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NCT00851591 · ClinicalTrials.gov registry record · NA
Effect of Fenugreek on Milk Production
A NA study, sponsored by Texas Tech University Health Sciences Center.
- Terminated
- Registry status
- NA
- Development phase
- 3
- Enrollment target
NCT00851591 is a NA study that was terminated before completion, run by Texas Tech University Health Sciences Center. The registered enrollment target is 3 participants.
The verdict
NCT00851591, a NA study, was terminated before completion, sponsored by Texas Tech University Health Sciences Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG fenugreek
- DRUG Placebo (Psyllium)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2008-09 |
| Est. Completion | 2012-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00851591
The ClinicalTrials.gov registry entry for NCT00851591 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Texas Tech University Health Sciences Center, which has 76 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which fenugreek is the first listed.
NCT00851591 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00851591 about?
NCT00851591 is a clinical study titled "Effect of Fenugreek on Milk Production". 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 ...
What is the current status of trial NCT00851591?
This trial is currently terminated. It is a NA study. The enrollment target is 3 participants. The study started on 2008-09. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00851591?
The interventions under investigation include: fenugreek (DRUG), Placebo (Psyllium) (DRUG).
Who is sponsoring clinical trial NCT00851591?
This trial is sponsored by Texas Tech University Health Sciences Center, which has 76 total clinical trials registered on ClinicalTrials.gov.
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