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

Phase 4CompletedNCT05465460

Chulalongkorn University70 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Preterm Birth Postpartum Women

Interventions

Banana BlossomDRUG

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

PlaceboDRUG

Placebo tablet orally four times per day for 14 days

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Vorapong Phupong

Bangkok, Thailand

Outcomes

Primary Outcomes

Breast milk volume per day at day 14

Breast milk volume measurement in milliliters

Time frame: at day 14

Breast milk volume per day at day 3

Breast milk volume measurement in milliliters

Time frame: at day 3

Breast milk volume per day at day 7

Breast milk volume measurement in milliliters

Time frame: at day 7

Secondary Outcomes

percentage of good satisfaction

satisfaction evaluated by 5 Likert scales

Time frame: at 14 days

percentage of side effects during intervention

percentage of participants with side effects such as headache, nausea/vomiting assessing by asking

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

percentage of drug compliance

percentage of complete drug use assessing by remained drug counting

Time frame: at 14 days

factors associated with increasing breast milk volume

factors associated with increasing breast milk volume assessing by univariate and multivariate analysis

Time frame: at 14 days

Data from ClinicalTrials.gov

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