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

Radicle™ Relief 2: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Pain and Other Health Outcomes

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

Study Overview

• Status: Completed
• Conditions: Pain; Neuropathic Pain; Nociceptive Pain
• Intervention / Treatment: Dietary supplement: Placebo Control Form 1; Dietary supplement: Placebo Control Form 2; Dietary supplement: Placebo Control Form 3; Dietary supplement: Relief Active Study Product 1.1 Usage; Dietary supplement: Relief Active Study Product 1.2 Usage; Dietary supplement: Relief Active Study Product 2.1 Usage; Dietary supplement: Relief Active Study Product 3.1 Usage; Dietary supplement: Relief Active Study Product 3.2 Usage; Dietary supplement: Relief Active Study Product 3.3 Usage

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 Type: Interventional
• Enrollment (Actual): 2016
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Del Mar, California, United States, 92014
      • Radicle Science, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 2.1; Relief Product Form 2 - active product 1	Dietary supplement: Relief Active Study Product 2.1 Usage; Participants will use their Radicle Relief Active Study Product 2.1 as directed for a period of 6 weeks.
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 1.2; 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.
Placebo Comparator: Placebo Control 2; Relief Product Form 2 - control	Dietary supplement: Placebo Control Form 2; Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.
Placebo Comparator: Placebo Control 3; Relief Product Form 3 - control	Dietary supplement: Placebo Control Form 3; Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks.
Experimental: Active Product 3.1; Relief Product Form 3 - active product 1	Dietary supplement: Relief Active Study Product 3.1 Usage; Participants will use their Radicle Relief Active Study Product 3.1 as directed for a period of 6 weeks.
Experimental: Active Product 3.2; Relief Product Form 3 - active product 2	Dietary supplement: Relief Active Study Product 3.2 Usage; Participants will use their Radicle Relief Active Study Product 3.2 as directed for a period of 6 weeks.
Experimental: Active Product 3.3; Relief Product Form 3 - active product 3	Dietary supplement: Relief Active Study Product 3.3 Usage; Participants will use their Radicle Relief Active Study Product 3.3 as directed for a period of 6 weeks.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in focus (cognitive function)	Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; with higher scores corresponding to greater cognitive function)	6 weeks
Change in mood (emotional distress-depression)	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)	6 weeks
Change in libido	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)	6 weeks

Collaborators and Investigators

• Sponsor: Radicle Science
• Investigators: Principal Investigator: Emily K. Pauli, PharmD, Radicle Science Inc.

Publications and helpful links

Helpful Links

• Radicle Science, Inc

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2024
• Primary Completion (Actual): July 17, 2024
• Study Completion (Actual): July 17, 2024

Study Registration Dates

• First Submitted: April 6, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Neuralgia; Nociceptive Pain
• Other Study ID Numbers: RADX-2303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared with researchers outside of Radicle Collaborators on this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No