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A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on pain and related health outcomes.
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.
Eligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (2) express acceptance in taking a product and not knowing its formulation until the end of the study.
Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.
Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at 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 | Placebo Comparator | Relief Product Placebo Control |
|
| Active Product 1 | Experimental | Relief Active Product 1 |
|
| Active Product 2 | Experimental | Relief Active Product 2 |
|
| Active Product 3 | Experimental | Relief Active Product 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relief Product Placebo Control | Dietary Supplement | Participants will use their Relief Product Control as directed for a period of 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Collective | Difference in rates of change over time in pain collective score as assessed by a collective of PROMIS Pain Interference 6A, Neuropathic Pain 5A, Nociceptive Pain 5A, and Pain Intensity 1A (scale 16-90; with higher scores corresponding to greater pain) | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in feelings of anxiety | Change in feelings of anxiety: Difference between rates of change over time as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety) | 7 weeks |
| Change in sleep |
| Measure | Description | Time Frame |
|---|---|---|
| Minimal clinically important difference (MCID) in mood (emotional distress-depression) | Minimal clinically important difference (MCID) in mood (emotional distress-depression): Likelihood of experiencing minimal clinically important difference in mood score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress) | 7 weeks |
Inclusion
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Susan Hewlings | Radicle Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radicle Science Inc. | Del Mar | California | 92014 | United States |
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| Label | URL |
|---|---|
| Related Info | 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 their assigned sex at birth and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.
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The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
| Relief Active Product 1 | Dietary Supplement | Participants will use their Relief Active Product 1 as directed for a period of 6 weeks. |
|
| Relief Active Product 2 | Dietary Supplement | Participants will use their Relief Active Product 2 as directed for a period of 6 weeks. |
|
| Relief Active Product 3 | Dietary Supplement | Participants will use their Relief Active Product 3 as directed for a period of 6 weeks. |
|
Change in sleep: Difference in rates of change over time in sleep score as assessed by PROMIS Sleep Disturbance 4A (scale 4-20; where higher scores correspond to higher levels of sleep disturbance)
| 7 weeks |
| Change in mood (emotional distress-depression) | Change in mood (emotional distress-depression): Difference in rates of change over time in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress) | 7 weeks |
| Minimal clinically important difference (MCID) in sleep | Minimal clinically important difference (MCID) in sleep: Likelihood of experiencing minimal clinically important difference in sleep score as assessed by PROMIS Sleep Disturbance 4A (scale 4-20; where higher scores correspond to higher levels of sleep disturbance) | 7 weeks |
| Change in Pain Intensity | Change in Pain Intensity: Difference in rates of change over time in pain intensity score as assessed by PROMIS Pain Intensity 3A (scale 0-10; with higher scores corresponding to more severe pain intensity) | 7 weeks |
| Change in nociceptive pain | Change in nociceptive pain: Difference in rates of change over time in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A (scale 5-25; with higher scores corresponding to greater nociceptive pain) | 7 weeks |
| Change in neuropathic pain | Change in neuropathic pain: Difference in rates of change over time in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A (scale 5-25; with higher scores corresponding to greater neuropathic pain) | 7 weeks |
| Minimal clinically important difference (MCID) in feelings of anxiety | Minimal clinically important difference (MCID) in feelings of anxiety: Likelihood of experiencing minimal clinically important difference as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety) | 7 weeks |
| Minimal clinically important difference (MCID) in pain intensity | Minimal clinically important difference (MCID) in pain intensity: Likelihood of experiencing minimal clinically important difference in pain intensity, as assessed by PROMIS Pain Intensity 3A (scale 0-10; with higher scores corresponding to more severe pain intensity) | 7 weeks |
| Minimal clinically important difference (MCID) in nociceptive pain | Minimal clinically important difference (MCID) in nociceptive pain: Likelihood of experiencing minimal clinically important difference in nociceptive pain as assessed by PROMIS Nociceptive Pain 5A (scale 5-25; with higher scores corresponding to greater nociceptive pain) | 7 weeks |
| Minimal clinically important difference (MCID) in neuropathic pain | Minimal clinically important difference (MCID) in neuropathic pain: Likelihood of experiencing minimal clinically important difference in neuropathic pain as assessed by PROMIS Neuropathic Pain 5A (scale 5-25; with higher scores corresponding to greater neuropathic pain) | 7 weeks |
| Minimal clinically important difference (MCID) in pain interference | Minimal clinically important difference (MCID) in pain interference: Likelihood of experiencing minimal clinically important difference in pain interference, as measured by PROMIS Pain interference (6-30; where lower scores indicate less pain interference). | 7 weeks |
| Change in pain interference | Difference between rates of change over time, as measured by PROMIS Pain interference (6-30; where lower scores indicate less pain interference). | 7 weeks |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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