Trial | NCT04657809  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Indication/Condition

    Anosmia [, ]

  • Intervention/Treatment

    Insulin film ...

  • Study Participants

    40
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

Threshold test
identification test.
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 Started
Oct 01
2020
Primary Completion
Feb 18
2021
Study Completion
Mar 20
2021
Last Update
Oct 26
2021

Combination Product Insulin film

Insulin suspension vials

Device Fast dissolving film

Fast dissolving film

Insulin fast dissolving film Experimental

Formulated bioadhesive fast dissolving film contains 100IU of insulin

Plain fast dissolving film Placebo Comparator

Formulated bioadhesive fast dissolving film contains no drug

Criteria 

Inclusion Criteria:

anosmia post covid-19 infection

Exclusion Criteria:

nasal polyps or fractions or syrgery in nose from 6 months or less
No Results Posted