Radicle Relief 24_RLN: A Study Assessing the Impact of Health and Wellness Products on Pain and Related Health Outcomes.

NCT07160712 | Completed

• 1 other identifier: RADX_P_2403_RLN
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on pain and related health outcomes.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Collective

  Difference in rates of change over time in pain collective score as assessed by a collective of PROMIS Pain Interference 6A, Neuropathic Pain 5A, Nociceptive Pain 5A, and Pain Intensity 1A (scale 16-90; with higher scores corresponding to greater pain)

  7 weeks

Secondary Outcomes (3)

• Change in feelings of anxiety

  7 weeks

• Change in sleep

  7 weeks

• Change in mood (emotional distress-depression)

  7 weeks

Other Outcomes (11)

• Minimal clinically important difference (MCID) in mood (emotional distress-depression)

  7 weeks

• Minimal clinically important difference (MCID) in sleep

  7 weeks

• Change in Pain Intensity

  7 weeks

Study Arms (4)

Placebo Control

PLACEBO COMPARATOR

Relief Product Placebo Control

Dietary Supplement: Relief Product Placebo Control

Active Product 1

EXPERIMENTAL

Relief Active Product 1

Dietary Supplement: Relief Active Product 1

Active Product 2

EXPERIMENTAL

Relief Active Product 2

Dietary Supplement: Relief Active Product 2

Active Product 3

EXPERIMENTAL

Relief Active Product 3

Dietary Supplement: Relief Active Product 3

Interventions

Relief Product Placebo Control DIETARY_SUPPLEMENT

Participants will use their Relief Product Control as directed for a period of 6 weeks.

Placebo Control

Relief Active Product 1 DIETARY_SUPPLEMENT

Participants will use their Relief Active Product 1 as directed for a period of 6 weeks.

Active Product 1

Relief Active Product 2 DIETARY_SUPPLEMENT

Participants will use their Relief Active Product 2 as directed for a period of 6 weeks.

Active Product 2

Relief Active Product 3 DIETARY_SUPPLEMENT

Participants will use their Relief Active Product 3 as directed for a period of 6 weeks.

Active Product 3

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Individuals who report any of the following during screening will 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
• 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
• Been diagnosed with Gastric Ulcerations
• Lack of reliable daily access to the internet

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science Inc.

Del Mar, California, 92014, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: August 29, 2025
• First Posted: September 8, 2025
• Study Start: September 4, 2025
• Primary Completion: December 8, 2025
• Study Completion: December 8, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)