Clinical Study on the Treatment of Rhinitis Sicca With Sodium Hyaluronate Adjustable Nasal Irrigator

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.

Study Overview

• Status: Recruiting
• Conditions: Rhinitis Sicca
• Intervention / Treatment: Drug: Physiological seawater adjustable nasal irrigator; Drug: Sodium hyaluronate adjustable nasal irrigator

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Cuida Meng, Doctor; Phone Number: 86+13596096000; Email: mengcd@jlu.edu.cn

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Recruiting
      • China-Japan Union Hospital of Jilin University
      • Contact: Liwei Sun, Doctor; Phone Number: 86+18243189793; Email: sunliwei@jlu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Physiological seawater adjustable nasal irrigator	Drug: Physiological seawater adjustable nasal irrigator; Nasal spray of Physiological seawater.
Experimental: Experimental group; Sodium hyaluronate adjustable nasal irrigator	Drug: Sodium hyaluronate adjustable nasal irrigator; Nasal spray of Sodium hyaluronate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual Analogue Scale (VAS)	Two weeks after the treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Nasal endoscopy examination score	Two weeks after the treatment

Collaborators and Investigators

• Sponsor: China-Japan Union Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2025
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): June 12, 2026

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2025052906

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No