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临床试验/CTRI/2024/06/068849
CTRI/2024/06/068849尚未招募不适用

A study of clinical and dermoscopic findings in patients of mucocutaneous adverse drug reactions attending tertiary care center Bhavnagar - Cross sectional observational study

Dr Ram jignashaben meramanbhai1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月22日最近更新:

试验速览

阶段
不适用
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 clinical and dermoscopic findings in patients of mucocutaneous adverse drug reactions

研究概览

简要总结

1)  Prior permission of ethical committee of GMC Bhavnagar will be taken.

 2) Patient who comes to dermatology OPD and whose clinical diagnosis of mucocutaneous

adverse drug reaction will be made ( those who fulfilled the category of probable or possible

drug reaction as per Naranjo’s causality assessment scale

       3)The patient will be assessed as per inclusion and exclusion criteria and will be included

after the consent is given by patient

 4)The patient will be examined with full exposure of body in examination room and relevant

history taken

5) On the basis of history given by the patient newest single largest lesion will be Identified

and dermoscopy will be performed with DERMLITE DL5 dermoscope and the necessary

investigation(CBC,RFT,LFT,ELECTROLYTE,RBS) will be carried out .Data will be entered

in excel file. analysis will be done by using appropriate statistical software

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

  • Patients of age 18-80 years presenting with mucocutaneous lesions following intake of any drugs those who fulfilled the category of probable or possible drug reaction as per Naranjo’s causality assessment scale .

排除标准

  • Patients who are unwilling to give consent will be excluded from the study.
  • Patients below 18 years of age Patients with hair and nail changes of mucocutaneous adverse drug reactions.

结局指标

主要结局

To study clinical and dermoscopic findings in patients of mucocutaneous adverse drug reactions

时间窗: At the end of 12 months

次要结局

  • 1)TO OBSERVE NEW DERMOSCOPIC FINDINGS IF ANY(2)To evaluate offending drug in particular drug reaction.)

研究者

发起方
Dr Ram jignashaben meramanbhai
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Ram jignashaben meramanbhai

Government medical college Bhavnagar

研究点 (1)

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