Radicle Revive17 A Randomized, Double-Blind Study of Health and Wellness Products for Menopausal Women Experiencing Hot Flashes

What this Trial Is About

This research aims to evaluate the effects of health and wellness products on menopausal-related health issues, focusing on cognitive function and hot flash symptoms. The study is a randomized, double-blind, placebo-controlled trial involving adult women who are peri or postmenopausal and regularly experience hot flashes. It targets those not currently using hormone replacement therapy and excludes individuals with significant health risks or contraindications. Participants will be randomly assigned to use either an active Revive health product or a placebo control product for 12 weeks. Both groups will follow product use as directed, with no knowledge of their assigned product until the studys conclusion. The trial is conducted entirely remotely, without in-person visits, and collects data electronically. During the 13-week study period, participants will self-report health outcomes such as cognitive function, feelings of anxiety, hot flash frequency, intensity, and interference through electronic surveys. The study monitors these measures throughout the product use period, with the primary outcome being change in cognitive function. Participants are expected to have internet access to provide daily data. Safety and adherence are observed through remote data collection and electronic reporting.

Radicle Revive™: A Study Assessing the Impact of Health and Wellness Products on Menopausal-Related Health Issues Associated Health Outcomes and Related Health Outcomes