Plant-Based Health Products for Perimenopausal Women's Wellness
Revive Product Form - Placebo Control
+ Revive Product Form - Active
Other Study
Summary
Study start date: August 26, 2025
Actual date on which the first participant was enrolled.The study focuses on evaluating the effects of plant-based health and wellness products on women who are experiencing perimenopause. The main goal is to see if these products can help improve health issues commonly reported by perimenopausal women, such as mood swings, sleep disturbances, and other related symptoms. This research is important because it seeks to offer alternative, potentially more natural options for managing these symptoms, which can significantly impact quality of life during this stage. Participants in the study take part by using the health products provided, with some receiving a placebo to ensure the results are scientifically valid. All participation is done virtually, with no need for in-person visits. Over a period of 13 weeks, participants submit reports on their health and any changes they experience through electronic surveys. This study design ensures that the experiences and outcomes are accurately measured while maintaining the anonymity of the products being tested, ensuring unbiased results.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.900 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 37 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location