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

Premenstrual Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06124326
• Other study ID #: 20338
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 31, 2023
• Est. completion date: January 20, 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 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: January 20, 2024
• Est. primary completion date: January 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Premenstrual Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Premenstrual Syndrome Supplement
Ginger, Curcumin, Organic Turmeric, Black Pepper, Magnesium, Zinc, Vitamin B6, Vitamin D.

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 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
Primary	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
Primary	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
Primary	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
Primary	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