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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05589948
• Other study ID #: RADX-22D04
• Status: Completed
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: November 2023
• Source: Radicle Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1211
• Est. completion date: August 15, 2023
• Est. primary completion date: May 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 105 Years

Eligibility

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 feelings of anxiety or stress as a primary issue (desire to reduce anxiety or less stress)
• Selects feelings of anxiety/stress, looking to improve their feelings of anxiety/stress, 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:

• 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 (monoamine oxidase inhibitors)
• Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Stress

Intervention

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.
• Radicle Calm Study Placebo Control 2
Participants will use their Radicle Calm Placebo Control Product 2 as directed for a period of 4 weeks.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Radicle Science, Inc	Del Mar	California

Sponsors (1)

Lead Sponsor	Collaborator
Radicle Science

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in mood (emotional distress)	Mean difference in mood score as assessed by PROMIS Emotional Distress-Depression 4A (scale 4-20; where lower scores correspond to lower levels of emotional distress)	4 weeks
Other	Change in libido	Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 4-20; where lower scores correspond to less interest in sexual activity)	4 weeks
Primary	Change in feelings of anxiety	Mean difference in feelings of anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety)	4 weeks
Secondary	Minimal clinically important difference (MCID) in anxiety	Likelihood of experiencing a MCID in anxiety score as assessed by PROMIS Anxiety 8A	4 weeks
Secondary	Change in stress	Mean difference in stress score as assessed by PROMIS Stress 8A (scale 8-40; where lower scores correspond to less stress)	4 weeks
Secondary	Minimal clinically important difference (MCID) in stress	Likelihood of experiencing a MCID in stress score as assessed by PROMIS Stress 8A	4 weeks
Secondary	Change in sleep disturbance	Mean difference in sleep disturbance score as assessed by PROMIS Sleep 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance)	4 weeks
Secondary	Change in cognitive function	Mean difference in cognitive function score as assessed by PROMIS Cognition Function 4A (scale 4-20; where lower scores correspond to poorer cognitive function)	4 weeks

External Links

•   Radicle Science, Inc