Effect of Fenugreek on Milk Production (fenugreek)

This study has been terminated.
(Low enrollment; investigator chose not to continue study)
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier:
NCT00851591
First received: February 24, 2009
Last updated: June 30, 2014
Last verified: June 2014
Results First Received: January 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Lactation
Interventions: Drug: fenugreek
Drug: Placebo (Psyllium)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
3 patients were recruited to participate. Recruitment was stopped due to a similar study had already been published and the inability to recruit patients.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
1 Group Scheduled to Receive Fenugreek fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days
2 Group Scheduled to Receive Placebo Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days

Participant Flow:   Overall Study
    1 Group Scheduled to Receive Fenugreek     2 Group Scheduled to Receive Placebo  
STARTED     2 [1]   1 [2]
COMPLETED     0     1  
NOT COMPLETED     2     0  
Withdrawal by Subject                 2                 0  
[1] These 2 participants did not receive treatment.
[2] One received treatment.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
2 Group Scheduled to Receive Placebo Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days
1 Group Scheduled to Receive Fenugreek fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days
Total Total of all reporting groups

Baseline Measures
    2 Group Scheduled to Receive Placebo     1 Group Scheduled to Receive Fenugreek     Total  
Number of Participants  
[units: participants]
  1     2     3  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1     2     3  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     1     2     3  
Male     0     0     0  



  Outcome Measures

1.  Primary:   The Main Outcome Variable of This Study is the Quantity of Milk Produced.   [ Time Frame: "Day 0" , "Day 8" ]

2.  Secondary:   Secondary Outcome Variables Are to Include Milk-fat Content and Protein Content.   [ Time Frame: day 0; day 8 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Thomas Hale, PhD.
Organization: Texas Tech University Health Sciences Center
phone: 806-354-5528
e-mail: thomas.hale@ttuhsc.edu


No publications provided


Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT00851591     History of Changes
Other Study ID Numbers: A08-3479
Study First Received: February 24, 2009
Results First Received: January 24, 2014
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration