Effects of Seed Cycling Capsules on Premenstrual Syndrome Symptoms and Menstrual Cycle Length
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89118
- Citruslabs
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Seed Cycling Capsules
Participants will take Two Moons Seed Cycling Capsules daily for two menstrual cycles.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Menstrual Cramp Severity
Time Frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
Self-reported severity of premenstrual and menstrual cramps assessed using study questionnaires and compared between Baseline, Cycle 1, and Cycle 2.
|
Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
|
Change in Bloating Severity
Time Frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
Self-reported severity of abdominal bloating associated with the menstrual cycle assessed using study questionnaires.
|
Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
|
Change in Fatigue Severity
Time Frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
Self-reported fatigue associated with the menstrual cycle assessed using study questionnaires.
|
Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
|
Change in Hormonal Acne Severity
Time Frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
Self-reported severity and frequency of hormonal acne symptoms assessed using study questionnaires.
|
Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
|
Change in Mood Symptoms
Time Frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
Self-reported mood-related symptoms including low mood, irritability, and anger associated with the menstrual cycle.
|
Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
|
Change in Sleep Quality
Time Frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
Self-reported sleep quality and insomnia symptoms associated with the menstrual cycle.
|
Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
|
Change in Breast Tenderness Severity
Time Frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
Self-reported breast tenderness associated with the menstrual cycle.
|
Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
|
Change in Libido
Time Frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
Self-reported sex drive and libido associated with the menstrual cycle.
|
Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Assessment of Overall Menstrual Experience
Time Frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
Participant-reported assessment of the overall effect of the study product on menstrual health and menstrual cycle experience.
|
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
Time Frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
Participant-reported satisfaction with the study product following use during the study period.
|
Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
|
Participant Perception of Product Effectiveness
Time Frame: Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
Participant-reported perception of the effectiveness of the study product in improving menstrual symptoms.
|
Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle)
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- #20756
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.