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

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

• Биопрепарат Intranasal PRP Plus Topical Insulin
  Autologous platelet-rich plasma administered intranasally with the addition of topical insulin applied to the olfactory cleft.
• Биопрепарат Intranasal PRP Plus Saline (Placebo)
  Autologous platelet-rich plasma administered intranasally with saline applied in place of topical insulin as a placebo comparator.

Первичные конечные точки

• Change in Olfactory Function [Срок оценки: Baseline to 12 months post-intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07383415 · H25-02495

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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