Polycystic Ovary Syndrome, Premenstrual Syndrome
Conditions
Brief summary
This is a virtual single group study that will last 12 weeks. Participants will take 1 scoop of the female hormone balance supplement, and mix it with their drink of choice every morning. Questionnaires will be completed at baseline, 1 week, 2 weeks, 4 weeks, and 12 weeks
Interventions
DIETARY_SUPPLEMENTFemale Hormone Balance Supplement
The product contains: Myo-Inositol D-Chiro Inositol Folic Acid Vitamin D Vitamin B12
Sponsors
Citruslabs
Rael
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged between 18 - 55 * BMI less than 35 * Self-reported concerns around irregular menstrual cycles and ovulation, mood swings, stress, irritability, and low energy * Generally healthy - don't live with any uncontrolled chronic disease * Self-reported symptoms of PCOS - irregular periods * Self-reported concerns with hormonal skin issues
Exclusion criteria
* Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders * Anyone with known severe allergic reactions * Anyone who is pregnant, breastfeeding, or attempting to become pregnant * Unwilling to follow the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in menstrual cycle regularity. | Baseline to Week 12 | Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., Very regular) and 1 representing the least favorable/worst outcome (e.g., Extremely irregular). |
| Changes in hormonal acne. | Baseline to Week 12 | Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., Not at all) and 1 representing the least favorable/worst outcome (e.g., Severe). |
| Changes in skin issues throughout the menstrual cycle. | Baseline to Week 12 | Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., Not at all) and 1 representing the least favorable/worst outcome (e.g., Severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in energy. | Baseline to Week 12 | Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., Not at all) and 1 representing the least favorable/worst outcome (e.g., Severe). |
| Changes in overall mood. | Baseline to Week 12 | Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., Not at all) and 1 representing the least favorable/worst outcome (e.g., Severe). |
| Changes in menstrual cramps. | Baseline to Week 12 | Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., Not at all) and 1 representing the least favorable/worst outcome (e.g., Severe). |
| Changes in stress levels. | Baseline to Week 12 | Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., Not at all) and 1 representing the least favorable/worst outcome (e.g., Severe). |
| Changes in food cravings. | Baseline to Week 12 | Study-specific questionnaires completed by participants. Questionnaires utilize a 5-point Likert scale with 5 representing the most favorable/best outcome (e.g., Not at all) and 1 representing the least favorable/worst outcome (e.g., Severe). |
Countries
United States
Outcome results
None listed