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NCT05328414
Preparation and Characterization Intranasal Film Loaded With Steroid as a Local Treatment of Anosmia in Compare to Insulin Intranasal Film
Phase 1, PHASE2 trial testing Prednisolone in Smell Loss in 200 participants. Completed in 20 May 2023.
18 March 2023
Quick facts
| Lead sponsor | Deraya University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 200 |
| Start date | 1 March 2022 |
| Primary completion | 18 March 2023 |
| Estimated completion | 20 May 2023 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Prednisolone — full drug profile →
Conditions studied
- Smell Loss — all drugs for Smell Loss →
Sponsor
Deraya University
Who can join
Adults 18 to 50, any sex, with Smell Loss. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Comparison Between Intranasal Insulin Films Alone and Combined Intranasal Insulin Plus Steroid Films for Post Viral Olfactory Dysfunction.
Hamead K, Ahmed MI, Karim ARAA, Moneim RAA, et al · · 2025 · PMID 40093474 · DOI 10.1007/s12070-024-05296-1
Verify or expand the search:
- PubMed search for NCT05328414
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other recruiting trials for Smell Loss
Currently open trials in the same condition.
- NCT06892704 — Olfactory Cleft Obstruction and Electrophysiological Field Potentials Predict Olfactory Restoration by Dupilumab in CRSw · recruiting
- NCT06733636 — Scents of Progress: Leveraging a Novel Device for Olfactory Training in Older Adults · NA · recruiting
- NCT07021040 — Olfactory Biopsies · NA · recruiting
- NCT05364125 — Olfactory Training on Smell Dysfunction Patients in HK · NA · recruiting
Other Deraya University trials
Trials by the same sponsor.
- NCT07528625 — Behavioral Interventions as Primary Prevention for Non-Communicable Diseases Among Young People · NA · not yet recruiting
- NCT07535827 — Insulin Intratympanic Application · EARLY_PHASE1 · enrolling by invitation
- NCT07534280 — Herbal Tea Extract for Management of Rhinosinusitis · NA · completed
- NCT07524686 — Spinal Mobilization With Leg Movement Versus Neurodynamic Mobilization in Lumbar Radiculopathy · NA · completed
- NCT07368517 — Dry Needling for Mechanical Neck Pain · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05328414 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Deraya University
- Last refreshed: 1 June 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05328414.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing