Clinical trial NCT06930248: Efficacy of Platelet-rich Plasma in Management of Anosmia
Official title: Efficacy of Platelet-rich Plasma in Management of Anosmia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anosmia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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 .


Eligibility criteria: 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 ..

Primary outcomes:
measure: degree of regaining olfactory function using N-butanol threshold test
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Croy I, Nordin S, Hummel T. Olfactory disorders and quality of life--an updated review. Chem Senses. 2014 Mar;39(3):185-94. doi: 10.1093/chemse/bjt072. Epub 2014 Jan 15.
citation: Nordin S, Bramerson A. Complaints of olfactory disorders: epidemiology, assessment and clinical implications. Curr Opin Allergy Clin Immunol. 2008 Feb;8(1):10-5. doi: 10.1097/ACI.0b013e3282f3f473.
citation: Landis BN, Konnerth CG, Hummel T. A study on the frequency of olfactory dysfunction. Laryngoscope. 2004 Oct;114(10):1764-9. doi: 10.1097/00005537-200410000-00017.
citation: Murphy C, Schubert CR, Cruickshanks KJ, Klein BE, Klein R, Nondahl DM. Prevalence of olfactory impairment in older adults. JAMA. 2002 Nov 13;288(18):2307-12. doi: 10.1001/jama.288.18.2307.