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临床试验/CTRI/2022/08/044645
CTRI/2022/08/044645已完成未知

An open-label, single-arm study to evaluate the efficacy and safety of a Nursing Gel in healthy pregnant female (3rd trimester) and lactating female (post pregnancy mother having 0 month to 3 months old baby) subjects with sore & cracked nipples.

Zydus Wellness Ltd0 个研究点目标入组 60 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
入组人数
60

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

  • 1)Sex: Females, either of the following
  • a.Healthy pregnant females (3rd trimester).
  • b.Lactating females (post pregnancy mothers having 0 to 3 months old baby).
  • 2)Subjects with mild to moderate nipple soreness/pain based on visual analogue scale (VAS).
  • 3)For Post Pregnancy Mothers: Subjects having history of delivery within 42 weeks.
  • 4)For Pregnant females: Primipara (woman who is giving birth for the first time) subjects, who are diagnosed as pregnant female by gynaecologist.

排除标准

  • 1)Subjects having contraindications for breastfeeding
  • 2)Newborn with no oral, palatal or maxillofacial abnormalities.
  • 3)Subjects with history of development of any breast problem: Mastitis, engorgement etc.
  • 4)Subjects not willing to discontinue other nipple crack preventing method during application.
  • 5)Subjects who are not taking any pain management medication e.g., NSAIDâ??s, pain killers, etc.
  • 6)Participation in a similar clinical study within the previous 90 days.

研究者

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