Chronic sinusitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects shall be Chinese citizens aged 18 to 60, regardless of gender. 2. Subjects shall meet the diagnostic criteria for chronic sinusitis (Chinese guide for diagnosis and treatment of chronic sinusitis 2018) and meet the surgical indications 3. The subject is in good health and has no clinically significant disease that interferes with the test schedule or operation or affects the safety of the subject. 4. Subjects shall be able to comply with the treatment and follow-up schedule. 5. Fertile female subjects must have negative urine HCG at screening.
Exclusion criteria
Exclusion criteria: 1. Subjects with acute sinusitis and acute nasal infection. 2. Subjects with any clinical abnormalities in vital signs or clinically significant abnormalities in ecg results at screening or baseline follow-up. 3. Subjects with clinically significant cardiovascular, lung, kidney, liver, metabolic disease, hematological or neurological disease, or subjects with impaired immune system. 4. Subjects suffering from upper respiratory tract infection. 5. Subjects with septal deviation requiring corrective surgery. 6. Subjects are members of the research team directly involved in this study. 7. Subjects with nasal vestibular inflammation, nasal tumor and other nasal diseases. 8. Subjects plan to get pregnant within three months 9. Subjects who have participated in clinical drug trials within three months. 10. Subjects who used drugs that may affect the results of the test and stop for less than the prescribed time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual analogue scale;quality of life (QOL);sinonasal outcome test-20 (SNOT-20);Lund-Kenenedy;Lund-Mackay; | — |
Countries
China
Contacts
Tongji Hospital of Tongji University