"Insulin Fast Dissolving Film for Intranasal Delivery Via Olfactory Region, a Promising Approach for the Treatment of Anosmia in COVID 19 Patients: Design, In-vitro Characterization and Clinical Evaluation."
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Soad Ali
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Smell sensation improvement
研究概览
简要总结
The study aimed to investigate the efficacy of insulin in a new dosage form ( fast dissolving film) in treatment of anosmia in patients post infested with Covid-19. The study implication based in two methods evaluations
- Threshold test
- identification test.
详细描述
This study was designed to improve smell disorders after corona infection that is very anxious for all patients.
Inclusion criteria were loss of smell, post covid-19 infection, age from 18 to 70 years and accept sharing and follow up.
The application of dosage form by ENT specialist at otorhinolaryngology clinic at Minia University hospital. Dose was 100iu of insulin 3 times weekly for 4 weeks. The new dosage form with insulin was compared with a placebo to ensure statistical improvement.
The tests were performed in each visit. Primary outcome was the improvement of smell sensors in those patients
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •anosmia post covid-19 infection
排除标准
- •nasal polyps or fractions or syrgery in nose from 6 months or less
结局指标
主要结局
Smell sensation improvement
时间窗: 4 weeks
By decrease the threshold sensation with butanol test
次要结局
未报告次要终点