NCT07744997 · Radicle Science
Radicle RestTM VGI: A Study Assessing the Impact of Health and Wellness Products on Sleep and Related Health Outcomes
What this study is about
Radicle RestTM VGI: A randomly assigned, where neither patients nor doctors know which treatment is given, placebo- controlled study assessing the impact of health and wellness products on sleep and related health outcomes.
View original scientific description
Radicle RestTM VGI: A randomized, double-blind, placebo- controlled study assessing the impact of health and wellness products on sleep and related health outcomes.
Interventions
DIETARY_SUPPLEMENT
Placebo Rest Control
Participants will use their Placebo Rest Control as directed for a period of 6 weeks
DIETARY_SUPPLEMENT
Active Rest Product 1
Participants will use their Active Rest Product 1 as directed for a period of 6 weeks
Primary outcome measures
Change in sleep
Time frame: 7 weeks
Change in sleep: Difference in rates of change over time in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants must meet all the following criteria:
- Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
- Assigned sex at birth will determine sex-specific recruitment and PROs (male vs female) employed, when needed
- Resides in the United States
- Has the opportunity for at least 30% improvement in their primary health outcome
- Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study 3.2
Exclusion criteria
- Individuals who report any of the following during screening may be excluded from participation:
- Report being pregnant, trying to become pregnant, or breastfeeding
- Unable to provide a valid US shipping address and mobile phone number
- Reports current enrollment in another clinical trial
- Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
- Unable to read and understand English at a 7th grade level
- Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
- Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.
- NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
- Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.
- Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products
- Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products and/or pose a safety risk
- Lack of reliable daily access to the internet
Where
- Del Mar, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 18, 2026 · Source of record for eligibility and locations