Radicle Relief RAL™: A Study Assessing the Impact of Health and Wellness Products on Pain Relief and Related Health Outcomes

Radicle Relief RAL™: A Randomized, Double-Blind, Placebo-Controlled Study Assessing the Impact of Health and Wellness Products on Pain Relief and Related Health Outcomes

Radicle Relief RAL: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on pain relief and related health outcomes.

Study Overview

• Status: Active, not recruiting
• Conditions: Pain Interference
• Intervention / Treatment: Dietary supplement: Pain Relief Supplement Product Placebo Control; Dietary supplement: Pain Relief Supplement Active Product 1

Detailed Description

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

Eligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (2) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.

Self-reported data are collected electronically from eligible participants for 8 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

• Study Type: Interventional
• Enrollment (Estimated): 715
• 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

3.1 Inclusion

Participants must meet all the following criteria:

• Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities

  • Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
• Resides in the United States
• Has the opportunity for at least 30% improvement in their primary health outcome
• Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

3.2 Exclusion

Individuals who report any of the following during screening may be excluded from participation:

• Report being pregnant, trying to become pregnant, or breastfeeding
• Unable to provide a valid US shipping address and mobile phone number
• Reports current enrollment in another clinical trial
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Unable to read and understand English at a 7th grade level
• Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.

• Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.

  • NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure

• Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.

  • Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products
• Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products and/or pose a safety risk
• Lack of reliable daily access to the internet

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Control; Pain Relief Supplement Product Placebo Control	Dietary supplement: Pain Relief Supplement Product Placebo Control; Participants will use their Pain Relief Supplement Product Placebo Control as directed for a period of 8 weeks
Experimental: Active Relief Product 1; Pain Relief Supplement Active Product 1	Dietary supplement: Pain Relief Supplement Active Product 1; Participants will use their Pain Relief Supplement Active Product 1 as directed for a period of 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Interference	Change in Pain Interference: Difference in rates of change over time in pain interference score as assessed by PROMIS Pain Interference 6A (scale 6-30; with higher scores corresponding to more severe pain interference)	9 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity	Change in Pain Intensity: Difference in rates of change over time in pain intensity score as assessed by PROMIS Pain Intensity 3A (scale 3-15; with higher scores corresponding to more severe pain intensity)	9 weeks
Change in sleep	Change in sleep: Difference in rates of change over time in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)	9 weeks
Change in Physical Function	Change in physical function: Difference in rates of change over time in physical function score as assessed by Patient Reported Outcome Measurement System (PROMIS) Physical Function 8C (scale 8-40; where higher scores correspond to better physical function)	9 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minimal clinically important difference (MCID) in pain interference	Minimal clinically important difference (MCID) in pain interference: Likelihood of experiencing minimal clinically important difference in pain interference, as measured by PROMIS Pain interference (6-30; where lower scores indicate less pain interference).	9 weeks
Minimal clinically important difference (MCID) in pain intensity	Minimal clinically important difference (MCID) in pain intensity: Likelihood of experiencing minimal clinically important difference in pain intensity, as assessed by PROMIS Pain Intensity 3A (scale 3-15; with higher scores corresponding to more severe pain intensity)	9 weeks
Minimal clinically important difference (MCID) in sleep	Minimal clinically important difference (MCID) in sleep: Likelihood of experiencing minimal clinically important difference in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)	9 weeks
Minimal clinically important difference (MCID) in Physical Function	Minimal clinically important difference (MCID) in physical function: Likelihood of experiencing minimal clinically important difference in physical function score as assessed by PROMIS Physical Function 8C (scale 8-40; where higher scores correspond to better physical function)	9 weeks

Collaborators and Investigators

• Sponsor: Radicle Science
• Investigators: Principal Investigator: Susan Hewlings, Radicle Science

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2025
• Primary Completion (Estimated): January 4, 2027
• Study Completion (Estimated): January 4, 2027

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: December 1, 2025
• First Posted (Actual): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: RADX_P_2503_RAL

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