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.
1 other identifier
interventional
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2019
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2019
CompletedFirst Posted
Study publicly available on registry
March 15, 2019
CompletedStudy Start
First participant enrolled
March 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedMarch 15, 2019
March 1, 2019
6 months
March 14, 2019
March 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Breastfeeding Related Mastalgia
Visual Pain Score
7 days
Secondary Outcomes (1)
Adverse events
7 days
Study Arms (2)
Evening Primrose Oil
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
botanical oil derivative from the seeds of Evening Primrose (Oenothera biennis),1,300 milligrams t.i.d.
Eligibility Criteria
You may qualify if:
- currently breastfeeding
- recent delivery within the trailing 60 days
You may not qualify if:
- history of seizure disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2019
First Posted
March 15, 2019
Study Start
March 15, 2019
Primary Completion
August 30, 2019
Study Completion
September 30, 2019
Last Updated
March 15, 2019
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share