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:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT05398367
Eligibility Criteria:
Inclusion Criteria: Participants in the study must:
* Be struggling with diagnosed or perceived low milk supply
* Be willing to consume a randomly assigned galactagogue or placebo supplement
* Be willing to provide a blood sample at each lactation consult (day 1, 10, 20)
* Be willing to provide 24-hour expressed milk volume either using pre- and post-feed weights, total pump output, or a combination of both on day 1, 10, and 20
Exclusion Criteria: Participants will be excluded if:
* They have a history of breast reduction
* They have a history of utilizing in vitro fertilization
* They are not a biological female with mammary glands present for producing milk
* They have consumed galactagogues with the intention of increasing their milk supply during the current lactation cycle
* They are under age 18 or above age 39
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT05398367
Study Brief:
Protocol Section:
NCT05398367