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

Официальное название

Radicle Revive™: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Menopausal-Related Health Issues Associated Health Outcomes and Related Health Outcomes

Обзор

Radicle Revive™: A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on menopausal-related health issues associated health outcomes.

Подробное описание

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

Eligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome, (2) express acceptance in taking a product and not knowing its formulation until the end of the study, and Peri or Post menopausal women (3) regularly experiencing hot flashes and (4) Not taking a HRT medication.

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 those who report they 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 enrollment and throughout the active period of study product usage. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Вмешательства

• Пищевая добавка Revive Product Placebo Control
  Participants will use their Control as directed for a period of 12 weeks.
• Пищевая добавка Revive Active Product 1
  Participants will use their Active product as directed for a period of 12 weeks.

Первичные конечные точки

• Change in cognitive function [Срок оценки: 13 weeks]

Вторичные конечные точки (8)

• Change in cognitive abilities [Срок оценки: 13 weeks]
• Change in feelings of anxiety [Срок оценки: 13 weeks]
• Hot Flash Interference over 12 weeks [Срок оценки: From Baseline to week 12 of product consumption.]
• Hot Flash Frequency [Срок оценки: From baseline to day 14 of product consumption.]
• Hot Flash Interference over 14 days [Срок оценки: From Baseline to day 14 of product consumption.]
• Hot Flash Frequency [Срок оценки: From baseline to week 12 of product consumption.]
• Hot Flash Intensity [Срок оценки: From baseline to week 12 of product consumption.]
• Hot Flash Intensity [Срок оценки: From baseline to day 14 of product consumption.]

Критерии участия

Inclusion

Participants must meet all the following criteria:

• Adults, at least 40 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities
• Assigned sex at birth will determine sex-specific recruitment
• Resides in the United States
• Has the opportunity for at least 30% improvement in their primary health outcome
• Peri or Post Menopausal women who have been experiencing hot flashes for the past 3 months or longer
• Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

Exclusion

Individuals who report any of the following during screening may be excluded from participation:

• Report 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 at a 7th grade level
• 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, seizure medications, 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
• Lack of reliable daily access to the internet
• Currently taking a HRT medication
• Pre-Menopausal women

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

США · 1 центр

• Radicle Science Inc. — Del Mar

Идентификаторы

NCT: NCT07548307 · RADX_P_2605_RGW

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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