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临床试验/CTRI/2020/11/028927
CTRI/2020/11/028927尚未招募不适用

A prospective observational study to assess clinical,histopathological and bacteriological findings in treated cases of leprosy with persistent skin lesions after completing 6 months of paucibacillary and 12 months of multibacillary Multidrug therapy

未提供1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年11月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
To observe the clinical,Slit skin smear findings, Histopathological findings in treated cases of

研究概览

简要总结

A Prospective observational study to assess the  clinical,histopathological and bacteriological findings in treated cases of leprosy with persistent skin lesions after completion of 6 months of paucibacillary and 12 months of multibacillary multidrug therapy , that will be conducted in PGIMER,Chandigarh. For clinical findings , we will do clinical examination to assess morphology of skin lesion,the spectrum of leprosy. For histopathological findings ,skin biopsy will be done. For bacteriological findings , SSS will be  done from the persistent skin lesion. We will assess the frequency of drug resistance in these patients.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients of either gender with age>18 years.
  • 2.Leprosy patients with persistent skin lesions ,those who didn’t show desired response in terms of no change in skin lesions or still showing signs of disease activity in terms of infiltrated lesions or occurrence of new lesions, after completing 6 months of paucibacillary and 12 months of multibacillary MDT.
  • 3.Patients who can give valid consent.

排除标准

  • 1.Patients with lepra reaction.
  • 2.Those who are not willing to provide consent for the study.

结局指标

主要结局

To observe the clinical,Slit skin smear findings, Histopathological findings in treated cases of

时间窗: Baseline

leprosy with persistent skin lesions after completion of 6 months of paucibacillary and 12 months of multibacillary WHO Multidrug therapy.

时间窗: Baseline

次要结局

  • To assess the frequency of drug resistance in these patients(Baseline)

研究者

发起方
未提供

研究点 (1)

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