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NCT Number: NCT07383415

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intranasal PRP Plus Topical Insulin

Biological

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amin Javer, MD

CONTACT

[email protected]

604-806-9926

Sponsors and collaborators

Lead sponsor

Amin Javer

Other

Registry information

Official study 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

Acronym: PRP-I RCT

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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