Clinical Assessment of Insulin Fast Dissolving Film in Treatment of Post Infection Anosmia
NCT ID: NCT04657809
Last Updated: 2021-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2020-10-01
2021-03-20
Brief Summary
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1. Threshold test
2. identification test.
Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Insulin fast dissolving film
Formulated bioadhesive fast dissolving film contains 100IU of insulin
Insulin film
Insulin suspension vials
Fast dissolving film
Fast dissolving film
Plain fast dissolving film
Formulated bioadhesive fast dissolving film contains no drug
Insulin film
Insulin suspension vials
Fast dissolving film
Fast dissolving film
Interventions
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Insulin film
Insulin suspension vials
Fast dissolving film
Fast dissolving film
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
Yes
Sponsors
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Minia University
OTHER
Soad Ali
OTHER
Responsible Party
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Soad Ali
Assistant Professor
Principal Investigators
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Soad Mohamed
Role: STUDY_DIRECTOR
Deraya
Locations
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Soad
Minya, , Egypt
Countries
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References
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Webster KE, O'Byrne L, MacKeith S, Philpott C, Hopkins C, Burton MJ. Interventions for the prevention of persistent post-COVID-19 olfactory dysfunction. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD013877. doi: 10.1002/14651858.CD013877.pub3.
O'Byrne L, Webster KE, MacKeith S, Philpott C, Hopkins C, Burton MJ. Interventions for the treatment of persistent post-COVID-19 olfactory dysfunction. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD013876. doi: 10.1002/14651858.CD013876.pub3.
Other Identifiers
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S85insu23fdf
Identifier Type: -
Identifier Source: org_study_id