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RCT of Evening Primrose Oil for the Treatment of Breastfeeding Pain

Evening Primrose Oil for the Treatment of Breastfeeding Related Mastalgia: A Randomized, Double Blinded, Placebo-Controlled Clinical Trial.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03876899
Enrollment
80
Registered
2019-03-15
Start date
2019-03-15
Completion date
2019-09-30
Last updated
2019-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Feeding

Brief summary

Breastfeeding related mastalgia is a common post-partum complaint. We propose a double-blind, randomized, placebo-controlled trial that investigates the use of Evening Primrose Oil in the treatment of breastfeeding related mastalgia.

Interventions

DIETARY_SUPPLEMENTEvening Primrose Oil

botanical oil derivative from the seeds of Evening Primrose (Oenothera biennis),1,300 milligrams t.i.d.

DIETARY_SUPPLEMENTPlacebo

Pill

Sponsors

St. Luke's Hospital, Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Double blind, randomized, placebo-controlled trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* currently breastfeeding * recent delivery within the trailing 60 days

Exclusion criteria

* history of seizure disorder

Design outcomes

Primary

MeasureTime frameDescription
Breastfeeding Related Mastalgia7 daysVisual Pain Score

Secondary

MeasureTime frameDescription
Adverse events7 daysEpistaxis, Change in perceived lochia flow.

Contacts

Primary ContactRichard Vigh, MD
richard.vigh@sluhn.org484-526-4000
Backup ContactJames Anasti, MD
anastij@sluhn.org484-526-4000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026