Study to Evaluate the Efficacy of Your Super's Moon Balance and Its Impact on Premenstrual Syndrome and Menstrual Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in perceived discomfort associated with menstruation
研究概览
简要总结
This is an open-label observational single-group clinical trial to study the efficacy of a commercially available dietary supplement and its effect on common PMS and menstrual symptoms, as well as health-related biomarkers.
详细描述
It is hypothesized that the dietary supplement marketed as "YOUR SUPER Moon Balance" will improve subjective wellbeing in trial participants by alleviating common symptoms of PMS and menstrual symptoms, such as pain, cramps, bloating, and lack of energy. Further, the ability of the supplement to reduce biomarkers of inflammation (CRP) and stress (cortisol), and promote sleep, will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Individuals with a regular menstruation
- •Age 18-40
- •Moderate self-reported discomfort during menstruation-related to bloating, cramps, fatigue, mood swings, or other PMS-related symptoms
- •Must be in generally good health - no unstable, uncontrolled health condition
- •BMI under 35
- •Self-reported sleep-issues
- •Willingness to refrain from ibuprofen or naproxen sodium (such as Advil, Aleve, Motrin or Midol) during each period (pill bleed) during the study
- •Agree to not change their diet significantly during the duration of the study
- •Agree to not change the intensity of their workouts for the duration of the study
- •Must get their period regularly
排除标准
- •Severe chronic conditions, including oncological and psychiatric disorders
- •Known to have any severe allergic reactions
- •Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study
- •Participants unwilling to follow the study protocol
- •Have used a similar product (ingredients) in the 6 weeks prior to the study
结局指标
主要结局
Change in perceived discomfort associated with menstruation
时间窗: 12 weeks
Perceived discomfort caused by several of the most common menstrual symptoms (energy, sleep, mood, comfort, and overall fewer PMS symptoms) Each endpoint will be reported by the participant on a scale of perceived discomfort at the end of each menstrual cycle. Participants will complete the surveys for each menstrual cycle. The study uses a questionnaire including a scale from 0-7 to assess the severity of symptoms(0=no symptoms and 7=very severe symptoms).
次要结局
- Changes in saliva cortisol levels(12 weeks)
- Change in blood biomarkers: C-reactive protein(12 weeks)