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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-05-20

Brief Summary

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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

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Conditions

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Smell Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo group

Group Type PLACEBO_COMPARATOR

Prednisolone

Intervention Type DRUG

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

steroid based intranasal film

Group Type EXPERIMENTAL

Prednisolone

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Deraya University

OTHER

Sponsor Role lead

Responsible Party

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Soad Ali

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Soad A. Mohamad

Minya, Minya Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Pinsfilm

Identifier Type: -

Identifier Source: org_study_id

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