NCT05589935

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

Radicle Relief 1™: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Pain and Other Health Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 457 (actual)
• Sponsor: Radicle Science · Industry
• Sex: All
• Age: 21 Years – 105 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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

Conditions

• Pain
• Nociceptive Pain
• Neuropathic Pain

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Relief Study Product Usage	Participants instructed to use study product daily as directed for a period of 4 weeks

Timeline

• Start date: 2022-11-22
• Primary completion: 2022-12-23
• Completion: 2023-05-24
• First posted: 2022-10-21
• Last updated: 2023-11-22

Locations

1 site across 1 country: United States