Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns
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|ClinicalTrials.gov Identifier: NCT05465460|
Recruitment Status : Not yet recruiting
First Posted : July 19, 2022
Last Update Posted : July 19, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Preterm Birth Postpartum Women||Drug: Banana Blossom Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
Placebo tablet orally four times per day for 14 days
- Breast milk volume per day at day 14 [ Time Frame: at day 14 ]Breast milk volume measurement in milliliters
- Breast milk volume per day at day 3 [ Time Frame: at day 3 ]Breast milk volume measurement in milliliters
- Breast milk volume per day at day 7 [ Time Frame: at day 7 ]Breast milk volume measurement in milliliters
- percentage of good satisfaction [ Time Frame: at 14 days ]satisfaction evaluated by 5 Likert scales
- 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
- percentage of drug compliance [ Time Frame: at 14 days ]percentage of complete drug use assessing by remained drug counting
- 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
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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|
- Postpartum women of preterm newborns
- 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.
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
|Contact: Apisit Rungruengsirichok, M.D.||+email@example.com|
|Contact: Vorapong Phupong, M.D.||+firstname.lastname@example.org|
|Study Director:||Vorapong Phupong, M.D.||Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology|
|Responsible Party:||Vorapong Phupong, Prof. Vorapong Phupong, Chulalongkorn University|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Obstetric Labor, Premature
Obstetric Labor Complications
Female Urogenital Diseases and Pregnancy Complications