跳至主要内容
临床试验/NCT06437717
NCT06437717已完成不适用

Role of Nanoemulsified Sesame Oil in Post-operative Care After Endoscopic Sinus Surgery

Mansoura University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
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

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 …).

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noha A.Elkholy

Lecturer

Mansoura University

研究点 (2)

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