Preparation and Characterization Intranasal Film Loaded With Steroid as a Local Treatment of Anosmia in Compare to Insulin Intranasal Film

Deraya University200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Smell Loss

Interventions

PrednisoloneDRUG

intranasal fast dissolving film to be applied intranasal. it contains 0.005 mg Presdnisolone

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Soad A. Mohamad

Minya, Minya Governorate, Egypt

Outcomes

Primary Outcomes

Smell restoring

Discrmination test; to recogonize the odd odor three times trial

Time frame: three week

Smell restoring

Sniffs test; to recogonize the first concentration he could identify

Time frame: three week

Secondary Outcomes

inflammation

to measure the extent of inflammation the reddness and size

Time frame: three weeks

Data from ClinicalTrials.gov

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