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

Study Overview
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Brief Summary
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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)

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

Conditions
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Premenstrual Syndrome

Intervention / Treatment
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* Dietary Supplement: Premenstrual Syndrome Supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Premenstrual Syndrome Supplement<br>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<br>* Ginger, Curcumin, Organic Turmeric, Black Pepper, Magnesium, Zinc, Vitamin B6, Vitamin D.<br>|

What is the study measuring?
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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 |