CTRI/2022/08/044605已完成未知
An open-label, single-arm study to evaluate the efficacy and safety of a Stretchmark Oil & Oil Free Hair Oil in healthy pregnant female (1st and 2nd trimester) and lactating female (post pregnancy mother having 0 month to 3 months old baby) subjects.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 53
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 (1st and 2nd Trimester).
- •b.Lactating females (post pregnancy mothers having 0 to 3 months old baby).
- •2)Subjects having stretch mark on their abdomen at the time of enrollment.
- •3)Atleast 12 healthy pregnant females (1st and 2nd trimester) without stretchmarks will be enrolled.
- •4)Subjects complaining of having at least 50 to 100 hair fall per day.
- •5)Subjects with 50 counts of hair fall from hair combing method (60-sec hair count) at screening visit (if screening and enrollment on same day) or on enrollment day before test product application.
- •6)For Post Pregnancy Mothers: Subjects having history of delivery within 42 weeks.
- •7)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 with a history of severe hair fall due to any clinically significant problems/s like anaemia, thyroid problems etc.
- •2)History of any dermatological condition of the scalp other than hair loss and/or dandruff.
- •3)History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
- •4)Skin disease (e.g., moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, atopic dermatitis or any other condition as per Investigatorâ??s discretion), which would interfere with the test readings.
- •5)Participation in a similar clinical study within the previous 90 days.
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