NCT02233439Unknown不适用
Efficacy of Herbal Galactogogues: a Double-blinded, Placebo-controlled Randomized Trial.
Università degli Studi dell'Insubria2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2014年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Percentage of mothers who exclusively breastfeed their child
研究概览
简要总结
The purpose of this study is to assess the effectiveness of a commercially available product containing a combination of Silybum marianum and Galega officinalis to support continuation or augmentation of breast milk production.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- 是
入选标准
- •singleton, term delivery
- •>2.5 kg newborn weight
- •lactation-deficiency
排除标准
- •Neonatal Intensive Care Unit admission
- •use of galactagogue drugs
结局指标
主要结局
Percentage of mothers who exclusively breastfeed their child
时间窗: At 6 weeks postpartum
次要结局
- Rate of breastfeeding (either exclusively or as a supplement to formula feeding )(at 6 weeks and 3 months)
- Volume (mL) and frequency (times a day) of formula(6 weeks postpartum)
- weight gain experienced by the newborns(6 weeks postpartum)
- serum prolactin level(at baseline and 6 weeks after treatment)
- Rate of maternal allergic reactions and gastrointestinal side effects(6 weeks postpartum)
研究者
Antonella Cromi
Associate professor
Università degli Studi dell'Insubria
研究点 (2)
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