Radicle Women's HealthTM: A Randomized, Double-Blind, Placebo- Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Fatigue and Related Health Outcomes Among Women Experiencing Menopausal Symptoms
Radicle Science
Summary
Radicle Women's HealthTM: A randomized, double-blind, placebo- controlled direct-to-consumer study assessing the impact of health and wellness products on fatigue and related health outcomes among women experiencing menopausal symptoms.
Description
This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States. Eligible participants (1) are female, (2) aged 35-60, (3) currently experience menopausal symptoms, (4) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, and (5) express acceptance in taking a product and not knowing its formulation 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-establis…
Eligibility
- Age range
- 35–60 years
- Sex
- Female
- Healthy volunteers
- Yes
3.1 Inclusion Participants must meet all the following criteria: * Adults, 35-60 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities * Assigned sex at birth is female * Experience at least two menopausal symptoms * Resides in the United States * Has the opportunity for at least 30% improvement in their primary health outcome * Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study 3.2 Exclusion Individuals who report any of the following during screening may b…
Interventions
- Dietary SupplementFatigue Product Placebo Control
Participants will use their Fatigue Product Placebo Control as directed for a period of 6 weeks.
- Dietary SupplementFatigue Active Product 1
Participants will use their Fatigue Active Product 1 as directed for a period of 6 weeks.
Location
- Radicle Science Inc.Del Mar, California