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临床试验/NCT04487613
NCT04487613已完成4 期

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

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2021年3月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
88
试验地点
1
主要终点
Breast milk volume at postpartum day 3

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Postpartum women

排除标准

  • 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.

研究组 & 干预措施

Moringa oleifera leaf

Active Comparator

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

干预措施: Moringa oleifera leaf (Drug)

Placebo

Placebo Comparator

Participants received placebo capsule orally twice daily for 3 days.

干预措施: Placebo (Drug)

结局指标

主要结局

Breast milk volume at postpartum day 3

时间窗: 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).

次要结局

  • percentage of good satisfaction(3 days)
  • quality of life scores(3 days)
  • side effects(3 days)
  • Compliance(3 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vorapong Phupong

Prof. Vorapong Phupong

Chulalongkorn University

研究点 (1)

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