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Radicle Relief 2: A Study of Health and Wellness Products on Pain and Health Outcomes

Primary Purpose

Pain, Neuropathic Pain, Nociceptive Pain

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relief Active Study Product 1.1 Usage
Relief Active Study Product 1.2 Usage
Placebo Control Form 1
Relief Active Study Product 2.1 Usage
Placebo Control Form 2
Sponsored by
Radicle Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pain

Eligibility Criteria

21 Years - 105 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Radicle Science, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

Placebo Control 1

Active Product 1.1

Active Product 1.2

Placebo Control 2

Active Product 2.1

Arm Description

Relief Product Form 1 - control

Relief Product Form 1 - active product 1

Relief Product Form 1 - active product 2

Relief Product Form 2 - control

Relief Product Form 2- active product 1

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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')
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)
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)
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)
Minimal clinically important difference (MCID) in pain interference
Likelihood of experiencing MCID in pain interference score as assessed by PROMIS Pain Interference 6A
Minimal clinically important difference (MCID) in neuropathic pain
Likelihood of experiencing MCID in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A
Minimal clinically important difference (MCID) in nociceptive pain
Likelihood of experiencing MCID in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A
Minimal clinically important difference (MCID) in pain intensity
Likelihood of experiencing MCID in pain intensity score as assessed by PROMIS Pain Intensity 1A

Full Information

First Posted
April 6, 2023
Last Updated
October 23, 2023
Sponsor
Radicle Science
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1. Study Identification

Unique Protocol Identification Number
NCT05837923
Brief Title
Radicle Relief 2: A Study of Health and Wellness Products on Pain and Health Outcomes
Official Title
Radicle™ Relief 2: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Pain and Other Health Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
December 25, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radicle Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Neuropathic Pain, Nociceptive Pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be stratified based on gender at birth then randomized to one of the study arms
Masking
ParticipantInvestigator
Masking Description
Participants will be blinded to the product they receive.
Allocation
Randomized
Enrollment
1810 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo Control 1
Arm Type
Placebo Comparator
Arm Description
Relief Product Form 1 - control
Arm Title
Active Product 1.1
Arm Type
Experimental
Arm Description
Relief Product Form 1 - active product 1
Arm Title
Active Product 1.2
Arm Type
Experimental
Arm Description
Relief Product Form 1 - active product 2
Arm Title
Placebo Control 2
Arm Type
Placebo Comparator
Arm Description
Relief Product Form 2 - control
Arm Title
Active Product 2.1
Arm Type
Experimental
Arm Description
Relief Product Form 2- active product 1
Intervention Type
Dietary Supplement
Intervention Name(s)
Relief Active Study Product 1.1 Usage
Intervention Description
Participants will use their Radicle Relief Active Study Product 1.1 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Relief Active Study Product 1.2 Usage
Intervention Description
Participants will use their Radicle Relief Active Study Product 1.2 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Control Form 1
Intervention Description
Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Relief Active Study Product 2.1 Usage
Intervention Description
Participants will use their Radicle Relief Active Study Product 2.1 as directed for a period of 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Control Form 2
Intervention Description
Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.
Primary Outcome Measure Information:
Title
Change in pain interference
Description
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)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in neuropathic pain
Description
Mean difference in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A (scale 5-25; with higher scores corresponding to greater neuropathic pain)
Time Frame
6 weeks
Title
Change in nociceptive pain
Description
Mean difference in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A (scale 5-25; with higher scores corresponding to greater nociceptive pain)
Time Frame
6 weeks
Title
Change in pain intensity
Description
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')
Time Frame
6 weeks
Title
Change in feelings of anxiety
Description
Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
Time Frame
6 weeks
Title
Change in sleep
Description
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)
Time Frame
6 weeks
Title
Change in energy (fatigue)
Description
Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; with higher scores corresponding to greater fatigue)
Time Frame
6 weeks
Title
Minimal clinically important difference (MCID) in pain interference
Description
Likelihood of experiencing MCID in pain interference score as assessed by PROMIS Pain Interference 6A
Time Frame
6 weeks
Title
Minimal clinically important difference (MCID) in neuropathic pain
Description
Likelihood of experiencing MCID in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A
Time Frame
6 weeks
Title
Minimal clinically important difference (MCID) in nociceptive pain
Description
Likelihood of experiencing MCID in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A
Time Frame
6 weeks
Title
Minimal clinically important difference (MCID) in pain intensity
Description
Likelihood of experiencing MCID in pain intensity score as assessed by PROMIS Pain Intensity 1A
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Change in focus (cognitive function)
Description
Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; with higher scores corresponding to greater cognitive function)
Time Frame
6 weeks
Title
Change in mood (emotional distress-depression)
Description
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)
Time Frame
6 weeks
Title
Change in libido
Description
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)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily K. Pauli, PharmD
Organizational Affiliation
Radicle Science, Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radicle Science, Inc
City
Del Mar
State/Province
California
ZIP/Postal Code
92014
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will not be shared with researchers outside of Radicle Collaborators on this study.
Links:
URL
http://radiclescience.com
Description
Radicle Science, Inc

Learn more about this trial

Radicle Relief 2: A Study of Health and Wellness Products on Pain and Health Outcomes

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