Role of Nanoemulsified Sesame Oil in Post-operative Care After Endoscopic Sinus Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sinonasal Outcome Test 22 (SNOT-22)
研究概览
简要总结
The goal of our thesis is to design, develop and characterize a novel thermodynamically stable NE by spontaneous method intended for topical use. Subsequently, appraisal of nanoemulsified sesame oil formulation has been performed on the post-operative symptoms in CRS patients who have undergone ESS (endoscopic sinus surgery) combined with different types of nasal irrigation which may affect formulation efficacy.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age between 18 and 60 years old.
- •chronic rhinosinusitis patients who have undergone endoscopic sinus surgery.
排除标准
- •Patients with history of allergy for sesame seed derivatives.
- •Patients with chronic diseases which affecting the process of healing (uncontrolled DM, renal failure and hepatic failure).
- •Patients with nasal granulomas.
- •Patients with invasive fungal rhinosinusitis.
- •Patients with history of radio and/or chemotherapy exposure.
- •Patients with systemic diseases affecting integrity of nasal mucosa (e.g. CF, scleroderma, Sjogren syndrome …).
研究组 & 干预措施
Ringer's lactate solution as nasal irrigation followed by sesame oil nasal drops
干预措施: application of different topical nasal solutions (Other)
only normal saline as nasal irrigation
干预措施: application of different topical nasal solutions (Other)
normal saline as nasal irrigation followed by sesame oil nasal drops
干预措施: application of different topical nasal solutions (Other)
only Ringer's lactate solution as nasal irrigation
干预措施: application of different topical nasal solutions (Other)
结局指标
主要结局
Sinonasal Outcome Test 22 (SNOT-22)
时间窗: weekly for three months
Lund-Kennedy endoscopic grading system
时间窗: once monthly for three months
次要结局
未报告次要终点
研究者
Noha A.Elkholy
Lecturer
Mansoura University