Efficacy of Platelet-rich Plasma in Management of Anosmia

NCT ID: NCT06930248

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-05-01

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 .

Conditions

Anosmia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Group A

all patients who suffer from anosmia

Group Type: EXPERIMENTAL

Platelet rich plasma injection

Intervention Type: 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.

Interventions

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.

Intervention Type: BIOLOGICAL

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 ..

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Nasr Mohamed Ibrahim

Specialist Otorhinolaryngology department Qena General hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mohammed N Mohammed, specialist

Role: CONTACT

mohamed.ibrahim3@med.sohag.edu.eg

+0201063260365

Waleed A Waleed, Professor

Role: CONTACT

References

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.

Reference Type: BACKGROUND

PMID: 24429163 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18188011 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15454769 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12425708 (View on PubMed)

Other Identifiers

Soh-Med-24-04-02MD

Identifier Type: -

Identifier Source: org_study_id