator | Calm Product Form 4 - control |
|
| Active Product 4.1 | Experimental | Calm Product Form 4 - active product 1 |
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| Calm Active Study Product 1.2 Usage | Dietary Supplement | Participants will use their Radicle Calm Active Study Product 1.2 as directed for a period of 6 weeks. |
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| Calm Active Study Product 1.3 Usage | Dietary Supplement | Participants will use their Radicle Calm Active Study Product 1.3 as directed for a period of 6 weeks. |
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| Placebo Control Form 1 | Dietary Supplement | Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks. |
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| Placebo Control Form 2 | Dietary Supplement | Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks. |
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| Calm Active Study Product 2.1 Usage | Dietary Supplement | Participants will use their Radicle Calm Active Study Product 2.1 as directed for a period of 6 weeks. |
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| Placebo Control Form 3 | Dietary Supplement | Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks. |
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| Calm Active Study Product 3.1 Usage | Dietary Supplement | Participants will use their Radicle Calm Active Study Product 3.1 as directed for a period of 6 weeks. |
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| Placebo Control Form 4 | Dietary Supplement | Participants will use their Placebo Control Form 4 as directed for a period of 6 weeks. |
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| Calm Active Study Product 4.1 Usage | Dietary Supplement | Participants will use their Radicle Calm Active Study Product 4.1 as directed for a period of 6 weeks. |
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Mean difference in cognitive function score as assessed by PROMIS Cognition Function 4A (scale 4-20; where lower scores correspond to poorer cognitive function)
| 6 weeks |
| Change in sleep | Mean difference in sleep score as assessed by PROMIS Sleep Disturbance 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance) | 6 weeks |
| Change in mood (emotional distress) | Mean difference in mood score as assessed by PROMIS Emotional Distress-Depression 4A (scale 4-20; where lower scores correspond to lower levels of emotional distress) | 6 weeks |
| Change in libido | Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; where lower scores correspond to less interest in sexual activity) | 6 weeks |
| Minimal clinically important difference (MCID) in feelings of anxiety | Likelihood of achieving a MCID in sleep disturbance, as measured by PROMIS Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety) | 6 weeks |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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