Clinical trial NCT05589948: Radicle Calm 1: A Study of Health and Wellness Products on Feelings of Anxiety, Stress and Other Health Outcomes
Official title: Radicle™ Calm 1: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Feelings of Anxiety, Stress and Other Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Stress
Lead sponsor: Radicle Science
Sponsor class: INDUSTRY
First posted: 2022-10-21
Enrollment: 1211
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 arms
Primary purpose: OTHER

Brief summary: A randomized, blinded, placebo-controlled, direct-to-consumer study assessing the impact of health and wellness products on feelings of anxiety, stress and other health outcomes

Detailed description: This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm, age 21 and older and residing in the United States.

Eligible participants will (1) endorse a desire for less feelings of anxiety and/or stress, (2) indicate an interest in taking a health and wellness product to potentially improve their anxiety and/or stress, 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 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:

* Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities
* Resides in the United States
* Endorses feelings of anxiety or stress as a primary issue (desire to reduce anxiety or less stress)
* Selects feelings of anxiety/stress, looking to improve their feelings of anxiety/stress, and/or reduce reliance on medications as a reason for their interest in taking a health and wellness product
* Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

Exclusion Criteria:

* Pregnant, trying to become pregnant, or breastfeeding
* Unable to provide a valid physical shipping address
* Reports a diagnosis of liver or kidney disease
* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
* Unable to read and understand English
* Lack of reliable daily access to the internet
* Reports taking anticoagulants, any medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or MAOIs (monoamine oxidase inhibitors)
* 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 feelings of anxiety
timeFrame: 4 weeks
Secondary outcomes:
measure: Minimal clinically important difference (MCID) in anxiety
timeFrame: 4 weeks
measure: Change in stress
timeFrame: 4 weeks
measure: Minimal clinically important difference (MCID) in stress
timeFrame: 4 weeks
measure: Change in sleep disturbance
timeFrame: 4 weeks
measure: Change in cognitive function
timeFrame: 4 weeks
Other outcomes:
measure: Change in mood (emotional distress)
timeFrame: 4 weeks
measure: Change in libido
timeFrame: 4 weeks
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: