Revive for Perimenopause

Overseen By Susan Hewlings

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Radicle Science

Must not be taking: Anticoagulants, Antidepressants, Antipsychotics, others

Disqualifiers: Pregnancy, Heavy drinking, Major illness, others

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how plant-based health products affect women experiencing perimenopause symptoms. Participants will receive either the active product (Revive Product Form - Active) or a placebo to assess improvements in self-reported health issues. It suits women in the U.S. who identify as perimenopausal and believe a 30% improvement in their main health concern is possible. Participants must be open to receiving a placebo (a non-active substance). As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on natural health solutions for perimenopause.

Will I have to stop taking my current medications?

If you are taking medications that interact with the study products, like anticoagulants or antidepressants, you may need to stop them to join the trial. It's best to discuss your specific medications with the trial team to see if they pose a safety risk.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Revive Product Form - Active is a plant-based health product designed for women experiencing perimenopause. Previous studies have not identified any major safety concerns. However, they indicate that individuals with heart, liver, or kidney problems could face serious risks when using this product.

In general, the treatment is considered safe for most people. Caution is advised for those with heart, liver, or kidney issues. Consulting a healthcare provider before starting any new treatment is essential, especially for those with existing health conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Revive for perimenopause is unique because it offers a new approach to managing symptoms through its specific formulation, which may differ from traditional hormone therapy and lifestyle changes typically used. Unlike existing treatments that primarily focus on hormone replacement, Revive uses a novel combination of active ingredients designed to address hormonal imbalances more directly and potentially with fewer side effects. Researchers are excited about this treatment because it could provide a more targeted and safer option for women experiencing perimenopause, offering relief without the risks associated with long-term hormone therapy.

What evidence suggests that this treatment might be an effective treatment for perimenopause?

Research has shown that the Revive Product Form - Active, which participants in this trial may receive, may help women with perimenopausal symptoms. In one study, many participants experienced at least a 30% improvement in their main health issues. Another study found that by day 60, 93% of users no longer had hot flashes. Additionally, 88% reported relief from sweating, 91% felt less anxious, and 90% felt less depressed. These results suggest that the Revive product could effectively ease several symptoms of perimenopause. ^{1 2 3 5 6}

Who Is on the Research Team?

Susan Hewlings

Principal Investigator

Radicle Science

Are You a Good Fit for This Trial?

This trial is for perimenopausal women aged 37-55 living in the US, who have not used similar products to those being tested. Participants must be healthy without major illnesses or surgeries in the past 3 months, not pregnant or breastfeeding, and not heavy drinkers. They should have internet access and understand English.

Inclusion Criteria

Resides in the United States

Has the opportunity for at least 30% improvement in their primary health outcome

I am experiencing symptoms of transitioning into menopause.

Exclusion Criteria

I am currently using products similar to the study medication.

I have heart, liver, or kidney issues that make certain treatments unsafe for me.

Lack of reliable daily access to the internet

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive plant-based health and wellness products or placebo for 13 weeks

13 weeks

All assessments are electronic; no in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Revive Product Form - Active
• Revive Product Form - Placebo Control

Trial Overview The trial is testing a plant-based health product against a placebo in perimenopausal women. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real product until the end of the study.

How Is the Trial Designed?

Group I: Active Product Experimental Treatment 1 Intervention

Revive Product Form - Active

Group II: Placebo Control Placebo Group 1 Intervention

Revive Product Form - Control

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07117994

NCT07117994 | Radicle Revive 24: A Study of Health and ... Has the opportunity for at least 30% improvement in their primary health outcome; Indicates having peri-menopausal issues for 3 months or longer; Expresses a ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07148011

Study Details | NCT07148011 | Radicle Revive™ CSP: A ... Identifies menstrual status as perimenopausal; Has the opportunity for at least 30% improvement in their primary health outcome; Expresses a ...

3. ctv.veeva.com ctv.veeva.com/study/radicle-revive-24-a-study-of-health-and-wellness-products-on-hormonal-health-and-associated-health

Radicle Revive 24: A Study of Health and Wellness Products ... Radicle Revive 24: A Study of Health and Wellness Products on Hormonal Health and Associated Health Outcomes in Women With Peri-Menopausal ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40677428/

Effectiveness of Multisymptom Support for Better Relief and ... By day 60, 93% of patients achieved complete resolution of hot flashes, 88% for sweating, 91% for anxiety, and 90% for depressive mood (p < 0.05) ...

5. withpower.com withpower.com/trial/radicle-revive-for-menopause-7f4ce

Radicle Revive for Menopause · Info for Participants This trial is for women experiencing menopause with related issues like depression, insomnia, cognitive problems, anxiety, fatigue, and low sex drive.

6. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07148011

Revive Product Form - Clinical Trials Registry - ICH GCP A randomized, double-blind, placebo-controlled, trial evaluating plant-based health and wellness products on perimenopausal women's ...