Radicle Revive™ 24: A Randomized, Double-Blind, Placebo-Controlled, Direct-to-Consumer Trial Assessing the Impact of Health and Wellness Products on Hormonal Health and Associated Health Outcomes in Women With Menopausal Health Issues
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- Change in Pain Interference
Study Overview
Brief Summary
A randomized, double-blind, placebo-controlled, direct-to-consumer trial assessing the impact of health and wellness products on hormonal health and associated health outcomes in women with menopausal health issues
Detailed Description
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.
Eligible participants (1) are females, (2) have menopausal health issues for 3 months or longer, (3) have the opportunity to improve by at least 30%, and (4) express acceptance in taking study products and not knowing the formulation identities until the end of the study.
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 women who are 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 7 weeks. Participant reports of health indicators will be collected at 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Masking Description
The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
Eligibility Criteria
- Ages
- 21 Years to 105 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 less pain as a primary desire
- •Selects pain and/or looking to improve their pain 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
Exclusion Criteria
- •reports being pregnant, trying to become pregnant, or breastfeeding
- •Unable to provide a valid US shipping address and mobile phone number
- •The calculated validated health survey (PRO) score during enrollment represents less than mild severity
- •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
- •Reports current enrollment in a clinical trial
- •Lack of reliable daily access to the internet
- •Reports current or recent (within 3 months) use of chemotherapy or immunotherapy
- •Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied, or a substantial safety risk: Anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, or MAO
Outcomes
Primary Outcomes
Change in Pain Interference
Time Frame: 6 weeks
Mean difference 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 pain intensity
Time Frame: 6 weeks
Mean difference in pain intensity score as assessed by PROMIS Pain Intensity 3A (scale 3-15; with higher scores corresponding to more severe pain intensity)
Change in interest in sexual activity
Time Frame: 6 weeks
Mean difference in interest in sexual activity score as assessed by PROMIS Sexual Function and Satisfaction v2.0 (scale 2-10; with lower scores corresponding to less interest in sexual activity)
Change in feelings of anxiety
Time Frame: 6 weeks
Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
Change in feelings of depression
Time Frame: 6 weeks
Mean difference in depression score as assessed by PROMIS Depression 4A (scale 4-20; with higher scores corresponding to more severe depression)
Change in cognitive function
Time Frame: 6 weeks
Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A (scale 4-20; with lower scores corresponding to better cognitive function)
Change in sleep disturbance
Time Frame: 6 weeks
Mean difference in sleep disturbance score as assessed by PROMIS Sleep Disturbance 4A (scale 4-20; with higher scores corresponding to more severe sleep disturbance)
Change in fatigue
Time Frame: 6 weeks
Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; with higher scores corresponding to more severe fatigue)
Secondary Outcomes
- Change in other menopausal health issues(6 weeks)
- Minimal clinically important difference (MCID) in pain interference(6 weeks)
- Minimal clinically important difference (MCID) in pain intensity(6 weeks)
- Minimal clinically important difference (MCID) in interest in sexual function(6 weeks)
- Minimal clinically important difference (MCID) in feelings of anxiety(6 weeks)
- Minimal clinically important difference (MCID) in feelings of depression(6 weeks)
- Minimal clinically important difference (MCID) in cognitive function(6 weeks)
- Minimal clinically important difference (MCID) in sleep disturbance(6 weeks)
- Minimal clinically important difference (MCID) in fatigue(6 weeks)