CTRI/2019/09/021400尚未招募2 期
An Open Label Single Arm Clinical Study to Evaluate the Safety and Efficacy of HQMZ111831 as a Lactation Support in Lactating Mothers - Quista_Momz
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Lactating mothers aged >=18 years <=40 years and has completed 48 hours of post-partum period, who are planning at least three months of breast feeding to the infant
- •Mother confirms her intention to breastfeed and refrains from joining work outside during the study period.
- •Mother is non-smoker and non-alcoholic.
- •Infant is judged to be in good health.
- •Mothers planning only with the conventional breast feeding method and not intending to use breast pump.
- •Mother confirms her intention to breastfeed and refrains from taking any other
- •supplement or galactogogues during the study period.
排除标准
- •Mother has any anatomical defect in the breast or nipple like mastectomy, retracted nipples which may interfere with the normal breast feeding.
- •Mother is allergic or intolerant to any ingredient found in the study product.
- •An adverse maternal, fetal or infant medical history that has potential effects on child growth and or development.
- •Mother and or newborn infant has major illness that requires intensive care admission.
- •Infant has major congenital anomaly.
- •Infant with cleft lip, palate which may impair breast feeding.
研究者
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