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A randomized controlled clinical trial of lavatory nasal lavage with hydrogen-enriched saline for the treatment of allergic rhinitis

A randomized controlled clinical trial of lavatory nasal lavage with hydrogen-enriched saline for the treatment of allergic rhinitis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029229
Enrollment
Unknown
Registered
2020-01-19
Start date
2020-04-01
Completion date
Unknown
Last updated
2020-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinitis

Interventions

Group A (hydrogen-rich brine group):nasal irrigation
Group B (saline group):nasal irrigation

Sponsors

Department of Otolaryngology, Tongji University Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) the subject shall be a Chinese citizen aged 18 to 65, regardless of gender. 2) subjects must be diagnosed with AR (allergic rhinitis) during screening and baseline follow-up Treatment guide, Chinese journal of otolaryngology, head and neck surgery, 2016,51 (01) : 6-24). Criteria for AR inclusion: at least 3 of the 4 symptoms of nasal itching, sneezing, runny nose and nasal congestion. And a score of 2 or more for at least two symptoms. 3) the subject is in good health and has no disturbance to the test schedule or operation or to the subject the safety of the resulting effects of clinically significant disease. 4) subject shall provide written informed consent, and subject shall be able to follow medication and follow-up schedule. 5) for fertile female subjects, urine HCG must be negative during screening.

Exclusion criteria

Exclusion criteria: 1) subjects with acute sinusitis and acute nasal infection. 2) any clinical abnormalities in vital signs or clinical ekg results at screening or baseline follow-up subjects with significant abnormalities. 3) cardiovascular, lung, kidney, liver, metabolic diseases, hematology or neuropathy of clinical significance Subjects with disease, or with compromised immune systems. 4) subjects with upper respiratory tract infection. 5) subjects with nasal septum deviation requiring corrective surgery. 6) subjects are members of the research team directly involved in this study. 7) complicated with nasal vestibular inflammation, nasal tumor and other nasal diseases. 8) family planning within three months. 9) have participated in a clinical drug trial within three months. 10) use drugs that may affect the test results and stop taking the drugs for less than the prescribed time.

Design outcomes

Primary

MeasureTime frame
Nasal and eye symptom scores;

Secondary

MeasureTime frame
Blood immune index;Nasal resistance;Nasal nitric oxide;Number of eosinophil cells in nasal secretions;Eosinophilic cationic protein of Nasal discharge;

Countries

China

Contacts

Public ContactYu Shaoqing

Department of Otolaryngology, Tongji University Affiliated Hospital

yu_shaoqing@163.com+86 13916455012

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026