Smell Loss
Conditions
Brief summary
This study is a growing step of phase I study published on March 2021. The study was implicated on Minia university on small scale of patient (20) to investigate the impact of insulin as fast dissolving films for intranasal delivery to treat anosmia in post COVID-19 infections. this record will modify the first formulation by addition certain concentration of steroid.
Interventions
DRUGPrednisolone
intranasal fast dissolving film to be applied intranasal. it contains 0.005 mg Presdnisolone
Sponsors
Deraya University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* All patients' adults aged from 18 years to 50 will included in the study. * A confirmed case (positive PCR), recovered/discharged (2 negative PCR), * suffering from sudden recent anosmia or hyposmia with or without loss of taste.
Exclusion criteria
1. Patients with chronic sinusitis. 2. Patients with acute allergic rhinitis. 3. Patients' nasal polyposis 4. Patients with history of nasal surgery, severe head trauma or any medical condition that may affect sense of smell. 5. Patient poly morbidities or poly pharmacy. 6. Elder, pregnant, or nursing woman. 7. Patients with chronic diseases. 8. Autoimmune diseases. 9. Patient suffering end organ problems.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smell restoring | three week | Discrmination test; to recogonize the odd odor three times trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| inflammation | three weeks | to measure the extent of inflammation the reddness and size |
Countries
Egypt
Outcome results
None listed