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

In order to establish the quality of life and safety effects 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)