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

May 31, 2023 updated by: Soad Ali, Deraya University

Steroid Loaded Intranasal Films as a Local Treatment of Anosmia

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • المنيا
      • Minya, المنيا, Egypt, 05673
        • Soad A. Mohamad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
Drug: Prednisolone
intranasal fast dissolving film to be applied intranasal. it contains 0.005 mg Presdnisolone
Experimental: steroid based intranasal film
Drug: Prednisolone
intranasal fast dissolving film to be applied intranasal. it contains 0.005 mg Presdnisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smell restoring
Time Frame: three week
Discrmination test; to recogonize the odd odor three times trial
three week
Smell restoring
Time Frame: three week
Sniffs test; to recogonize the first concentration he could identify
three week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
inflammation
Time Frame: three weeks
to measure the extent of inflammation the reddness and size
three weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deraya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

March 18, 2023

Study Completion (Actual)

May 20, 2023

Study Registration Dates

First Submitted

March 27, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pinsfilm

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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