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Randomized, Placebo-Controlled Study of an Herbal Tea to Support Lactation

NCT02190448 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-07-05

No results posted yet for this study

Summary

The overall aims of this project are to 1) determine the quality of life effects of a combination herbal galactagogue tea in lactating women, and 2) measure changes in maternal blood concentration of oxytocin, prolactin, and milk production. The defined outcome measures will include quality of life measures in the breastfeeding woman and basic infant health. If the tea proves safe and effective, then it can provide a proven all-natural and organic supplement for increasing lactation in women. This in turn will increase quality of life for both the infant and the mother.

Conditions

  • Lactation

Interventions

DIETARY_SUPPLEMENT

study herbal tea

3-5 cups, 8oz tea daily for 4 weeks

DIETARY_SUPPLEMENT

herbal placebo tea

3-5 cups, 8oz each daily for 4 weeks

Sponsors & Collaborators

  • Traditional Medicinals Corporation

    collaborator UNKNOWN

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Bernadette Marriott, PhD · Medical University of South Carolina

  • Carol Wagner, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02190448 on ClinicalTrials.gov