Skip to content

A randomized, double - blind, controlled study of the efficacy and safety of hydrogen rich saline irrigation in patients with rhinitis to improve the physiological function of nasal mucosa.

A randomized, double - blind, controlled study of the efficacy and safety of hydrogen rich saline irrigation in patients with rhinitis to improve the physiological function of nasal mucosa.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16009778
Enrollment
Unknown
Registered
2016-11-08
Start date
2016-12-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Rhinitis

Interventions

Allergic rhinitis treatment group:hydrogen rich saline
Allergic rhinitis in control group:Normal saline
Chronic nasosinusitis treatment group:hydrogen rich saline
Chronic nasosinusitis in control group:normal salin

Sponsors

Shanghai Tongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Subjects should be Chinese citizens aged 18-60 years old, male and female; 2. Subjects in the screening and baseline follow-up must be diagnosed as allergic rhinitis or chronic nasal sinusitis; 1) allergic rhinitis diagnostic criteria: (according to 2015 Tianjin diagnostic criteria for the diagnosis and treatment of allergic rhinitis guide, Chinese Journal of Otorhinolaryngology Head and neck surgery, 2016,51 (01): 6-24)), with nasal itching, sneezing, runny nose and nasal symptoms in 4 at least 3, and at least two symptoms the score of 2 points or 2 points; 2) Diagnostic criteria for chronic rhinosinusitis: (with chronic nasal sinusitis in Kunming 2012 - Guidelines for diagnosis and treatment, the Chinese Journal of Otorhinolaryngology Head and neck surgery, 2013,48 (02): 92-94)), according to the subjective standard for evaluation VAS standard table in the standard for evaluation of more than 5 points or more, can be recruited; 3. The subjects should be in good health, and had no disease which can influence the test pocess, or safety of the subjects; 4. Subjects should signed the informed consent, and were required to follow up the medication schedule; 5. Female subjects with fertility, in the screening of urine HCG must be negative.

Exclusion criteria

Exclusion criteria: 1. Patients with acute sinusitis and nasal acute infection; 2. In the screening or baseline follow-up, the subjects had any clinical abnormalities or ECG results and clinical significant abnormalities; 3. The clinical significance of cardiovascular, lung, kidney, liver, metabolic diseases, hematologic or neurological disease subjects, or subjects with impaired immune systems; 4. Subjects had upper respiratory tract infection. 5. Subjects with nasal septum deviation and need to be corrected for surgery; 6. Subjects participated in the test are members of the research team or the host party staff. 7. Patients with other nasal diseases as nasal vestibule inflammation and nasal tumor etc.; 8. Subjects have pregnant planning within 3 month; 9. Participated in other clinical drug trials in 3 months; 10. Researchers think the subjects should not be included in the test for other reason; 11. Subjects have use of the drug may affect the results of the test, and the withdrawal time is less than the prescribed time.

Design outcomes

Primary

MeasureTime frame
saccharin test (second);number of the inflammatory cel (One / field of vision);Symptoms and signs scores(score);

Countries

China

Contacts

Public ContactYU Shaoqing

Shanghai Tongji Hospital

yu_shaoqing@163.com+86 13916455012

Outcome results

None listed

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