NCT05465460

Brief Summary

The purpose of this study is to assess the effect of banana blossom in increasing breast milk volume

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

July 13, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

July 7, 2022

Last Update Submit

February 6, 2024

Conditions

Preterm BirthPostpartum Women

Outcome Measures

Primary Outcomes (3)

  • Breast milk volume per day at day 14

    Breast milk volume measurement in milliliters

    at day 14

  • Breast milk volume per day at day 3

    Breast milk volume measurement in milliliters

    at day 3

  • Breast milk volume per day at day 7

    Breast milk volume measurement in milliliters

    at day 7

Secondary Outcomes (4)

  • percentage of good satisfaction

    at 14 days

  • percentage of side effects during intervention

    day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14

  • percentage of drug compliance

    at 14 days

  • factors associated with increasing breast milk volume

    at 14 days

Study Arms (2)

Banana blossom

ACTIVE COMPARATOR

Participants received banana blossom 225 mg tablet orally four time per day for 14 days.

Drug: Banana Blossom

Placebo

PLACEBO COMPARATOR

Participants received placebo tablet orally four time per day for 14 days.

Drug: Placebo

Interventions

Banana BlossomDRUG

Banana Blossom 225 mg tablet orally four times per day for 14 days

Banana blossom
PlaceboDRUG

Placebo tablet orally four times per day for 14 days

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Postpartum women of preterm newborns

You may not qualify if:

  • Postpartum women with contraindication for breast feeding such as HIV, herpes zoster at breast, infected wound at breast.
  • Postpartum women with preeclampsia, diabetes mellitus, postpartum hemorrhage.
  • Postpartum women with allergy to banana blossom.
  • Postpartum women with previous breast surgery or nipple surgery.
  • Postpartum women who smoking.
  • Preterm newborns with unstable conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vorapong Phupong

Bangkok, 10330, Thailand

Location

Related Publications (14)

  • Hill PD, Aldag JC, Chatterton RT, Zinaman M. Comparison of milk output between mothers of preterm and term infants: the first 6 weeks after birth. J Hum Lact. 2005 Feb;21(1):22-30. doi: 10.1177/0890334404272407.

    PMID: 15681632BACKGROUND

  • Yu X, Li J, Lin X, Luan D. Association between Delayed Lactogenesis â…¡ and Early Milk Volume among Mothers of Preterm Infants. Asian Nurs Res (Korean Soc Nurs Sci). 2019 May;13(2):93-98. doi: 10.1016/j.anr.2019.02.001. Epub 2019 Feb 16.

    PMID: 30776448BACKGROUND

  • Ronnestad A, Abrahamsen TG, Medbo S, Reigstad H, Lossius K, Kaaresen PI, Egeland T, Engelund IE, Irgens LM, Markestad T. Late-onset septicemia in a Norwegian national cohort of extremely premature infants receiving very early full human milk feeding. Pediatrics. 2005 Mar;115(3):e269-76. doi: 10.1542/peds.2004-1833. Epub 2005 Feb 1.

    PMID: 15687416BACKGROUND

  • Lai CT, Hale TW, Simmer K, Hartmann PE. Measuring milk synthesis in breastfeeding mothers. Breastfeed Med. 2010 Jun;5(3):103-7. doi: 10.1089/bfm.2009.0074.

    PMID: 20433368BACKGROUND

  • Amornlerdpison D CV, Narkprasom K, Yimyam S. Bioactive Compounds and Antioxidant Properties of Banana Inflorescence in a Beverage for Maternal Breastfeeding. Applied Sciences. 2020; 11(1):343.

    BACKGROUND

  • Koduri PB, Rillema JA. Saponin effects of prolactin-like stimulation of ornithine decarboxylase activity in mouse mammary gland explants. Horm Metab Res. 1992 Dec;24(12):562-4. doi: 10.1055/s-2007-1003390.

    PMID: 1478613BACKGROUND

  • Mathew NS, Negi PS. Traditional uses, phytochemistry and pharmacology of wild banana (Musa acuminata Colla): A review. J Ethnopharmacol. 2017 Jan 20;196:124-140. doi: 10.1016/j.jep.2016.12.009. Epub 2016 Dec 14.

    PMID: 27988402BACKGROUND

  • Mahmood A, Omar MN, Ngah N. Galactagogue effects of Musa x paradisiaca flower extract on lactating rats. Asian Pac J Trop Med. 2012 Nov;5(11):882-6. doi: 10.1016/S1995-7645(12)60164-3.

    PMID: 23146802BACKGROUND

  • Slusher T, Slusher IL, Biomdo M, Bode-Thomas F, Curtis BA, Meier P. Electric breast pump use increases maternal milk volume in African nurseries. J Trop Pediatr. 2007 Apr;53(2):125-30. doi: 10.1093/tropej/fml066.

    PMID: 17409102BACKGROUND

  • Jones E, Dimmock PW, Spencer SA. A randomised controlled trial to compare methods of milk expression after preterm delivery. Arch Dis Child Fetal Neonatal Ed. 2001 Sep;85(2):F91-5. doi: 10.1136/fn.85.2.f91.

    PMID: 11517200BACKGROUND

  • Geddes D, Hartmann P, Jones E. Preterm birth: Strategies for establishing adequate milk production and successful lactation. Semin Fetal Neonatal Med. 2013 Jun;18(3):155-159. doi: 10.1016/j.siny.2013.04.001. Epub 2013 Apr 26.

    PMID: 23623976BACKGROUND

  • 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.

    PMID: 32421208RESULT

  • Nordin ZM BI, Omar MN, Mahmood A. Effect of consuming lactogenic biscuits formulated with banana (Musa x paradisiaca) flower flour on expressed breast milk (EBM) among lactating working women. Food Research 2019;4(2):294-300.

    RESULT

  • Khorana M, Wongsin P, Torbunsupachai R, Kanjanapattanakul W. Effect of Domperidone on Breast Milk Production in Mothers of Sick Neonates: A Randomized, Double-Blinded, Placebo-Controlled Trial. Breastfeed Med. 2021 Mar;16(3):245-250. doi: 10.1089/bfm.2020.0234. Epub 2020 Nov 17.

    PMID: 33202169RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Vorapong Phupong, M.D.

    Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Vorapong Phupong

Study Record Dates

First Submitted

July 7, 2022

First Posted

July 19, 2022

Study Start

July 13, 2022

Primary Completion

August 31, 2023

Study Completion

August 31, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Locations

TH(1)