Radicle Rest 2: A Study of Health and Wellness Products on Sleep and Health Outcomes
NCT ID: NCT05657808
Last Updated: 2024-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
4152 participants
INTERVENTIONAL
2023-01-09
2024-04-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Radicle Calm 2: A Study of Health and Wellness Products on Feelings of Anxiety, Stress, and Health Outcomes
NCT05837910
Radicle Rest 24: A Study of Health and Wellness Products on Sleep and Related Health Outcomes
NCT06347744
Radicle Energy2: A Study of Health and Wellness Products on Fatigue and Other Health Outcomes
NCT06074627
Radicle Energy 24: A Study of Health and Wellness Products on Fatigue and Related Health Outcomes
NCT06201689
Radicle Relaxation 24: A Study of Health and Wellness Products on Stress and Related Health Outcomes
NCT06378801
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Eligible participants will (1) endorse a desire for improved sleep, (2) indicate an interest in taking a health and wellness product to potentially help their sleep, 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 are collected electronically from eligible participants over 7 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo Control 1
Rest Product Form 1 - control
Placebo Control Form 1
Participants will use Placebo Control Form 1 as directed for a period of 6 weeks.
Placebo Control 2
Rest Product Form 2 - control
Placebo Control Form 2
Participants will use Placebo Control Form 2 as directed for a period of 6 weeks.
Active Product 1.1
Rest Product Form 1 - active product 1
Rest Study Active Product 1.1 Usage
Participants will use Radicle Rest Active Product 1.1 as directed for a period of 6 weeks.
Active Product 1.2
Rest Product Form 1 - active product 2
Rest Study Active Product 1.2 Usage
Participants will use Radicle Rest Active Product 1.2 as directed for a period of 6 weeks.
Active Product 2.1
Rest Product Form 2 - active product 1
Rest Study Active Product 2.1 Usage
Participants will use Radicle Rest Active Product 2.1 as directed for a period of 6 weeks.
Active Product 2.2
Rest Product Form 2 - active product 2
Rest Study Active Product 2.2 Usage
Participants will use Radicle Rest Active Product 2.2 as directed for a period of 6 weeks.
Placebo Control 3
Rest Product Form 3 - control
Placebo Control Form 3
Participants will use Placebo Control Form 3 as directed for a period of 6 weeks.
Active Product 3.1
Rest Product Form 3 - active product 1
Rest Study Active Product 3.1 Usage
Participants will use Radicle Rest Active Product 3.1 as directed for a period of 6 weeks.
Placebo Control 4
Rest Product Form 4 - control
Placebo Control Form 4
Participants will use Placebo Control Form 4 as directed for a period of 6 weeks.
Active Product 4.1
Rest Product Form 4 - active product 1
Rest Study Active Product 4.1 Usage
Participants will use Radicle Rest Active Product 4.1 as directed for a period of 6 weeks.
Active Product 4.2
Rest Product Form 4 - active product 2
Rest Study Active Product 4.2 Usage
Participants will use Radicle Rest Active Product 4.2 as directed for a period of 6 weeks.
Active Product 4.3
Rest Product Form 4 - active product 3
Rest Study Active Product 4.3 Usage
Participants will use Radicle Rest Active Product 4.3 as directed for a period of 6 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rest Study Active Product 1.1 Usage
Participants will use Radicle Rest Active Product 1.1 as directed for a period of 6 weeks.
Rest Study Active Product 1.2 Usage
Participants will use Radicle Rest Active Product 1.2 as directed for a period of 6 weeks.
Rest Study Active Product 2.1 Usage
Participants will use Radicle Rest Active Product 2.1 as directed for a period of 6 weeks.
Rest Study Active Product 2.2 Usage
Participants will use Radicle Rest Active Product 2.2 as directed for a period of 6 weeks.
Placebo Control Form 1
Participants will use Placebo Control Form 1 as directed for a period of 6 weeks.
Placebo Control Form 2
Participants will use Placebo Control Form 2 as directed for a period of 6 weeks.
Placebo Control Form 3
Participants will use Placebo Control Form 3 as directed for a period of 6 weeks.
Rest Study Active Product 3.1 Usage
Participants will use Radicle Rest Active Product 3.1 as directed for a period of 6 weeks.
Placebo Control Form 4
Participants will use Placebo Control Form 4 as directed for a period of 6 weeks.
Rest Study Active Product 4.1 Usage
Participants will use Radicle Rest Active Product 4.1 as directed for a period of 6 weeks.
Rest Study Active Product 4.2 Usage
Participants will use Radicle Rest Active Product 4.2 as directed for a period of 6 weeks.
Rest Study Active Product 4.3 Usage
Participants will use Radicle Rest Active Product 4.3 as directed for a period of 6 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Resides in the United States
* Endorses better sleep as a primary desire
* Selects sleep, looking to improve their sleep, 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
* Unable to provide a valid US shipping address
* The calculated validated health survey (PRO) measurement result is less than mild severity/impairment
* 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
* Reports current enrollment in a clinical trial
* Lack of reliable daily access to the internet
* Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection
* Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied: anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or monoamine oxidase inhibitors (MAOIs)
* Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: New York Heart Association (NYHA) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias
21 Years
105 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Radicle Science
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Emily K. Pauli, PharmD
Role: PRINCIPAL_INVESTIGATOR
Radicle Science Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Radicle Science, Inc
Del Mar, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Radicle Science, Inc
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RADX-2301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.