A Single-center, Non-randomized, Open, Single-arm Confirmatory Clinical Study to Evaluate the Safety and Efficacy of Platelet Rich Plasma Injection for Patients With Atrophic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- The change of mucociliary clearance function using the saccharin test
研究概览
简要总结
The goal of the suggested research is to develop a treatment option using platelet rich plasma injection for regeneration of atropic nasal mucosa.
Specific aims of the suggested research is to (1) access the effect of platelet rich plasma in the patients with atropic rhinitis . Moreover, we will (2) compare the conservative treatments including saline nasal irrigation or saline nasal spray.
详细描述
Clinical trials of platelet rich plasma injection for regeneration of atropic nasal mucosa.
-
Injection interval and follow-up duration
-
Injection interval 2 weeks (upto total 3 consecutive injection)
-
Follow-up duration: 6 months
-
Observation items, clinical assessment items and evaluation method
-
Access the nasal mucosal status using nasal speculum.
-
Access the nasal mucociliary function using saccharin test (primary outcome; once per month).
-
Fill in the nasal symptom scores using Nasal Obstruction Symptom Evaluation(NOSE) Instrument, Sino-Nasal outcome Test 20, and Visual analog scale (secondary outcome; once per month)
-
The other atrophic rhinitis patients who did not want to perform platelet rich plasma injection
-
Random allocation to saline nasal irrigation or saline nasal spray group
-
Perform same observation items, clinical assessment items and evaluation method as well as platelet rich plasma injection group
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (>18 years)
- •Complaint of atrophic rhinitis symptoms including nasal crusting, nasal burning sensation, and postnasal drip
- •Atrophic rhinitis view on nasal endoscopic finding
- •Patients who informed sufficient about other atrophic rhinitis treatment options including Young's operation, lubricants, or saline irrigation, but, want more other active treatment option.
排除标准
- •Platelet related disorders
- •Low serum platelet (<100,000/㎕)
- •Other hematologic disorders
- •Septicemia
- •Take anticoagulant drugs
研究组 & 干预措施
platelet rich plasma injection group
To evaluate the safety and efficacy of plasma rich platelet injection on inferior turbinate mucosa in patients with atrophic rhinitis
干预措施: Plasma rich platelet injection (Device)
platelet rich plasma injection group
To evaluate the safety and efficacy of plasma rich platelet injection on inferior turbinate mucosa in patients with atrophic rhinitis
干预措施: Saline nasal spray (Device)
结局指标
主要结局
The change of mucociliary clearance function using the saccharin test
时间窗: 2, 4, 8, 12, and 24th week
The change in saccharin test time of the 2, 4, 8, 12, and 24th week after first treatment
次要结局
- The change of nasal symptoms using the Visual analog scale(2, 4, 8, 12, and 24th week)
- The change of nasal symptoms using the Sino-Nasal outcome Test 20(2, 4, 8, 12, and 24th week)
- The change of nasal symptoms using the Nasal Obstruction Symptom Evaluation(NOSE) Instrument(2, 4, 8, 12, and 24th week)
研究者
Sung Won Kim
Professor
Seoul St. Mary's Hospital