The Effect of Platelet-rich Plasma Nasal Injection in the Treatment of Traumatic Olfactory Dysfunction
NCT ID: NCT06290219
Last Updated: 2024-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
80 participants
INTERVENTIONAL
2024-03-20
2024-12-31
Brief Summary
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Detailed Description
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The purpose of this study is to explore the efficacy of injecting high-concentration platelet plasma combined with hyaluronic acid into the nasal olfactory mucosa in the treatment of traumatic anosmia. A total of 80 patients with olfactory dysfunction were collected from otolaryngology, head and neck outpatient clinics. Selection criteria are 18 years of age or older, and loss of olfactory function for more than 6 months after head trauma. Exclusion criteria are pregnant or lactating women, patients with compromised immune function, patients with acute or chronic sinus infection, patients with nasal polyps, patients with a history of sinonasal cancer, and patients with low platelets or hemophilia and other blood and blood cell-related diseases.
This study will establish experimental groups and control groups according to random distribution. Subjects in both groups received zinc tablets and olfactory training for 12 weeks. The experimental group additionally received an injection of platelet-rich plasma combined with hyaluronic acid. After treatment, patients return to the clinic to track the olfactory condition.
Before treatment, the subjects evaluated their olfactory function using a Visual Analogue Scale (VAS) and performed the phenyl ethyl alcohol odor detection threshold test and the traditional Chinese version of the University of Pennsylvania Olfactory Identification Test. In the experimental group, 10cc of blood will be drawn from the subjects in the experimental group, the drawn blood will be centrifuged, the centrifuge tube will be inverted 20 times to mix the plasma and hyaluronic acid, and finally 5cc of the plasma mixed with hyaluronic acid will be drawn out using an empty syringe. The project investigator injects plasma mixed with hyaluronic acid into the nasal septum and the medial side of the middle turbinate of the patient's nasal cavity under a nasal endoscope. The two groups will undergo the same olfactory tests three months later to compare the changes in olfactory function of the two groups of patients before and after treatment to explore the efficacy of injecting high-concentration platelet plasma combined with hyaluronic acid into the nasal olfactory mucosa to treat traumatic anosmia.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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platelet-rich plasma combined with hyaluronic acid nasal injection
a nasal injection of platelet-rich plasma combined with hyaluronic acid at the first day of the treatment. At the same time, one tablet of zinc gluconate (10mg) three times a day for 12 weeks and traditional olfactory training with 4 separate bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil. Patients were told to sniff each odorant for 10 seconds, twice a day for 12 weeks.
platelet-rich plasma combined with hyaluronic acid
The project investigator injects plasma mixed with hyaluronic acid into the nasal septum and the medial side of the middle turbinate of the patient's nasal cavity under a nasal endoscope.
Zinc Gluconate 10 MG Oral Tablet
one tablet three times a day for a period of 12 weeks
4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil
Sniffing each odorant for 10 seconds, twice a day for 12 weeks
Control
one tablet of zinc gluconate (10mg) three times a day for 12 weeks and traditional olfactory training with 4 separate bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove. Patients were told to sniff each odorant for 10 seconds, twice a day for 12 weeks.
Zinc Gluconate 10 MG Oral Tablet
one tablet three times a day for a period of 12 weeks
4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil
Sniffing each odorant for 10 seconds, twice a day for 12 weeks
Interventions
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platelet-rich plasma combined with hyaluronic acid
The project investigator injects plasma mixed with hyaluronic acid into the nasal septum and the medial side of the middle turbinate of the patient's nasal cavity under a nasal endoscope.
Zinc Gluconate 10 MG Oral Tablet
one tablet three times a day for a period of 12 weeks
4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil
Sniffing each odorant for 10 seconds, twice a day for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Taichung Veterans General Hospital
OTHER
Responsible Party
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Rong-San Jiang
Professor
Principal Investigators
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Rong-San Jiang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Taichung Veterans General Hospital
Locations
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Taichung Veterans General Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Yan CH, Jang SS, Lin HC, Ma Y, Khanwalkar AR, Thai A, Patel ZM. Use of platelet-rich plasma for COVID-19-related olfactory loss: a randomized controlled trial. Int Forum Allergy Rhinol. 2023 Jun;13(6):989-997. doi: 10.1002/alr.23116. Epub 2022 Dec 21.
Steffens Y, Le Bon SD, Lechien J, Prunier L, Rodriguez A, Saussez S, Horoi M. Effectiveness and safety of PRP on persistent olfactory dysfunction related to COVID-19. Eur Arch Otorhinolaryngol. 2022 Dec;279(12):5951-5953. doi: 10.1007/s00405-022-07560-y. Epub 2022 Jul 29.
Lechien JR, Le Bon SD, Saussez S. Platelet-rich plasma injection in the olfactory clefts of COVID-19 patients with long-term olfactory dysfunction. Eur Arch Otorhinolaryngol. 2023 May;280(5):2351-2358. doi: 10.1007/s00405-022-07788-8. Epub 2022 Dec 15.
Goljanian Tabrizi A, Asadi M, Mohammadi M, Abedi Yekta A, Sohrabi M. Efficacy of Platelet-Rich Plasma as an Adjuvant Therapy to Endoscopic Sinus Surgery in Anosmia Patients with Sinonasal Polyposis: A Randomized Controlled Clinical Trial. Med J Islam Repub Iran. 2021 Nov 24;35:156. doi: 10.47176/mjiri.35.156. eCollection 2021.
AlRajhi B, Alrodiman OA, Alhuzali AF, Alrashed H, Alrodiman YA, Alim B. Platelet-rich plasma for the treatment of COVID-19 related olfactory dysfunction: a systematic review. Rhinology. 2023 Dec 1;61(6):498-507. doi: 10.4193/Rhin23.168.
Study Documents
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Related Links
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Institutional website
Other Identifiers
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CF23509A
Identifier Type: -
Identifier Source: org_study_id
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