A Single Group Study to Evaluate the Effects of a Supplement on 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 gastrointestinal discomfort.
研究概览
简要总结
This is a virtual single-group study that will last three menstrual cycles (approximately 12 weeks). During the first menstrual cycle, participants will take the supplement as needed (pro re nata) when they feel symptoms of PMS, such as cramping or bloating. For the second and third menstrual cycles, Participants will take 2 capsules per day with water for 1 week, starting 4 days before their menstrual cycle and finishing on Day 3 of their cycle. Questionnaires will be completed at the following time points:
- Baseline
- Day 7 of their first cycle during the trial (After using the product PRN during their period)
- 4 days before their second period during the trial (After using the product PRN for the previous month)
- Day 3 of their second period during the trial (After using the product for 7 days straight)
- Day 3 of their third period of the trial (After using the product for 7 days straight)
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
- •Self-reported moderate discomfort during menstruation related to pelvic cramps, bloating, fatigue, or mood swings.
- •Self-reported symptoms during their menstrual cycle with gas, heartburn, and acid reflux
- •Generally healthy - don't live with any uncontrolled chronic disease
- •Has a menstrual cycle between 21 and 35 days in length
- •Able to predict their menstrual cycle and timing of their menstruation
排除标准
- •Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- •Current use of any blood thinning medication
- •Anyone with known severe allergic reactions.
- •Women who are pregnant, breastfeeding, or attempting to become pregnant
- •Unwilling to follow the study protocol.
- •Anyone with a diagnosis of a condition relating to the menstrual cycle or reproductive system? e.g., polycystic ovary syndrome (PCOS), premenstrual dysphoric disorder (PMDD), endometriosis, etc.
- •Anyone currently on hormonal birth control, or has been on hormonal birth control in the last 3 months
结局指标
主要结局
Changes in gastrointestinal discomfort.
时间窗: Baseline to Week 12
Participants will complete study-specific questionnaires. Questionnaires will include 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 overall mood.
时间窗: Baseline to Week 12
Participants will complete study-specific questionnaires. Questionnaires will include 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 pelvic cramps.
时间窗: Baseline to Week 12
Participants will complete study-specific questionnaires. Questionnaires will include 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 energy levels.
时间窗: Baseline to Week 12
Participants will complete study-specific questionnaires. Questionnaires will include 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 bloating.
时间窗: Baseline to Week 12
Participants will complete study-specific questionnaires. Questionnaires will include 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
未报告次要终点