Effects of Seed Cycling Capsules on Premenstrual Syndrome Symptoms and Menstrual Cycle Length
15 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89118
- Citruslabs
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Menstrual Cramp Severity
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Participant Assessment of Overall Menstrual Experience
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
8 de julio de 2025
Finalización primaria (Actual)
27 de septiembre de 2025
Finalización del estudio (Actual)
27 de septiembre de 2025
Fechas de registro del estudio
Enviado por primera vez
9 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
15 de junio de 2026
Publicado por primera vez (Actual)
17 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- #20756
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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