NCT07148011

Radicle Revive™ CSP: A Trial Evaluating Plant-Based Health and Wellness Products on Perimenopausal Women's Self-Reported Health Issues and Outcomes

Radicle Revive™ CSP: A Randomized, Double-Blind, Placebo-Controlled, Trial Evaluating Plant-Based Health and Wellness Products on Perimenopausal Women's Self-Reported Health Issues and Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 900 (actual)
• Sponsor: Radicle Science · Industry
• Sex: Female
• Age: 37 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A randomized, double-blind, placebo-controlled, trial evaluating plant-based health and wellness products on perimenopausal women's self-reported health issues and outcomes

Detailed 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) are perimenopausal, (3) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, 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, trying to become 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 13 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

• Perimenopause

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Revive Product Form - Placebo Control	Participants will use their Revive Product Form - Placebo Control as directed for a period of 12 weeks.
DIETARY_SUPPLEMENT	Revive Product Form - Active	Participants will use their Revive Product Form - Active as directed for a period of 12 weeks.

Timeline

• Start date: 2025-08-26
• Primary completion: 2026-01-08
• Completion: 2026-01-08
• First posted: 2025-08-29
• Last updated: 2026-01-23

Locations

1 site across 1 country: United States