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

Phase 2

Completed

• Conditions: Anosmia
• Interventions: Combination Product: Insulin film; Device: Fast dissolving film

• Registration Number: NCT04657809
• Lead Sponsor: Soad Ali

Brief Summary

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.

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 Timeline

• Study Start: 2020-10-01
• Study First Submitted: 2020-12-02
• Study First Submitted QC: 2020-12-02
• Study First Posted: 2020-12-08
• Primary Completion: 2021-02-18
• Study Completion: 2021-03-20
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-25
• Last Update Posted: 2021-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• anosmia post covid-19 infection

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plain fast dissolving film	Fast dissolving film	Formulated bioadhesive fast dissolving film contains no drug
Insulin fast dissolving film	Insulin film	Formulated bioadhesive fast dissolving film contains 100IU of insulin
Insulin fast dissolving film	Fast dissolving film	Formulated bioadhesive fast dissolving film contains 100IU of insulin
Plain fast dissolving film	Insulin film	Formulated bioadhesive fast dissolving film contains no drug

Primary Outcome Measures

Name	Time	Method
Smell sensation improvement	4 weeks	By decrease the threshold sensation with butanol test

Trial Locations

Locations (1)

Soad; 🇪🇬 Minya, Egypt