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Galactagogue Supplement
Galactagogue Supplements for Low Milk Supply
N/A
Recruiting
Led By Hope K Lima, PhD
Research Sponsored by Winthrop University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intervention will last 20 days and 24-hour breast milk expression volume will be measured on day 1, 10, and 20 and used to calculate change in 24-hour breast milk expression volume over the trial period
Awards & highlights
Study Summary
This trial is testing whether taking oat mama, moringa, or shatavari supplements for 20 days can increase milk production, as measured by increased serum prolactin levels.
Who is the study for?
This trial is for breastfeeding women aged 18-39 who feel they have low milk supply and haven't used galactagogues in their current lactation cycle. They must not have had breast reduction surgery, be willing to take a supplement or placebo, provide blood samples, and track milk volume over 20 days.Check my eligibility
What is being tested?
The study tests if Oat Mama Lactation Supplement, moringa, or shatavari can boost milk production by increasing serum prolactin levels compared to a placebo. Participants will use these supplements for 20 days with effects measured through blood tests and milk volume tracking.See study design
What are the potential side effects?
Potential side effects of the supplements may include digestive discomfort or allergic reactions; however, specific side effects related to these particular galactagogues are not detailed in this summary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intervention will last 20 days and blood samples will be taken on day 1, 10, am 20 and change in serum prolactin will be measured using a human serum prolactin elisa kit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intervention will last 20 days and blood samples will be taken on day 1, 10, am 20 and change in serum prolactin will be measured using a human serum prolactin elisa kit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Breast Milk Supply
Change in Serum Prolactin
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Shatavari SupplementExperimental Treatment1 Intervention
Participants will receive a 20 day supply of shatavari supplement for consumption per the manufacturer instructions
Group II: Oat Mama Lactation SupplementExperimental Treatment1 Intervention
Participants will receive a 20 day supply of oat mama lactation supplement for consumption per the manufacturer instructions
Group III: Moringa SupplementExperimental Treatment1 Intervention
Participants will receive a 20 day supply of moringa supplement for consumption per the manufacturer instructions
Group IV: PlaceboPlacebo Group1 Intervention
Participants will receive a 20 day supply of placebo pills containing a mixture of flour and brown sugar. Participants will consume 2 placebo pills once per day for 20 days.
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Who is running the clinical trial?
Winthrop UniversityLead Sponsor
2 Previous Clinical Trials
113 Total Patients Enrolled
Hope K Lima, PhDPrincipal InvestigatorWinthrop University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a breast reduction surgery.I do not have mammary glands for milk production.I am either younger than 18 or older than 39.I am willing to measure and report my milk volume on day 1, 10, and 20.I am willing to take a randomly chosen breast milk increasing supplement or a placebo.
Research Study Groups:
This trial has the following groups:- Group 1: Shatavari Supplement
- Group 2: Placebo
- Group 3: Moringa Supplement
- Group 4: Oat Mama Lactation Supplement
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are octogenarians being accepted as participants in this clinical trial?
"The participant criteria for this clinical trial necessitates that individuals must be between 18 and 40 years old."
Answered by AI
Does my medical profile meet the criteria to join this experimental program?
"Applicants must possess lactation, mammary glands and fall within the 18 to 40 age bracket in order to be considered for this clinical investigation. A total of 120 participants are being enrolled."
Answered by AI
Are participants being actively sought for this investigation?
"Affirmative, the clinicaltrials.gov website mentions that this trial is currently enrolling individuals for participation. It was initially posted on June 1st 2022 and has since been revised on May 25th of the same year. The goal is to recruit 120 patients from one main location."
Answered by AI
What is the estimated participant pool for this clinical trial?
"Affirmative. According to information found on clinicaltrials.gov, this clinical trial was originally published on June 1st 2022 and is still searching for participants with an update made as recently as May 25th 2022. The experiment requires 120 people at a single location."
Answered by AI
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