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

Not Applicable

Completed

• Conditions: Premenstrual Syndrome; Polycystic Ovary Syndrome
• Interventions: Dietary Supplement: Female Hormone Balance Supplement

• 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

Study Timeline

• Study Start: 2023-08-30
• Study First Submitted: 2023-11-04
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-09
• Primary Completion: 2024-01-19
• Study Completion: 2024-01-19
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Female Hormone Balance Supplement	Female Hormone Balance Supplement	Participants will add 1 scoop of the powder to a drink of choice every morning.

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