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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Change in Olfactory Function
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PRP Plus Topical Insulin
Participants receive intranasal platelet-rich plasma in combination with topical insulin.
干预措施: Intranasal PRP Plus Topical Insulin (Biological)
PRP Alone
Participants receive intranasal platelet-rich plasma with saline instead of insulin.
干预措施: Intranasal PRP Plus Saline (Placebo) (Biological)
结局指标
主要结局
Change in Olfactory Function
时间窗: Baseline to 12 months post-intervention
Change in olfactory function from baseline as measured using a validated smell identification test.
次要结局
未报告次要终点
研究者
Amin Javer
MD
St. Paul's Hospital, Canada