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
Purpose
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
Conditions
- Menopause
- Sleep Disturbance
- Anxiety
- Depression
- Cognitive Function
- Fatigue
- Libido
Eligibility
- Eligible Ages
- Between 21 Years and 105 Years
- Eligible Genders
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- 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.
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Placebo control 4.1.0 |
Revive product form 4.1 - control |
|
|
Experimental Active product 4.1.1 |
Revive product form 4.1 - active product 1 |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Radicle Science
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.
