Clinical Assessment of Insulin Fast Dissolving Film in Treatment of Post Infection Anosmia

October 25, 2021 updated by: Soad Ali

"Insulin Fast Dissolving Film for Intranasal Delivery Via Olfactory Region, a Promising Approach for the Treatment of Anosmia in COVID 19 Patients: Design, In-vitro Characterization and Clinical Evaluation."

The study aimed to investigate the efficacy of insulin in a new dosage form ( fast dissolving film) in treatment of anosmia in patients post infested with Covid-19. The study implication based in two methods evaluations

  1. Threshold test
  2. identification test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was designed to improve smell disorders after corona infection that is very anxious for all patients.

Inclusion criteria were loss of smell, post covid-19 infection, age from 18 to 70 years and accept sharing and follow up.

The application of dosage form by ENT specialist at otorhinolaryngology clinic at Minia University hospital. Dose was 100iu of insulin 3 times weekly for 4 weeks. The new dosage form with insulin was compared with a placebo to ensure statistical improvement.

The tests were performed in each visit. Primary outcome was the improvement of smell sensors in those patients

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Egypt
      • Minya, Egypt, 05637
        • Soad

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • anosmia post covid-19 infection

Exclusion Criteria:

  • nasal polyps or fractions or syrgery in nose from 6 months or less

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
Experimental: Insulin fast dissolving film
Formulated bioadhesive fast dissolving film contains 100IU of insulin
Combination product: Insulin film
Insulin suspension vials
Device: Fast dissolving film
Fast dissolving film
Placebo Comparator: Plain fast dissolving film
Formulated bioadhesive fast dissolving film contains no drug
Combination product: Insulin film
Insulin suspension vials
Device: Fast dissolving film
Fast dissolving film

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smell sensation improvement
Time Frame: 4 weeks
By decrease the threshold sensation with butanol test
4 weeks

Collaborators and Investigators

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

Sponsor

Soad Ali

Collaborators

Minia University

Investigators

  • Study Director: Soad Mohamed, Deraya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 1, 2020

Primary Completion (Actual)

February 18, 2021

Study Completion (Actual)

March 20, 2021

Study Registration Dates

First Submitted

December 2, 2020

First Submitted That Met QC Criteria

December 2, 2020

First Posted (Actual)

December 8, 2020

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S85insu23fdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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