Status:
COMPLETED
Randomized, Placebo-Controlled Study of an Herbal Tea to Support Lactation
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Traditional Medicinals Corporation
Conditions:
Lactation
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief 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 ...
Detailed Description
In order to establish the quality of life of combination herbal galactagogue tea in lactating women, a randomized controlled trial of combination herbal galactagogue tea vs. placebo is being undertake...
Eligibility Criteria
Inclusion
- Women between the ages of 18 and 45 years
- Good general health
- Lactating
- Singleton birth
- Two to twelve weeks postpartum
- Have a full term (\>37 weeks gestation) healthy infant
- Is successfully fully breastfeeding at the time they enter the study
- Intend to fully breastfeed their infants for the following 4 weeks at the time of enrollment.
Exclusion
- Chronic illnesses (e.g. diabetes, hypertension, bronchial asthma, Gastroesophageal Reflux Disease (GERD), atopic dermatitis, celiac disease or gluten sensitivity, Crohn's Disease, ulcerative colitis, eating disorders, breast cancer, blood disorder, psychiatric)
- Pre-pregnant BMI (\>50)
- History of alcohol, drug abuse or cigarette smoking
- Currently using the following pharmaceuticals: diuretics, pseudoephedrine, anticholinergics, and an estrogen-containing birth control pill or using an estrogen-containing device
- Currently consuming other drugs/herbals used to induce milk production including metoclopramide, domperidone, or other drugs/herbals (i.e. fenugreek capsules, goat's rue products, or "More Milk" capsules or tinctures)
- Sensitivity or known allergies to peanuts, soybeans, or chick peas
- Sensitivity or known allergies to plants in the Apiaceae/carrot plant family (e.g. anise, celery, coriander, fennel) or the compound anethole
- Sensitivity or known allergies to plants in the Asteraceae/daisy family (e.g. blessed thistle, echinacea, or calendula)
- Taking a selective serotonin reuptake inhibitor (SSRI)
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02190448
Start Date
March 1 2013
End Date
April 1 2015
Last Update
July 5 2018
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425