Preparation and Characterization Intranasal Film Loaded With Steroid as a Local Treatment of Anosmia in Compare to Insulin Intranasal Film
- Registration Number
- NCT05328414
- Lead Sponsor
- Deraya University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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
- Patients with chronic sinusitis.
- Patients with acute allergic rhinitis.
- Patients' nasal polyposis
- Patients with history of nasal surgery, severe head trauma or any medical condition that may affect sense of smell.
- Patient poly morbidities or poly pharmacy.
- Elder, pregnant, or nursing woman.
- Patients with chronic diseases.
- Autoimmune diseases.
- Patient suffering end organ problems.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Prednisolone - steroid based intranasal film Prednisolone -
- Primary Outcome Measures
Name Time Method Smell restoring three week Sniffs test; to recogonize the first concentration he could identify
- Secondary Outcome Measures
Name Time Method inflammation three weeks to measure the extent of inflammation the reddness and size
Trial Locations
- Locations (1)
Soad A. Mohamad
🇪🇬Minya, المنيا, Egypt