NCT05783232

Radicle Health1: A Study of Health and Wellness Formulations and Their Effects on Overall Health

Radicle™ Health1: A Randomized, Blinded, Placebo-controlled Study of Health and Wellness Formulations and Their Effects on Overall Health

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,494 (actual)
• Sponsor: Radicle Science · Industry
• Sex: All
• Age: 21 Years – 105 Years
• Healthy volunteers: Accepted

Summary

A randomized, blinded, placebo-controlled study of health and wellness product formulations and their effects on overall health

Detailed description

This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States. Eligible participants will (1) endorse a desire for better health during screening; (2) indicate an interest in taking a health and wellness product to potentially help improve their health, 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 will be 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

• Sleep
• Pain
• Depression
• Anxiety

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo Control Form 1 Capsules	Participants will use their Placebo Control Form 1 Capsules as directed for a period of 4 weeks.
DIETARY_SUPPLEMENT	Health Active Study Product 1.1 Capsules	Participants will use their Radicle Health Active Study Product 1.1 Capsules as directed for a period of 4 weeks.
DIETARY_SUPPLEMENT	Health Active Study Product 1.2 Capsules	Participants will use their Radicle Health Active Study Product 1.2 Capsules as directed for a period of 4 weeks.
DIETARY_SUPPLEMENT	Health Active Study Product 1.3 Capsules	Participants will use their Radicle Health Active Study Product 1.3 Capsules as directed for a period of 4 weeks.

Timeline

• Start date: 2023-03-21
• Primary completion: 2023-06-09
• Completion: 2023-10-27
• First posted: 2023-03-24
• Last updated: 2023-11-22

Locations

1 site across 1 country: United States