Radicle Menstrual Wellness™ CSP: A Randomized, Double-Blind, Placebo-Controlled, Trial Evaluating Plant-Based Health and Wellness Products on Menstrual Wellness in Premenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 850
- 试验地点
- 1
- 主要终点
- Change in Menstrual Distress
研究概览
简要总结
A randomized, double-blind, placebo-controlled, trial evaluating plant-based health and wellness products on menstrual wellness in premenopausal women
详细描述
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 premenopausal, (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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adults, at least 21 years old 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 premenopausal
- •Reports an average menstrual cycle length of 3 - 6 weeks
- •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
排除标准
- •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
研究组 & 干预措施
Placebo Control
Menstrual Wellness Product Control
干预措施: Menstrual Wellness Product Placebo Control (Dietary Supplement)
Active Product 1
Menstrual Wellness Product 1
干预措施: Menstrual Wellness Product 1 (Dietary Supplement)
结局指标
主要结局
Change in Menstrual Distress
时间窗: 13 weeks
Difference between rates of change over time in Menstrual Distress as assessed by MEDI-Q (scale 0-125; higher scores = worse menstrual distress)
次要结局
- Change in Wellbeing(13 weeks)
- Change in Pain Interference(13 weeks)
- Change in Pain Intensity(13 weeks)