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

Last updated: January 7, 2025
Sponsor: Radicle Science
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Insomnia

Menopause

Treatment

Radicle Revive Placebo Control Form 4.1

Radicle Revive Active Study Product 4.1 Usage

Clinical Study ID

NCT06749288
RADX-P-2414
  • Ages 21-105
  • Female
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults, 21 years of age and older at the time of electronic consent, inclusive ofall 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 intaking 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

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 lessthan mild severity

  • Reports a diagnosis of liver or kidney disease

  • Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages perday)

  • 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 ofthe active ingredients studied, or a substantial safety risk: Anticoagulants, amedication that warns against grapefruit consumption, corticosteroids at dosesgreater than 5 mgs per day, oral anti-infectives (antibiotics, antifungals,antivirals) to treat an acute infection, antipsychotics, or MAO

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: Radicle Revive Placebo Control Form 4.1
Phase:
Study Start date:
January 01, 2025
Estimated Completion Date:
June 01, 2026

Study 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.

Connect with a study center

  • Radicle Science, Inc

    Del Mar, California 92014
    United States

    Active - Recruiting

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