Clinical trial NCT05783232: Radicle Health1: A Study of Health and Wellness Formulations and Their Effects on Overall Health
Official title: Radicle™ Health1: A Randomized, Blinded, Placebo-controlled Study of Health and Wellness Formulations and Their Effects on Overall Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Pain
Depression
Anxiety
Lead sponsor: Radicle Science
Sponsor class: INDUSTRY
First posted: 2023-03-24
Enrollment: 1494
Sex: ALL
Minimum age (years): 21
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be stratified based on gender at birth then randomized to one of the study arm
Primary purpose: OTHER

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in overall health-related quality of life
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in physical function
timeFrame: 4 weeks
measure: Change in feelings of anxiety
timeFrame: 4 weeks
measure: Change in feelings of depression
timeFrame: 4 weeks
measure: Change in fatigue
timeFrame: 4 weeks
measure: Change in sleep disturbance
timeFrame: 4 weeks
measure: Change in socialization ability
timeFrame: 4 weeks
measure: Change in pain
timeFrame: 4 weeks
measure: Change in cognitive function
timeFrame: 4 weeks
measure: Change in libido
timeFrame: 4 weeks
measure: Minimal clinical importance difference (MCID) in overall health-related quality of life
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Del Mar
country: United States
facility: Radicle Science, Inc
state: California
Study officials:
affiliation: Radicle Science, Inc
name: Emily K. Pauli, PharmD
role: PRINCIPAL_INVESTIGATOR
References: