Radicle Revive 24: A Study of Health and Wellness Products on Hormonal Health and Associated Health Outcomes in Women With Peri-Menopausal Health Issues

Radicle Science

Status: Active, not recruiting

Conditions: Menopause; Fatigue; Sleep; Stress

Treatments: Dietary Supplement: Radicle Revive Placebo Control Form 1; Dietary Supplement: Radicle Revive Active Study Product 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT07117994

RADX_P_2414_VPH

Details and patient eligibility

About

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 Peri-Menopausal Health Issues

Full 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 peri-menopausal-related health issues for 3 months or longer, (3) have the opportunity to improve by at least 30% in the primary outcome, 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 ag 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.

Enrollment: 498 patients

Sex: Female

Ages: 40 to 105 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults, at least 40 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
• Assigned sex at birth is female
• Resides in the United States
• Identifies menstrual status as perimenopausal
• Has the opportunity for at least 30% improvement in their primary health outcome
• Indicates having peri-menopausal issues for 3 months or longer
• 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

• Individuals who report any of the following during screening will be excluded from participation:
• Reports being 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
• 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, 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 the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products and/or pose a safety risk to participants
• Reports an allergy to and/or disinterest in any of the possible study product ingredients
• Lack of reliable daily access to the internet

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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498 participants in 2 patient groups, including a placebo group

Placebo Control 1

Placebo Comparator group

Description:

Radicle Revive Placebo Control Form 1

Treatment:

Dietary Supplement: Radicle Revive Placebo Control Form 1

Active Product 1

Experimental group

Description:

Radicle Revive Active Study Product 1

Treatment:

Dietary Supplement: Radicle Revive Active Study Product 1