The Efficacy of Local Application of B-sitosterol Versus Vasline in Cases of Idiopathic Epistaxis
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
- 否
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
81 patients will be managed by vasline
干预措施: vasline (Drug)
Group B
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
Nada Mohamed Hussain Mohamed
residant doctor at Assiut university hospital
Assiut University
