Trial Outcomes & Findings for Effect of Fenugreek on Milk Production (NCT NCT00851591)

Results Overview

The single value of this variable was calculated average from day 0 and day 8.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

"Day 0" , "Day 8"

Results posted on

2018-06-26

Participant Flow

3 patients were recruited to participate. Recruitment was stopped due to a similar study had already been published and the inability to recruit patients.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	2	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Effect of Fenugreek on Milk Production

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2 Group Scheduled to Receive Placebo n=1 Participants Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days	1 Group Scheduled to Receive Fenugreek n=2 Participants fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: "Day 0" , "Day 8"

The single value of this variable was calculated average from day 0 and day 8.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: day 0; day 8

Population: 0 patient samples

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.

Outcome measures

Outcome data not reported

Adverse Events

1 Group Scheduled to Receive Fenugreek

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2 Group Scheduled to Receive Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas Hale, PhD.

Texas Tech University Health Sciences Center

Phone: 806-354-5528

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place