Effect of Moringa Oleifera Capsule in Increasing Breast Milk Volume in Early Postpartum Patients

Postpartum Women Clinical Trial

Official title:

Effect of Moringa Oleifera Capsule in Increasing Breast Milk Volume in Early Postpartum Patients: A Double Blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04487613
• Other study ID #: 704/2020
• Status: Completed
• Phase: Phase 4
• Start date: March 15, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 30, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postpartum Women

Intervention

Drug:
• Moringa oleifera leaf
450 mg capsule
• Placebo
placebo capsule

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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.2 — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	percentage of good satisfaction	satisfaction evaluated by 5 scales	3 days
Secondary	quality of life scores	Quality of life measuring by Thai version of WHO-QOL questionaire	3 days
Secondary	side effects	percentage of side effects such as headache, nausea/vomiting	3 days
Secondary	Compliance	percentage of complete drug use	3 days