NCT04487613

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 8, 2022

Status Verified

July 1, 2022

Enrollment Period

1.2 years

First QC Date

July 23, 2020

Last Update Submit

July 6, 2022

Conditions

Postpartum Women

Outcome Measures

Primary Outcomes (1)

  • Breast milk volume at postpartum day 3

    Breast milk volume measuring by weighting the infant fully clothed before and after each feeding with an electronic weigh scale for the period of 24 hours (at postpartum day 3). The sum of weight difference in gram was then converted to breast milk volume in milliliter (1 g = 1 mL).

    day 3

Secondary Outcomes (4)

  • percentage of good satisfaction

    3 days

  • quality of life scores

    3 days

  • side effects

    3 days

  • Compliance

    3 days

Study Arms (2)

Moringa oleifera leaf

ACTIVE COMPARATOR

Participants received Moringa oleifera leaf 450 mg capsule orally twice daily for 3 days.

Drug: Moringa oleifera leaf

Placebo

PLACEBO COMPARATOR

Participants received placebo capsule orally twice daily for 3 days.

Drug: Placebo

Interventions

Moringa oleifera leafDRUG

450 mg capsule

Moringa oleifera leaf
PlaceboDRUG

placebo capsule

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postpartum women

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Location

Related Publications (9)

  • 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.

    PMID: 31427892BACKGROUND

  • 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.

    PMID: 30035142BACKGROUND

  • 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.

    PMID: 25935822BACKGROUND

  • Zapantis A, Steinberg JG, Schilit L. Use of herbals as galactagogues. J Pharm Pract. 2012 Apr;25(2):222-31. doi: 10.1177/0897190011431636.

    PMID: 22392841BACKGROUND

  • 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.

    PMID: 24892837BACKGROUND

  • 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.

    PMID: 25808883BACKGROUND

  • 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.

    PMID: 2834941BACKGROUND

  • 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.

    PMID: 27505611RESULT

  • 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.

    PMID: 33822798DERIVED

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Vorapong Phupong

Study Record Dates

First Submitted

July 23, 2020

First Posted

July 27, 2020

Study Start

March 15, 2021

Primary Completion

May 31, 2022

Study Completion

June 30, 2022

Last Updated

July 8, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)