CTRI/2024/07/070830已完成不适用
A Clinical Study to Evaluate the Earthsukh Anti-Ageing activity of Ghee Based Balm on Healthy Human Subjects
Earthsukh1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年7月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change in Skin moisturization, Elasticity, Melanin content, Lightness, Firmness, TEWL
研究概览
简要总结
Single-arm clinical study to evaluate the Anti-Ageing Activity of Ghee Based Balm
- Ghee-Based Balm
The products will be tested on 36 human volunteers.
Assessment would Notice the improvement in Skin brightening, Skin hydration, Melanin content, and skin Lightness with follow-up visits on Day 0, Day 15, and Day 28.
The study is done as per BIS standard 4011
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
入选标准
- •Gender: Non-pregnant, non-lactating female aged between 40 to
- •Subjects willing to give written informed consent 3) Women of childbearing potential must have a negative urine pregnancy test before study entry.
- •Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
- •Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
排除标准
- •Subjects who are pregnant, breastfeeding, or planning to become pregnant during the study.
- •Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
- •Have open sores or open lesions in the treatment area(s).
- •Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.
- •Have participated in any interventional clinical trial in the previous 30 days.
- •Have a known sensitivity to any of the constituents of the test product
- •Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.
- •Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past 2 years.
结局指标
主要结局
Change in Skin moisturization, Elasticity, Melanin content, Lightness, Firmness, TEWL
时间窗: Day0, Day15 and Day 28
次要结局
- To assess the safety and tolerability(Day0, and Day28)
研究者
Dr Robin Chugh
CCFT Laboratories
研究点 (1)
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