AnxietyNCT05589948
Radicle Calm 1: A Study of Health and Wellness Products on Feelings of Anxiety, Stress and Other Health Outcomes
A study testing Radicle Calm Study Active Product 1.1, Radicle Calm Study Active Product 2.1 and Radicle Calm Study Active Product 2.2 in people with Anxiety and Stress, run by Radicle Science at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 to 105 yearsHealthy volunteers can take part
- What is being tested?
- Radicle Calm Study Active Product 1.1, Radicle Calm Study Active Product 2.1 and Radicle Calm Study Active Product 2.2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,211 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2022to 15 Aug 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Being tested
- Radicle Calm Study Placebo Control 1, Radicle Calm Study Placebo Control 2, Radicle Calm Study Active Product 1.1, Radicle Calm Study Active Product 2.1, Radicle Calm Study Active Product 2.2
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radicle Calm Study Placebo Control 1Dietary supplement
Participants will use their Radicle Calm Placebo Control Product 1 as directed for a period of 4 weeks.
Radicle Calm Study Placebo Control 2Dietary supplement
Participants will use their Radicle Calm Placebo Control Product 2 as directed for a period of 4 weeks.
Radicle Calm Study Active Product 1.1Dietary supplement
Participants will use their Radicle Calm Active Product 1.1 as directed for a period of 4 weeks.
Radicle Calm Study Active Product 2.1Dietary supplement
Participants will use their Radicle Calm Active Product 2.1 as directed for a period of 4 weeks.
Radicle Calm Study Active Product 2.2Dietary supplement
Participants will use their Radicle Calm Active Product 2.2 as directed for a period of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control 1 | Placebo comparator | Calm Product Form 1 - control Receives: Dietary Supplement: Radicle Calm Study Placebo Control 1 |
| Placebo Control 2 | Placebo comparator | Calm Product Form 2 - control Receives: Dietary Supplement: Radicle Calm Study Placebo Control 2 |
| Active Product 1.1 | Experimental | Calm Product Form 1 - active product 1 Receives: Dietary Supplement: Radicle Calm Study Active Product 1.1 |
| Active Product 2.1 | Experimental | Calm Product Form 2 - active product 1 Receives: Dietary Supplement: Radicle Calm Study Active Product 2.1 |
| Active Product 2.2 | Experimental | Calm Product Form 2 - active product 2 Receives: Dietary Supplement: Radicle Calm Study Active Product 2.2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in feelings of anxiety
Mean difference in feelings of anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety)
Measured: 4 weeks
Secondary outcomes (5)
Minimal clinically important difference (MCID) in anxiety
Likelihood of experiencing a MCID in anxiety score as assessed by PROMIS Anxiety 8A
Measured: 4 weeks
Change in stress
Mean difference in stress score as assessed by PROMIS Stress 8A (scale 8-40; where lower scores correspond to less stress)
Measured: 4 weeks
Minimal clinically important difference (MCID) in stress
Likelihood of experiencing a MCID in stress score as assessed by PROMIS Stress 8A
Measured: 4 weeks
Change in sleep disturbance
Mean difference in sleep disturbance score as assessed by PROMIS Sleep 4A (scale 4-20; where lower scores correspond to better sleep quality/less sleep disturbance)
Measured: 4 weeks
Change in cognitive function
Mean difference in cognitive function score as assessed by PROMIS Cognition Function 4A (scale 4-20; where lower scores correspond to poorer cognitive function)
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 posted21 Oct 2022
- Study start10 Oct 2022
- Primary completion3 May 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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 arms
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,211 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
- NCT05589948
- Sponsor's protocol ID
- RADX-22D04
- Status last verified
- Nov 2023
- First submitted
- 18 Oct 2022
- 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™ 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
- ClinicalTrials.gov ID
- NCT05589948
- Acronym / sponsor ID
- RADX-22D04
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,211 participants (actual)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 3 May 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 21 Oct 2022 (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, 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- Participants will be stratified based on gender at birth then randomized to one of the study arms
| Arm | Type | Receives |
|---|---|---|
| Placebo Control 1 | Placebo comparator | Dietary Supplement: Radicle Calm Study Placebo Control 1Calm Product Form 1 - control |
| Placebo Control 2 | Placebo comparator | Dietary Supplement: Radicle Calm Study Placebo Control 2Calm Product Form 2 - control |
| Active Product 1.1 | Experimental | Dietary Supplement: Radicle Calm Study Active Product 1.1Calm Product Form 1 - active product 1 |
| Active Product 2.1 | Experimental | Dietary Supplement: Radicle Calm Study Active Product 2.1Calm Product Form 2 - active product 1 |
| Active Product 2.2 | Experimental | Dietary Supplement: Radicle Calm Study Active Product 2.2Calm Product Form 2 - active product 2 |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Radicle Calm Study Placebo Control 1Participants will use their Radicle Calm Placebo Control Product 1 as directed for a period of 4 weeks. | Dietary supplement | Placebo Control 1 |
| Radicle Calm Study Placebo Control 2Participants will use their Radicle Calm Placebo Control Product 2 as directed for a period of 4 weeks. | Dietary supplement | Placebo Control 2 |
| Radicle Calm Study Active Product 1.1Participants will use their Radicle Calm Active Product 1.1 as directed for a period of 4 weeks. | Dietary supplement | Active Product 1.1 |
| Radicle Calm Study Active Product 2.1Participants will use their Radicle Calm Active Product 2.1 as directed for a period of 4 weeks. | Dietary supplement | Active Product 2.1 |
| Radicle Calm Study Active Product 2.2Participants will use their Radicle Calm Active Product 2.2 as directed for a period of 4 weeks. | Dietary supplement | Active Product 2.2 |
Primary outcome
Change in feelings of anxiety
Time frame: 4 weeks
Mean difference in feelings of anxiety score as assessed by Patient Reported Outcome Measurement System (PROMIS) Anxiety 8A (scale 8-40; where lower scores correspond to less feelings of anxiety)
5 secondary outcomes
Minimal clinically important difference (MCID) in anxiety
Time frame: 4 weeks
Change in stress
Time frame: 4 weeks
Minimal clinically important difference (MCID) in stress
Time frame: 4 weeks
Change in sleep disturbance
Time frame: 4 weeks
Change in cognitive function
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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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 Radicle Calm Study Active Product 1.1, Radicle Calm Study Active Product 2.1 and Radicle Calm Study Active Product 2.2 in people with Anxiety and Stress, 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 5 inclusion and 8 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 feelings of anxiety (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.