NCT02190448

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2013

Completed
1 year until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

July 5, 2018

Status Verified

July 1, 2018

Enrollment Period

2.1 years

First QC Date

July 15, 2013

Last Update Submit

July 2, 2018

Conditions

Lactation

Keywords

galactogoguelactationmilk productionbreastfeeding

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • Oxytocin in maternal blood

    4 weeks

  • Prolactin in maternal blood

    4 weeks

  • Composition of breast milk

    4 weeks

Study Arms (2)

study herbal tea

EXPERIMENTAL

Supplementation of 3-5, 8 oz cups of study tea daily for 4 weeks.

Dietary Supplement: study herbal tea

herbal placebo tea

PLACEBO COMPARATOR

Supplementation of 3-5, 8oz cups of tea daily for 4 weeks.

Dietary Supplement: herbal placebo tea

Interventions

study herbal teaDIETARY_SUPPLEMENT

3-5 cups, 8oz tea daily for 4 weeks

study herbal tea
herbal placebo teaDIETARY_SUPPLEMENT

3-5 cups, 8oz each daily for 4 weeks

herbal placebo tea

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (3)

  • 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.

    PMID: 21332371BACKGROUND

  • Turkyilmaz 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.

    PMID: 21261516BACKGROUND

  • Foong 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.

    PMID: 32421208DERIVED

Related Links

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Bernadette Marriott, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

  • Carol Wagner, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2013

First Posted

July 15, 2014

Study Start

March 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

July 5, 2018

Record last verified: 2018-07

Locations

US(1)