SleepNCT05783232
Radicle Health1: A Study of Health and Wellness Formulations and Their Effects on Overall Health
A study testing Health Active Study Product 1.1 Capsules, Health Active Study Product 1.2 Capsules and Health Active Study Product 1.3 Capsules in people with Sleep and Pain, run by Radicle Science at 1 site in United States.
Trial summary
A randomized, blinded, placebo-controlled study of health and wellness product formulations and their effects on overall health Read more about this study
- Who is it for?
- Ages 21 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Pain, Depression
- What is being tested?
- Health Active Study Product 1.1 Capsules, Health Active Study Product 1.2 Capsules and Health Active Study Product 1.3 Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,494 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2023to 27 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Radicle™ Health1: A Randomized, Blinded, Placebo-controlled Study of Health and Wellness Formulations and Their Effects on Overall Health
A randomized, blinded, placebo-controlled study of health and wellness product formulations and their effects on overall health
Read the 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.
- Conditions
- Sleep, Pain, Depression, Anxiety
- Being tested
- Placebo Control Form 1 Capsules, Health Active Study Product 1.1 Capsules, Health Active Study Product 1.2 Capsules, Health Active Study Product 1.3 Capsules
- Medical subject headings
- Pain, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Control Form 1 CapsulesDietary supplement
Participants will use their Placebo Control Form 1 Capsules as directed for a period of 4 weeks.
Health Active Study Product 1.1 CapsulesDietary supplement
Participants will use their Radicle Health Active Study Product 1.1 Capsules as directed for a period of 4 weeks.
Health Active Study Product 1.2 CapsulesDietary supplement
Participants will use their Radicle Health Active Study Product 1.2 Capsules as directed for a period of 4 weeks.
Health Active Study Product 1.3 CapsulesDietary supplement
Participants will use their Radicle Health Active Study Product 1.3 Capsules as directed for a period of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control 1 Capsules | Placebo comparator | Health Product Form 1 Capsules - control Receives: Dietary Supplement: Placebo Control Form 1 Capsules |
| Active Product 1.1 Capsules | Experimental | Health Product Form 1 Capsules - active product 1 Receives: Dietary Supplement: Health Active Study Product 1.1 Capsules |
| Active Product 1.2 Capsules | Experimental | Health Product Form 1 Capsules - active product 2 Receives: Dietary Supplement: Health Active Study Product 1.2 Capsules |
| Active Product 1.3 Capsules | Experimental | Health Product Form 1 Capsules - active product 3 Receives: Dietary Supplement: Health Active Study Product 1.3 Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall health-related quality of life
Mean difference in overall health score as assessed by Patient Reported Outcome Measurement System (PROMIS) 29+2 Profile (PROPr; scale 70-120; with higher scores corresponding to greater overall health across 7 health domains: physical function, ability to participate in social roles and activities, cognitive function, anxiety, depression, fatigue, sleep disturbance, pain interference and pain intensity)
Measured: 4 weeks
Secondary outcomes (10)
Change in physical function
Mean difference in physical function score as assessed by PROMIS PROPr items related to physical function (scale 4-20; with higher scores corresponding to greater physical function)
Measured: 4 weeks
Change in feelings of anxiety
Mean difference in feelings of anxiety score as assessed by PROMIS PROPr items related to anxiety (scale 4-20; with higher scores corresponding to more severe feelings of anxiety)
Measured: 4 weeks
Change in feelings of depression
Mean difference in feelings of depression score as assessed by PROMIS PROPr items related to depression (scale 4-20; with higher scores corresponding to more severe feelings of depression)
Measured: 4 weeks
Change in fatigue
Mean difference in fatigue score as assessed by PROMIS PROPr questions related to fatigue (scale 4-20; with higher scores corresponding to more severe fatigue)
Measured: 4 weeks
Change in sleep disturbance
Mean difference in sleep disturbance score as assessed by PROMIS PROPr items related to sleep disturbance (scale 4-20; with higher scores corresponding to greater sleep disturbance)
Measured: 4 weeks
Change in socialization ability
Mean difference in socialization ability score as assessed by PROMIS PROPr items related to (scale 4-20; with higher scores corresponding to greater ability to participate in social roles and activities)
Measured: 4 weeks
Change in pain
Mean difference in pain score as assessed by PROMIS PROPr items related to pain (scale 1-15; with higher scores corresponding to greater pain)
Measured: 4 weeks
Change in cognitive function
Mean difference in cognitive function score as assessed by PROMIS PROPr items related to cognitive function (scale 2-10; with higher scores corresponding to greater cognitive function)
Measured: 4 weeks
Change in libido
Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; where higher scores correspond to greater interest in sexual activities)
Measured: 4 weeks
Minimal clinical importance difference (MCID) in overall health-related quality of life
Likelihood of achieving a MCID in overall health-related quality of life, as measured by PROMIS PROPr (scale 70-120; with higher scores corresponding to greater overall health-related quality of life)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start21 Mar 2023
- Primary completion9 Jun 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Radicle ScienceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be stratified based on gender at birth then randomized to one of the study arm
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,494 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radicle Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emily K. Pauli, PharmD, Principal investigator, Radicle Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783232
- Sponsor's protocol ID
- RADX-22D07
- Status last verified
- Nov 2023
- First submitted
- 8 Mar 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared with researchers outside of Radicle Collaborators on this study.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radicle™ Health1: A Randomized, Blinded, Placebo-controlled Study of Health and Wellness Formulations and Their Effects on Overall Health
- ClinicalTrials.gov ID
- NCT05783232
- Acronym / sponsor ID
- RADX-22D07
- Conditions
- Sleep, Pain, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,494 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Participants will be stratified based on gender at birth then randomized to one of the study arm
| Arm | Type | Receives |
|---|---|---|
| Placebo Control 1 Capsules | Placebo comparator | Dietary Supplement: Placebo Control Form 1 CapsulesHealth Product Form 1 Capsules - control |
| Active Product 1.1 Capsules | Experimental | Dietary Supplement: Health Active Study Product 1.1 CapsulesHealth Product Form 1 Capsules - active product 1 |
| Active Product 1.2 Capsules | Experimental | Dietary Supplement: Health Active Study Product 1.2 CapsulesHealth Product Form 1 Capsules - active product 2 |
| Active Product 1.3 Capsules | Experimental | Dietary Supplement: Health Active Study Product 1.3 CapsulesHealth Product Form 1 Capsules - active product 3 |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Control Form 1 CapsulesParticipants will use their Placebo Control Form 1 Capsules as directed for a period of 4 weeks. | Dietary supplement | Placebo Control 1 Capsules |
| Health Active Study Product 1.1 CapsulesParticipants will use their Radicle Health Active Study Product 1.1 Capsules as directed for a period of 4 weeks. | Dietary supplement | Active Product 1.1 Capsules |
| Health Active Study Product 1.2 CapsulesParticipants will use their Radicle Health Active Study Product 1.2 Capsules as directed for a period of 4 weeks. | Dietary supplement | Active Product 1.2 Capsules |
| Health Active Study Product 1.3 CapsulesParticipants will use their Radicle Health Active Study Product 1.3 Capsules as directed for a period of 4 weeks. | Dietary supplement | Active Product 1.3 Capsules |
Primary outcome
Change in overall health-related quality of life
Time frame: 4 weeks
Mean difference in overall health score as assessed by Patient Reported Outcome Measurement System (PROMIS) 29+2 Profile (PROPr; scale 70-120; with higher scores corresponding to greater overall health across 7 health domains: physical function, ability to participate in social roles and activities, cognitive function, anxiety, depression, fatigue, sleep disturbance, pain interference and pain intensity)
10 secondary outcomes
Change in physical function
Time frame: 4 weeks
Change in feelings of anxiety
Time frame: 4 weeks
Change in feelings of depression
Time frame: 4 weeks
Change in fatigue
Time frame: 4 weeks
Change in sleep disturbance
Time frame: 4 weeks
Change in socialization ability
Time frame: 4 weeks
Change in pain
Time frame: 4 weeks
Change in cognitive function
Time frame: 4 weeks
Change in libido
Time frame: 4 weeks
Minimal clinical importance difference (MCID) in overall health-related quality of life
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Radicle Science, IncLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data will not be shared with researchers outside of Radicle Collaborators on this study.
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily K. Pauli, PharmD principal investigator
Radicle Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Active Study Product 1.1 Capsules, Health Active Study Product 1.2 Capsules and Health Active Study Product 1.3 Capsules in people with Sleep and Pain, run by Radicle Science at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in overall health-related quality of life (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.