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

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07511192
Enrollment
162
Registered
2026-04-06
Start date
2026-05-01
Completion date
2027-12-01
Last updated
2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epistaxis

Brief 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.

Interventions

DRUGvasline

patients with epistaxis will be managed by vasline

DRUGB-sitosterol

patients with epistaxis will be managed by B-sitosterol

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
frequency of bleeding episodes1 monthtotal Number of bleeding episodes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026