跳至主要内容
临床试验/CTRI/2021/03/031869
CTRI/2021/03/031869已完成2/3 期

Evaluatation of the efficacy of kailas jeevan in the managemnt of diaper dermatitis in children -an open clinical study

Kailas Jeevan manufacturers1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年3月15日最近更新:

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
At the end of the treatment period the subjects will have improvement in signs and symptoms of Diaper dermatitis

研究概览

简要总结

Diaper dermatitis (DD) is one of the most common skin conditions that infants suffer from and their caregivers manage in the first months post-birth.

Diaper dermatitis can be seen mentioned in Ayurveda as Ahipootana is caused by frequent stagnated urine, faeces and sweat around the anal region for longer duration, resulting into spota with kandu around the anal region. Similar condition can be seen in diarrhoea with anal excoriation and even in diaper dermatitis. If it is ignored, lead to wide spread infection by bacteria or fungi necessitating vigorous and prolonged treatment.**[1,**2,3]

Ahiputan in Ayurveda is said to be darunand ghora.[1,2] Clinical condition like diarrhoea can increase the incidence rate of NAPKIN RASH in babies.[2] The prevalence of diaper dermatitis has been reported from 4-35% in the 1st two years of life and in India it is 13%.**[**4]

 The infants skin cannot withstand the toxicity of most substances like urine and faeces as they make skin delicate**[5] and skin is a potential portal of entry for invasive infective organisms in neonates and infants. Skin break down is very common during infancy period which will enhance the condition like anal excoriation and diaper dermatitis.[**6,7]

 The usage of Kailas Jeevan which is a protective liniment used in variety of skin conditions especially those that have burning sensation exfoliation, cracked skin etc is time proven as the medicament is in market since last 60 years**[8]** But there are no known clinical research works as on date and also there is a need for an effective medication in Napkin rash. So there is need to study on Diaper dermatitis with Kailas Jeevan. .

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
0.00 Day(s) 至 36.00 Month(s)(—)
性别
All

入选标准

  • Neonates, Infants and Toddlers from birth to 3 years suffering from signs and symptoms of Diaper Dermatitis.

排除标准

  • Children under the medication for systemic and topical diseases.
  • Children with with severe infective Diaper Dermatitis needing emergency medications Children with acute or chronic illnesses that necessitates exclusion will be excluded.

结局指标

主要结局

At the end of the treatment period the subjects will have improvement in signs and symptoms of Diaper dermatitis

时间窗: 18 months

次要结局

  • There will be no intended secondary outcome(18 months)

研究者

发起方
Kailas Jeevan manufacturers
申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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