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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00851591 |
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Date of registration:
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24/02/2009 |
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Primary sponsor: |
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Public title:
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Effect of Fenugreek on Milk Production
fenugreek |
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Scientific title:
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Effect of Fenugreek on Milk Production |
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Date of first enrolment:
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September 2008 |
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Target sample size:
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56 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT00851591 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Thomas W Hale, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Texas Tech University Health Sciences Center |
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Key inclusion & exclusion criteria
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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:
1. Diuretics
2. Pseudoephedrine
3. Anticholinergics
4. Warfarin or any anticoagulant
5. 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
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Lactation
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Intervention(s)
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Drug: fenugreek
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Drug: Psyllium
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Primary Outcome(s)
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The main outcome variable of this study will be the quantity of milk produced.
[Time Frame: day 0; day 8]
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Secondary Outcome(s)
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Secondary outcome variables will include milk-fat content and protein content.
[Time Frame: day 0; day 8]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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