AnosmiaPRP-I RCTNCT07383415
Intranasal Platelet-Rich Plasma With or Without Topical Insulin for Post-Inflammatory Anosmia
A study testing Intranasal PRP Plus Topical Insulin in people with Anosmia and Inflammatory Anosmia, run by Amin Javer.
Trial summary
This study evaluates whether adding topical insulin to intranasal platelet-rich plasma (PRP) improves smell recovery in adults with post-inflammatory anosmia. Participants will be randomly assigned to receive either intranasal PRP combined with topical insulin or intranasal PRP alone. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anosmia, Inflammatory Anosmia
- What is being tested?
- Intranasal PRP Plus Topical Insulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with olfactory dysfunction despite olfactory training therapy
- Loss of smell within the past 5 years
- Loss of smell occurred after an infection
- Platelet count is over 150,000 platelets per microliter
Who cannot join
- Have a history of or currently have sinonasal tumours Have a history of surgery or radiotherapy for the base of your skull Have been treated with antibiotics in the past month before surgery Have a condition called systemic vasculitis or any bleeding disorder Have a suspected or known allergy to insulin or PRP or Platelet Lysate (PL) Have inhaled drugs (i.e cocaine) in the past 6 months of your enrollment Smell loss is due to a head trauma or after surgery Unable to complete the Sniffin Stick Smell test or questionnaires
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessing the Effectiveness of Combined Intranasal Platelet-rich Plasma Plus Topical Insulin Versus Platelet-rich Plasma Alone in the Treatment of Post Inflammatory Anosmia: a Randomized Controlled Trial
This study evaluates whether adding topical insulin to intranasal platelet-rich plasma (PRP) improves smell recovery in adults with post-inflammatory anosmia. Participants will be randomly assigned to receive either intranasal PRP combined with topical insulin or intranasal PRP alone. Changes in olfactory function will be assessed over time to compare the effectiveness and safety of the two treatments.
Read the detailed description
Post-inflammatory anosmia is a common cause of persistent olfactory dysfunction with limited effective treatment options. Platelet-rich plasma (PRP) has been proposed as a regenerative therapy due to its high concentration of growth factors, while topical insulin has demonstrated potential neurotrophic and anti-inflammatory effects in olfactory tissue.
This randomized controlled trial aims to evaluate whether the addition of topical insulin to intranasal PRP provides greater improvement in olfactory function compared with intranasal PRP alone in adults with post-inflammatory anosmia. Participants will be randomly assigned to receive either combined intranasal PRP plus topical insulin or intranasal PRP alone.
Olfactory function will be assessed at baseline and at predefined follow-up time points using validated smell testing methods. Safety and tolerability of the interventions will also be monitored throughout the study. The results of this study will contribute to understanding the potential role of regenerative and neurotrophic therapies in the management of post-inflammatory anosmia
- Conditions
- Anosmia, Inflammatory Anosmia
- Being tested
- Intranasal PRP Plus Topical Insulin, Intranasal PRP Plus Saline (Placebo)
- Keywords
- PRP, PRP-INSULIN
- Medical subject headings
- Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal PRP Plus Topical InsulinBiological
Autologous platelet-rich plasma administered intranasally with the addition of topical insulin applied to the olfactory cleft.
Intranasal PRP Plus Saline (Placebo)Biological
Autologous platelet-rich plasma administered intranasally with saline applied in place of topical insulin as a placebo comparator.
| Study group | Role | What they receive |
|---|---|---|
| PRP Plus Topical Insulin | Active comparator | Participants receive intranasal platelet-rich plasma in combination with topical insulin. Receives: Biological: Intranasal PRP Plus Topical Insulin |
| PRP Alone | Placebo comparator | Participants receive intranasal platelet-rich plasma with saline instead of insulin. Receives: Biological: Intranasal PRP Plus Saline (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Olfactory Function
Change in olfactory function from baseline as measured using a validated smell identification test.
Measured: Baseline to 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start30 Mar 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnosmiaStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amin Javer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amin Javer, St. Paul's Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383415
- Sponsor's protocol ID
- H25-02495
- Acronym
- PRP-I RCT
- Status last verified
- Jan 2026
- First submitted
- 26 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of Combined Intranasal Platelet-rich Plasma Plus Topical Insulin Versus Platelet-rich Plasma Alone in the Treatment of Post Inflammatory Anosmia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07383415
- Acronym / sponsor ID
- PRP-I RCT / H25-02495
- Conditions
- Anosmia, Inflammatory Anosmia
- Keywords
- PRP, PRP-INSULIN
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Amin JaverUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 3 Feb 2026 (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.
This study evaluates whether adding topical insulin to intranasal platelet-rich plasma (PRP) improves smell recovery in adults with post-inflammatory anosmia. Participants will be randomly assigned to receive either intranasal PRP combined with topical insulin or intranasal PRP alone. Changes in olfactory function will be assessed over time to compare the effectiveness and safety of the two treatments.
Detailed description
Post-inflammatory anosmia is a common cause of persistent olfactory dysfunction with limited effective treatment options. Platelet-rich plasma (PRP) has been proposed as a regenerative therapy due to its high concentration of growth factors, while topical insulin has demonstrated potential neurotrophic and anti-inflammatory effects in olfactory tissue.
This randomized controlled trial aims to evaluate whether the addition of topical insulin to intranasal PRP provides greater improvement in olfactory function compared with intranasal PRP alone in adults with post-inflammatory anosmia. Participants will be randomly assigned to receive either combined intranasal PRP plus topical insulin or intranasal PRP alone.
Olfactory function will be assessed at baseline and at predefined follow-up time points using validated smell testing methods. Safety and tolerability of the interventions will also be monitored throughout the study. The results of this study will contribute to understanding the potential role of regenerative and neurotrophic therapies in the management of post-inflammatory anosmia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP Plus Topical Insulin | Active comparator | Biological: Intranasal PRP Plus Topical InsulinParticipants receive intranasal platelet-rich plasma in combination with topical insulin. |
| PRP Alone | Placebo comparator | Biological: Intranasal PRP Plus Saline (Placebo)Participants receive intranasal platelet-rich plasma with saline instead of insulin. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with olfactory dysfunction despite olfactory training therapy
- Loss of smell within the past 5 years
- Loss of smell occurred after an infection
- Platelet count is over 150,000 platelets per microliter
Key exclusion criteria (1 listed)
- Have a history of or currently have sinonasal tumours Have a history of surgery or radiotherapy for the base of your skull Have been treated with antibiotics in the past month before surgery Have a condition called systemic vasculitis or any bleeding disorder Have a suspected or known allergy to insulin or PRP or Platelet Lysate (PL) Have inhaled drugs (i.e cocaine) in the past 6 months of your enrollment Smell loss is due to a head trauma or after surgery Unable to complete the Sniffin Stick Smell test or questionnaires
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 |
|---|---|---|
| Intranasal PRP Plus Topical InsulinAutologous platelet-rich plasma administered intranasally with the addition of topical insulin applied to the olfactory cleft. | Biological | PRP Plus Topical Insulin |
| Intranasal PRP Plus Saline (Placebo)Autologous platelet-rich plasma administered intranasally with saline applied in place of topical insulin as a placebo comparator. | Biological | PRP Alone |
Primary outcome
Change in Olfactory Function
Time frame: Baseline to 12 months post-intervention
Change in olfactory function from baseline as measured using a validated smell identification test.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Intranasal PRP Plus Topical Insulin in people with Anosmia and Inflammatory Anosmia, run by Amin Javer.
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 4 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: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amin Javer, MD (604-806-9926, sinusdoc@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Olfactory Function (time frame: Baseline to 12 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2026.