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.
調査の概要
研究の種類
介入
入学 (実際)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Nevada
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Las Vegas、Nevada、アメリカ、89118
- Citruslabs
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Menstrual Cramp Severity
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Participant Assessment of Overall Menstrual Experience
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年7月8日
一次修了 (実際)
2025年9月27日
研究の完了 (実際)
2025年9月27日
試験登録日
最初に提出
2026年6月9日
QC基準を満たした最初の提出物
2026年6月15日
最初の投稿 (実際)
2026年6月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月17日
QC基準を満たした最後の更新が送信されました
2026年6月15日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。