Radicle Relief 2: A Study of Health and Wellness Products on Pain and 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 adult participants, 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 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 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.

Official Title
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Radicle™ Relief 2: 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, Neuropathic Pain, Nociceptive Pain

Intervention / Treatment
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* Dietary Supplement: Relief Active Study Product 1.1 Usage
* Dietary Supplement: Relief Active Study Product 1.2 Usage
* Dietary Supplement: Placebo Control Form 1
* Dietary Supplement: Relief Active Study Product 2.1 Usage
* Dietary Supplement: Placebo Control Form 2


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 less pain as a primary desire Selects pain and/or looking to improve their pain 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 US shipping address and mobile phone number The calculated validated health survey (PRO) score during enrollment represents less than mild severity 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 Reports current enrollment in a clinical trial Lack of reliable daily access to the internet Reports current or recent (within 3 months) use of chemotherapy or immunotherapy Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied, or a substantial safety risk: Anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, or MAOIs (monoamine oxidase inhibitors) Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: NYHA (New York Heart Association) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias

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: Placebo Control 1<br>Relief Product Form 1 - control | Dietary Supplement: Placebo Control Form 1<br>* Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 1.1<br>Relief Product Form 1 - active product 1 | Dietary Supplement: Relief Active Study Product 1.1 Usage<br>* Participants will use their Radicle Relief Active Study Product 1.1 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 1.2<br>Relief Product Form 1 - active product 2 | Dietary Supplement: Relief Active Study Product 1.2 Usage<br>* Participants will use their Radicle Relief Active Study Product 1.2 as directed for a period of 6 weeks.<br>|
| Placebo Comparator: Placebo Control 2<br>Relief Product Form 2 - control | Dietary Supplement: Placebo Control Form 2<br>* Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.<br>|
| Experimental: Active Product 2.1<br>Relief Product Form 2- active product 1 | Dietary Supplement: Relief Active Study Product 2.1 Usage<br>* Participants will use their Radicle Relief Active Study Product 2.1 as directed for a period of 6 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) | 6 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) | 6 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) | 6 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') | 6 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) | 6 weeks | 
| Change in sleep | Mean difference in sleep score as assessed by PROMIS Sleep Disturbance Form 4A (scale 4-20; with higher scores corresponding to more severe sleep disturbance) | 6 weeks | 
| Change in energy (fatigue) | Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; with higher scores corresponding to greater fatigue) | 6 weeks | 
| Minimal clinically important difference (MCID) in pain interference | Likelihood of experiencing MCID in pain interference score as assessed by PROMIS Pain Interference 6A | 6 weeks | 
| Minimal clinically important difference (MCID) in neuropathic pain | Likelihood of experiencing MCID in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A | 6 weeks | 
| Minimal clinically important difference (MCID) in nociceptive pain | Likelihood of experiencing MCID in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A | 6 weeks | 
| Minimal clinically important difference (MCID) in pain intensity | Likelihood of experiencing MCID in pain intensity score as assessed by PROMIS Pain Intensity 1A | 6 weeks |