跳至主要内容
临床试验/CTRI/2023/05/053069
CTRI/2023/05/053069已完成不适用

SAFETY AND EFFICACY OF AUTOINOCULATION THERAPY IN CHRONIC RECALCITRANT DERMATOPHYTOSIS: A RANDOMIZED CONTROLLED TRAIL

SRMS IMS MEDICAL COLLEGE1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2023年5月6日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
AUTOINOCULATION FROM KOH POSITIVE SITE WILL BE PERFORMED

研究概览

简要总结

  • Dermatophytosis is prevalent in about20%–25% of total world population.
  • Dermatophytes includes group ofsuperficial filamentous fungi which infect the skin, nails and hair.
  • There is a rising trend ofpatients experiencing extensive, recalcitrant and relapse of dermatophytosis.
  • Antifungal agents usedconventionally are losing their relevance in the current clinical scenario.
  • Homologous   autoinoculation will be  done  after  an interval of 21 days
  • .

The 4mm tissue from koh positive site will be harvested and after breaking into small chunks, gently introduced deep into thesubcutis using 16-gaugeneedle.

  • Homogolus autoinoculation offers safe and effective treatment modality for tackling dermatophytic epidemic.

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients giving written informed consent.
  • Patients allowing to take photographs.
  • All patients of dermatophytosis showing positive result on KOH mount Patients of chronic recalcitrant1 dermatophytosis.

排除标准

  • Patients refusing to participate in the study.
  • Patients not willing to give written informed consent/click photographs.
  • Pregnant/lactating females.
  • Patients with concomitant chronic systemic disease like Hypertension, Diabetes mellitus or on immunosuppressant drugs.
  • Patients showing hypersensitivity to lignocaine.

结局指标

主要结局

AUTOINOCULATION FROM KOH POSITIVE SITE WILL BE PERFORMED

时间窗: BASELINE , 3 WEEKS , 6 WEEKS , 9 WEEKS

次要结局

  • PATIENT SATISFACTION GRADE WILL BE TAKEN INTO ACCOUNT ON EACH VISIT.(BASELINE , 3 WEEKS , 6 WEEKS , 9 WEEKS)

研究者

发起方
SRMS IMS MEDICAL COLLEGE
申办方类型
Private medical college

研究点 (1)

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