Radicle Relief 1: A Study of Health and Wellness Products on Pain and Other Health Outcomes

Radicle Science

Status

Completed

Conditions

Neuropathic Pain

Nociceptive Pain

Pain

Treatments

Dietary Supplement: Relief Study Product Usage

Study type

Interventional

Funder types

Industry

Identifiers

NCT05589935

RADX-22D05

Details and patient eligibility

About

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

Full description

This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm, 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 relieve 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 5 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

Enrollment

457 patients

Sex

All

Ages

21 to 105 years old

Volunteers

Accepts 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 pain as a primary issue (desire for less pain)
Selects their desire for less pain and/or reduce reliance on medications 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 physical shipping address
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
Lack of reliable daily access to the internet
Reports taking anticoagulants, any medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or MAOIs
Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection