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

NCT07511192 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: B-sitosterol versus vasline
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Epistaxis

Outcome Measures

Primary Outcomes (1)

• frequency of bleeding episodes

  total Number of bleeding episodes

  1 month

Study Arms (2)

Group A

ACTIVE COMPARATOR

81 patients will be managed by vasline

Drug: vasline

Group B

ACTIVE COMPARATOR

81 patients will be managed by B-sitosterol

Drug: B-sitosterol

Interventions

vasline DRUG

patients with epistaxis will be managed by vasline

Group A

B-sitosterol DRUG

patients with epistaxis will be managed by B-sitosterol

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Epistaxis

Interventions

Sitosterols

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phytosterols; Sterols; Membrane Lipids; Lipids; Phytochemicals; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant doctor at Assiut university hospital

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 6, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04