Status:

COMPLETED

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

Lead Sponsor:

Rael

Collaborating Sponsors:

Citruslabs

Conditions:

Premenstrual Syndrome

Eligibility:

FEMALE

18-40 years

Phase:

NA

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) whe...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 31 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 20 2024

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT06124326

Start Date

August 31 2023

End Date

January 20 2024

Last Update

August 23 2024

Active Locations (1)

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Citruslabs

Santa Monica, California, United States, 90404