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

Radicle Science

Status: Completed

Conditions: Depression; Anxiety; Pain; Sleep

Treatments: Dietary Supplement: Health Active Study Product 1.3 Capsules; Dietary Supplement: Health Active Study Product 1.1 Capsules; Dietary Supplement: Health Active Study Product 1.2 Capsules; Dietary Supplement: Placebo Control Form 1 Capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT05783232

RADX-22D07

Details and patient eligibility

About

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

Full description

This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.

Eligible participants will (1) endorse a desire for better health during screening; (2) indicate an interest in taking a health and wellness product to potentially help improve their health, 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 report they 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: 1,494 patients

Sex: All

Ages: 21 to 105 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 21 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

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,494 participants in 4 patient groups, including a placebo group

Placebo Control 1 Capsules

Placebo Comparator group

Description:

Health Product Form 1 Capsules - control

Treatment:

Dietary Supplement: Placebo Control Form 1 Capsules

Active Product 1.1 Capsules

Experimental group

Description:

Health Product Form 1 Capsules - active product 1

Treatment:

Dietary Supplement: Health Active Study Product 1.1 Capsules

Active Product 1.2 Capsules

Experimental group

Description:

Health Product Form 1 Capsules - active product 2

Treatment:

Dietary Supplement: Health Active Study Product 1.2 Capsules

Active Product 1.3 Capsules

Experimental group

Description:

Health Product Form 1 Capsules - active product 3

Treatment:

Dietary Supplement: Health Active Study Product 1.3 Capsules