Premenstrual Syndrome
Conditions
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)
Interventions
DIETARY_SUPPLEMENTPremenstrual Syndrome Supplement
Ginger, Curcumin, Organic Turmeric, Black Pepper, Magnesium, Zinc, Vitamin B6, Vitamin D.
Sponsors
Citruslabs
Rael
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in pelvic cramps. | Baseline to Week 12 | 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). |
| Changes in energy levels. | Baseline to Week 12 | 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). |
| Changes in overall mood. | Baseline to Week 12 | 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). |
| Changes in bloating. | Baseline to Week 12 | 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). |
| Changes in gastrointestinal discomfort. | Baseline to Week 12 | 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). |
Countries
United States
Outcome results
None listed