跳至主要内容
临床试验/CTRI/2024/01/061622
CTRI/2024/01/061622尚未招募1/2 期

A randomised comparative clinical study to evaluate the efficacy of external application of Tulsi swarasadi Taila and Durvadya Taila in the management of Atopic Dermatitis in Children.( 1 to 12 years)

PDEAS College Of Ayurved and Research Centre nigdi pune1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月5日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To study the efficacy of external application of Tulsi swarasadi Taila in the management of atopic dermatitis for 15 days in childern (1 to 12 years)for itching.

研究概览

简要总结

Human skin is outer protective and largest organ of the body.It constitute first line of defence mechanism.Atopic dermatitis is an acute ,sub-acute,but usually chronic pruritic inflammation of epidermis and dermis .It often has association with personal or family history of asthma and allergic rhinitis.Atopic dermatitis is an increasing concern in infant and young childern as their skin is more sensitive and susceptible to dryness and infection than in adults.Xerosis is hallmark of atopic dermatitis along with itching,exudation,erythema,crusting and scalling of skin.This disease is influencced by defective skin barrier ,immune dysregulation and exaggerated T-cell response to environmental factors and microbes that lead to chronic skin inflammation.The prevalance of atopic dermatitis is estimated to be 15-20% in children and the incidence is increased by 2-3 folds.Considering the sign and symptom of atopic dermatitis, in ayurveda vata-pitta dosha seems to be associated .To normaised the dosha as well as to improve the quality of skin ,Tulsi Swarasadi Taila has been chosen for the study.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
1.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • 1.Patient having symptoms of atopic dermatitis-Dry skin(Rukshata of twak),Itching(Kandu),Erythema(Raktavarnata of twak) and Eruption(Pidaka)-two or more of these symptoms should be present 2.Children between the age group of 1 to 12 years,irrespective of sex.

排除标准

  • 1.Weeping eczemas,infected lesion will be excluded from the study.
  • 2.Lichenified skin changes.
  • 3.Childern having any other associated illness like diarrhea,acute respiratory infections and acute febrile illness or other disorders will be excluded from the study.
  • 4.Lesions greater than 9% body surface area.

结局指标

主要结局

To study the efficacy of external application of Tulsi swarasadi Taila in the management of atopic dermatitis for 15 days in childern (1 to 12 years)for itching.

时间窗: 15 days where follow up on 7th day,15th day.

次要结局

  • To observe adverse effects if any in 15 days(15 days where follow up on 7th day,15th day.)

研究者

发起方
PDEAS College Of Ayurved and Research Centre nigdi pune
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Aishwarya Dattatraya Kodre

PDEAS College of Ayurved and Research Centre,Nigdi,Pune

研究点 (1)

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