NCT05837910

Radicle Calm 2: A Study of Health and Wellness Products on Feelings of Anxiety, Stress, and Health Outcomes

Radicle™ Calm 2: A Randomized, Double-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: 3,853 (actual)
• Sponsor: Radicle Science · Industry
• Sex: All
• Age: 21 Years – 105 Years
• Healthy volunteers: Accepted

Summary

A randomized, double-blinded, placebo-controlled study assessing the impact of health and wellness products on feeling of anxiety, stress, and other health outcomes

Detailed description

This is a randomized, double-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 less anxiety or stress, (2) indicate an interest in taking a health and wellness product to potentially help their feelings of anxiety 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 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 7 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	Calm Active Study Product 1.1 Usage	Participants will use their Radicle Calm Active Study Product 1.1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Calm Active Study Product 1.2 Usage	Participants will use their Radicle Calm Active Study Product 1.2 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Calm Active Study Product 1.3 Usage	Participants will use their Radicle Calm Active Study Product 1.3 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Placebo Control Form 1	Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Placebo Control Form 2	Participants will use their Placebo Control Form 2 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Calm Active Study Product 2.1 Usage	Participants will use their Radicle Calm Active Study Product 2.1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Placebo Control Form 3	Participants will use their Placebo Control Form 3 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Calm Active Study Product 3.1 Usage	Participants will use their Radicle Calm Active Study Product 3.1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Placebo Control Form 4	Participants will use their Placebo Control Form 4 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENT	Calm Active Study Product 4.1 Usage	Participants will use their Radicle Calm Active Study Product 4.1 as directed for a period of 6 weeks.

Timeline

• Start date: 2023-04-03
• Primary completion: 2023-11-30
• Completion: 2024-04-26
• First posted: 2023-05-01
• Last updated: 2024-05-20

Locations

1 site across 1 country: United States