NCT06290219|UnknownPhase 3DMC
The Effect of Platelet-rich Plasma Nasal Injection in the Treatment of Traumatic Olfactory Dysfunction
PRP
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Sponsor study identifier
interventional
80
1 country
1
Study Start
March 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 25, 2024
Actual (reported)March 4, 2024
Actual (reported)March 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
phenyl ethyl alcohol odor detection threshold test
The phenyl ethyl alcohol (PEA) odor detection threshold test uses a rose-like PEA odorant to assess a patient's odor detection threshold.
up to 12 weeks
traditional Chinese version of University of Pennsylvania Smell Identification Test (TC-UPSIT)
TC-UPSIT is the traditional Chinese version of the University of Pennsylvania Smell Identification Test. It is a modified version of the North American version, with 8 unfamiliar odorants replaced by other odorants.29 The TC-UPSIT consists of 40 tests as it follows the North American version of the University of Pennsylvania Smell Identification Test. In each test, the brown strip at the bottom of the test page consists of microcapsules of an odorant, which is released by scratching the strip using a pencil tip. The patient sniffs the released odorant and selects a response from 4 odor descriptor options that are used to identify the odorant. The TC-UPSIT score is the number of correct responses among the 40 tests taken.
up to 12 weeks
Visual Analogue Scale
up to 12 weeks
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.
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.
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.
one tablet three times a day for a period of 12 weeks
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Treatment programme
platelet-rich plasma combined with hyaluronic acid
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
View registry recordTaichung Veterans General Hospital
Taichung, 40705, Taiwan
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.
Rong-San Jiang, MD, PhD
Taichung Veterans General Hospital
First Submitted
February 25, 2024
First Posted
March 4, 2024
Study Start
March 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2024
PFA 100 Evaluation and Reference Interval HOACNY
Sniffing each odorant for 10 seconds, twice a day for 12 weeks
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Contact the study team to confirm eligibility.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 4, 2024
Record last verified: 2024-03
all collected IPD
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Source: ClinicalTrials.gov.
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