COMPLETED

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

Conditions

Menopause Sleep Disturbance Anxiety Depression Cognitive Function Fatigue Libido

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2025-01-01

Study Completion:2025-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06749288

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 105 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Locations (Sites)

Radicle Science, Inc

Del Mar, California, 92014

United States

Collaborators and Investigators

Sponsor: Radicle Science

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-01

Study Completion Date2025-07-01

Study Record Updates

Study Start Date2025-01-01

Study Completion Date2025-07-01

Terms related to this study

Additional Relevant MeSH Terms

Menopause
Sleep Disturbance
Anxiety
Depression
Cognitive Function
Fatigue
Libido