Other Clinical Trial - Botulium Toxin Type A In Non Infectious Chronic

Status Completed

Clinical Trial Summary

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

Clinical Trial Description

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: - Group A (topical group) : 15 patients - Group B (injected group) : 15 patients All patients will be subjected to: 1. Full clinical evaluation: A) Full history taking B) Clinical examination by - anterior rhinoscopy to evaluate the nasal cavity to exclude purulent discharge , nasal polyps or anterior septal deviation. - nasal endoscopy to exclude nasal infection signs ,nasal polyps ,the posterior septal deviation or adenoid . 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 . 2. Intervention : - BTX -A available in the Egyptian market in the form of powder vial (Allergan) containing 100 Units, will be dissolved in 10 cc saline to obtain clear colorless solution in which each 1cc contain 10 Units. - 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. - 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 . 3. Follow Up Follow up visits will be at 1,2,4,6,8 weeks, patients will be assessed and questionnaired about severity of the symptoms and possible adverse effects including epistaxis and nasal dryness . ;

Study Design

Related Conditions & MeSH terms

Chronic Rhinosinusitis (Diagnosis)
Sinusitis

Clinical Trial Details

NCT number	NCT04572516
Study type	Interventional
Source	Benha University
Contact
Status	Completed
Phase	Phase 3
Start date	May 1, 2020
Completion date	July 15, 2021

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Botulium Toxin Type A In Non Infectious Chronic Rhinosinusitis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms