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临床试验/CTRI/2024/01/061229
CTRI/2024/01/061229尚未招募不适用

Comparison of middle ear changes between patients with and without allergic rhinitis.

Kasturba Medical College1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年1月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
Prevalence of middle ear pathology in patients with allergic rhinitis

研究概览

简要总结

Allergic rhinitis (AR) is a common condition affecting 20-30% of the population. This condition affects not only the nose but also the sinuses and ears in many ways. Many studies are there worldwide implicating AR as a cause of serous otitis media. But only few studies have actually studied the tympanic membrane (TM) changes observed in patients with allergic rhinitis. The aim of this study is to document the TM and middle ear changes observed in patients with AR and without AR

After obtaining the regulatory approvals including CTRI registration, the outpatients seen or inpatients admitted under the Department of ENT, Kasturba Hospital, Manipal will be screened for possible inclusion into the study. This is a prospective and comparative study with 90 subjects recruited (45 cases and 45 controls) then a work-up will be carried out through a questionnaire(SFAR) from which the subjects who have a score of more than 7 will be considered as cases and those with a score of less than 7 will be considered controls. Once patients and healthy controls give their written consent to participate in the study a detailed history and clinical examination of the patients will be done along with a complete audiological work up including tympanometry studies will be performed, the results will be compiled and analyzed.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients of 18 to 90 years with clinical diagnosis of allergic rhinitis on the basis of signs and symptoms using the SFAR score patients of 18 to 90 years without allergic rhinitis on the basis of signs and symptoms using the SFAR score.

排除标准

  • Patients with middle ear pathology Patients with prior history of ear surgery Patients with tympanic membrane perforation Patients with discharging ear Patients not willing to give consent to be part of the study.

结局指标

主要结局

Prevalence of middle ear pathology in patients with allergic rhinitis

时间窗: 1 - 2 Days

次要结局

  • To compare the middle ear status between patients with allergic rhinitis and without allergic rhinitis(1-4 Days)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Manimaran Marimuthu

Kasturba Medial College, Manipal University

研究点 (1)

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