Randomized, Placebo-Controlled Study of an Herbal Tea to Support Lactation
Randomized, Placebo-Controlled Study of an Herbal Tea to Support Lactation
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.
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 undertaken in 120 fully lactating women beginning at 2-12 weeks postpartum for four
 weeks. Women will be randomized to one of two teas: combination herbal galactagogue tea vs.
 an herbal placebo tea. The study duration will be 4 weeks total beginning in the second to
 twelfth week postpartum, with follow up phone calls at postpartum months 3, 6, 9 and 12, to
 ascertain if the mother is continuing to breastfeed. During the 4-week study, participants
 and their infants will have three scheduled outpatient visits to the Medical University of
 South Carolina or an affiliated study center: one visit at 2-12 weeks postpartum, a second
 visit at 4-14 weeks postpartum, and a final visit at 6-16 weeks postpartum. The first visit,
 will include watching a video on how to correctly steep the tea and then brewing tea in the
 presence of the study coordinator, in addition to the procedures listed below. This initial
 visit will last approximately 90 minutes. Each subsequent visit will take less than 60
 minutes for a maternal blood drawing, pumping a breast milk sample, answering questionnaires,
 and both weighing and measuring the infant. Study participants will be given a study journal
 to be completed with the number of cups of tea they drink every day and to document an
 assessment of how they felt throughout the day both physically and emotionally. All
 participants will receive telephone calls/texts, depending on the study participants
 preferred method of communication. This will be done by a Study Coordinator at the end of
 weeks 1 and 3 of the study in order to ensure safety and to remind them to complete their
 journals. This call will also be an opportunity to assess if the participant is in need of
 additional dietetic or lactation support by the team professionals or if she is having any
 difficulty brewing her tea. At the last study visit, participants will be asked to call and
 report any adverse events for 3 months after the end of their time on the active study.

 Post Active-Study Communication: After the active-study, the Study Coordinators will call
 each study participant when their infants are 3, 6, 9 and 12 months old, if applicable in
 order to record the number of months that she continues to fully or partially breastfeed.
Inclusion Criteria:

 -  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 Criteria:

 -  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)