RCT of Evening Primrose Oil for the Treatment of Breastfeeding Pain

Breast Feeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03876899
• Other study ID #: SLIR 2018-111
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: March 2019
• Source: St. Luke's Hospital, Pennsylvania
• Contact: Richard Vigh, MD
• Phone: 484-526-4000
• Email: richard.vigh[@]sluhn.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• currently breastfeeding

• recent delivery within the trailing 60 days

Exclusion Criteria:

• history of seizure disorder

Related Conditions & MeSH terms

• Breast Feeding

Intervention

Dietary Supplement:
• Evening Primrose Oil
botanical oil derivative from the seeds of Evening Primrose (Oenothera biennis),1,300 milligrams t.i.d.
• Placebo
Pill

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's Hospital, Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breastfeeding Related Mastalgia	Visual Pain Score	7 days
Secondary	Adverse events	Epistaxis, Change in perceived lochia flow.	7 days