Chronic Rhinosinusitis (Diagnosis) Clinical Trial
Official title:
Topical Application Versus Intra Turbinate Injection of Botulium Toxin Type A In The Treatment of Non Infectious Chronic Rhinosinusitis
Verified date | July 2021 |
Source | Benha University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The present work aims to assess the effectiveness and safety of topical application of BTX - A compared with its intra turbinate injection in controlling the symptoms in non infectious chronic rhinosinusitis patients
Status | Completed |
Enrollment | 30 |
Est. completion date | July 15, 2021 |
Est. primary completion date | June 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with persistent symptoms of chronic non infectious rhinosinusitis not responding to previous lines of treatment including antihistaminics ,nasal decongestant, and or nasal steroid spray will be included in this study. Exclusion Criteria: - Patients with major structural deformities(septal deviation , adenoid hypertrophy, nasal valve pathology or nasal polyps). - Having systemic illness such as DM, HTN, Malignancy or Tuberculosis. - History of nasal surgery such as turbinate reduction surgery orseptoplasty. - Acute rhinosinusitis findings; e.g purulent or mucopurulent nasal discharge - Radiological finding of nasal tumors or fungal sinusitis. - Any accompanying disease such as glaucoma or prostate hypertrophy or myasthenia that might be aggravated by anticholinergic therapy . - use of systemic or local corticosteroid less than 1 month prior the study. - Pregnancy or lactation. - History of allergy to botox or local anesthetic agents. |
Country | Name | City | State |
---|---|---|---|
Egypt | Benha University Hospital, Faculty of Medicine | Banha | Qalubia |
Lead Sponsor | Collaborator |
---|---|
Benha University |
Egypt,
Ozcan C, Vayisoglu Y, Dogu O, Görür K. The effect of intranasal injection of botulinum toxin A on the symptoms of vasomotor rhinitis. Am J Otolaryngol. 2006 Sep-Oct;27(5):314-8. — View Citation
Zhang EZ, Tan S, Loh I. Botolinum toxin in rhinitis: Literature review and posterior nasal injection in allergic rhinitis. Laryngoscope. 2017 Nov;127(11):2447-2454. doi: 10.1002/lary.26616. Epub 2017 Jul 6. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the rhinitis symptom severity | the rhinitis symptom severity questionnaire, this is questionnaire consists of 4 items (nasal obstruction, rhinorrhea , sneezing and or nasal itching) . each symptom given score from 0 to 3 ( 0 = none, 1 = mild, 2 = moderate and 3 = severe) | 2 months | |
Secondary | possible adverse effects | epistaxis and nasal dryness (yes/no) | 2 months |
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