Traumatic Olfactory Nerve Injury With Anosmia (Diagnosis)Phase 3PRPNCT06290219
The Effect of Platelet-rich Plasma Nasal Injection in the Treatment of Traumatic Olfactory Dysfunction
A Phase 3 study testing platelet-rich plasma combined with hyaluronic acid, Zinc Gluconate 10 MG Oral Tablet and 4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil in people with Traumatic Olfactory Nerve Injury With Anosmia (Diagnosis) and Effect of Drug, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Olfactory Nerve Injury With Anosmia (Diagnosis), Effect of Drug
- What is being tested?
- platelet-rich plasma combined with hyaluronic acid, Zinc Gluconate 10 MG Oral Tablet and 4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Mar 2024to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older, and loss of olfactory function for more than 6 months after head trauma
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taichung Veterans General Hospital
Taichung, 40705
Rong-San Jiang, MD, PhD, 800-555-5555 ext. 4088, rsjiang@vghtc.gov.tw
Kai-Li Liang, MD, +886423592525 ext. 82620, kellyliang1107@gmail.com
About this study
Official 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.
Read the detailed description
Causes of olfactory impairment include sinus diseases, post-viral olfactory dysfunction, neurological diseases, and post-traumatic lesions of the olfactory nerve. Since the outbreak of the COVID-19 in 2019, there has been a significant increase in the number of patients suffering from olfactory disorders, and the duration of loss of smell and taste varies. According to follow-up studies, nearly 46% of those patients still have symptoms of olfactory impairment one year after diagnosis, and nearly 7% have even completely lost their ability to smell. In recent years, injecting platelet-rich plasma into the nasal cavity has been a new method to improve the sense of smell. The effects of platelet-rich plasma can reduce chronic inflammation and cell-related damage and promote regeneration of olfactory tissue, while hyaluronic acid can promote the release of growth factors from platelets.
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.
- Being tested
- platelet-rich plasma combined with hyaluronic acid, Zinc Gluconate 10 MG Oral Tablet, 4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet-rich plasma combined with hyaluronic acidCombination 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.
Zinc Gluconate 10 MG Oral TabletDrug
Also called zinc tablet
one tablet three times a day for a period of 12 weeks
4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oilDevice
Sniffing each odorant for 10 seconds, twice a day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Zinc Gluconate 10 MG Oral Tablet; Device: 4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 12 weeks
Secondary outcomes (1)
Visual Analogue Scale
Before and after treatment, the subjects subjectively evaluated their olfactory function using a Visual Analogue Scale.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start20 Mar 2024 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Traumatic Olfactory Nerve Injury With Anosmia (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong-San Jiang, Taichung Veterans General Hospital
- Investigators
- Rong-San Jiang, MD, PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290219
- Sponsor's protocol ID
- CF23509A
- Acronym
- PRP
- Status last verified
- Mar 2024
- First submitted
- 25 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
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.
PubMed 36507615Steffens 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.
PubMed 35904632Lechien 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.
PubMed 36520209Goljanian 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.
PubMed 35341080AlRajhi 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.
PubMed 37772881
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Platelet-rich Plasma and Hyaluronic Acid Nasal Injection in the Treatment of Traumatic Olfactory Dysfunction
- ClinicalTrials.gov ID
- NCT06290219
- Acronym / sponsor ID
- PRP / CF23509A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 20 Mar 2024 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Causes of olfactory impairment include sinus diseases, post-viral olfactory dysfunction, neurological diseases, and post-traumatic lesions of the olfactory nerve. Since the outbreak of the COVID-19 in 2019, there has been a significant increase in the number of patients suffering from olfactory disorders, and the duration of loss of smell and taste varies. According to follow-up studies, nearly 46% of those patients still have symptoms of olfactory impairment one year after diagnosis, and nearly 7% have even completely lost their ability to smell. In recent years, injecting platelet-rich plasma into the nasal cavity has been a new method to improve the sense of smell. The effects of platelet-rich plasma can reduce chronic inflammation and cell-related damage and promote regeneration of olfactory tissue, while hyaluronic acid can promote the release of growth factors from platelets.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platelet-rich plasma combined with hyaluronic acid nasal injection | Experimental | 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 oila 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. |
| Control | Active comparator | Drug: Zinc Gluconate 10 MG Oral Tablet, Device: 4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oilone 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years of age or older, and loss of olfactory function for more than 6 months after head trauma
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| platelet-rich plasma combined with hyaluronic acidThe 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. | Combination product | platelet-rich plasma combined with hyaluronic acid nasal injection |
| Zinc Gluconate 10 MG Oral TabletAlso: zinc tabletone tablet three times a day for a period of 12 weeks | Drug | Control, platelet-rich plasma combined with hyaluronic acid nasal injection |
| 4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oilSniffing each odorant for 10 seconds, twice a day for 12 weeks | Device | Control, platelet-rich plasma combined with hyaluronic acid nasal injection |
Primary outcome
phenyl ethyl alcohol odor detection threshold test
Time frame: up to 12 weeks
The phenyl ethyl alcohol (PEA) odor detection threshold test uses a rose-like PEA odorant to assess a patient's odor detection threshold.
traditional Chinese version of University of Pennsylvania Smell Identification Test (TC-UPSIT)
Time frame: up to 12 weeks
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.
1 secondary outcome
Visual Analogue Scale
Time frame: up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Background: PubMed 36507615Yan 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.
- Background: PubMed 35904632Steffens 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.
- Background: PubMed 36520209Lechien 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.
- Background: PubMed 35341080Goljanian 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.
- Background: PubMed 37772881AlRajhi 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.
- Institutional websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all collected IPD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rong-San Jiang, MD, PhD principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing platelet-rich plasma combined with hyaluronic acid, Zinc Gluconate 10 MG Oral Tablet and 4 bottles of phenyl ethyl alcohol, lemon, eucalyptus, and clove oil in people with Traumatic Olfactory Nerve Injury With Anosmia (Diagnosis) and Effect of Drug, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rong-San Jiang, MD, PhD (800-555-5555 ext. 4088, rsjiang@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
phenyl ethyl alcohol odor detection threshold test (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06290219, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.