Effects of a Female Hormone Balance Supplement on Symptoms of Polycystic Ovary Syndrome and Severe Premenstrual Syndrome
- Conditions
- Premenstrual SyndromePolycystic Ovary Syndrome
- Registration Number
- NCT06124300
- Lead Sponsor
- Rael
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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").
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").
Trial Locations
- Locations (1)
Citruslabs
🇺🇸Santa Monica, California, United States
Citruslabs🇺🇸Santa Monica, California, United States