A Study to Assess the Effect of My Happy Flo on Alleviating Period Symptoms and Heavy Flows.
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
- Improvement in Period Symptoms
研究概览
简要总结
This clinical study aims to evaluate the effectiveness of My Happy Flo, a dietary supplement, in alleviating period symptoms and heavy menstrual flows. The study involves 40 participants, who will take the supplement daily for three menstrual cycles. Primary outcomes, such as the severity of heavy flows, prolonged periods, cramps, mood, energy levels, cycle regulation, and fatigue, will be measured using validated questionnaires completed after each menstrual cycle. Secondary outcomes, including Vitamin D and Iron levels, will be assessed through blood tests at the beginning and end of the study period.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, aged 18 or over
- •Experiencing heavy period flows
- •Two or more self-reported symptoms (prolonged periods, cramps, poor mood, fatigue, irregular cycle)
- •Signs of potential anemia or iron deficiency
- •No known allergies to the product ingredients
- •Willing to comply with study requirements and limit caffeine intake
- •Generally healthy - do not live with any uncontrolled chronic disease
排除标准
- •Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- •A diagnosis of sports anemia within the previous 6 months
- •Anyone with known severe allergic reactions that require an Epi-Pen
- •Women who are pregnant, breastfeeding, or trying to conceive
- •Anyone unwilling to follow the study protocol
- •Anyone who has undergone any surgeries or invasive treatments (such as immunotherapy, chemotherapy, radiation, or biological cancer) in the last 30 days or has any planned for the next 12 weeks
- •Anyone with a history of substance abuse
- •Anyone currently participating or planning to participate in a research study
- •Anyone taking prescription anticonvulsants (anti-seizure medications)
- •Anyone taking prescription anticoagulant medications (blood thinners)
- •Anyone taking any hormone-modulating medications (e.g., hormonal birth control, hormone replacement therapy, testosterone, tamoxifen, thyroid medications, etc.)
- •History of hysterectomy, oophorectomy, or other surgery to the reproductive organs
- •History of gynecologic cancer, such as cervical, ovarian, uterine, vaginal, or vulvar cancer
- •Currently experiencing menopausal or perimenopausal symptoms
- •Changes or cessation of hormonal birth control in the last three months
- •Active or abnormal uterine/vaginal bleeding
- •Resides in RI, NY, NJ, or AZ
结局指标
主要结局
Improvement in Period Symptoms
时间窗: Baseline (Day 0), Cycle 1, Cycle 2, and Cycle 3 - each Cycle is 28 days
Measurement of heavy flows, prolonged periods, cramps, mood disturbances, energy levels, cycle regulation, and fatigue using validated questionnaires.
次要结局
- Changes in Vitamin D Level(Baseline and Cycle 3 - each Cycle is 28 days)
- Changes in Iron Level(Baseline and Cycle 3 - each Cycle is 28 days)