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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05465460

Enrollment

Registered

2022-07-19

Start date

2022-07-13

Completion date

2023-08-31

Last updated

2024-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Women, Preterm Birth

Brief summary

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

Interventions

DRUGBanana Blossom

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

DRUGPlacebo

Placebo tablet orally four times per day for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Breast milk volume per day at day 14	at day 14	Breast milk volume measurement in milliliters
Breast milk volume per day at day 3	at day 3	Breast milk volume measurement in milliliters
Breast milk volume per day at day 7	at day 7	Breast milk volume measurement in milliliters

Secondary

Measure	Time frame	Description
percentage of good satisfaction	at 14 days	satisfaction evaluated by 5 Likert scales
factors associated with increasing breast milk volume	at 14 days	factors associated with increasing breast milk volume assessing by univariate and multivariate analysis
percentage of side effects during intervention	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
percentage of drug compliance	at 14 days	percentage of complete drug use assessing by remained drug counting

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026