Radicle Calm RDH: A Study Assessing the Impact of Health and Wellness Products on Feelings of Anxiety and Related Health Outcomes

NCT ID: NCT07219628

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-23
• Study Completion Date: 2025-12-14

Brief Summary

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

Detailed Description

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

Eligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome and (2) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.

Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Placebo Control

Calm Product Placebo Control

Group Type: PLACEBO_COMPARATOR

Calm Product Placebo Control

Intervention Type: DIETARY_SUPPLEMENT

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

Active Product 1

Calm Active Product 1

Group Type: EXPERIMENTAL

Calm Active Product 1

Intervention Type: DIETARY_SUPPLEMENT

Participants will use their Calm Active Product 1 as directed for a period of 6 weeks.

Interventions

Calm Product Placebo Control

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

Intervention Type: DIETARY_SUPPLEMENT

Calm Active Product 1

Participants will use their Calm Active Product 1 as directed for a period of 6 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Exclusion Criteria

• Report 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 Class III 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, antihypertensives, 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, MAOIs, or thyroid products.
• Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products.
• Lack of reliable daily access to the internet.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Radicle Science

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Hewlings

Role: PRINCIPAL_INVESTIGATOR

Radicle Science

Locations

Radicle Science Inc.

Del Mar, California, United States

Countries

United States

Related Links

https://www.radiclescience.com

Related Info

Other Identifiers

RADX_P_2402_RDH

Identifier Type: -

Identifier Source: org_study_id