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

NCT07148011 | Completed

• 1 other identifier: RADX_C_2507_SP
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Perimenopause

Outcome Measures

Primary Outcomes (1)

• Change in menopausal health issues

  Difference between rates of change over time in menopausal health issues assessed by Radicle General Menopausal Health Issues (Point range: 6 - 68; where higher scores correspond to more severe menopausal health issues)

  13 weeks

Secondary Outcomes (3)

• Change in feelings of anger

  13 weeks

• Change in feelings of anxiety

  13 weeks

• Change in sleep

  13 weeks

Other Outcomes (4)

• Minimal clinically important difference (MCID) in menopausal health issues

  13 weeks

• Minimal clinically important difference (MCID) in feelings of anger

  13 weeks

• Minimal clinically important difference (MCID) in feelings of anxiety

  13 weeks

Study Arms (2)

Placebo Control

PLACEBO COMPARATOR

Revive Product Form - Control

Dietary Supplement: Revive Product Form - Placebo Control

Active Product

EXPERIMENTAL

Revive Product Form - Active

Dietary Supplement: Revive Product Form - Active

Interventions

Revive Product Form - Placebo Control DIETARY_SUPPLEMENT

Participants will use their Revive Product Form - Placebo Control as directed for a period of 12 weeks.

Placebo Control

Revive Product Form - Active DIETARY_SUPPLEMENT

Participants will use their Revive Product Form - Active as directed for a period of 12 weeks.

Active Product

Eligibility Criteria

• Age: 37 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults, aged 37 - 55 years at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
• Assigned sex at birth is female
• Resides in the United States
• Identifies menstrual status as perimenopausal
• 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

You may not qualify if:

• Reports being pregnant, trying to become pregnant, or breastfeeding
• Unable to provide a valid US shipping address and mobile phone number
• Reports current enrollment in another clinical trial
• Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
• Unable to read and understand English
• Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
• Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients.
• NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
• Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.
• Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOIs, or thyroid products
• Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study products and/or pose a safety risk to participants
• Reports an allergy to and/or disinterest in any of the possible study product ingredients
• Lack of reliable daily access to the internet

Sponsors & Collaborators

• Radicle Science: lead

Study Sites (1)

Radicle Science, Inc

Del Mar, California, 92014, United States

Location

Related Links

• Related Info

Study Officials

• Susan Hewlings

  Radicle Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be stratified based on their age and health outcome score during enrollment then randomized to one of the study arms. Each participant will have an equal chance of being assigned to each study arm.

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: August 26, 2025
• Primary Completion: January 8, 2026
• Study Completion: January 8, 2026
• Last Updated: January 23, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)