Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT05398367
Status:
RECRUITING
Last Update Posted:
2025-03-28
First Post:
2022-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Galactagogue Use in Lactating Women With Low Milk Supply
Sponsor:
Winthrop University
Organization:
Study Overview
Official Title:
Effect of Single Ingredient and Blend Galactagogue Supplements on Increasing Milk Supply in Lactating Women Experiencing Diagnosed or Perceived Low Milk Supply
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to determine whether a 20-day supplement with either Oat Mama Lactation Supplement, moringa, or shatavari has any impact on milk production through an increase in serum prolactin levels when compared to the placebo group. This data will be used to determine if clinical recommendations can be made for the use of the studied supplements in increasing milk supply.
Detailed Description:
This study will be a double-blind randomized control trial where eligible participants will be randomized into one of four treatment groups: Oat Mama Lactation Supplement (O), moringa supplement (M), shatavari supplement (S), or control (C). All participants will receive a supplement or placebo for consumption throughout the 20-day trial period, and all participants will receive support from a lactation consultant once per week to receive appropriate guidance for increasing milk supply. 24-hour milk output will be recorded on day 1, 10, and 20 using either pre- and post-feeding weights, 24-hour pump output, or a combination of both. Additionally, blood samples will be taken on day 1, 10, and 20 and serum will be isolated for later analysis of serum prolactin levels.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: