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

Phase 4

Completed

• Conditions: Preterm Birth; Postpartum Women
• Interventions: Drug: Banana Blossom; Drug: Placebo

• Registration Number: NCT05465460
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-07
• Study Start: 2022-07-13
• Study First Submitted QC: 2022-07-17
• Study First Posted: 2022-07-19
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Banana blossom	Banana Blossom	Participants received banana blossom 225 mg tablet orally four time per day for 14 days.
Placebo	Placebo	Participants received placebo tablet orally four time per day for 14 days.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
percentage of good satisfaction	at 14 days	satisfaction evaluated by 5 Likert scales
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
factors associated with increasing breast milk volume	at 14 days	factors associated with increasing breast milk volume assessing by univariate and multivariate analysis

Trial Locations

Locations (1)

Vorapong Phupong; 🇹🇭 Bangkok, Thailand