We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Fenugreek on Milk Production (fenugreek)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00851591
Recruitment Status : Terminated (Low enrollment; investigator chose not to continue study)
First Posted : February 26, 2009
Results First Posted : July 28, 2014
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Lactation
Interventions: Drug: fenugreek
Drug: Placebo (Psyllium)

  Participant Flow

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

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 
Overall Participants Analyzed 
[Units: Participants]
 1   2   3 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      1 100.0%      2 100.0%      3 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      1 100.0%      2 100.0%      3 100.0% 
Male      0   0.0%      0   0.0%      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 reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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



Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT00851591     History of Changes
Other Study ID Numbers: A08-3479
First Submitted: February 24, 2009
First Posted: February 26, 2009
Results First Submitted: January 24, 2014
Results First Posted: July 28, 2014
Last Update Posted: December 5, 2017