NCT07308015招募中4 期
Clinical Study on the Treatment of Rhinitis Sicca With Sodium Hyaluronate Adjustable Nasal Irrigator
China-Japan Union Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年6月16日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
To observe the therapeutic effect of sodium hyaluronate adjustable nasal irrigator on various types of rhinitis sicca and compare it with the therapeutic effect of the commonly used physiological seawater nasal spray in clinical practice.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms: Dry nose sensation, little and thick nasal discharge, nosebleeds, itchy nasal cavity, and dryness in the nasopharynx. Physical signs: Nasal endoscopy often reveals dry and congested nasal mucosa, which appears grayish-white or dark red, losing its normal luster. There are often dry, thick secretions, scabs or blood scabs on it. The surface of the nasal mucosa is eroded and ulcers occur. The mucosal lesions are most obvious in the anterior part of the nasal cavity. A diagnosis can be made if one or more of the above symptoms and signs are present.
排除标准
- •Those with dry rhinitis and chronic inflammation of the lower respiratory tract.
- •Those confirmed by examination to be caused by certain latent lesions in the mouth, nose, throat, esophagu.s, neck or the whole body
- •Those who have used drugs for treating dry rhinitis or other medications within the past 30 days.
- •Pregnant or lactating women.
- •Those who are allergic to this medicine.
- •Those with severe cardiovascular, liver, kidney and hematopoietic system diseases, etc.
- •Mentally ill patients.
研究组 & 干预措施
Control group
Active Comparator
Physiological seawater adjustable nasal irrigator
干预措施: Physiological seawater adjustable nasal irrigator (Drug)
Experimental group
Experimental
Sodium hyaluronate adjustable nasal irrigator
干预措施: Sodium hyaluronate adjustable nasal irrigator (Drug)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: Two weeks after the treatment
次要结局
- Nasal endoscopy examination score(Two weeks after the treatment)
研究者
Dongdong Zhu
China-Japan Union Hospital
China-Japan Union Hospital
研究点 (1)
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