A Single Group Study to Evaluate the Effects of a Female Hormone Balance Supplement on Symptoms of Polycystic Ovary Syndrome and Severe Premenstrual Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in menstrual cycle regularity.
研究概览
简要总结
This is a virtual single group study that will last 12 weeks. Participants will take 1 scoop of the female hormone balance supplement, and mix it with their drink of choice every morning. Questionnaires will be completed at baseline, 1 week, 2 weeks, 4 weeks, and 12 weeks
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 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged between 18 - 55
- •BMI less than 35
- •Self-reported concerns around irregular menstrual cycles and ovulation, mood swings, stress, irritability, and low energy
- •Generally healthy - don't live with any uncontrolled chronic disease
- •Self-reported symptoms of PCOS - irregular periods
- •Self-reported concerns with hormonal skin issues
排除标准
- •Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- •Anyone with known severe allergic reactions
- •Anyone who is pregnant, breastfeeding, or attempting to become pregnant
- •Unwilling to follow the study protocol
结局指标
主要结局
Changes in menstrual cycle regularity.
时间窗: Baseline to Week 12
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Very regular") and 1 representing the least favorable/worst outcome (e.g., "Extremely irregular").
Changes in hormonal acne.
时间窗: Baseline to Week 12
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
Changes in skin issues throughout the menstrual cycle.
时间窗: Baseline to Week 12
Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., "Not at all") and 1 representing the least favorable/worst outcome (e.g., "Severe").
次要结局
- Changes in overall mood.(Baseline to Week 12)
- Changes in energy.(Baseline to Week 12)
- Changes in stress levels.(Baseline to Week 12)
- Changes in food cravings.(Baseline to Week 12)
- Changes in menstrual cramps.(Baseline to Week 12)