NCT07267728
已完成
不适用
A Clinical Study to Assess the Effect of a Dietary Supplement on Menstrual Cycle Symptoms
Muse Nutrition Ltd1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月1日最近更新:
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Muse Nutrition Ltd
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Menstrual Symptoms Questionnaire (MSQ) Scores
概览
简要总结
This is a single-group, virtual clinical trial evaluating the effects of a daily dietary supplement (DITTO Cycle Supplement) on menstrual cycle symptoms across three menstrual cycles. The study investigates changes in symptom severity and quality of life through validated questionnaires including the Menstrual Symptoms Questionnaire (MSQ).
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female-at-birth
- •Aged 18-45
- •In the last three menstrual cycles, has experienced three or more of the following symptoms associated with their menstrual cycle: Menstrual cramps, Bloating, Breast tenderness, Headaches, Fatigue, Muscle aches and/or joint pain, Cravings, Mood swings, Low mood, Feelings of anxiety, Irritability, Difficulty concentrating
- •Generally healthy - does not live with any uncontrolled chronic disease
- •Has a regular menstrual cycle length, between 23 and 35 days
- •Tracks their menstrual cycle and can predict their period dates
- •Anyone willing to comply with study requirements
- •Anyone with no known allergies to the ingredients listed in the product
排除标准
- •Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- •Women who are pregnant, breastfeeding, or trying to conceive
- •Anyone unwilling to follow the study protocol
- •Anyone in perimenopause, menopause, or experiencing menopausal-type symptoms
- •Anyone with planned surgery during the study period
- •Anyone with a history of substance abuse
- •Anyone diagnosed with high blood pressure, high cholesterol, heart disease, heart attack, stroke, irregular heartbeat (AFib), clogged arteries, poor circulation, heart failure, or other heart conditions
- •Anyone diagnosed with a hormone or reproductive health-related cancer or benign condition
- •Anyone diagnosed with a menstrual health condition such as endometriosis, PCOS, or adenomyosis
- •Anyone diagnosed with diabetes or other endocrine-related condition
结局指标
主要结局
Change in Menstrual Symptoms Questionnaire (MSQ) Scores
时间窗: Baseline, End of Cycle 1(28 days), End of Cycle 2(28 days), End of Cycle 3 (28 days)
Change from baseline in menstrual symptom severity as measured by the Menstrual Symptoms Questionnaire (MSQ), including cramps, bloating, fatigue, mood swings, breast tenderness, headaches, anxiety, irritability, and difficulty concentrating.
次要结局
- Change in Menstrual-Related Quality of Life(Baseline, End of Cycle 1(28 days), End of Cycle 2(28 days), End of Cycle 3 (28 days))
研究者
研究点 (1)
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