Postpartum WomenPhase 4NCT04487613
Effect of Moringa Oleifera Capsule in Increasing Breast Milk Volume in Early Postpartum Patients
A Phase 4 study testing Moringa oleifera leaf in people with Postpartum Women, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The purpose of this study is to assess the effect of Moringa oleifera leaf capsule in increasing breast milk volume Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Women
- What is being tested?
- Moringa oleifera leaf
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteThailand
- Study dates
- 15 Mar 2021to 30 Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postpartum women
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Moringa Oleifera Capsule in Increasing Breast Milk Volume in Early Postpartum Patients: A Double Blind Randomized Controlled Trial
The purpose of this study is to assess the effect of Moringa oleifera leaf capsule in increasing breast milk volume
- Conditions
- Postpartum Women
- Being tested
- Moringa oleifera leaf, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa oleifera leafDrug
450 mg capsule
PlaceboDrug
placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Moringa oleifera leaf | Active comparator | Participants received Moringa oleifera leaf 450 mg capsule orally twice daily for 3 days. Receives: Drug: Moringa oleifera leaf |
| Placebo | Placebo comparator | Participants received placebo capsule orally twice daily for 3 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: day 3
Secondary outcomes (4)
percentage of good satisfaction
satisfaction evaluated by 5 scales
Measured: 3 days
quality of life scores
Quality of life measuring by Thai version of WHO-QOL questionaire
Measured: 3 days
side effects
percentage of side effects such as headache, nausea/vomiting
Measured: 3 days
Compliance
percentage of complete drug use
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start15 Mar 2021
- Primary completion31 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Postpartum WomenStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vorapong Phupong, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487613
- Sponsor's protocol ID
- 704/2020
- Status last verified
- Jul 2022
- First submitted
- 23 Jul 2020
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31427892Maharlouei 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.
PubMed 30035142Frawley 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.
PubMed 25935822Zapantis A, Steinberg JG, Schilit L. Use of herbals as galactagogues. J Pharm Pract. 2012 Apr;25(2):222-31. doi: 10.1177/0897190011431636.
PubMed 22392841Raguindin 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.
PubMed 24892837Stohs 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.
PubMed 25808883Butte 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.
PubMed 2834941Paritakul 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.
PubMed 27505611Fungtammasan 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.
PubMed 33822798
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Moringa Oleifera Capsule in Increasing Breast Milk Volume in Early Postpartum Patients: A Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04487613
- Acronym / sponsor ID
- 704/2020
- Conditions
- Postpartum Women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect of Moringa oleifera leaf capsule in increasing breast milk volume
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moringa oleifera leaf | Active comparator | Drug: Moringa oleifera leafParticipants received Moringa oleifera leaf 450 mg capsule orally twice daily for 3 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo capsule orally twice daily for 3 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Postpartum women
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moringa oleifera leaf450 mg capsule | Drug | Moringa oleifera leaf |
| Placeboplacebo capsule | Drug | Placebo |
Primary outcome
Breast milk volume at postpartum day 3
Time frame: 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).
4 secondary outcomes
percentage of good satisfaction
Time frame: 3 days
quality of life scores
Time frame: 3 days
side effects
Time frame: 3 days
Compliance
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Background: PubMed 31427892Awaliyah 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.
- Background: PubMed 30035142Maharlouei 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.
- Background: PubMed 25935822Frawley 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.
- Background: PubMed 22392841Zapantis A, Steinberg JG, Schilit L. Use of herbals as galactagogues. J Pharm Pract. 2012 Apr;25(2):222-31. doi: 10.1177/0897190011431636.
- Background: PubMed 24892837Raguindin 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.
- Background: PubMed 25808883Stohs 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.
- Background: PubMed 2834941Butte 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.
- Results publication: PubMed 27505611Paritakul 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.
- Derived from this study: PubMed 33822798Fungtammasan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Moringa oleifera leaf in people with Postpartum Women, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast milk volume at postpartum day 3 (time frame: day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04487613, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2022.