Anxiety, Cognitive Function, Depression, Fatigue, Libido, Menopause, Sleep Disturbance
Conditions
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.
Interventions
DIETARY_SUPPLEMENTRadicle Revive Placebo Control Form 4.1
Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
DIETARY_SUPPLEMENTRadicle Revive Active Study Product 4.1 Usage
Participants will use their Radicle Revive Active Study Product 1.1 as directed for a period of 6 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 will be stratified then randomized to one of the study arms. Each participant will have an equal chance of being assigned to each study arm.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 105 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in feelings of anxiety | 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 | 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 | 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 | 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 | 6 weeks | Mean difference in fatigue score as assessed by PROMIS Fatigue 4A (scale 4-20; with higher scores corresponding to more severe fatigue) |
| Change in Pain Interference | 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 | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in other menopausal health issues | 6 weeks | Other menopausal health issues assessed by Radicle General Menopausal Health Issues (Point range: 10 - 48; where higher is more severe menopausal health issues) |
| Minimal clinically important difference (MCID) in interest in sexual function | 6 weeks | Likelihood of achieving a MCID in interest in sexual activity, as measured by PROMIS Sexual Function and Satisfaction v2.0 (scale 2-10; with lower scores corresponding to less interest in sexual activity) |
| Minimal clinically important difference (MCID) in feelings of anxiety | 6 weeks | Likelihood of achieving a MCID in anxiety, as measured by PROMIS Anxiety 4a (4-20; where lower scores indicate less anxiety). |
| Minimal clinically important difference (MCID) in feelings of depression | 6 weeks | Likelihood of achieving a MCID in depression , as measured by PROMIS Depression 4a (4-20; where lower scores indicate less depression). |
| Minimal clinically important difference (MCID) in cognitive function | 6 weeks | Likelihood of achieving a MCID in cognitive function , as measured by PROMIS cognitive function 4a (4-20; where lower scores indicate poorer cognitive function). |
| Minimal clinically important difference (MCID) in sleep disturbance | 6 weeks | Likelihood of achieving a MCID in sleep disturbance , as measured by PROMIS Sleep Disturbance 4a (4-20; where lower scores indicate less sleep disturbance). |
| Minimal clinically important difference (MCID) in fatigue | 6 weeks | Likelihood of achieving a MCID in fatigue, as measured by PROMIS Fatigue 4a (4-20; where lower scores indicate less fatigue). |
| Minimal clinically important difference (MCID) in pain interference | 6 weeks | Likelihood of achieving a MCID in pain interference, as measured by PROMIS Pain interference (6-30; where lower scores indicate less pain interference). |
| Minimal clinically important difference (MCID) in pain intensity | 6 weeks | Likelihood of achieving a MCID in pain intensity, as measured by PROMIS Pain intensity (3-15; where lower scores indicate less pain intensity). |
Countries
United States
Outcome results
None listed