The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Bloating
研究概览
简要总结
The purpose of this study is to assess Mixhers HERTIME supplements efficacy in alleviating menstrual cycle symptoms.
详细描述
All participants, after providing written informed consent, will drink a daily self-administered powder-mix supplement in water of either placebo or Mixhers HERTIME for 120 consecutive days. Surveys will be administered electronically to each participant in the first month to assess baseline menstrual cycle symptoms. In addition, before starting the supplement, participants will take the electronic survey "The Premenstrual Symptoms Screening Tool". During the first month of taking the supplement, participants will take an allergy and constitutional symptom survey electronically to assess for any adverse reactions to the product. Each month for four months, participants will complete an electronic survey assessing menstrual cycle symptoms after a menstrual cycle is completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Must be biologically female, must have a regular menstrual cycle (defined as a menstrual bleed every 23-35 days), must be a student, staff, or faculty member at Midwestern University Glendale, Arizona campus
排除标准
- •not pregnant or planning to become pregnant, must not be on anticoagulants, must not have allergies to lemon or stevia
研究组 & 干预措施
Mixhers HERTIME
1 daily powder stick packet (3.0-3.3 g) of Mixhers HERTIME herbal supplement mixed into water
干预措施: Mixhers HERTIME (Dietary Supplement)
Placebo
1 daily powder stick packet (3 g) of a matching placebo powder supplement mixed into water
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Bloating
时间窗: 120 days
Measured through post-menstrual bleeding electronic survey 1-10 severity scale
Menstrual Cramping and/or Back Pain
时间窗: 120 days
Measured through post-menstrual bleeding electronic survey 1-10 severity scale
Mood Regulation
时间窗: 120 days
Measured through post-menstrual bleeding electronic survey 1-10 mood scale
Menstrual Bleeding Volume
时间窗: 120 days
Measured through post-menstrual bleeding electronic survey 1-10 scale of flow volume
Menstrual Bleeding Duration
时间窗: 120 days
Measured through post-menstrual bleeding electronic survey recording start and end day of menstrual bleeding
次要结局
- Number of pads/tampons/other products used during menstrual bleeding(120 days)
- Period symptom interference with social life activities(120 days)
- Any positive or negative mood changes noticed during period(120 days)
- Non-steroidal anti-inflammatory drug use for acute symptoms during menstrual bleeding(120 days)
- Fatigue(120 days)
- Acne(120 days)
- Difficulty Concentrating(120 days)
- Hypersomnia(120 days)
- Period symptom interference with school/work efficiency/productivity(120 days)
- Insomnia(120 days)
- Overeating/Food Cravings(120 days)
- Period symptom interference with physical activity (sports, gym, or daily performance)(120 days)
- Any positive or negative mood changes noticed during other weeks of the menstrual cycle not bleeding(120 days)