- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00851591
Effect of Fenugreek on Milk Production (fenugreek)
Each year, approximately 3 million mothers in the USA alone leave the hospital breastfeeding an infant. However, a large number discontinue breastfeeding, because milk synthesis is poor or simply stops. Termed "Insufficient Milk Syndrome," this condition probably accounts for approximately 5-10% of the total population of breastfeeding mothers and includes many mothers with premature infants, mothers with polycystic ovary syndrome, and a myriad of other unknown causes. The mother's inability to breastfeed causes enormous feelings of inadequacy, grief, depression, and other problems, not to mention increased health risks to the infant.
The most popular herbal remedy used around the world for increasing milk synthesis is fenugreek. Fenugreek (Trigonella foenum graecum) is a seed product from the legume family that is commonly sold, since the dried, ripe seed and extracts are used as an artificial flavor for maple syrup. When used orally in amounts commonly found in foods, it has been granted Generally Recognized as Safe (GRAS) status in the USA by the FDA. Although it is used by millions of women around the world to increase their milk supply, we have only one small case report which suggested it might actually increase the milk supply.
In this one study, the authors found an approximate 40% increase in milk production, although the study was not blinded, nor did they use a control population. For these reasons, we still do not know with certainty if fenugreek works as a galactagogue.
This study is designed to accurately determine if seven days of fenugreek will stimulate milk production in a selected group of subjects with poor milk supply. We hypothesize that the women enrolled in the test group will have increased milk production at the end of the 8-day study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Amarillo, Texas, United States, 79106
- Texas Tech University Health Sciences Center School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Mothers 2-12 weeks postpartum
- Mothers with term infants 37 weeks gestation or older
- Mothers with poor milk supply documented by professional lactation consultants
- Mothers whose milk supply is less than 600 cc per 24 hours
- Mothers who agree not to breastfeed or provide their milk to their infants during this study
Exclusion Criteria:
- Mothers with documented mastitis
- Mothers with breast engorgement
- Mothers with inverted nipples
- Maternal BMI greater than 35
- Mothers currently consuming Reglan, Domperidone or other drugs/herbals used to induce milk production
Mothers who are clinically ill or hospitalized, or taking the following medications:
- Diuretics
- Pseudoephedrine
- Anticholinergics
- Warfarin or any anticoagulant
- An estrogen-containing birth control pill
- Mothers with Diabetes mellitus
- Mothers who have had breast surgery that could alter milk synthesis or production
- Mothers diagnosed with Polycystic ovary syndrome
- Mothers with tubular breasts or breasts with insufficient glandular tissue
- Mothers diagnosed with Asthma or atopic disease
- Mothers who are known to be allergic to peanuts or soybeans
- Mothers who are pregnant
- Mothers whose milk supply per 24 hours exceeds 600 mL
- Mothers with Obstetrical evaluation recommending exclusion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fenugreek category 1
receive fenugreek
|
3 capsules 3 times per day with a full glass of water each dose for 7 days
Other Names:
|
Placebo Comparator: Placebo Category 2
receive placebo
|
3 capsules 3 times a day with a full glass of water each dose for 7 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Main Outcome Variable of This Study is the Quantity of Milk Produced.
Time Frame: "Day 0" , "Day 8"
|
The single value of this variable was calculated average from day 0 and day 8.
|
"Day 0" , "Day 8"
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Outcome Variables Are to Include Milk-fat Content and Protein Content.
Time Frame: day 0; day 8
|
Milk-fat content was not measured in these samples as we had decided to close the study. Protein content was not measured in these samples as we had decided to close the study. |
day 0; day 8
|
Collaborators and Investigators
Investigators
- Study Director: Thomas W Hale, PhD, Texas Tech University Health Sciences Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A08-3479
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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