The Effect of Platelet-rich Plasma Nasal Injection in the Treatment of Traumatic Olfactory Dysfunction

NCT06290219 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: CF23509A
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Traumatic Olfactory Nerve Injury With Anosmia (Diagnosis); Effect of Drug

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Visual Analogue Scale

  up to 12 weeks

Study Arms (2)

platelet-rich plasma combined with hyaluronic acid nasal injection

EXPERIMENTAL

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.

Combination Product: platelet-rich plasma combined with hyaluronic acid; Drug: Zinc Gluconate 10 MG Oral Tablet; Device: 4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil

Control

ACTIVE COMPARATOR

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.

Drug: Zinc Gluconate 10 MG Oral Tablet; Device: 4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil

Interventions

platelet-rich plasma combined with hyaluronic acid COMBINATION_PRODUCT

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.

platelet-rich plasma combined with hyaluronic acid nasal injection

Zinc Gluconate 10 MG Oral Tablet DRUG

one tablet three times a day for a period of 12 weeks

Also known as: zinc tablet

Control; platelet-rich plasma combined with hyaluronic acid nasal injection

4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil DEVICE

Sniffing each odorant for 10 seconds, twice a day for 12 weeks

Control; platelet-rich plasma combined with hyaluronic acid nasal injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older, and loss of olfactory function for more than 6 months after head trauma

You may not qualify if:

• 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

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 36507615 BACKGROUND

• 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.

  PMID: 35904632 BACKGROUND

• 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.

  PMID: 36520209 BACKGROUND

• 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.

  PMID: 35341080 BACKGROUND

• 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.

  PMID: 37772881 BACKGROUND

Related Links

• Institutional website

MeSH Terms

Conditions

Disease

Interventions

Hyaluronic Acid; gluconic acid; Tablets; Zinc

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Dosage Forms; Pharmaceutical Preparations; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Rong-San Jiang, MD, PhD

  Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong-San Jiang, MD, PhD

CONTACT

800-555-5555; rsjiang@vghtc.gov.tw

Kai-Li Liang, MD

CONTACT

800-555-5555; kellyliang1107@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 4, 2024
• Study Start: March 20, 2024
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: from January 1, 2027 to December 31, 2027
• Access Criteria: Permission from the principal investigator

Locations

TW (1)