Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns

February 6, 2024 updated by: Vorapong Phupong, Chulalongkorn University

Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns, a Randomized, Double Blinded, Placebo-controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Vorapong Phupong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Postpartum women of preterm newborns

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Banana blossom
Participants received banana blossom 225 mg tablet orally four time per day for 14 days.
Drug: Banana Blossom
Banana Blossom 225 mg tablet orally four times per day for 14 days
Placebo Comparator: Placebo
Participants received placebo tablet orally four time per day for 14 days.
Drug: Placebo
Placebo tablet orally four times per day for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast milk volume per day at day 14
Time Frame: at day 14
Breast milk volume measurement in milliliters
at day 14
Breast milk volume per day at day 3
Time Frame: at day 3
Breast milk volume measurement in milliliters
at day 3
Breast milk volume per day at day 7
Time Frame: at day 7
Breast milk volume measurement in milliliters
at day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of good satisfaction
Time Frame: at 14 days
satisfaction evaluated by 5 Likert scales
at 14 days
percentage of side effects during intervention
Time Frame: day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
percentage of participants with side effects such as headache, nausea/vomiting assessing by asking
day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
percentage of drug compliance
Time Frame: at 14 days
percentage of complete drug use assessing by remained drug counting
at 14 days
factors associated with increasing breast milk volume
Time Frame: at 14 days
factors associated with increasing breast milk volume assessing by univariate and multivariate analysis
at 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Study Director: Vorapong Phupong, M.D., Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2022

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

July 7, 2022

First Submitted That Met QC Criteria

July 17, 2022

First Posted (Actual)

July 19, 2022

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 667/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preterm Birth

Clinical Trials on Banana Blossom

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe