Randomized, Placebo-Controlled Study of an Herbal Tea to Support Lactation
Condition: Lactation
Study type: Interventional

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.
    

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 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.
    

Intervention name(s): study herbal tea; herbal placebo tea
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3-5 cups, 8oz tea daily for 4 weeks; 3-5 cups, 8oz each daily for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: galactogogue; lactation; milk production; breastfeeding