An Open-Label, Single-Group Study to Evaluate the Effect of Funk It Cycle Bites on PMS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in pain levels, including menstrual cramps. [Time Frame: Baseline to Month 4]
研究概览
简要总结
This is a virtual, open-label, single-group study that will last 4 menstrual cycles. All participants will complete a questionnaire at the end of their first period after enrolling (baseline/non-intervention cycle 1), then proceed to take the product daily and complete questionnaires at the end of their next 3 periods (intervention cycles 1, 2, and 3). The study will involve 30 female participants with regular menstrual cycles who experience PMS.
Questionnaires will be used to monitor menstrual pain/cramps, energy levels, mood, and hormonal acne experienced before and during the menstrual cycle. Likert scale responses will be statistically compared from baseline to each check-in. Participant responses on product feedback will be presented as % scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female aged 18-40
- •Have a regular menstrual cycle (every 21-35 days).
- •Suffer from mild to moderate menstrual pain.
- •May experience mood swings and/or hormonal acne related to the menstrual cycle.
- •Otherwise generally healthy.
- •Willing to consume the test product with a ginger flavor.
- •Willing to refrain from taking any other supplements or prescription medications that may target the menstrual cycle or premenstrual syndrome (PMS) symptoms throughout the study period.
- •Willing and able to adhere to the study protocol, including taking supplements at the required times and completing questionnaires via the technology portal.
- •Able to communicate in English.
- •Participants must provide written informed consent (ICF).
排除标准
- •Any unstable or uncontrolled medical or psychiatric illness.
- •Any uncontrolled chronic disease or condition that would prevent full participation in the study protocol.
- •A history of polycystic ovary syndrome (PCOS), endometriosis, premenstrual dysphoric disorder (PMDD), or undiagnosed vaginal bleeding.
- •Are taking hormonal contraception or exogenous sex hormones (estrogen, testosterone, progesterone), or have taken hormonal contraception or exogenous hormones in the past 6 months.
- •Are taking any prescription medication or supplements that target the menstrual cycle or PMS symptoms.
- •Are pregnant, breastfeeding, trying to become pregnant, or have been pregnant in the past 12 months.
- •Have any known severe allergic reactions, or any allergies of any severity to any of the test product's ingredients.
结局指标
主要结局
Changes in pain levels, including menstrual cramps. [Time Frame: Baseline to Month 4]
时间窗: 4 months
Survey-based assessment of acne using the Numerical Pain Rating Scale, a 0-10 point rating scale.
Changes in mood stability. [Time Frame: Baseline to Month 4]
时间窗: 4 months
Survey-based assessment using study-specific questionnaires. Responses will be gathered using a 5-point Likert scale.
Change in symptoms of premenstrual syndrome. [Time Frame: Baseline to Month 4]
时间窗: 4 months
Survey-based assessment of symptoms using the Premenstrual Symptoms Screening Tool (PSST). Responses will be gathered using a 4-point Likert scale.
Changes in energy levels. [Time Frame: Baseline to Month 4]
时间窗: 4 months
Survey-based assessment using study-specific questionnaires. Responses will be gathered using a 5-point Likert scale.
Changes in acne. [Time Frame: Baseline to Month 4]
时间窗: 4 months
Survey-based assessment of acne using the Acne Quality of Life (Acne-QOL) scale. Responses will be gathered using a 5-point Likert scale.
次要结局
- Participant enjoyment of the product.(4 months)