Fatigue
Conditions
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
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.
Interventions
DIETARY_SUPPLEMENTPlacebo Health Control Product
Participants will use their Placebo Health Control Product as directed for a period of 8 weeks
DIETARY_SUPPLEMENTActive Health Product
Participants will use their Active Health Product as directed for a period of 8 weeks
Sponsors
Radicle Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fatigue | 9 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep | 9 weeks | 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) |
| Change in Pain Interference | 9 weeks | 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) |
| Change in feelings of anxiety | 9 weeks | 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) |
| Change in feelings of anger | 9 weeks | 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) |
| Change in feelings of stress | 9 weeks | 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) |
Outcome results
None listed