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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 : June 26, 2018
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)
Enrollment 3
Recruitment Details 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  
Arm/Group Title 1 Group Scheduled to Receive Fenugreek 2 Group Scheduled to Receive Placebo
Hide Arm/Group Description fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days
Period Title: Overall Study
Started 2 [1] 1 [2]
Completed 0 1
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             2             0
[1]
These 2 participants did not receive treatment.
[2]
One received treatment.
Arm/Group Title 2 Group Scheduled to Receive Placebo 1 Group Scheduled to Receive Fenugreek Total
Hide Arm/Group Description Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days Total of all reporting groups
Overall Number of Baseline Participants 1 2 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 3 participants
Female
1
 100.0%
2
 100.0%
3
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title The Main Outcome Variable of This Study is the Quantity of Milk Produced.
Hide Description The single value of this variable was calculated average from day 0 and day 8.
Time Frame "Day 0" , "Day 8"
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 Group Scheduled to Receive Placebo
Hide Arm/Group Description:
Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Secondary Outcome Variables Are to Include Milk-fat Content and Protein Content.
Hide Description

Milk-fat content was not measured in these samples as we had decided to close the study.

Protein content was not measured in these samples as we had decided to close the study.

Time Frame day 0; day 8
Hide Outcome Measure Data
Hide Analysis Population Description
0 patient samples
Arm/Group Title Milk Fat and Milk Protein
Hide Arm/Group Description:

Milk fat levels were not determined in these samples as we had already decided to close study.

Milk Protein levels were not determined in these samples as we had already decided to close study.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 Group Scheduled to Receive Fenugreek 2 Group Scheduled to Receive Placebo
Hide Arm/Group Description Fenugreek Category: These patients were scheduled to take 3 capsules 3 times per day with a full glass of water and each dose was for 7 days. Psyllium Category: These patients were scheduled to take 3 capsules 3 times a day with a full glass of water and each dose was for 7 days.
All-Cause Mortality
1 Group Scheduled to Receive Fenugreek 2 Group Scheduled to Receive Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1 Group Scheduled to Receive Fenugreek 2 Group Scheduled to Receive Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1 Group Scheduled to Receive Fenugreek 2 Group Scheduled to Receive Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
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
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: June 26, 2018