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