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FatigueNCT07735247

Radicle Women's Health DNS™: A Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Women's Health Outcomes

A study testing Active Health Product in people with Fatigue, run by Radicle Science.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Radicle Women's Health DNSTM: A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related women's health outcomes Read more about this study

Who is it for?
Ages 21 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for
Fatigue
What is being tested?
Active Health Product
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
550 participants
Where
No sites listed yet
Study dates
14 Jul 2026to 14 Jul 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 21 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

3.1 Inclusion

Participants must meet all the following criteria:

  • Adult females, 21-60 years of age (inclusive) 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
  • 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

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 supplements with rhodiola root or maca root extract
  • Lack of reliable daily access to the internet

About this study

Official title: Radicle Women's Health DNS™: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Women's Health Outcomes

Radicle Women's Health DNSTM: A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related women's 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) be women ages 21-60, (2) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

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 9 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
Fatigue
Being tested
Placebo Health Control Product, Active Health Product
Medical subject headings
Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo Health Control ProductDietary supplement

    Participants will use their Placebo Health Control Product as directed for a period of 8 weeks

  • Active Health ProductDietary supplement

    Participants will use their Active Health Product as directed for a period of 8 weeks

Study groups in NCT07735247
Study groupRoleWhat they receive
Health & Fatigue ProductExperimentalHealth \& Fatigue Active Product
Receives: Dietary Supplement: Active Health Product
Health & Fatigue Placebo ControlPlacebo comparatorHealth \& Fatigue Placebo Control Health Product
Receives: Dietary Supplement: Placebo Health Control Product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in fatigue

    Change in fatigue: Difference in rates of change over time in fatigue score as assessed by Patient Reported Outcome Measurement System (PROMIS) Fatigue 8A (scale 8-40; where higher scores correspond to more severe fatigue)

    Measured: 9 weeks

Secondary outcomes (5)

  1. Change in sleep

    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)

    Measured: 9 weeks

  2. Change in Pain Interference

    Change in Pain Interference: Difference in rates of change over time in pain interference score as assessed by PROMIS Pain Interference 6A (scale 6-30; with higher scores corresponding to more severe pain interference)

    Measured: 9 weeks

  3. 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: 9 weeks

  4. Change in feelings of anger

    Change in feelings of anger: Difference between rates of change over time in anger score as assessed by PROMIS Anger 5A (scale 5-25; with higher scores corresponding to more severe anger)

    Measured: 9 weeks

  5. Change in feelings of stress

    Change in feelings of stress: Difference between rates of change over time in feelings of stress score as assessed Perceived Stress Scale 4 (PSS-4) (scale 0-16; where lower scores correspond to less stress)

    Measured: 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2026
  2. Study start14 Jul 2026 (estimated)
  3. Primary completion14 Jul 2027 (estimated)
  4. Study completion14 Jul 2027 (estimated)

Resources

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 who complete all enrollment requirements will be stratified before randomization. Stratification will be based on three factors: menstrual status (premenopausal, perimenopausal, postmenopausal), age (21-34, 35-48, 49-60 years), and health outcome score (categorized into four levels according to published PROMIS scoring guidelines), resulting in 36 total strata. Participants will then be randomized sequentially within each stratum to one of the study groups to ensure balanced allocation across treatment arms with respect to all stratification factors. After randomization, participants will receive their assigned study product along with written instructions for product use and study procedures.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
550 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07735247
Sponsor's protocol ID
RADX_P_2605_DNS
Status last verified
May 2026
First submitted
14 Jul 2026
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Active Health Product in people with Fatigue, run by Radicle Science.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

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 fatigue (time frame: 9 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07735247.

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 29 Jul 2026.

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