Preparation and Characterization Intranasal Film Loaded With Steroid as a Local Treatment of Anosmia in Compare to Insulin Intranasal Film
NCT ID: NCT05328414
Last Updated: 2023-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
200 participants
INTERVENTIONAL
2022-03-01
2023-05-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo group
Prednisolone
intranasal fast dissolving film to be applied intranasal. it contains 0.005 mg Presdnisolone
steroid based intranasal film
Prednisolone
intranasal fast dissolving film to be applied intranasal. it contains 0.005 mg Presdnisolone
Interventions
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Prednisolone
intranasal fast dissolving film to be applied intranasal. it contains 0.005 mg Presdnisolone
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
50 Years
ALL
Yes
Sponsors
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Deraya University
OTHER
Responsible Party
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Soad Ali
Clinical professor
Locations
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Soad A. Mohamad
Minya, Minya Governorate, Egypt
Countries
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Other Identifiers
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Pinsfilm
Identifier Type: -
Identifier Source: org_study_id
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