NCT05589948

Radicle Calm 1: A Study of Health and Wellness Products on Feelings of Anxiety, Stress and Other Health Outcomes

Radicle™ Calm 1: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Feelings of Anxiety, Stress and Other Health Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,211 (actual)
• Sponsor: Radicle Science · Industry
• Sex: All
• Age: 21 Years – 105 Years
• Healthy volunteers: Accepted

Summary

A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of health and wellness products on feelings of anxiety, stress 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 feelings of anxiety and/or stress, (2) indicate an interest in taking a health and wellness product to potentially improve their anxiety and/or stress, 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 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

• Anxiety
• Stress

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Radicle Calm Study Placebo Control 1	Participants will use their Radicle Calm Placebo Control Product 1 as directed for a period of 4 weeks.
DIETARY_SUPPLEMENT	Radicle Calm Study Placebo Control 2	Participants will use their Radicle Calm Placebo Control Product 2 as directed for a period of 4 weeks.
DIETARY_SUPPLEMENT	Radicle Calm Study Active Product 1.1	Participants will use their Radicle Calm Active Product 1.1 as directed for a period of 4 weeks.
DIETARY_SUPPLEMENT	Radicle Calm Study Active Product 2.1	Participants will use their Radicle Calm Active Product 2.1 as directed for a period of 4 weeks.
DIETARY_SUPPLEMENT	Radicle Calm Study Active Product 2.2	Participants will use their Radicle Calm Active Product 2.2 as directed for a period of 4 weeks.

Timeline

• Start date: 2022-10-10
• Primary completion: 2023-05-03
• Completion: 2023-08-15
• First posted: 2022-10-21
• Last updated: 2023-11-22

Locations

1 site across 1 country: United States