Effects of Seed Cycling Capsules on Premenstrual Syndrome Symptoms and Menstrual Cycle Length

Superlune Inc. d/b/a Two Moons Health40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Premenstrual Syndrome Menstrual Symptoms

Interventions

Two Moons Seed Cycling CapsulesDIETARY_SUPPLEMENT

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Citruslabs

Las Vegas, Nevada, United States

Outcomes

Primary Outcomes

Change in Menstrual Cramp Severity

Self-reported severity of premenstrual and menstrual cramps assessed using study questionnaires and compared between Baseline, Cycle 1, and Cycle 2.

Time frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)

Change in Bloating Severity

Self-reported severity of abdominal bloating associated with the menstrual cycle assessed using study questionnaires.

Time frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)

Change in Fatigue Severity

Self-reported fatigue associated with the menstrual cycle assessed using study questionnaires.

Time frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)

Change in Hormonal Acne Severity

Self-reported severity and frequency of hormonal acne symptoms assessed using study questionnaires.

Time frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)

Change in Mood Symptoms

Self-reported mood-related symptoms including low mood, irritability, and anger associated with the menstrual cycle.

Time frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)

Change in Sleep Quality

Self-reported sleep quality and insomnia symptoms associated with the menstrual cycle.

Time frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)

Change in Breast Tenderness Severity

Data from ClinicalTrials.gov

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Secondary Outcomes

Participant Assessment of Overall Menstrual Experience

Participant-reported assessment of the overall effect of the study product on menstrual health and menstrual cycle experience.

Time frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)

Participant Satisfaction With Seed Cycling Capsules

Participant-reported satisfaction with the study product following use during the study period.

Time frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)

Participant Perception of Product Effectiveness

Participant-reported perception of the effectiveness of the study product in improving menstrual symptoms.

Time frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)