Comparative study of the role of oral steroids with itraconazole antibiotics in allergic fungal rhinosinusitis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Compare efficacy of oral itraconazole and oral antibiotics versus oral steroids in Allergic Fungal
研究概览
简要总结
A single centre prospective Randomised Clinical Trial for 18 months with the intention to compare the efficacy of two drug regimens: Oral Steroids in tapering doses and oral antibiotics versus oral steroids in tapering doses with oral itraconazole in 100 cases of Allergic Fungal Rhinosinusitis diagnosed on the basis of NCCT scan Nose Paranasal sinuses findings is planned. The patients with contraindications for steroid use, history of previous surgery, Samter’s triad, hepatic disease, drugs metabolised extensively by CYP3A4 are excluded. The treatment outcomes will be assesed pre and post 15 day treatment by using tools like NCCT nose PNS (Lund and Mackey radiological scoring system), nasal endoscopy (Kupferberg Endoscopic Scoring and Lund Kennedy scoring system), serum Total IgE levels, Sinonasal Outcome Test -22 score and Visual analogue scale scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 99.99 Year(s)（—）
- 性别
- All
入选标准
- •Patients of allergic fungal rhinosinusitis diagnosed on the basis of NCCT scan Nose Paranasal sinuses findings.
排除标准
- •1.History of previous surgery
- •Contraindications of steroid use: a.
- •Diabetes mellitus b.
- •Peptic ulcer disease c.
- •Tuberculosis d.
- •Osteoporosis e.
- •Glaucoma f.
- •Congestive heart failure g.
- •Subcapsular cataract
- •Samter’s triad (bronchial asthma, nasal polyps, aspirin intolerance)
- •Hepatic disease
- •Drugs metabolised extensively by CYP3A4.
结局指标
主要结局
Compare efficacy of oral itraconazole and oral antibiotics versus oral steroids in Allergic Fungal
时间窗: 15 days per participant
Rhinosinusitis using:
时间窗: 15 days per participant
1. NCCT nose PNS (Lund and Mackey radiological scoring system)
时间窗: 15 days per participant
2. serum Total IgE levels
时间窗: 15 days per participant
次要结局
- Compare efficacy of oral itraconazole and oral antibiotics versus oral steroids in Allergic Fungal(Rhinosinusitis using:)
研究者
Tanisha Goel
Government Medical College and Hospital, Chandigarh