<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04487613</url>
  </required_header>
  <id_info>
    <org_study_id>704/2020</org_study_id>
    <nct_id>NCT04487613</nct_id>
  </id_info>
  <brief_title>Effect of Moringa Oleifera Capsule in Increasing Breast Milk Volume in Early Postpartum Patients</brief_title>
  <official_title>Effect of Moringa Oleifera Capsule in Increasing Breast Milk Volume in Early Postpartum Patients: A Double Blind Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chulalongkorn University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chulalongkorn University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effect of Moringa oleifera leaf capsule in&#xD;
      increasing breast milk volume&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2021</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Breast milk volume at postpartum day 3</measure>
    <time_frame>day 3</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>percentage of good satisfaction</measure>
    <time_frame>3 days</time_frame>
    <description>satisfaction evaluated by 5 scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life scores</measure>
    <time_frame>3 days</time_frame>
    <description>Quality of life measuring by Thai version of WHO-QOL questionaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>side effects</measure>
    <time_frame>3 days</time_frame>
    <description>percentage of side effects such as headache, nausea/vomiting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>3 days</time_frame>
    <description>percentage of complete drug use</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Postpartum Women</condition>
  <arm_group>
    <arm_group_label>Moringa oleifera leaf</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants received Moringa oleifera leaf 450 mg capsule orally twice daily for 3 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received placebo capsule orally twice daily for 3 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Moringa oleifera leaf</intervention_name>
    <description>450 mg capsule</description>
    <arm_group_label>Moringa oleifera leaf</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo capsule</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Postpartum women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Postpartum women with contraindication for breast feeding such as HIV, untreated&#xD;
             tuberculosis, on chemotherapeutic drugs, on radioactive drugs, substance abuse.&#xD;
&#xD;
          -  Postpartum women with unstable conditions such as postpartum hemorrhage.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Medicine, Chulalongkorn University</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <reference>
    <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>
    <PMID>31427892</PMID>
  </reference>
  <reference>
    <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>
    <PMID>30035142</PMID>
  </reference>
  <reference>
    <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>
    <PMID>25935822</PMID>
  </reference>
  <reference>
    <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>
    <PMID>22392841</PMID>
  </reference>
  <reference>
    <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>
    <PMID>24892837</PMID>
  </reference>
  <reference>
    <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>
    <PMID>25808883</PMID>
  </reference>
  <reference>
    <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>
    <PMID>2834941</PMID>
  </reference>
  <results_reference>
    <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>
    <PMID>27505611</PMID>
  </results_reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 6, 2022</last_update_submitted>
  <last_update_submitted_qc>July 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chulalongkorn University</investigator_affiliation>
    <investigator_full_name>Vorapong Phupong</investigator_full_name>
    <investigator_title>Prof. Vorapong Phupong</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04487613
org study id: 704/2020
nct id: NCT04487613
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the effect of Moringa oleifera leaf capsule in
      increasing breast milk volume
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Breast milk volume at postpartum day 3
time frame: day 3
description: 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).
measure: percentage of good satisfaction
time frame: 3 days
description: satisfaction evaluated by 5 scales
measure: quality of life scores
time frame: 3 days
description: Quality of life measuring by Thai version of WHO-QOL questionaire
measure: side effects
time frame: 3 days
description: percentage of side effects such as headache, nausea/vomiting
measure: Compliance
time frame: 3 days
description: percentage of complete drug use
arm group label: Moringa oleifera leaf
arm group type: Active Comparator
description: Participants received Moringa oleifera leaf 450 mg capsule orally twice daily for 3 days.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants received placebo capsule orally twice daily for 3 days.
intervention type: Drug
intervention name: Moringa oleifera leaf
description: 450 mg capsule
arm group label: Moringa oleifera leaf
intervention type: Drug
intervention name: Placebo
description: placebo capsule
arm group label: Placebo
criteria: 
gender: Female
gender based: Yes
gender description: female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Thailand
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.
PMID: 31427892
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.
PMID: 30035142
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.
PMID: 25935822
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.
PMID: 22392841
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.
PMID: 24892837
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.
PMID: 25808883
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.
PMID: 2834941
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.
PMID: 27505611
responsible party type: Principal Investigator
investigator affiliation: Chulalongkorn University
investigator full name: Vorapong Phupong
investigator title: Prof. Vorapong Phupong
sharing ipd: No