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

Completed · Not applicable · Has a placebo group

Conditions studied: Lactation

In brief

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.

Key facts

Study ID

NCT02190448

Run by

Medical University of South Carolina

People needed

60

Starts

2013-03-01

Expected to finish

2015-04-01

Last updated by the study team

2018-07-05

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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