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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lactation

Intervention / Treatment
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* Dietary Supplement: study herbal tea
* Dietary Supplement: herbal placebo tea


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study herbal tea<br>Supplementation of 3-5, 8 oz cups of study tea daily for 4 weeks. | Dietary Supplement: study herbal tea<br>* 3-5 cups, 8oz tea daily for 4 weeks<br>|
| Placebo Comparator: herbal placebo tea<br>Supplementation of 3-5, 8oz cups of tea daily for 4 weeks. | Dietary Supplement: herbal placebo tea<br>* 3-5 cups, 8oz each daily for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | To determine quality of life, the following measurement tools will be compared across the 3 study visits: • The Satisfaction with Life Scale (Diener, Emmons et al. 1985; Pavot, Diener et al. 1991; Pavot and Diener 1993; Shevlin, Brunsden et al. 1998)-an overall global life satisfaction questionnaire. | 4 weeks | 
| Quality of life | To determine quality of life, the following measurement tools will be compared across the 3 study visits: • World Health Organization's World Health Organization Quality of Life - Brief Survey [WHOQOL-BREF] (WHO 1997; Skevington, Lotfy et al. 2004)-Current perception of position in life in context of personal culture and value systems. | 4 weeks | 
| Quality of life | To determine quality of life, the following measurement tools will be compared across the 3 study visits: • Edinburgh Postpartum Depression Inventory:(Murray and Carothers 1990)-a postpartum depression screen | 4 weeks | 
| Quality of life | To determine quality of life, the following measurement tools will be compared across the 3 study visits: • State-Trait Anxiety Inventory (STAI-Y) (Spielberger, Gorsuch et al. 1970; Ramanaiah, Franzen et al. 1983; Spielberger and Vagg 1984) -differentiates between temporary or emotional state anxiety versus long standing personality trait anxiety in adults. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxytocin in maternal blood | Blood will be collected at each of the 3 study visits. We will measure changes in maternal blood concentrations of oxytocin, across study groups. | 4 weeks | 
| Prolactin in maternal blood | Blood will be collected at each of the 3 study visits. We will measure changes in maternal blood concentrations of prolactin, across study groups. | 4 weeks | 
| Composition of breast milk | Measuring the quantities and quality of breast milk at the 3 study visits between groups. Checking the composition for milk caloric density and fatty acid content between the placebo and the combination galactagogue tea. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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galactogogue, lactation, milk production, breastfeeding