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

NCT06124326 | Completed

• 1 other identifier: 20338
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Premenstrual Syndrome

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Premenstrual Syndrome Supplement

EXPERIMENTAL

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

Interventions

Premenstrual Syndrome Supplement DIETARY_SUPPLEMENT

Ginger, Curcumin, Organic Turmeric, Black Pepper, Magnesium, Zinc, Vitamin B6, Vitamin D.

Premenstrual Syndrome Supplement

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rael: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 9, 2023
• Study Start: August 31, 2023
• Primary Completion: January 20, 2024
• Study Completion: January 20, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Locations

US (1)