Effects of Seed Cycling Capsules on Premenstrual Syndrome Symptoms and Menstrual Cycle Length
2026年6月15日 更新者:Superlune Inc. d/b/a Two Moons Health
This virtual, single-arm clinical trial will evaluate the effects of Seed Cycling Capsules on symptoms associated with premenstrual syndrome (PMS) and menstrual cycle characteristics.
Forty female participants aged 18 to 45 years will use the study products daily for two menstrual cycles.
Participants will complete questionnaires at baseline, at the end of their period during Cycle 1, and at the end of their period during Cycle 2.
研究概览
研究类型
介入性
注册 (实际的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Nevada
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Las Vegas、Nevada、美国、89118
- Citruslabs
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- Be female.
- Be 18-45 years of age.
- Have experienced at least five of the following symptoms during the last three menstrual cycles:
Heavy flow Prolonged, shortened, or irregular periods Headaches or migraines Low mood Fatigue Bloating Premenstrual or menstrual cramps Breast tenderness Poor sleep Constipation or diarrhea Weight gain or fluctuations Irritability or anger Sick days or reduced social activity due to menstrual symptoms Hormonal acne
- Be generally healthy.
- Have a menstrual cycle length between 23 and 35 days.
- Track menstrual cycles and be able to predict period dates.
- Be willing to refrain from taking products, medications, or supplements targeting menstrual health during the study.
Exclusion Criteria:
- Use of hormonal contraception.
- Allergy to sesame.
- Chronic conditions that would interfere with study participation, including oncological and psychiatric disorders.
- Pregnant, breastfeeding, or trying to conceive.
- Unwillingness to follow the protocol.
- Menopause or menopausal symptoms.
- Recent or planned invasive medical procedures.
- History of substance abuse.
- Diabetes or other endocrine-related conditions.
- Current or planned participation in another research study.
- Use of hormone-modulating medications or therapies.
- Planned insertion or replacement of an IUD within 12 weeks.
- Diagnosis of endometriosis, polycystic ovary syndrome (PCOS), or adenomyosis.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Seed Cycling Capsules
Participants will take Two Moons Seed Cycling Capsules daily for two menstrual cycles.
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Participants will take Two Moons Seed Cycling Capsules daily for two menstrual cycles.
Participants will take two capsules with the first meal of the day according to the following schedule: Zest Capsules from Days 1-14 of the cycle, and Zen Capsules from Days 15-28 of the cycle.
Participants will continue this schedule for two menstrual cycles regardless of when subsequent menstrual periods occur.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Menstrual Cramp Severity
大体时间:Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Self-reported severity of premenstrual and menstrual cramps assessed using study questionnaires and compared between Baseline, Cycle 1, and Cycle 2.
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Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Change in Bloating Severity
大体时间:Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Self-reported severity of abdominal bloating associated with the menstrual cycle assessed using study questionnaires.
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Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Change in Fatigue Severity
大体时间:Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Self-reported fatigue associated with the menstrual cycle assessed using study questionnaires.
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Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Change in Hormonal Acne Severity
大体时间:Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Self-reported severity and frequency of hormonal acne symptoms assessed using study questionnaires.
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Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Change in Mood Symptoms
大体时间:Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Self-reported mood-related symptoms including low mood, irritability, and anger associated with the menstrual cycle.
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Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Change in Sleep Quality
大体时间:Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Self-reported sleep quality and insomnia symptoms associated with the menstrual cycle.
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Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Change in Breast Tenderness Severity
大体时间:Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Self-reported breast tenderness associated with the menstrual cycle.
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Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Change in Libido
大体时间:Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Self-reported sex drive and libido associated with the menstrual cycle.
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Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Participant Assessment of Overall Menstrual Experience
大体时间:Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Participant-reported assessment of the overall effect of the study product on menstrual health and menstrual cycle experience.
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Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Participant Satisfaction With Seed Cycling Capsules
大体时间:Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Participant-reported satisfaction with the study product following use during the study period.
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Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Participant Perception of Product Effectiveness
大体时间:Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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Participant-reported perception of the effectiveness of the study product in improving menstrual symptoms.
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Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年7月8日
初级完成 (实际的)
2025年9月27日
研究完成 (实际的)
2025年9月27日
研究注册日期
首次提交
2026年6月9日
首先提交符合 QC 标准的
2026年6月15日
首次发布 (实际的)
2026年6月17日
研究记录更新
最后更新发布 (实际的)
2026年6月17日
上次提交的符合 QC 标准的更新
2026年6月15日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.