Preparation and Characterization Intranasal Film Loaded With Steroid as a Local Treatment of Anosmia in Compare to Insulin Intranasal Film

D

Deraya University

Status and phase

Completed
Phase 2
Phase 1

Conditions

Smell Loss

Treatments

Drug: Prednisolone

Study type

Interventional

Funder types

Other

Identifiers

NCT05328414
Pinsfilm

Details and patient eligibility

About

This study is a growing step of phase I study published on March 2021. The study was implicated on Minia university on small scale of patient (20) to investigate the impact of insulin as fast dissolving films for intranasal delivery to treat anosmia in post COVID-19 infections. this record will modify the first formulation by addition certain concentration of steroid.

Enrollment

200 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • All patients' adults aged from 18 years to 50 will included in the study.
  • A confirmed case (positive PCR), recovered/discharged (2 negative PCR),
  • suffering from sudden recent anosmia or hyposmia with or without loss of taste.

Exclusion criteria

  1. Patients with chronic sinusitis.
  2. Patients with acute allergic rhinitis.
  3. Patients' nasal polyposis
  4. Patients with history of nasal surgery, severe head trauma or any medical condition that may affect sense of smell.
  5. Patient poly morbidities or poly pharmacy.
  6. Elder, pregnant, or nursing woman.
  7. Patients with chronic diseases.
  8. Autoimmune diseases.
  9. Patient suffering end organ problems.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

200 participants in 2 patient groups, including a placebo group

Placebo group
Placebo Comparator group
Treatment:
Drug: Prednisolone
steroid based intranasal film
Experimental group
Treatment:
Drug: Prednisolone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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