Effect of Fenugreek on Milk Production (fenugreek)

• ClinicalTrials.gov Identifier: NCT00851591
• Recruitment Status: Terminated
• First Posted: February 26, 2009
• Results First Posted: July 28, 2014
• Last Update Posted: June 26, 2018
• Sponsor: Texas Tech University Health Sciences Center
• 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

Participant Flow

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
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.

Baseline Characteristics

Arm/Group Title		2 Group Scheduled to Receive Placebo	1 Group Scheduled to Receive Fenugreek	Total
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
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%

Outcome Measures

1. Primary Outcome

Title	The Main Outcome Variable of This Study is the Quantity of Milk Produced.
Description	The single value of this variable was calculated average from day 0 and day 8.
Time Frame	"Day 0" , "Day 8"

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	2 Group Scheduled to Receive Placebo
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.
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

Outcome Measure Data

Analysis Population Description

0 patient samples

Arm/Group Title	Milk Fat and Milk Protein
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.

Adverse Events

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
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	--/--	--/--
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%)
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%)

Limitations and Caveats

[Not Specified]

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
• EMail: thomas.hale@ttuhsc.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Foong SC, Tan ML, Foong WC, Marasco LA, Ho JJ, Ong JH. Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants. Cochrane Database Syst Rev. 2020 May 18;5(5):CD011505. doi: 10.1002/14651858.CD011505.pub2.

• Responsible Party: Texas Tech University Health Sciences Center
• ClinicalTrials.gov Identifier: NCT00851591
• 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