Menstrual Discomfort, Menstrual Pain, PMS
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTMoon Balance
Moon Balance is a blend of 6 food ingredients
Sponsors
Citruslabs
Your Super, INC.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Individuals with a regular menstruation * Age 18-40 * Moderate self-reported discomfort during menstruation-related to bloating, cramps, fatigue, mood swings, or other PMS-related symptoms * Must be in generally good health - no unstable, uncontrolled health condition * BMI under 35 * Self-reported sleep-issues * Willingness to refrain from ibuprofen or naproxen sodium (such as Advil, Aleve, Motrin or Midol) during each period (pill bleed) during the study * Agree to not change their diet significantly during the duration of the study * Agree to not change the intensity of their workouts for the duration of the study * Must get their period regularly
Exclusion criteria
* Severe chronic conditions, including oncological and psychiatric disorders * Known to have any severe allergic reactions * Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study * Participants unwilling to follow the study protocol * Have used a similar product (ingredients) in the 6 weeks prior to the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in perceived discomfort associated with menstruation | 12 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood biomarkers: C-reactive protein | 12 weeks | Change in C-Reactive Protein (CRP) with an at-home blood test after 12 weeks compared to baseline results. |
| Changes in saliva cortisol levels | 12 weeks | Change in saliva cortisol levels with an at-home test after 12 weeks compared to baseline results. |
Countries
United States
Outcome results
None listed