Radicle Revive 24: A Study of Health and Wellness Products on Menopausal Health and Related Health Outcomes

NCT ID: NCT06749288

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-07-01

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.

Conditions

Menopause; Sleep Disturbance; Anxiety; Depression; Cognitive Function; Fatigue; Libido

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Placebo control 4.1.0

Revive product form 4.1 - control

Group Type: PLACEBO_COMPARATOR

Radicle Revive Placebo Control Form 4.1

Intervention Type: DIETARY_SUPPLEMENT

Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.

Active product 4.1.1

Revive product form 4.1 - active product 1

Group Type: EXPERIMENTAL

Radicle Revive Active Study Product 4.1 Usage

Intervention Type: DIETARY_SUPPLEMENT

Participants will use their Radicle Revive Active Study Product 1.1 as directed for a period of 6 weeks.

Interventions

Radicle Revive Placebo Control Form 4.1

Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Radicle 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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Radicle Science

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radicle Science, Inc

Del Mar, California, United States

Countries

United States

Related Links

http://radiclescience.com

Related Info

Other Identifiers

RADX-P-2414

Identifier Type: -

Identifier Source: org_study_id