LactationSLSNCT02190448
Randomized, Placebo-Controlled Study of an Herbal Tea to Support Lactation
A study testing study herbal tea in people with Lactation, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation
- What is being tested?
- study herbal tea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A 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.
Read the 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.
- Conditions
- Lactation
- Being tested
- study herbal tea, herbal placebo tea
- Keywords
- galactogogue, lactation, milk production, breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
study herbal teaDietary supplement
3-5 cups, 8oz tea daily for 4 weeks
herbal placebo teaDietary supplement
3-5 cups, 8oz each daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| study herbal tea | Experimental | Supplementation of 3-5, 8 oz cups of study tea daily for 4 weeks. Receives: Dietary Supplement: study herbal tea |
| herbal placebo tea | Placebo comparator | Supplementation of 3-5, 8oz cups of tea daily for 4 weeks. Receives: Dietary Supplement: herbal placebo tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 4 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startMar 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for LactationStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Traditional Medicinals Corporation
- Responsible party
- Sponsor
- Investigators
- Bernadette Marriott, PhD, Principal investigator, Medical University of South CarolinaCarol Wagner, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190448
- Sponsor's protocol ID
- SLS2013
- Acronym
- SLS
- Status last verified
- Jul 2018
- First submitted
- 15 Jul 2013
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Academy Of Breastfeeding Medicine Protocol Committee. ABM Clinical Protocol #9: Use of galactogogues in initiating or augmenting the rate of maternal milk secretion (First Revision January 2011). Breastfeed Med. 2011 Feb;6(1):41-9. doi: 10.1089/bfm.2011.9998.
PubMed 21332371Turkyilmaz C, Onal E, Hirfanoglu IM, Turan O, Koc E, Ergenekon E, Atalay Y. The effect of galactagogue herbal tea on breast milk production and short-term catch-up of birth weight in the first week of life. J Altern Complement Med. 2011 Feb;17(2):139-42. doi: 10.1089/acm.2010.0090. Epub 2011 Jan 24.
PubMed 21261516Foong SC, Tan ML, Foong WC, Marasco LA, Ho JJ, Ong JH. Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants. Cochrane Database Syst Rev. 2020 May 18;5(5):CD011505. doi: 10.1002/14651858.CD011505.pub2.
PubMed 32421208
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled Study of an Herbal Tea to Support Lactation
- ClinicalTrials.gov ID
- NCT02190448
- Acronym / sponsor ID
- SLS / SLS2013
- Conditions
- Lactation
- Keywords
- galactogogue, lactation, milk production, breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Traditional Medicinals Corporation
- Study start
- Mar 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study herbal tea | Experimental | Dietary Supplement: study herbal teaSupplementation of 3-5, 8 oz cups of study tea daily for 4 weeks. |
| herbal placebo tea | Placebo comparator | Dietary Supplement: herbal placebo teaSupplementation of 3-5, 8oz cups of tea daily for 4 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women between the ages of 18 and 45 years
- Good general health
- Lactating
- Singleton birth
- Two to twelve weeks postpartum
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| study herbal tea3-5 cups, 8oz tea daily for 4 weeks | Dietary supplement | study herbal tea |
| herbal placebo tea3-5 cups, 8oz each daily for 4 weeks | Dietary supplement | herbal placebo tea |
Primary outcome
Quality of life
Time frame: 4 weeks
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.
Quality of life
Time frame: 4 weeks
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.
Quality of life
Time frame: 4 weeks
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
Quality of life
Time frame: 4 weeks
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.
3 secondary outcomes
Oxytocin in maternal blood
Time frame: 4 weeks
Prolactin in maternal blood
Time frame: 4 weeks
Composition of breast milk
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Background: PubMed 21332371Academy Of Breastfeeding Medicine Protocol Committee. ABM Clinical Protocol #9: Use of galactogogues in initiating or augmenting the rate of maternal milk secretion (First Revision January 2011). Breastfeed Med. 2011 Feb;6(1):41-9. doi: 10.1089/bfm.2011.9998.
- Background: PubMed 21261516Turkyilmaz C, Onal E, Hirfanoglu IM, Turan O, Koc E, Ergenekon E, Atalay Y. The effect of galactagogue herbal tea on breast milk production and short-term catch-up of birth weight in the first week of life. J Altern Complement Med. 2011 Feb;17(2):139-42. doi: 10.1089/acm.2010.0090. Epub 2011 Jan 24.
- Derived from this study: PubMed 32421208Foong SC, Tan ML, Foong WC, Marasco LA, Ho JJ, Ong JH. Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants. Cochrane Database Syst Rev. 2020 May 18;5(5):CD011505. doi: 10.1002/14651858.CD011505.pub2.
- Steeped with Love StudyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernadette Marriott, PhD principal investigator
Medical University of South Carolina
Carol Wagner, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing study herbal tea in people with Lactation, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02190448, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.