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

• Sponsor: Rael (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06124300
• Collaborator: Citruslabs (Industry)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 4.7
• Patients Per Site Per Month: 8.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome; Premenstrual Syndrome	Dietary Supplement: Female Hormone Balance Supplement	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Aug 30, 2023
• Anticipated Primary Completion Date: Jan 19, 2024
• Anticipated Study Completion Date: Jan 19, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Female Hormone Balance Supplement Participants will add 1 scoop of the powder to a drink of choice every morning.	Dietary Supplement: Female Hormone Balance Supplement; The product contains: Myo-Inositol D-Chiro Inositol Folic Acid Vitamin D Vitamin B12

Outcome Measures

Primary Outcome Measures

1. 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").

2. 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").

3. 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

1. 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").

2. 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").

3. 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").

4. 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").

5. 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").

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Citruslabs	Santa Monica	California	United States	90404

Sponsors and Collaborators

• Rael
• Citruslabs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rael
• ClinicalTrials.gov Identifier: NCT06124300
• Other Study ID Numbers: 20336
• First Posted: Nov 9, 2023
• Last Update Posted: Nov 9, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Syndrome; Premenstrual Syndrome; Hormones

Study Results

No Results Posted as of Nov 9, 2023