跳至主要内容
临床试验/NCT00851591
NCT00851591终止不适用

Effect of Fenugreek on Milk Production

Texas Tech University Health Sciences Center1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
1
主要终点
The Main Outcome Variable of This Study is the Quantity of Milk Produced.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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:
  • 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

研究组 & 干预措施

Fenugreek category 1

Experimental

receive fenugreek

干预措施: fenugreek (Drug)

Placebo Category 2

Placebo Comparator

receive placebo

干预措施: Placebo (Psyllium) (Drug)

结局指标

主要结局

The Main Outcome Variable of This Study is the Quantity of Milk Produced.

时间窗: "Day 0" , "Day 8"

The single value of this variable was calculated average from day 0 and day 8.

次要结局

  • Secondary Outcome Variables Are to Include Milk-fat Content and Protein Content.(day 0; day 8)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Effect of Fenugreek on Milk Production | 临床试验