Sodium hyaluronate adjustable nasal irrigator for dry nose (rhinitis sicca)
Clinical Study on the Treatment of Rhinitis Sicca With Sodium Hyaluronate Adjustable Nasal Irrigator
This trial will test whether a sodium hyaluronate adjustable nasal irrigator helps people with rhinitis sicca more than a commonly used physiological seawater nasal spray.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | China-Japan Union Hospital Academic / other |
| Locations | 1 site (Changchun, Jilin) |
| Trial ID | NCT07308015 on ClinicalTrials.gov |
What this trial studies
This phase 4 interventional study compares a sodium hyaluronate adjustable nasal irrigator to a physiological seawater adjustable nasal irrigator in people with rhinitis sicca. Participants who meet clinical and endoscopic criteria for rhinitis sicca will be treated with one of the two nasal irrigation devices. The study will track symptom changes, endoscopic findings, and other clinical measures to compare therapeutic effects across different presentations of rhinitis sicca. Results aim to clarify whether sodium hyaluronate offers advantages over standard seawater irrigation in routine practice.
Who should consider this trial
Good fit: Adults with symptoms and endoscopic signs of rhinitis sicca who have not used treatments for dry rhinitis or other medications in the past 30 days and who are not pregnant or lactating are the intended participants.
Not a fit: People whose nasal dryness is caused by other identified lesions, those with chronic lower respiratory tract inflammation, or those allergic to the product are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the sodium hyaluronate irrigator could reduce nasal dryness, crusting, and related symptoms and improve nasal mucosal healing and comfort.
How similar studies have performed: Previous studies and clinical use of saline and sodium hyaluronate nasal irrigations have shown symptom improvement for nasal dryness, though direct head-to-head data using adjustable irrigators are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: 1. Those with dry rhinitis and chronic inflammation of the lower respiratory tract. 2. Those confirmed by examination to be caused by certain latent lesions in the mouth, nose, throat, esophagu.s, neck or the whole body 3. Those who have used drugs for treating dry rhinitis or other medications within the past 30 days. 4. Pregnant or lactating women. 5. Those who are allergic to this medicine. 6. Those with severe cardiovascular, liver, kidney and hematopoietic system diseases, etc. 7. Mentally ill patients.
Where this trial is running
Changchun, Jilin
- China-Japan Union Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
Study contacts
- Study coordinator: Cuida Meng, Doctor
- Email: mengcd@jlu.edu.cn
- Phone: 86+13596096000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.