Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT05237661
Eligibility Criteria:
Inclusion Criteria:
* Individuals with a regular menstruation
* Age 18-40
* Moderate self-reported discomfort during menstruation-related to bloating, cramps, fatigue, mood swings, or other PMS-related symptoms
* Must be in generally good health - no unstable, uncontrolled health condition
* BMI under 35
* Self-reported sleep-issues
* Willingness to refrain from ibuprofen or naproxen sodium (such as Advil, Aleve, Motrin or Midol) during each period (pill bleed) during the study
* Agree to not change their diet significantly during the duration of the study
* Agree to not change the intensity of their workouts for the duration of the study
* Must get their period regularly
Exclusion Criteria:
* Severe chronic conditions, including oncological and psychiatric disorders
* Known to have any severe allergic reactions
* Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study
* Participants unwilling to follow the study protocol
* Have used a similar product (ingredients) in the 6 weeks prior to the study
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT05237661
Study Brief:
Protocol Section:
NCT05237661