跳至主要内容
临床试验/CTRI/2022/02/040478
CTRI/2022/02/040478尚未招募不适用

Effect of NasoBiome on Nasal microbiome profile of patients suffering from Atrophic Rhinitis- A Randomized control trial.

Department of Science and Technology Government of Odisha1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To assess the improvement in clinical features following intervention using endoscopy score.

研究概览

简要总结

Atrophic rhinitis is a chronic, gradually progressing degenerative condition of the nasal cavity characterized by a foul odor (ozena), nasal obstruction, dryness, and crusting. The etiology of primary atrophic rhinitis is mostly unknown. Progressive metaplasia and atrophy of all mucosal components (epithelium, vessels, and glands) takes place because of increased osteoclastic activity, resulting in a volumetric decrease of sinonasal structures. The turbinate show shrinkage and the inferior turbinate is affected the most. Endoscopic inspection reveals a large, wide nasal cavity with dried mucosa. Classically, the management of patients with primary atrophic rhinitis is aimed at alleviating symptoms using nasal irrigation douche or ointment application. In 1971, Young et al proposed closure of the nostril (Young’s operation), and Saunders et al suggested endonasal microplasty (intranasal implant insertion) for the surgical management of primary atrophic rhinitis. However, Young’s operation has its demerit on the possibility of decreased patient’s quality of life.

This study hypothesises that NasoBiome spray will be able to modulate the nasal microbiome of profile of patients with Atrophic Rhinitis thereby curing the disease condition.

This is a RCT where the cases will be treated with the NasoBiome solution nasal spray and the controls will be treated with Normal saline nasal spray for a duration of 3 months after which they will be checked on several parameters like the clinical improvement, histopathological improvement, radiological improvement and microbiome profile change.

研究设计

研究类型
Interventional
分配方式
Stratified randomization
盲法
Participant and Investigator Blinded

入排标准

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

入选标准

  • •Adults (more than 18 years); Atrophic Rhinitis based on clinical examination2.

排除标准

  • •Pregnancy, comorbidities that preclude travel for follow up, declining to be included in the study, a SNOT22 score of less than 10.

结局指标

主要结局

To assess the improvement in clinical features following intervention using endoscopy score.

时间窗: 3 years

To assess the change in nasal microbiome following intervention

时间窗: 3 years

次要结局

  • To assess the improvement in clinical features following intervention using endoscopy score.(To assess the change in nasal microbiome following intervention)

研究者

发起方
Department of Science and Technology Government of Odisha
申办方类型
Government funding agency

研究点 (1)

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