Efficacy of Platelet-rich Plasma in Management of Anosmia

April 8, 2025 updated by: Mohamed Nasr Mohamed Ibrahim, Sohag University

Olfactory dysfunction is a prevalent disorder that affects up to 20% of the general population and has significant effects on a person's quality of life as well as increased morbidity and mortality (Croy I et al., 2014;Nordin S et al

.,2008). Anosmia is the inability to perceive the odor or a lack of functioning olfaction; it may be temporary or permanent. Organic anosmia is loss of smell due to nasal obstruction caused by sinonasal diseases (as nasal polyps, tumors, postoperative) preventing odorant molecules from reaching olfactory mucosa. Functional anosmia affects up to 5% of the general population and 10% of those older than 65 . Functional anosmia is due to damage of peripheral olfactory area causing permanent loss of smell as post-traumatic, post viral infection. . 20% of individuals aged 20 to 90 years have impaired olfactory Function . The etiology of olfactory dysfunction is quite varied, including post viral posttraumatic, and idiopathic loss of smell. Unfortunately, with these etiologies, the likelihood of spontaneous recovery is generally poor with only approximately one-third of people regaining function and the duration of loss negatively correlating with recovery rate . Treatment for olfactory dysfunction is also limited. Best evidence studies recommend olfactory training and topical steroid nasal irrigations as potential therapeutics, yet both have limited efficacy . PRP is an autologous materials known to have anti-inflammatory and proregenerative properties including up regulation of growth factors including transforming growth factor, vascular endothelial growth factor, epidermal growth factor, and insulin-like growth factor. It has been used as a safe therapy effective in treating inflammation, wound healing, and peripheral neuropathies in other clinical settings. In particular, PRP has been shown to promote axon regeneration and neuroregeneration .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Waleed A Waleed, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • sex:both gender.
  • UPSIT score up to 10 of 40
  • all patients who suffer from anosmia
  • normal airway passage
  • CT free of any sinonasal obstrucive lesions.

Exclusion Criteria:

  • Age: below 18 years old and above 50years old.
  • All patients with bilateral nasal obstruction related to chronic sinusitis, bilateral nasal polyposis,septum ,turbinate hypertrophy,tumors.
  • UPSIT score more than 10 of 40.
  • Traumatic causes of anosmia.
  • All patients with medical history of blood diseases and diabetic and hypertensive patients.
  • any medical treatment affect coagulation or bone marrow for 2 weeks prior to testing ..

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
all patients who suffer from anosmia
Biological: Platelet rich plasma injection
Our first step is the local anesthesia using a solution of decongestion nasal drops with 5% Emla and 10% Xylocaine spray in cotton, which is placed in the nose for 30 minutes. The 2nd step of the administration is the PRP injection in the olfactory area of the noseVia1 ml syringe with 30 G needle, PRP is injected in the olfactory area(located at superior turbinate and superior portion of lateral an medial portion of nasal cavity) approximately every 1 cm2 with the help of a nasal endoscope. The procedure is repeated 3 times with a 4 week interval with follow up patients for 6 months. A 4th time is injected after 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
degree of regaining olfactory function using N-butanol threshold test
Time Frame: Using N-butanol or 2-phenylethanol,the 2-phenylethanol has arose smell and a longer expiration date (1.5 year) while the n-butanol has an alcohol like smell and expiration date (7-8months) as it is very volatile
Using N-butanol or 2-phenylethanol,the 2-phenylethanol has arose smell and a longer expiration date (1.5 year) while the n-butanol has an alcohol like smell and expiration date (7-8months) as it is very volatile

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

April 8, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

April 16, 2025

Last Update Submitted That Met QC Criteria

April 8, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-04-02MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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