RCT of Evening Primrose Oil for the Treatment of Breastfeeding Pain

NCT ID: NCT03876899

Last Updated: 2019-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-15

Study Completion Date

2019-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Feeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind, randomized, placebo-controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Evening Primrose Oil

Group Type ACTIVE_COMPARATOR

Evening Primrose Oil

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Pill

Interventions

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Evening Primrose Oil

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Pill

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* currently breastfeeding
* recent delivery within the trailing 60 days

Exclusion Criteria

* history of seizure disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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St. Luke's Hospital, Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Richard Vigh, MD

Role: CONTACT

484-526-4000

James Anasti, MD

Role: CONTACT

484-526-4000

Other Identifiers

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SLIR 2018-111

Identifier Type: -

Identifier Source: org_study_id

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