Cognitive FunctionNCT07548307
Radicle Revive™: A Study Assessing the Impact of Health and Wellness Products on Menopausal-Related Health Issues Associated Health Outcomes and Related Health Outcomes
A study testing Revive Active Product 1 in people with Cognitive Function, run by Radicle Science at 1 site in United States.
Trial summary
Radicle Revive™: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on menopausal-related health issues associated health outcomes. Read more about this study
- Who is it for?
- Ages 40 to 105 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function
- What is being tested?
- Revive Active Product 1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 990 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2026to 7 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 105 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must meet all the following criteria:
- Adults, at least 40 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
- Resides in the United States
- Has the opportunity for at least 30% improvement in their primary health outcome
- Peri or Post Menopausal women who have been experiencing hot flashes for the past 3 months or longer
- 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
- 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
Show all 15Show fewer
- 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
- Currently taking a HRT medication
- Pre-Menopausal women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radicle Revive™: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Menopausal-Related Health Issues Associated Health Outcomes and Related Health Outcomes
Radicle Revive™: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on menopausal-related health issues associated health outcomes.
Read the detailed description
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.
Eligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, (2) express acceptance in taking a product and not knowing its formulation until the end of the study, and Peri or Post menopausal women (3) regularly experiencing hot flashes and (4) Not taking a HRT medication.
Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.
Self-reported data are collected electronically from eligible participants for 13 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.
- Conditions
- Cognitive Function
- Being tested
- Revive Product Placebo Control, Revive Active Product 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revive Product Placebo ControlDietary supplement
Participants will use their Control as directed for a period of 12 weeks.
Revive Active Product 1Dietary supplement
Participants will use their Active product as directed for a period of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Control | Placebo comparator | Revive Product Placebo Control Receives: Dietary Supplement: Revive Product Placebo Control |
| Active Revive Product 1 | Experimental | Revive Active Product 1 Receives: Dietary Supplement: Revive Active Product 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive function
Change in cognitive function: Difference in rates of change over time in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where lower scores correspond to worse cognitive function)
Measured: 13 weeks
Secondary outcomes (8)
Change in cognitive abilities
Change in cognitive abilities: Difference between rates of change over time in Cognitive Abilities score as assessed by PROMIS Cognitive Function - Abilities 8a (scale 8-40; where the higher scores correspond to better cognitive abilities)
Measured: 13 weeks
Change in feelings of anxiety
Change in feelings of anxiety: Difference between rates of change over time in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)
Measured: 13 weeks
Hot Flash Interference over 12 weeks
Hot Flash interference assessed by a single self report item. Indicating hot flash interference in the previous 24 hours. Scale 1-7 with higher scores indication greater interference.
Measured: From Baseline to week 12 of product consumption.
Hot Flash Frequency
Hot Flash frequency assessed by a single self-report item. Indicating hot flash frequency in the previous 24 hours. Options ranged from 0 to 6. With higher scores indicating greater frequency of hot flashes.
Measured: From baseline to day 14 of product consumption.
Hot Flash Interference over 14 days
Hot Flash interference assessed by a single self report item. Indicating hot flash interference in the previous 24 hours. Scale 1-7 with higher scores indication greater interference.
Measured: From Baseline to day 14 of product consumption.
Hot Flash Frequency
Hot Flash frequency assessed by a single self-report item. Indicating hot flash frequency in the previous 24 hours. Options ranged from 0 to 6. With higher scores indicating greater frequency of hot flashes.
Measured: From baseline to week 12 of product consumption.
Hot Flash Intensity
Hot Flash intensity assessed by a single self-report item. Indicating hot flash intensity in the previous 24 hours. Options ranged from 1 to 7. With higher scores indicating greater intensity of hot flashes.
Measured: From baseline to week 12 of product consumption.
Hot Flash Intensity
Hot Flash intensity assessed by a single self-report item. Indicating hot flash intensity in the previous 24 hours. Options ranged from 1 to 7. With higher scores indicating greater intensity of hot flashes.
Measured: From baseline to day 14 of product consumption.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start9 Apr 2026
- Primary completion7 Apr 2027 (estimated)
- Study completion7 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies 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 menstrual status, hot flash interference, and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 990 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radicle Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Hewlings, Principal investigator, Radicle Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548307
- Sponsor's protocol ID
- RADX_P_2605_RGW
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 20 Aug 2026
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radicle Revive™: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Menopausal-Related Health Issues Associated Health Outcomes and Related Health Outcomes
- ClinicalTrials.gov ID
- NCT07548307
- Acronym / sponsor ID
- RADX_P_2605_RGW
- Conditions
- Cognitive Function
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 990 participants (estimated)
- Lead sponsor
- Radicle ScienceIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 7 Apr 2027 (estimated)
- Study completion
- 7 Apr 2027 (estimated)
- First posted
- 23 Apr 2026 (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.
Radicle Revive™: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on menopausal-related health issues associated health outcomes.
Detailed description
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.
Eligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, (2) express acceptance in taking a product and not knowing its formulation until the end of the study, and Peri or Post menopausal women (3) regularly experiencing hot flashes and (4) Not taking a HRT medication.
Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.
Self-reported data are collected electronically from eligible participants for 13 weeks. Participant reports of health indicators will be collected at enrollment and throughout the active period of study product usage. 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
- 2
- Model description
- Participants will be stratified based on menstrual status, hot flash interference, and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.
| Arm | Type | Receives |
|---|---|---|
| Placebo Control | Placebo comparator | Dietary Supplement: Revive Product Placebo ControlRevive Product Placebo Control |
| Active Revive Product 1 | Experimental | Dietary Supplement: Revive Active Product 1Revive Active Product 1 |
Who may qualify
- Ages
- 40 to 105 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults, at least 40 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
- Resides in the United States
- Has the opportunity for at least 30% improvement in their primary health outcome
- Peri or Post Menopausal women who have been experiencing hot flashes for the past 3 months or longer
Key exclusion criteria (15 listed)
- 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)
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 |
|---|---|---|
| Revive Product Placebo ControlParticipants will use their Control as directed for a period of 12 weeks. | Dietary supplement | Placebo Control |
| Revive Active Product 1Participants will use their Active product as directed for a period of 12 weeks. | Dietary supplement | Active Revive Product 1 |
Primary outcome
Change in cognitive function
Time frame: 13 weeks
Change in cognitive function: Difference in rates of change over time in cognitive function score as assessed by PROMIS Cognitive Function 8A (scale 8-40; where lower scores correspond to worse cognitive function)
8 secondary outcomes
Change in cognitive abilities
Time frame: 13 weeks
Change in feelings of anxiety
Time frame: 13 weeks
Hot Flash Interference over 12 weeks
Time frame: From Baseline to week 12 of product consumption.
Hot Flash Frequency
Time frame: From baseline to day 14 of product consumption.
Hot Flash Interference over 14 days
Time frame: From Baseline to day 14 of product consumption.
Hot Flash Frequency
Time frame: From baseline to week 12 of product consumption.
Hot Flash Intensity
Time frame: From baseline to week 12 of product consumption.
Hot Flash Intensity
Time frame: From baseline to day 14 of product consumption.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Related InfoLink 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.
Susan Hewlings principal investigator
Radicle Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revive Active Product 1 in people with Cognitive Function, 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 7 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 cognitive function (time frame: 13 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 20 Aug 2026.