Effects of a Female Hormone Balance Supplement on Symptoms of Polycystic Ovary Syndrome and Severe Premenstrual Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

A Single Group Study to Evaluate the Effects of a Female Hormone Balance Supplement on Symptoms of Polycystic Ovary Syndrome and Severe Premenstrual Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06124300
• Other study ID #: 20336
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: January 19, 2024

Study information

• Verified date: November 2023
• Source: Rael
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: January 19, 2024
• Est. primary completion date: January 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Premenstrual Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Female Hormone Balance Supplement
The product contains: Myo-Inositol D-Chiro Inositol Folic Acid Vitamin D Vitamin B12

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Rael	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in menstrual cycle regularity.	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").	Baseline to Week 12
Primary	Changes in hormonal acne.	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").	Baseline to Week 12
Primary	Changes in skin issues throughout the menstrual cycle.	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").	Baseline to Week 12
Secondary	Changes in overall mood.	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").	Baseline to Week 12
Secondary	Changes in stress levels.	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").	Baseline to Week 12
Secondary	Changes in food cravings.	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").	Baseline to Week 12
Secondary	Changes in energy.	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").	Baseline to Week 12
Secondary	Changes in menstrual cramps.	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").	Baseline to Week 12