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

NCT07262775 | Active Not Recruiting

• 1 other identifier: RADX_P_2503_RAL
• Study Type: interventional
• Target: 715
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Interference

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Pain Intensity

  9 weeks

• Change in sleep

  9 weeks

• Change in Physical Function

  9 weeks

Other Outcomes (4)

• Minimal clinically important difference (MCID) in pain interference

  9 weeks

• Minimal clinically important difference (MCID) in pain intensity

  9 weeks

• Minimal clinically important difference (MCID) in sleep

  9 weeks

Study Arms (2)

Placebo Control

PLACEBO COMPARATOR

Pain Relief Supplement Product Placebo Control

Dietary Supplement: Pain Relief Supplement Product Placebo Control

Active Relief Product 1

EXPERIMENTAL

Pain Relief Supplement Active Product 1

Dietary Supplement: Pain Relief Supplement Active Product 1

Interventions

Pain Relief Supplement Product Placebo Control DIETARY_SUPPLEMENT

Participants will use their Pain Relief Supplement Product Placebo Control as directed for a period of 8 weeks

Placebo Control

Pain Relief Supplement Active Product 1 DIETARY_SUPPLEMENT

Participants will use their Pain Relief Supplement Active Product 1 as directed for a period of 8 weeks

Active Relief Product 1

Eligibility Criteria

• Age: 21 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science Inc.

Del Mar, California, 92014, United States

Location

Related Links

• Related Info

Study Officials

• Susan Hewlings

  Radicle Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be stratified based on their assigned sex at birth and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 4, 2025
• Study Start: December 18, 2025
• Primary Completion (Estimated): January 4, 2027
• Study Completion (Estimated): January 4, 2027
• Last Updated: April 21, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)