CTRI/2023/06/054313已完成Unknown
A Prospetive, single arm, open label, single centre clinical study to evaluate the safety and efficacy of Nimson kesh silk plus oil in controlling hairfall and premature greying
Aryanveda Cosmeceuticals1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年3月7日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- • Reduced hairfall as per the 60 seconds hairfall on Day 28 when compared with the baseline value
研究概览
简要总结
This study is an prospective , single arm,open label, single centre clinical study to evaluate the safety and efficacy of Nimson Keshsilk Plus oil in Controlling Hair fall and premature greying
Primary Objective :
• Prevention or control of premature greying of hair
• Reduced hair fall ensuring thicker and stronger hair growth.
Secondary Objective :
• To test the ability of the test product to nourish the hair measured by measuring the length and strand
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects aged between 18 to 65 years.
- •Patients having Khalitya (Baldness) and Palitya (premature Greying) as per Ayurvedic classical texts and as per modern parameters i.e., Hair fall, Dandruff and Dryness of hairs have been selected irrespective of any bar of caste, gender, religion and occupation.
排除标准
- •Signs of allergy, irritation or intolerance to the components of the test product Patients who have been diagnosed to have local disease like Alopecia areata, Alopecia totalis, Tinea capitis, Folliculitis devaculans.
- •Patient with hair fall related to any Systemic disorders, any Hormonal disorders, Post CA treatments and Vitiligo.
- •Pregnancy or lactation.
- •Participation in other clinical trials.
- •Unwilling/unable to sign the informed consent.
结局指标
主要结局
• Reduced hairfall as per the 60 seconds hairfall on Day 28 when compared with the baseline value
时间窗: day 28
• Improvement in the Greying Severity score in comparison with the baseline
时间窗: day 28
次要结局
- • Increase in hair length to establish the ability of the oil to Nourish the hair.(• Number of subjects experiencing eye or skin irritation or any adverse events in the treatment phase.)
研究者
研究点 (1)
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