Topical Application Versus Intra Turbinate Injection of Botulium Toxin Type A In The Treatment of Non Infectious Chronic Rhinosinusitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- the rhinitis symptom severity
研究概览
简要总结
The present work aims to assess the effectiveness and safety of topical application of BTX - A compared with its intra turbinate injection in controlling the symptoms in non infectious chronic rhinosinusitis patients
详细描述
A prospective comparative study will be carried out on 30 participant of both sex at Otorhinolaryngology Department, Benha University Hospital, it will include patients suffering from non infectious chronic rhinosinustitis symptoms in the form of nasal blockage, rhinorrhea, itching and/or sneezing.
The patients will be divided randomly into two groups:
- Group A (topical group) : 15 patients
- Group B (injected group) : 15 patients
All patients will be subjected to:
- Full clinical evaluation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with persistent symptoms of chronic non infectious rhinosinusitis not responding to previous lines of treatment including antihistaminics ,nasal decongestant, and or nasal steroid spray will be included in this study.
排除标准
- •Patients with major structural deformities(septal deviation , adenoid hypertrophy, nasal valve pathology or nasal polyps).
- •Having systemic illness such as DM, HTN, Malignancy or Tuberculosis.
- •History of nasal surgery such as turbinate reduction surgery orseptoplasty.
- •Acute rhinosinusitis findings; e.g purulent or mucopurulent nasal discharge
- •Radiological finding of nasal tumors or fungal sinusitis.
- •Any accompanying disease such as glaucoma or prostate hypertrophy or myasthenia that might be aggravated by anticholinergic therapy .
- •use of systemic or local corticosteroid less than 1 month prior the study.
- •Pregnancy or lactation.
- •History of allergy to botox or local anesthetic agents.
研究组 & 干预措施
Topical group
Topical application in the form of merocel soaked with 20 units of BTX_A (2ml) will be placed at each side of the nasal cavity for 30 minutes.
干预措施: BTX A Topical (Drug)
Injection group
20 units of BTX_A (2ml) will be injected submucosally in each inferior turbinate using insulin syringe needle after local anesthesia using 10% xylocaine spray .
干预措施: BTX A Injection (Drug)
结局指标
主要结局
the rhinitis symptom severity
时间窗: 2 months
the rhinitis symptom severity questionnaire, this is questionnaire consists of 4 items (nasal obstruction, rhinorrhea , sneezing and or nasal itching) . each symptom given score from 0 to 3 ( 0 = none, 1 = mild, 2 = moderate and 3 = severe)
次要结局
- possible adverse effects(2 months)
研究者
Abdelrahman Ahmed Abdelalim
MD Lecturer
Benha University