Radicle Relief 2: A Study of Health and Wellness Products on Pain and Health Outcomes
Study Details
Study Description
Brief Summary
A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on pain and other health outcomes
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Control 1 Relief Product Form 1 - control |
Dietary Supplement: Placebo Control Form 1
Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
|
| Experimental: Active Product 1.1 Relief Product Form 1 - active product 1 |
Dietary Supplement: Relief Active Study Product 1.1 Usage
Participants will use their Radicle Relief Active Study Product 1.1 as directed for a period of 6 weeks.
|
| Experimental: Active Product 1.2 Relief Product Form 1 - active product 2 |
Dietary Supplement: Relief Active Study Product 1.2 Usage
Participants will use their Radicle Relief Active Study Product 1.2 as directed for a period of 6 weeks.
|
Outcome Measures
Primary Outcome Measures
- Change in pain interference [6 weeks]
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)
Secondary Outcome Measures
- Change in neuropathic pain [6 weeks]
Mean difference in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A (scale 5-25; with higher scores corresponding to greater neuropathic pain)
- Change in nociceptive pain [6 weeks]
Mean difference in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A (scale 5-25; with higher scores corresponding to greater nociceptive pain)
- Change in pain intensity [6 weeks]
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')
- Change in feelings of anxiety [6 weeks]
Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
- Change in sleep [6 weeks]
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)
- Change in energy (fatigue) [6 weeks]
Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; with higher scores corresponding to greater fatigue)
- Minimal clinically important difference (MCID) in pain interference [6 weeks]
Likelihood of experiencing MCID in pain interference score as assessed by PROMIS Pain Interference 6A
- Minimal clinically important difference (MCID) in neuropathic pain [6 weeks]
Likelihood of experiencing MCID in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A
- Minimal clinically important difference (MCID) in nociceptive pain [6 weeks]
Likelihood of experiencing MCID in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A
- Minimal clinically important difference (MCID) in pain intensity [6 weeks]
Likelihood of experiencing MCID in pain intensity score as assessed by PROMIS Pain Intensity 1A
Other Outcome Measures
- Change in focus (cognitive function) [6 weeks]
Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; with higher scores corresponding to greater cognitive function)
- Change in mood (emotional distress-depression) [6 weeks]
Mean difference 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)
- Change in libido [6 weeks]
Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; with higher scores corresponding to greater interest in sexual activity)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Radicle Science, Inc | Del Mar | California | United States | 92014 |
Sponsors and Collaborators
- Radicle Science
Investigators
- Principal Investigator: Emily K. Pauli, PharmD, Radicle Science, Inc
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- RADX-2303