Effects of Seed Cycling Capsules on Premenstrual Syndrome Symptoms and Menstrual Cycle Length
2026년 6월 15일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Nevada
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Las Vegas, Nevada, 미국, 89118
- Citruslabs
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Menstrual Cramp Severity
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Participant Assessment of Overall Menstrual Experience
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 7월 8일
기본 완료 (실제)
2025년 9월 27일
연구 완료 (실제)
2025년 9월 27일
연구 등록 날짜
최초 제출
2026년 6월 9일
QC 기준을 충족하는 최초 제출
2026년 6월 15일
처음 게시됨 (실제)
2026년 6월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 15일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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