NCT07308015

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
1mo left

Started Jun 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Jun 2025Jun 2026

Study Start

First participant enrolled

June 16, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2026

Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

December 15, 2025

Last Update Submit

December 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale (VAS)

    Two weeks after the treatment

Secondary Outcomes (1)

  • Nasal endoscopy examination score

    Two weeks after the treatment

Study Arms (2)

Control group

ACTIVE COMPARATOR

Physiological seawater adjustable nasal irrigator

Drug: Physiological seawater adjustable nasal irrigator

Experimental group

EXPERIMENTAL

Sodium hyaluronate adjustable nasal irrigator

Drug: Sodium hyaluronate adjustable nasal irrigator

Interventions

Nasal spray of Physiological seawater.

Control group

Nasal spray of Sodium hyaluronate

Experimental group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China-Japan Union Hospital of Jilin University

Changchun, Jilin, 130000, China

RECRUITING

Central Study Contacts

Cuida Meng, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
China-Japan Union Hospital

Study Record Dates

First Submitted

December 15, 2025

First Posted

December 29, 2025

Study Start

June 16, 2025

Primary Completion (Estimated)

June 12, 2026

Study Completion (Estimated)

June 12, 2026

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations