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

Assiut University

Status and phase: Not yet enrolling; Phase 4

Conditions: Epistaxis

Treatments: Drug: B-sitosterol; Drug: vasline

Study type: Interventional

Funder types: Other

Identifiers

NCT07511192

B-sitosterol versus vasline

Details and patient eligibility

About

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.

Enrollment: 162 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Group A

Active Comparator group

Description:

81 patients will be managed by vasline

Treatment:

Drug: vasline

Group B

Active Comparator group

Description:

81 patients will be managed by B-sitosterol

Treatment:

Drug: B-sitosterol