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

Radicle Science

Status: Completed

Conditions: Anxiety; Stress

Treatments: Dietary Supplement: Radicle Calm Study Placebo Control 2; Dietary Supplement: Radicle Calm Study Active Product 2.2; Dietary Supplement: Radicle Calm Study Active Product 2.1; Dietary Supplement: Radicle Calm Study Active Product 1.1; Dietary Supplement: Radicle Calm Study Placebo Control 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05589948

RADX-22D04

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,211 patients

Sex: All

Ages: 21 to 105 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,211 participants in 5 patient groups, including a placebo group

Placebo Control 1

Placebo Comparator group

Description:

Calm Product Form 1 - control

Treatment:

Dietary Supplement: Radicle Calm Study Placebo Control 1

Placebo Control 2

Placebo Comparator group

Description:

Calm Product Form 2 - control

Treatment:

Dietary Supplement: Radicle Calm Study Placebo Control 2

Active Product 1.1

Experimental group

Description:

Calm Product Form 1 - active product 1

Treatment:

Dietary Supplement: Radicle Calm Study Active Product 1.1

Active Product 2.1

Experimental group

Description:

Calm Product Form 2 - active product 1

Treatment:

Dietary Supplement: Radicle Calm Study Active Product 2.1

Active Product 2.2

Experimental group

Description:

Calm Product Form 2 - active product 2

Treatment:

Dietary Supplement: Radicle Calm Study Active Product 2.2