Radicle Relief 1: A Study of Health and Wellness Products on Pain and Other Health Outcomes

Study Overview
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Brief Summary
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A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on pain and other health outcomes

Detailed Description
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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 pain, (2) indicate an interest in taking a health and wellness product to potentially help relieve their pain, 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 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

Official Title
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Radicle Relief 1™: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Pain and Other Health Outcomes

Conditions
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Pain, Nociceptive Pain, Neuropathic Pain

Intervention / Treatment
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* Dietary Supplement: Relief Study Product Usage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities Resides in the United States Endorses pain as a primary issue (desire for less pain) Selects their desire for less pain and/or reduce reliance on medications as a reason for their interest in taking a health and wellness product Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study Exclusion Criteria: Reports being pregnant, trying to become pregnant, or breastfeeding Unable to provide a valid physical shipping address Reports a diagnosis of liver or kidney disease Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) Unable to read and understand English Lack of reliable daily access to the internet Reports taking anticoagulants, any medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or MAOIs Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be stratified based on gender at birth then randomized to one of the study arms
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control 1<br>Relief Product Form 1 - control | Dietary Supplement: Relief Study Product Usage<br>* Participants instructed to use study product daily as directed for a period of 4 weeks<br>|
| Experimental: Active Product 1.1<br>Relief Product Form 1 - active product 1 | Dietary Supplement: Relief Study Product Usage<br>* Participants instructed to use study product daily as directed for a period of 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain interference | Mean difference in pain interference score as assessed by Patient Reported Outcome Measurement System (PROMIS) Pain Interference 6A [scale 6-30; with higher scores corresponding to greater pain interference] | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in neuropathic pain | Mean difference in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A [scale 5-25; with higher scores corresponding to greater neuropathic pain] | 4 weeks | 
| Change in nociceptive pain | Mean difference in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A [scale 5-25; with higher scores corresponding to greater nociceptive pain] | 4 weeks | 
| Change in pain intensity | Mean difference in pain intensity score as assessed by PROMIS Pain Intensity 1A [scale 1-10; with 0 being 'No pain' and 10 being 'The worst imaginable pain'] | 4 weeks | 
| Change in feelings of anxiety | Mean difference in anxiety score as assessed by PROMIS Anxiety 4A [scale 4-20; with higher scores corresponding to more severe anxiety] | 4 weeks | 
| Change in sleep disturbance | Mean difference in sleep disturbance score as assessed by PROMIS Sleep Disturbance Form 4A [scale 4-20; with higher scores corresponding to more severe sleep disturbance] | 4 weeks | 
| Minimal clinically important difference (MCID) in pain interference | Likelihood of experiencing MCID in pain interference score as assessed by PROMIS Pain Interference 6A | 4 weeks | 
| Minimal clinically important difference (MCID) in neuropathic pain | Likelihood of experiencing MCID in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A | 4 weeks | 
| Minimal clinically important difference (MCID) in nociceptive pain | Likelihood of experiencing MCID in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A | 4 weeks | 
| Minimal clinically important difference (MCID) in pain intensity | Likelihood of experiencing MCID in pain intensity score as assessed by PROMIS Pain Intensity 1A | 4 weeks |