Benha University Hospital, Faculty of Medicine
Banhā, Qalyubia Governorate, 13512, Egypt
NCT Number: NCT04572516
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
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Banhā, Qalyubia Governorate, 13512, Egypt
A prospective comparative study will be carried out on 30 participant of both sex at Otorhinolaryngology Department, Benha University Hospital, it will include patients suffering from non infectious chronic rhinosinustitis symptoms in the form of nasal blockage, rhinorrhea, itching and/or sneezing.
The patients will be divided randomly into two groups:
All patients will be subjected to:
A) Full history taking B) Clinical examination by
C) Investigations:CT nose and paranasal sinuses coronal cuts to exclude fungal sinusitis, nasal polyps or other structural abnormalities e.g; posterior septal deviation, conchae bullosa or any other nasal pathology .
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In group A (topical group) ,topical application in the form of merocel soaked with 20 units of BTX_A (2ml) will be placed at each side of the nasal cavity for 30 minutes.
Other names: Topical
In group B (injected group), 20 units of BTX_A(2ml) will be injected submucosally in each inferior turbinate using insulin syringe needle after local anesthesia using 10% xylocaine spray .
Other names: Injection
Time frame: 2 months
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)
Time frame: 2 months
epistaxis and nasal dryness (yes/no)
Benha University
Other
Topical Application Versus Intra Turbinate Injection of Botulium Toxin Type A In The Treatment of Non Infectious Chronic Rhinosinusitis
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