Rhinitis SiccaPhase 4NCT07308015
Clinical Study on the Treatment of Rhinitis Sicca With Sodium Hyaluronate Adjustable Nasal Irrigator
A Phase 4 study testing Physiological seawater adjustable nasal irrigator and Sodium hyaluronate adjustable nasal irrigator in people with Rhinitis Sicca, run by China-Japan Union Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rhinitis Sicca
- What is being tested?
- Physiological seawater adjustable nasal irrigator and Sodium hyaluronate adjustable nasal irrigator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2025to 12 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130000
Liwei Sun, Doctor, 86+18243189793, sunliwei@jlu.edu.cn
About this study
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.
- Conditions
- Rhinitis Sicca
- Being tested
- Physiological seawater adjustable nasal irrigator, Sodium hyaluronate adjustable nasal irrigator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological seawater adjustable nasal irrigatorDrug
Nasal spray of Physiological seawater.
Sodium hyaluronate adjustable nasal irrigatorDrug
Nasal spray of Sodium hyaluronate
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Physiological seawater adjustable nasal irrigator Receives: Drug: Physiological seawater adjustable nasal irrigator |
| Experimental group | Experimental | Sodium hyaluronate adjustable nasal irrigator Receives: Drug: Sodium hyaluronate adjustable nasal irrigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
Measured: Two weeks after the treatment
Secondary outcomes (1)
Nasal endoscopy examination score
Measured: Two weeks after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start16 Jun 2025
- Primary completion12 Jun 2026 (estimated)
- Study completion12 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis SiccaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongdong Zhu, China-Japan Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308015
- Sponsor's protocol ID
- 2025052906
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Treatment of Rhinitis Sicca With Sodium Hyaluronate Adjustable Nasal Irrigator
- ClinicalTrials.gov ID
- NCT07308015
- Acronym / sponsor ID
- 2025052906
- Conditions
- Rhinitis Sicca
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China-Japan Union HospitalUniversity, hospital or other
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 12 Jun 2026 (estimated)
- Study completion
- 12 Jun 2026 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Physiological seawater adjustable nasal irrigatorPhysiological seawater adjustable nasal irrigator |
| Experimental group | Experimental | Drug: Sodium hyaluronate adjustable nasal irrigatorSodium hyaluronate adjustable nasal irrigator |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiological seawater adjustable nasal irrigatorNasal spray of Physiological seawater. | Drug | Control group |
| Sodium hyaluronate adjustable nasal irrigatorNasal spray of Sodium hyaluronate | Drug | Experimental group |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: Two weeks after the treatment
1 secondary outcome
Nasal endoscopy examination score
Time frame: Two weeks after the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Physiological seawater adjustable nasal irrigator and Sodium hyaluronate adjustable nasal irrigator in people with Rhinitis Sicca, run by China-Japan Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cuida Meng, Doctor (86+13596096000, mengcd@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: Two weeks after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.