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
Not provided
Not provided
Not provided
Not provided
Not provided
A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of health and wellness products on feelings of anxiety, stress and other health outcomes
This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm, age 21 and older and residing in the United States.
Eligible participants will (1) endorse a desire for less feelings of anxiety and/or stress, (2) indicate an interest in taking a health and wellness product to potentially improve their anxiety and/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 are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.
Self-reported data will be collected electronically from eligible participants over 5 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Control 1 | Placebo Comparator | Calm Product Form 1 - control |
|
| Placebo Control 2 | Placebo Comparator | Calm Product Form 2 - control |
|
| Active Product 1.1 | Experimental | Calm Product Form 1 - active product 1 |
|
| Active Product 2.1 | Experimental | Calm Product Form 2 - active product 1 |
|
| Active Product 2.2 | Experimental | Calm Product Form 2 - active product 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radicle Calm Study Placebo Control 1 | Dietary Supplement | Participants will use their Radicle Calm Placebo Control Product 1 as directed for a period of 4 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) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal clinically important difference (MCID) in anxiety | Likelihood of experiencing a MCID in anxiety score as assessed by PROMIS Anxiety 8A | 4 weeks |
| Change in stress | Mean difference in stress score as assessed by PROMIS Stress 8A (scale 8-40; where lower scores correspond to less stress) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 4 weeks |
| Change in libido |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
| Label | URL |
|---|---|
| Radicle Science, Inc | View source |
Not provided
Data will not be shared with researchers outside of Radicle Collaborators on this study.
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will be stratified based on gender at birth then randomized to one of the study arms
Not provided
Not provided
The investigator is blinded to the participants assigned study products. Participants are blinded to the study product they received.
| Radicle Calm Study Placebo Control 2 | Dietary Supplement | Participants will use their Radicle Calm Placebo Control Product 2 as directed for a period of 4 weeks. |
|
| Radicle Calm Study Active Product 1.1 | Dietary Supplement | Participants will use their Radicle Calm Active Product 1.1 as directed for a period of 4 weeks. |
|
| Radicle Calm Study Active Product 2.1 | Dietary Supplement | Participants will use their Radicle Calm Active Product 2.1 as directed for a period of 4 weeks. |
|
| Radicle Calm Study Active Product 2.2 | Dietary Supplement | Participants will use their Radicle Calm Active Product 2.2 as directed for a period of 4 weeks. |
|
| 4 weeks |
| Minimal clinically important difference (MCID) in stress | Likelihood of experiencing a MCID in stress score as assessed by PROMIS Stress 8A | 4 weeks |
| Change in sleep disturbance | Mean difference in sleep disturbance score as assessed by PROMIS Sleep 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance) | 4 weeks |
| Change in cognitive function | Mean difference in cognitive function score as assessed by PROMIS Cognition Function 4A (scale 4-20; where lower scores correspond to poorer cognitive function) | 4 weeks |
Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 4-20; where lower scores correspond to less interest in sexual activity)
| 4 weeks |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
Not provided
Not provided