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Completed

NCT Number: NCT05328414

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

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.

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Key information

Conditions

Smell Loss Anosmia Nervous System Diseases Neurologic Manifestations Olfaction Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Soad A. Mohamad

Minya, Minya Governorate, 05673, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Prednisolone

Drug

intranasal fast dissolving film to be applied intranasal. it contains 0.005 mg Presdnisolone

Primary outcomes

  1. Smell restoring

    Time frame: three week

    Discrmination test; to recogonize the odd odor three times trial

  2. Smell restoring

    Time frame: three week

    Sniffs test; to recogonize the first concentration he could identify

Secondary outcomes

  1. inflammation

    Time frame: three weeks

    to measure the extent of inflammation the reddness and size

Sponsors and collaborators

Lead sponsor

Deraya University

Other

Registry information

Official study title

Steroid Loaded Intranasal Films as a Local Treatment of Anosmia

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2022
Registry last updated
Jun 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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