RCT of Evening Primrose Oil for the Treatment of Breastfeeding Pain

March 14, 2019 updated by: St. Luke's Hospital, Pennsylvania

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • currently breastfeeding
  • recent delivery within the trailing 60 days

Exclusion Criteria:

  • history of seizure disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Pill
Active Comparator: Evening Primrose Oil
Dietary supplement: Evening Primrose Oil
botanical oil derivative from the seeds of Evening Primrose (Oenothera biennis),1,300 milligrams t.i.d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding Related Mastalgia
Time Frame: 7 days
Visual Pain Score
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 7 days
Epistaxis, Change in perceived lochia flow.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Luke's Hospital, Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 15, 2019

Primary Completion (Anticipated)

August 30, 2019

Study Completion (Anticipated)

September 30, 2019

Study Registration Dates

First Submitted

March 14, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

March 15, 2019

Last Update Submitted That Met QC Criteria

March 14, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLIR 2018-111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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