Radicle Health1: A Study of Health and Wellness Formulations and Their Effects on Overall Health

NCT05783232 | Completed

• 1 other identifier: RADX-22D07
• Study Type: interventional
• Target: 1,494
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, blinded, placebo-controlled study of health and wellness product formulations and their effects on overall health

Conditions

Sleep; Pain; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in overall health-related quality of life

  Mean difference in overall health score as assessed by Patient Reported Outcome Measurement System (PROMIS) 29+2 Profile (PROPr; scale 70-120; with higher scores corresponding to greater overall health across 7 health domains: physical function, ability to participate in social roles and activities, cognitive function, anxiety, depression, fatigue, sleep disturbance, pain interference and pain intensity)

  4 weeks

Secondary Outcomes (10)

• Change in physical function

  4 weeks

• Change in feelings of anxiety

  4 weeks

• Change in feelings of depression

  4 weeks

• Change in fatigue

  4 weeks

• Change in sleep disturbance

  4 weeks

Study Arms (4)

Placebo Control 1 Capsules

PLACEBO COMPARATOR

Health Product Form 1 Capsules - control

Dietary Supplement: Placebo Control Form 1 Capsules

Active Product 1.1 Capsules

EXPERIMENTAL

Health Product Form 1 Capsules - active product 1

Dietary Supplement: Health Active Study Product 1.1 Capsules

Active Product 1.2 Capsules

EXPERIMENTAL

Health Product Form 1 Capsules - active product 2

Dietary Supplement: Health Active Study Product 1.2 Capsules

Active Product 1.3 Capsules

EXPERIMENTAL

Health Product Form 1 Capsules - active product 3

Dietary Supplement: Health Active Study Product 1.3 Capsules

Interventions

Placebo Control Form 1 Capsules DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 1 Capsules as directed for a period of 4 weeks.

Placebo Control 1 Capsules

Health Active Study Product 1.1 Capsules DIETARY_SUPPLEMENT

Participants will use their Radicle Health Active Study Product 1.1 Capsules as directed for a period of 4 weeks.

Active Product 1.1 Capsules

Health Active Study Product 1.2 Capsules DIETARY_SUPPLEMENT

Participants will use their Radicle Health Active Study Product 1.2 Capsules as directed for a period of 4 weeks.

Active Product 1.2 Capsules

Health Active Study Product 1.3 Capsules DIETARY_SUPPLEMENT

Participants will use their Radicle Health Active Study Product 1.3 Capsules as directed for a period of 4 weeks.

Active Product 1.3 Capsules

Eligibility Criteria

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

You may qualify if:

• years of age and older
• Resides in the United States
• Endorses: a desire for better sleep and/or focus, less pain, less feelings of stress, depression, and/or anxiety, and/or more energy (less fatigue)
• Expresses a willingness to take a study product that may contain cannabinoids (or placebo) and not know the product identity 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 physical shipping address and mobile phone number
• Reports a diagnosis of liver or kidney disease
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Reports current enrollment in a clinical trial
• The QOL score greater than 5 during enrollment
• Unable to read and understand English
• Lack of reliable daily access to the internet
• Reports taking any medication that warns against grapefruit consumption
• Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection

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

Pain; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; 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 assigned study products. Participants are blinded to the study product they received.
• 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 arm

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 24, 2023
• Study Start: March 21, 2023
• Primary Completion: June 9, 2023
• Study Completion: October 27, 2023
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)