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临床试验/NCT07511192
NCT07511192尚未招募4 期

The Efficacy of Local Application of B-sitosterol Versus Vasline in Cases of Idiopathic Epistaxis

Assiut University0 个研究点目标入组 162 人开始时间: 2026年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
162
主要终点
frequency of bleeding episodes

研究概览

简要总结

Epistaxis, commonly known as nosebleed, is a frequent otorhinolaryngological complaint, affecting a large proportion of the population. Approximately 60% of individuals experience at least one episode during their lifetime, while around 6% require medical intervention'. The majority of cases are anterior in origin, arising from Kiesselbach's plexus in the anterior nasal septum(2) Idiopathic epistaxis refers to recurrent nasal bleeding without any identifiable local or systemic cause. (3) Factors such as mucosal dryness, minor trauma, inflammation, and environmental conditions can predispose the nasal mucosa to bleeding(4) Maintaining mucosal integrity and hydration is essential in preventing recurrence.

Conservative management remains the first-line treatment for anterior epistaxis. Strategies include direct nasal compression, topical vasoconstrictors, nasal packing, and application of moisturizing agents(5) Petroleum jelly (Vaseline) is widely used as a topical agent to maintain hydration, protect the mucosa, and reduce crust formation, thereby minimizing the risk of further bleeding(6) B-sitosterol, a plant-derived phytosterol, has shown anti-inflammatory, immunomodulatory, and tissue-healing properties in several experimental and clinical studies'(7,8) Its anti-inflammatory activity may stabilize the nasal mucosa and enhance repair processes, suggesting a potential therapeutic rol in conditions like idiopathic epistaxis(9) Previous studies hav demonstrated B-sitosterol's efficacy in reducing mucosal inflammation and promoting healing in other mucosal tissues, although its use in ENT applications remains underexplored'(7,8) Considering these properties, B-sitosterol may represent a promising topical alternative to conventional moisturizers such as Vaseline for managing idiopathic epistaxis. This study aims to evaluate and compare the efficacy of local B-sitosterol versus Vaseline in reducing the frequency, duration, and severity of nosebleeds in affected patients.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with recurrent idiopathic anterior epistaxis > = 2 episodes in last month
  • No systemic bleeding disorders
  • no nasal trauma or surgery in last months

排除标准

  • Patients on anticoagulants
  • Systemic disease affecting hemostasis (e.g. liver disease)
  • Known allergy to B-sitosterol or vasline

研究组 & 干预措施

Group A

Active Comparator

81 patients will be managed by vasline

干预措施: vasline (Drug)

Group B

Active Comparator

81 patients will be managed by B-sitosterol

干预措施: B-sitosterol (Drug)

结局指标

主要结局

frequency of bleeding episodes

时间窗: 1 month

total Number of bleeding episodes

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nada Mohamed Hussain Mohamed

residant doctor at Assiut university hospital

Assiut University

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