Effect of Drug Clinical Trial
— PRPOfficial title:
The Effect of Platelet-rich Plasma and Hyaluronic Acid Nasal Injection in the Treatment of Traumatic Olfactory Dysfunction
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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | December 31, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years of age or older, and loss of olfactory function for more than 6 months after head trauma Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taichung Veterans General Hospital | Taichung |
Lead Sponsor | Collaborator |
---|---|
Taichung Veterans General Hospital |
Taiwan,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | Visual Analogue Scale | Before and after treatment, the subjects subjectively evaluated their olfactory function using a Visual Analogue Scale. | up to 12 weeks |
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