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

NCT07511192 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2026-04-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

vasline

patients with epistaxis will be managed by vasline

DRUG

B-sitosterol

patients with epistaxis will be managed by B-sitosterol

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-05-31
Completion
2027-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07511192 on ClinicalTrials.gov