Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seed Cycling Capsules | Experimental | Participants will take Two Moons Seed Cycling Capsules daily for two menstrual cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Two Moons Seed Cycling Capsules | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. | Day 28 (end of first 28-day intervention cycle), and Day 56 (end of second 28-day intervention cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Assessment of Overall Menstrual Experience | 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 |
Not provided
Inclusion Criteria:
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
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Las Vegas | Nevada | 89118 | United States |
Not provided
| ID | Term |
|---|---|
| D011293 | Premenstrual Syndrome |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Change in Breast Tenderness Severity | 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 | 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) |
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 | 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) |