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Completed

NCT Number: NCT05465460

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

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

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Postpartum Women Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Vorapong Phupong

Bangkok, 10330, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Banana Blossom

Drug

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

Placebo

Drug

Placebo tablet orally four times per day for 14 days

Primary outcomes

  1. Breast milk volume per day at day 14

    Time frame: at day 14

    Breast milk volume measurement in milliliters

  2. Breast milk volume per day at day 3

    Time frame: at day 3

    Breast milk volume measurement in milliliters

  3. Breast milk volume per day at day 7

    Time frame: at day 7

    Breast milk volume measurement in milliliters

Secondary outcomes

  1. percentage of good satisfaction

    Time frame: at 14 days

    satisfaction evaluated by 5 Likert scales

  2. 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

  3. percentage of drug compliance

    Time frame: at 14 days

    percentage of complete drug use assessing by remained drug counting

  4. 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

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2022
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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