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Completed

NCT Number: NCT06124326

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)

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Key information

Conditions

Premenstrual Syndrome Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Premenstrual Syndrome Supplement

Dietary Supplement

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

Primary outcomes

  1. Changes in pelvic cramps.

    Time frame: 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").

  2. Changes in energy levels.

    Time frame: 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").

  3. Changes in overall mood.

    Time frame: 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").

  4. Changes in bloating.

    Time frame: 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").

  5. Changes in gastrointestinal discomfort.

    Time frame: 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").

Sponsors and collaborators

Lead sponsor

Rael

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 9, 2023
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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