A Clinical Study to Assess the Effect of a Dietary Supplement on Menstrual Cycle Symptoms
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
- Change in Menstrual Symptoms Questionnaire (MSQ) Scores
研究概览
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 through validated questionnaires including the Menstrual Symptoms Questionnaire (MSQ), and proportion of participants experiencing symptom reduction.
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, generally healthy
- •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
- •Natural menstrual cycle or regular withdrawal bleeds if on hormonal contraception
- •Has a regular menstrual cycle length, between 21 and 35 days
- •Tracks their menstrual cycle and can predict their period dates
- •Willing to comply with study requirements
- •Willing to refrain from taking any other products, medications, or supplements that target menstrual health during the test period
- •No known allergies to the ingredients listed in the product
排除标准
- •Anyone diagnosed with chronic conditions that may affect study outcome (e.g. heart conditions, diabetes, endocrine-related disorders, reproductive health-related cancers)
- •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
- •Started, changed, or stopped taking hormonal birth control in the last three months
- •Anyone with planned surgery during the study period
- •Anyone with a history of substance abuse
- •Anyone currently participating or planning to participate in a research study
- •Has a planned insertion or replacement of an IUD in the next 12 weeks
研究组 & 干预措施
DITTO Cycle Supplement
Participants will take two capsules of the DITTO Cycle Supplement once daily, starting two days after menstrual bleeding ends, for the duration of three menstrual cycles.
干预措施: DITTO Cycle Supplement (Dietary Supplement)
结局指标
主要结局
Change in Menstrual Symptoms Questionnaire (MSQ) Scores
时间窗: Baseline, Menstrual Cycle 1, Menstrual Cycle 2, Menstrual Cycle 3 (each measured 2 days following menstruation)
Change from baseline in menstrual symptom severity as measured by the validated 24-item Menstrual Symptoms Questionnaire (MSQ). Rated on a 5-point Likert scale (Never, Rarely, Sometimes, Often, Always). Higher scores indicate greater symptom severity.
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
- Symptom Severity Ratings(Baseline, Menstrual Cycle 1, Menstrual Cycle 2, Menstrual Cycle 3 (each measured 2 days following menstruation))
- Proportion of participants with perceived reduction in menstrual cycle symptoms(Baseline, Menstrual Cycle 1, Menstrual Cycle 2, Menstrual Cycle 3 (each measured 2 days following menstruation))
- 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))