跳至主要内容
临床试验/CTRI/2022/07/044171
CTRI/2022/07/044171招募中不适用

Efficacy of probiotics combined with standard topical therapy compared to standard topical therapy in atopic dermatitis : a randomised study

RESEARCH CELL ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年7月30日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
64
试验地点
1
主要终点
1. Change in SCORAD

研究概览

简要总结

This study will be conducted in atopicdermatitis patients, attending Dermatology, Venereology and Leprology OPD atAIIMS JODHPUR through telemedicine or Physical OPD consultation.

Diagnosisbased on U.K. working party diagnostic criteria and patients fulfilling theselection criteria, will be recruited in the study after informed writtenconsent.  Detailed history and clinicalexamination of the selected patients will be done.Random allocation and allocation concealment will be done using Lottery method.Single blinding will be done and randomization sequence will be transferredin an opaque sealed envelope

For both thegroup SCORAD scoring will be done, Level of IL-31 will be measured to be takenas baseline value.

Group A will be treated with topicalcorticosteroid and emollient twice daily as per standard treatment protocol.

Topicalcorticosteroid will be given for maximum of 4 weeks in both the groups.

In Group A Probiotic rhamosus GG will becontinued for 8 more weeks. Total 12 weeks Probiotics Lactobacillus rhamnosusGG will be given in Group A.

 Group B willbe given topical corticosteroid (acc. to standard topical treatment protocol)-

1.Mild: SCORAD<25 / or transient eczema -topical mid potency steroid + emollientapplication twice daily

2.    Moderate: SCORAD25-50 / or recurrent eczema-topical mid potency steroid + emollientapplication twice daily

Follow up:Every 2 weeks for the first month and then monthly follow up will be done fortreatment response, number of episodes of flare up,  need for topical corticosteroid therapy forflare up and side effects related to therapy.

SCORADcalculation will be done at 0 and 12 weeks.

Level of IL-31will be done at 0 and 12 weeks.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

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

入选标准

  • Clinically diagnosed cases of atopic dermatitis (U.K. Working Party diagnostic criteria) Patient with SCORAD of <50 Patients whose parents or legal representative signed the written informed consent Treatment wash off period of atleast 2 months for systemic corticosteroids and immunosuppressants.

排除标准

  • Patient with chronic underlying disease (uncontrolled diabetes mellitus, uncontrolled hypertension, active tuberculosis) or is on immunosuppressive therapy.
  • Children with severe hepatic, renal or other systemic disease.

结局指标

主要结局

1. Change in SCORAD

时间窗: 1. Change in SCORAD at 0 and 12 week

次要结局

  • 1. IL-31 level value change(2. Number of replapses)

研究者

发起方
RESEARCH CELL ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR
申办方类型
Research institution and hospital

研究点 (1)

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