NCT05328414已完成1 期
Steroid Loaded Intranasal Films as a Local Treatment of Anosmia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Smell restoring
研究概览
简要总结
This study is a growing step of phase I study published on March 2021. The study was implicated on Minia university on small scale of patient (20) to investigate the impact of insulin as fast dissolving films for intranasal delivery to treat anosmia in post COVID-19 infections. this record will modify the first formulation by addition certain concentration of steroid.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients' adults aged from 18 years to 50 will included in the study.
- •A confirmed case (positive PCR), recovered/discharged (2 negative PCR),
- •suffering from sudden recent anosmia or hyposmia with or without loss of taste.
排除标准
- •Patients with chronic sinusitis.
- •Patients with acute allergic rhinitis.
- •Patients' nasal polyposis
- •Patients with history of nasal surgery, severe head trauma or any medical condition that may affect sense of smell.
- •Patient poly morbidities or poly pharmacy.
- •Elder, pregnant, or nursing woman.
- •Patients with chronic diseases.
- •Autoimmune diseases.
- •Patient suffering end organ problems.
研究组 & 干预措施
Placebo group
Placebo Comparator
干预措施: Prednisolone (Drug)
steroid based intranasal film
Experimental
干预措施: Prednisolone (Drug)
结局指标
主要结局
Smell restoring
时间窗: three week
Sniffs test; to recogonize the first concentration he could identify
次要结局
- inflammation(three weeks)
研究者
Soad Ali
Clinical professor
Deraya University
研究点 (1)
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