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OpenTrials
Completed

NCT Number: NCT04657809

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

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.

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Key information

Conditions

Anosmia Nervous System Diseases Neurologic Manifestations Olfaction Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Soad

Minya, 05637, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • anosmia post covid-19 infection

Exclusion criteria

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

Treatment and study plan

Insulin film

Combination Product

Insulin suspension vials

Fast dissolving film

Device

Fast dissolving film

Primary outcomes

  1. Smell sensation improvement

    Time frame: 4 weeks

    By decrease the threshold sensation with butanol test

Sponsors and collaborators

Lead sponsor

Soad Ali

Other

Collaborators

  • Minia University

Registry information

Official study title

"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."

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2020
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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