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NCT Number: NCT06930248

Efficacy of Platelet-rich Plasma in Management of Anosmia

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 .

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

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 ..

Treatment and study plan

Platelet rich plasma injection

Biological

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.

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohammed N Mohammed, specialist

CONTACT

[email protected]

+0201063260365

Waleed A Waleed, Professor

CONTACT

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2025
Registry last updated
Apr 16, 2025

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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