Radicle Calm 1: A Study of Health and Wellness Products on Feelings of Anxiety, Stress and Other Health Outcomes
NCT ID: NCT05589948
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1211 participants
INTERVENTIONAL
2022-10-10
2023-08-15
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Placebo Control 1
Calm Product Form 1 - control
Radicle Calm Study Placebo Control 1
Participants will use their Radicle Calm Placebo Control Product 1 as directed for a period of 4 weeks.
Placebo Control 2
Calm Product Form 2 - control
Radicle Calm Study Placebo Control 2
Participants will use their Radicle Calm Placebo Control Product 2 as directed for a period of 4 weeks.
Active Product 1.1
Calm Product Form 1 - active product 1
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.
Active Product 2.1
Calm Product Form 2 - active product 1
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.
Active Product 2.2
Calm Product Form 2 - active product 2
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
105 Years
ALL
Yes
Sponsors
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Radicle Science
INDUSTRY
Responsible Party
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Principal Investigators
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Emily K. Pauli, PharmD
Role: PRINCIPAL_INVESTIGATOR
Radicle Science Inc.
Locations
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Radicle Science, Inc
Del Mar, California, United States
Countries
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Related Links
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Radicle Science, Inc
Other Identifiers
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RADX-22D04
Identifier Type: -
Identifier Source: org_study_id