Radicle Calm 24: A Study of Health and Wellness Products on Feelings of Anxiety and Related Health Outcomes

NCT06431074 | Completed

• 1 other identifier: RADX-P-2402
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on feelings of anxiety and related health outcomes

Conditions

Anxiety; Stress

Outcome Measures

Primary Outcomes (1)

• 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)

  6 weeks

Secondary Outcomes (7)

• Change in stress

  6 weeks

• Change in sleep

  6 weeks

• Change in mood (emotional distress)

  6 weeks

• Minimal clinically important difference (MCID) in feelings of anxiety

  6 weeks

• Minimal clinically important difference (MCID) in stress

  6 weeks

Other Outcomes (23)

• Change in saliva concentration of at-home (direct-to-consumer) specimen assay (1)

  6 weeks

• Change in saliva concentration of at-home (direct-to-consumer) specimen assay (2)

  6 weeks

• Change in saliva concentration of at-home (direct-to-consumer) specimen assay (3)

  6 weeks

Study Arms (4)

Placebo Control 1

PLACEBO COMPARATOR

Calm Product Form 1 - control

Dietary Supplement: Placebo Control Form 1

Active Product 1.1

EXPERIMENTAL

Calm Product Form 1 - active product 1

Dietary Supplement: Calm Active Study Product 1.1 Usage

Placebo Control 6.1.0

PLACEBO COMPARATOR

Calm Product 6.1 - control

Dietary Supplement: Placebo Control 6.1

Active Product 6.1.1

EXPERIMENTAL

Calm Product 6.1 - active product 1

Dietary Supplement: Calm Active Study Product 6.1 Usage

Interventions

Placebo Control Form 1 DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.

Placebo Control 1

Calm Active Study Product 1.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Calm Active Study Product 1.1 as directed for a period of 6 weeks.

Active Product 1.1

Placebo Control 6.1 DIETARY_SUPPLEMENT

Participants will use their Placebo Control 6.1 as directed for a period of 6 weeks.

Placebo Control 6.1.0

Calm Active Study Product 6.1 Usage DIETARY_SUPPLEMENT

Participants will use their Radicle Calm Active Study Product 6.1 as directed for a period of 6 weeks.

Active Product 6.1.1

Eligibility Criteria

• Age: 21 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, at least 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities. Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed
• Resides in the United States
• Endorses less anxiety as a primary desire
• Has the opportunity for at least 20% improvement in their primary health outcome
• Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

You may not qualify if:

• Reports being pregnant, trying to become pregnant, or breastfeeding
• Unable to provide a valid US shipping address and mobile phone number
• Reports current enrollment in another clinical trial
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Unable to read and understand English
• Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
• Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients. NYHA (New York Heart Association) Class Ill or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
• Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. Anticoagulants, antihypertensive, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOls (monoamine oxidase inhibitors), or thyroid products
• Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s)
• Lack of reliable daily access to the internet

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science, Inc

Del Mar, California, 92014, United States

Location

Related Links

• Radicle Science, Inc

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Emily K. Pauli, PharmD

  Radicle Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator is blinded to the participants' study product assignment. Participants are blinded to the study product they are assigned.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be stratified based on gender at birth, then randomized to one of the study arms

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 28, 2024
• Study Start: May 30, 2024
• Primary Completion: August 4, 2025
• Study Completion: August 11, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)