Chronic hypertrophic rhinitis
Conditions
Interventions
control group:Inject saline into inferior nasal concha
experimental group:Inject BTX-A into inferior nasal concha
Sponsors
Tongji Hospital of Tongji University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Subjects shall be Chinese citizens aged 18 to 60 years; 2. Subjects must be diagnosed with CHR at screening and baseline follow-up; CHR diagnostic criteria: chronic inflammation of the nasal cavity characterized by mucosal, submucosal, or even localized or diffuse hypertrophy of the bone, with symptoms such as nasal congestion that are at least 3 months old; 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; 11. Subjects whom the researchers think should not be included because of other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TNSS; | — |
Secondary
| Measure | Time frame |
|---|---|
| visual analogue scale(VAS);Nasal resistance;The concentration of NO in nasal exhalation; | — |
Countries
China
Contacts
Public ContactYu Shaoqing
Tongji Hospital of Tongji University
Outcome results
None listed