NCT05465460已完成4 期
Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns, a Randomized, Double Blinded, Placebo-controlled Trial
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
- 70
- 试验地点
- 1
- 主要终点
- Breast milk volume per day at day 14
研究概览
简要总结
The purpose of this study is to assess the effect of banana blossom 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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postpartum women of preterm newborns
排除标准
- •Postpartum women with contraindication for breast feeding such as HIV, herpes zoster at breast, infected wound at breast.
- •Postpartum women with preeclampsia, diabetes mellitus, postpartum hemorrhage.
- •Postpartum women with allergy to banana blossom.
- •Postpartum women with previous breast surgery or nipple surgery.
- •Postpartum women who smoking.
- •Preterm newborns with unstable conditions.
研究组 & 干预措施
Banana blossom
Active Comparator
Participants received banana blossom 225 mg tablet orally four time per day for 14 days.
干预措施: Banana Blossom (Drug)
Placebo
Placebo Comparator
Participants received placebo tablet orally four time per day for 14 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Breast milk volume per day at day 14
时间窗: at day 14
Breast milk volume measurement in milliliters
Breast milk volume per day at day 3
时间窗: at day 3
Breast milk volume measurement in milliliters
Breast milk volume per day at day 7
时间窗: at day 7
Breast milk volume measurement in milliliters
次要结局
- percentage of good satisfaction(at 14 days)
- percentage of side effects during intervention(day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
- percentage of drug compliance(at 14 days)
- factors associated with increasing breast milk volume(at 14 days)
研究者
Vorapong Phupong
Prof. Vorapong Phupong
Chulalongkorn University
研究点 (1)
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