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

NCT07735247 | Not Yet Recruiting

• 1 other identifier: RADX_P_2605_DNS
• Study Type: interventional
• Target: 550
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Fatigue

Outcome Measures

Primary Outcomes (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)

  9 weeks

Secondary Outcomes (5)

• Change in sleep

  9 weeks

• Change in Pain Interference

  9 weeks

• Change in feelings of anxiety

  9 weeks

• Change in feelings of anger

  9 weeks

• Change in feelings of stress

  9 weeks

Other Outcomes (6)

• Minimal clinically important difference (MCID) in fatigue

  9 weeks

• Minimal clinically important difference (MCID) in sleep

  9 weeks

• Minimal clinically important difference (MCID) in pain interference

  9 weeks

Study Arms (2)

Health & Fatigue Product

EXPERIMENTAL

Health \& Fatigue Active Product

Dietary Supplement: Active Health Product

Health & Fatigue Placebo Control

PLACEBO COMPARATOR

Health \& Fatigue Placebo Control Health Product

Dietary Supplement: Placebo Health Control Product

Interventions

Placebo Health Control Product DIETARY_SUPPLEMENT

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

Health & Fatigue Placebo Control

Active Health Product DIETARY_SUPPLEMENT

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

Health & Fatigue Product

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radicle Science: lead

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 29, 2026
• Study Start: July 14, 2026
• Primary Completion (Estimated): July 14, 2027
• Study Completion (Estimated): July 14, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-05