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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05465460
Recruitment Status : Not yet recruiting
First Posted : July 19, 2022
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
Vorapong Phupong, Chulalongkorn University

Study Description
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Brief Summary:
The purpose of this study is to assess the effect of banana blossom in increasing breast milk volume

Condition or disease Intervention/treatment Phase
Preterm Birth Postpartum Women Drug: Banana Blossom Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns, a Randomized, Double Blinded, Placebo-controlled Trial
Estimated Study Start Date : July 9, 2022
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : September 30, 2023
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05465460


Contacts
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Contact: Apisit Rungruengsirichok, M.D. +6626492115 rung.apisit@gmail.com
Contact: Vorapong Phupong, M.D. +6626492115 vorapong.p@chula.ac.th

Sponsors and Collaborators
Chulalongkorn University
Investigators
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Study Director: Vorapong Phupong, M.D. Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology
More Information
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Publications of Results:
Nordin ZM BI, Omar MN, Mahmood A. Effect of consuming lactogenic biscuits formulated with banana (Musa x paradisiaca) flower flour on expressed breast milk (EBM) among lactating working women. Food Research 2019;4(2):294-300.

Other Publications:
Amornlerdpison D CV, Narkprasom K, Yimyam S. Bioactive Compounds and Antioxidant Properties of Banana Inflorescence in a Beverage for Maternal Breastfeeding. Applied Sciences. 2020; 11(1):343.

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Responsible Party: Vorapong Phupong, Prof. Vorapong Phupong, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT05465460    
Other Study ID Numbers: 667/2022
First Posted: July 19, 2022    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
 Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases