Clinical trial NCT06749288: Radicle Revive 24: A Study of Health and Wellness Products on Menopausal Health and Related Health Outcomes
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Menopause
Sleep Disturbance
Anxiety
Depression
Cognitive Function
Fatigue
Libido
Lead sponsor: Radicle Science
Sponsor class: INDUSTRY
First posted: 2024-12-27
Enrollment: 500
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in feelings of anxiety
timeFrame: 6 weeks
measure: Change in feelings of anxiety
timeFrame: 6 weeks
measure: Change in feelings of depression
timeFrame: 6 weeks
measure: Change in cognitive function
timeFrame: 6 weeks
measure: Change in cognitive function
timeFrame: 6 weeks
measure: Change in sleep disturbance
timeFrame: 6 weeks
measure: Change in sleep disturbance
timeFrame: 6 weeks
measure: Change in fatigue
timeFrame: 6 weeks
measure: Change in feelings of depression
timeFrame: 6 weeks
measure: Change in fatigue
timeFrame: 6 weeks
measure: Change in Pain Interference
timeFrame: 6 weeks
measure: Change in pain intensity
timeFrame: 6 weeks
measure: Change in interest in sexual activity
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in other menopausal health issues
timeFrame: 6 weeks
measure: Minimal clinically important difference (MCID) in feelings of anxiety
timeFrame: 6 weeks
measure: Minimal clinically important difference (MCID) in feelings of anxiety
timeFrame: 6 weeks
measure: Minimal clinically important difference (MCID) in feelings of depression
timeFrame: 6 weeks
measure: Minimal clinically important difference (MCID) in feelings of depression
timeFrame: 6 weeks
measure: Minimal clinically important difference (MCID) in cognitive function
timeFrame: 6 weeks
measure: Minimal clinically important difference (MCID) in cognitive function
timeFrame: 6 weeks
measure: Minimal clinically important difference (MCID) in sleep disturbance
timeFrame: 6 weeks
measure: Minimal clinically important difference (MCID) in sleep disturbance
timeFrame: 6 weeks
measure: Minimal clinically important difference (MCID) in fatigue
timeFrame: 6 weeks
measure: Minimal clinically important difference (MCID) in fatigue
timeFrame: 6 weeks
measure: Minimal clinically important difference (MCID) in pain interference
timeFrame: 6 weeks
measure: Minimal clinically important difference (MCID) in pain intensity
timeFrame: 6 weeks
measure: Minimal clinically important difference (MCID) in interest in sexual function
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Del Mar
country: United States
facility: Radicle Science, Inc
state: California
Study officials:
References: