A Single Group Study to Evaluate the Effects of a Supplement on Premenstrual Syndrome

This is a virtual single-group study that will last three menstrual cycles (approximately 12 weeks). During the first menstrual cycle, participants will take the supplement as needed (pro re nata) when they feel symptoms of PMS, such as cramping or bloating. For the second and third menstrual cycles, Participants will take 2 capsules per day with water for 1 week, starting 4 days before their menstrual cycle and finishing on Day 3 of their cycle. Questionnaires will be completed at the following time points:

• Baseline
• Day 7 of their first cycle during the trial (After using the product PRN during their period)
• 4 days before their second period during the trial (After using the product PRN for the previous month)
• Day 3 of their second period during the trial (After using the product for 7 days straight)
• Day 3 of their third period of the trial (After using the product for 7 days straight)

Study Overview

• Status: Completed
• Conditions: Premenstrual Syndrome
• Intervention / Treatment: Dietary supplement: Premenstrual Syndrome Supplement

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female, aged 18-40
• Self-reported moderate discomfort during menstruation related to pelvic cramps, bloating, fatigue, or mood swings.
• Self-reported symptoms during their menstrual cycle with gas, heartburn, and acid reflux
• Generally healthy - don't live with any uncontrolled chronic disease
• Has a menstrual cycle between 21 and 35 days in length
• Able to predict their menstrual cycle and timing of their menstruation

Exclusion Criteria:

• Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
• Current use of any blood thinning medication
• Anyone with known severe allergic reactions.
• Women who are pregnant, breastfeeding, or attempting to become pregnant
• Unwilling to follow the study protocol.
• Anyone with a diagnosis of a condition relating to the menstrual cycle or reproductive system? e.g., polycystic ovary syndrome (PCOS), premenstrual dysphoric disorder (PMDD), endometriosis, etc.
• Anyone currently on hormonal birth control, or has been on hormonal birth control in the last 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Premenstrual Syndrome Supplement; During the first menstrual cycle, participants will take the supplement as needed (pro re nata) when they feel symptoms of PMS, such as cramping or bloating. For the second and third menstrual cycles, Participants will take 2 capsules per day with water for 1 week, starting 4 days before their menstrual cycle and finishing on Day 3 of their cycle.	Dietary supplement: Premenstrual Syndrome Supplement; Ginger, Curcumin, Organic Turmeric, Black Pepper, Magnesium, Zinc, Vitamin B6, Vitamin D.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in pelvic cramps.	Participants will complete study-specific questionnaires. Questionnaires will include 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
Changes in energy levels.	Participants will complete study-specific questionnaires. Questionnaires will include 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
Changes in overall mood.	Participants will complete study-specific questionnaires. Questionnaires will include 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
Changes in bloating.	Participants will complete study-specific questionnaires. Questionnaires will include 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
Changes in gastrointestinal discomfort.	Participants will complete study-specific questionnaires. Questionnaires will include 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

Collaborators and Investigators

• Sponsor: Rael
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Actual): January 20, 2024
• Study Completion (Actual): January 20, 2024

Study Registration Dates

• First Submitted: November 4, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Menstruation Disturbances; Syndrome; Premenstrual Syndrome
• Other Study ID Numbers: 20338

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No