Clinical trial NCT04487613: Effect of Moringa Oleifera Capsule in Increasing Breast Milk Volume in Early Postpartum Patients
Official title: Effect of Moringa Oleifera Capsule in Increasing Breast Milk Volume in Early Postpartum Patients: A Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postpartum Women
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the effect of Moringa oleifera leaf capsule in increasing breast milk volume


Eligibility criteria: Inclusion Criteria:

* Postpartum women

Exclusion Criteria:

* Postpartum women with contraindication for breast feeding such as HIV, untreated tuberculosis, on chemotherapeutic drugs, on radioactive drugs, substance abuse.
* Postpartum women with unstable conditions such as postpartum hemorrhage.

Primary outcomes:
measure: Breast milk volume at postpartum day 3
timeFrame: day 3
Secondary outcomes:
measure: percentage of good satisfaction
timeFrame: 3 days
measure: quality of life scores
timeFrame: 3 days
measure: side effects
timeFrame: 3 days
measure: Compliance
timeFrame: 3 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Chulalongkorn University
Study officials:
References:
citation: Awaliyah SN, Rachmawati IN, Rahmah H. Breastfeeding self-efficacy as a dominant factor affecting maternal breastfeeding satisfaction. BMC Nurs. 2019 Aug 16;18(Suppl 1):30. doi: 10.1186/s12912-019-0359-6. eCollection 2019.
citation: Maharlouei N MD, Pourhaghighi A Medical student, Raeisi Shahraki H PhD, Zohoori D MD, Lankarani KB MD. Factors Affecting Exclusive Breastfeeding, Using Adaptive LASSO Regression. Int J Community Based Nurs Midwifery. 2018 Jul;6(3):260-271.
citation: Frawley J, Adams J, Steel A, Broom A, Gallois C, Sibbritt D. Women's Use and Self-Prescription of Herbal Medicine during Pregnancy: An Examination of 1,835 Pregnant Women. Womens Health Issues. 2015 Jul-Aug;25(4):396-402. doi: 10.1016/j.whi.2015.03.001. Epub 2015 Apr 29.
citation: Zapantis A, Steinberg JG, Schilit L. Use of herbals as galactagogues. J Pharm Pract. 2012 Apr;25(2):222-31. doi: 10.1177/0897190011431636.
citation: Raguindin PF, Dans LF, King JF. Moringa oleifera as a Galactagogue. Breastfeed Med. 2014 Jul-Aug;9(6):323-4. doi: 10.1089/bfm.2014.0002. Epub 2014 Jun 3. No abstract available.
citation: Stohs SJ, Hartman MJ. Review of the Safety and Efficacy of Moringa oleifera. Phytother Res. 2015 Jun;29(6):796-804. doi: 10.1002/ptr.5325. Epub 2015 Mar 24.
citation: Butte NF, Wong WW, Patterson BW, Garza C, Klein PD. Human-milk intake measured by administration of deuterium oxide to the mother: a comparison with the test-weighing technique. Am J Clin Nutr. 1988 May;47(5):815-21. doi: 10.1093/ajcn/47.5.815.
citation: Paritakul P, Ruangrongmorakot K, Laosooksathit W, Suksamarnwong M, Puapornpong P. The Effect of Ginger on Breast Milk Volume in the Early Postpartum Period: A Randomized, Double-Blind Controlled Trial. Breastfeed Med. 2016 Sep;11:361-5. doi: 10.1089/bfm.2016.0073. Epub 2016 Aug 9.
citation: Fungtammasan S, Phupong V. The effect of Moringa oleifera capsule in increasing breastmilk volume in early postpartum patients: A double-blind, randomized controlled trial. PLoS One. 2021 Apr 6;16(4):e0248950. doi: 10.1371/journal.pone.0248950. eCollection 2021.