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 is an open-label observational single-group clinical trial to study the efficacy of a commercially available dietary supplement and its effect on common PMS and menstrual symptoms, as well as health-related biomarkers.
It is hypothesized that the dietary supplement marketed as "YOUR SUPER Moon Balance" will improve subjective wellbeing in trial participants by alleviating common symptoms of PMS and menstrual symptoms, such as pain, cramps, bloating, and lack of energy. Further, the ability of the supplement to reduce biomarkers of inflammation (CRP) and stress (cortisol), and promote sleep, will be evaluated.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary supplement | Experimental | Dietary supplement: Moon Balance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moon Balance | Dietary Supplement | Moon Balance is a blend of 6 food ingredients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in perceived discomfort associated with menstruation | Perceived discomfort caused by several of the most common menstrual symptoms (energy, sleep, mood, comfort, and overall fewer PMS symptoms) Each endpoint will be reported by the participant on a scale of perceived discomfort at the end of each menstrual cycle. Participants will complete the surveys for each menstrual cycle. The study uses a questionnaire including a scale from 0-7 to assess the severity of symptoms(0=no symptoms and 7=very severe symptoms). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood biomarkers: C-reactive protein | Change in C-Reactive Protein (CRP) with an at-home blood test after 12 weeks compared to baseline results. | 12 weeks |
| Changes in saliva cortisol levels |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Gender identity
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susanne Mitschke | Citruslabs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Change in saliva cortisol levels with an at-home test after 12 weeks compared to baseline results.
| 12 weeks |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |