Intranasal Platelet-Rich Plasma With or Without Topical Insulin for Post-Inflammatory Anosmia

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07383415

Acronym

PRP-I RCT

Enrollment

Registered

2026-02-03

Start date

2026-03-30

Completion date

2027-01-01

Last updated

2026-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anosmia, Inflammatory Anosmia

Keywords

PRP, PRP-INSULIN

Brief 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. 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

Interventions

BIOLOGICALIntranasal PRP Plus Topical Insulin

Autologous platelet-rich plasma administered intranasally with the addition of topical insulin applied to the olfactory cleft.

BIOLOGICALIntranasal PRP Plus Saline (Placebo)

Autologous platelet-rich plasma administered intranasally with saline applied in place of topical insulin as a placebo comparator.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Olfactory Function	Baseline to 12 months post-intervention	Change in olfactory function from baseline as measured using a validated smell identification test.

Contacts

CONTACTAmin Javer, MD

sinusdoc@me.com604-806-9926

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026