Effects of Seed Cycling Capsules on Premenstrual Syndrome Symptoms and Menstrual Cycle Length
15 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
40
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Nevada
-
Las Vegas, Nevada, Förenta staterna, 89118
- Citruslabs
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Menstrual Cramp Severity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Participant Assessment of Overall Menstrual Experience
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
8 juli 2025
Primärt slutförande (Faktisk)
27 september 2025
Avslutad studie (Faktisk)
27 september 2025
Studieregistreringsdatum
Först inskickad
9 juni 2026
Först inskickad som uppfyllde QC-kriterierna
15 juni 2026
Första postat (Faktisk)
17 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- #20756
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .