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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: Clinical Trial NA study, sponsored by Texas Tech University Health Sciences Center.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The single value of this variable was calculated average from day 0 and day 8.
Interventions
- DRUG fenugreek
- DRUG Placebo (Psyllium)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2008-09 |
| Est. Completion | 2012-08 |
| Phase | NA |
Why NCT00851591 stopped before completion
NCT00851591 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which fenugreek is the first listed.
NCT00851591 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00851591's enrollment target sits among peer trials
3 1996th of 2000 higher than 4 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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