RCT of Evening Primrose Oil for the Treatment of Breastfeeding Pain

St. Luke's Hospital, Pennsylvania80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Breast Feeding

Interventions

Evening Primrose OilDIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

Pill

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * currently breastfeeding * recent delivery within the trailing 60 days Exclusion Criteria: * history of seizure disorder

Outcomes

Primary Outcomes

Breastfeeding Related Mastalgia

Visual Pain Score

Time frame: 7 days

Secondary Outcomes

Adverse events

Epistaxis, Change in perceived lochia flow.

Time frame: 7 days

Central Contacts

Richard Vigh, MD

CONTACT

484-526-4000 richard.vigh@sluhn.org

James Anasti, MD

CONTACT

484-526-4000 anastij@sluhn.org

Data from ClinicalTrials.gov

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