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临床试验/CTRI/2018/08/015311
CTRI/2018/08/015311尚未招募1 期

A Clinical Study To Evaluate The Efficacy Of Exfoliating Herbomineral bath powder in improving skin health, freshness and rejuvenation

KVM Research Laboratories1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年8月17日最近更新:

试验速览

阶段
1 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Assessment of patient response to topical application of IP in terms of skin health, freshness and rejuvenation

研究概览

简要总结

This study is to understand the efficacy of Herbomineral - a combination of different herbs and soils when used as a bath powder during a daily bath routine. This study involves 30 patients and the duration is 30 days. Each patient will be instructed to use the herbomineral bath powder instead of soap and the effect of topical application of Herbomineral will be studied and assessed.15 g of Herbomineral bath powder  is to be made into a paste with water. Thisquantity of Herbomineral is determined to be sufficient for a full body bath and the paste is to be applied externally and washed off with water after 15 minutes.  

This study will be conducted in compliancewith the protocol approved by the IEC. No deviation from the protocol will beimplemented without the prior review and approval of the IEC except where itmay be necessary to eliminate an immediate hazard to a research subject. In suchcase, the deviation will be reported to the IEC as soon as possible.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Any male or female adults between 18-60 years 2.Subject who is willing and is able to comply with all trial requirements.
  • 3.Subjects with all skin types 4.Subjects who have sensitive and acne prone skin.
  • 5.Subjects who have hyper pigmentation problems with skin irritation.

排除标准

  • 1.Subjects with chronic disorders 2.Population containing children and geriatric individuals 3.Pregnant women and nursing mothers 4.Subjects who have the habit of smoking and drinking alcohol 5.Subjects who are undergoing other cosmetic treatment.

结局指标

主要结局

Assessment of patient response to topical application of IP in terms of skin health, freshness and rejuvenation

时间窗: Day 0, Day 15 and Day 30

次要结局

  • Assessment of Exfoliating Effect of bath powder(Day 0, Day 15 and Day 30)

研究者

申办方类型
Research institution

研究点 (1)

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