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

Soad Ali

Status and phase: Completed; Phase 2

Conditions: Anosmia

Treatments: Device: Fast dissolving film; Combination Product: Insulin film

Study type: Interventional

Funder types: Other

Identifiers

NCT04657809

S85insu23fdf

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• anosmia post covid-19 infection

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Insulin fast dissolving film

Experimental group

Description:

Formulated bioadhesive fast dissolving film contains 100IU of insulin

Treatment:

Device: Fast dissolving film

Combination Product: Insulin film

Plain fast dissolving film

Placebo Comparator group

Description:

Formulated bioadhesive fast dissolving film contains no drug

Treatment:

Device: Fast dissolving film

Combination Product: Insulin film