Efficacy of Bee Venom Phonophoresis in Treating Chronic Sinusitis:

NCT07151313 | Not Yet Recruiting DMC

• 1 other identifier: SU.REC.2025(48H)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This double-blind, randomized controlled trial (BEE-SONIC) aims to evaluate the efficacy of bee venom phonophoresis in the treatment of chronic sinusitis. Thirty adult patients (aged 18-65 years) with clinically diagnosed chronic or acute sinusitis will be randomized into two groups: the intervention group will receive bee venom phonophoresis using low-to-moderate intensity ultrasound, while the control group will receive standard care consisting of oral decongestants and saline nasal irrigation. Primary outcomes include improvement in symptom severity (SNOT-22, Visual Analog Scale) and quality of life (SF-33). Secondary outcomes include reduction in facial pain, nasal congestion, and patient satisfaction. Data will be collected at baseline, midpoint, and post-intervention, and analyzed using paired t-tests and ANOVA. The study has received ethics approval from Sinai University's Human Research Ethics Committee, and informed consent will be obtained from all participants.

Conditions

Chronic Sinusitis; Acute Sinusitis; Rhinosinusitis

Keywords

Sinusitis; Rhinosinusitis, Chronic; Rhinosinusitis, Acute

Outcome Measures

Primary Outcomes (2)

• Change in Sinusitis Symptom Severity

  Measured using the Sino-Nasal Outcome Test (SNOT-22) questionnaire, which assesses nasal, facial, and functional symptoms on a 0-5 Likert scale (total score range: 0-110; higher scores indicate worse symptoms).

  Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).

• Change in Pain Intensity

  Measured using a Visual Analog Scale (VAS) for facial pain, ranging from 0 (no pain) to 10 (worst imaginable pain).

  Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).

Secondary Outcomes (1)

• Change in Quality of Life

  Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).

Study Arms (2)

Bee Venom Phonophoresis

EXPERIMENTAL

Participants receive bee venom phonophoresis therapy three times per week for the study duration. Ultrasound parameters set at 1 MHz frequency, low-to-moderate intensity, applied in circular or linear motion for 5-10 minutes per sinus. Bee venom is mixed with ultrasound coupling gel and applied to targeted sinus areas. Intervention Name: Bee Venom Phonophoresis

Device: Bee Venom Phonophoresis; Biological: Bee Venom Phonophoresis

Standard Care

PLACEBO COMPARATOR

Participants receive standard medical treatment for sinusitis, consisting of oral decongestants and saline nasal irrigation, according to local clinical guidelines.

Drug: Standard Care (oral decongestants + saline nasal irrigation)

Interventions

Bee Venom Phonophoresis DEVICE

Ultrasound therapy device

Bee Venom Phonophoresis

Standard Care (oral decongestants + saline nasal irrigation) DRUG

(oral decongestants + saline nasal irrigation)

Standard Care

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 to 65 years.
• Clinical diagnosis of chronic sinusitis (symptoms ≥ 12 weeks) or acute sinusitis confirmed by an otolaryngologist.
• Willing and able to provide written informed consent.

You may not qualify if:

• Known allergy or hypersensitivity to bee venom or bee products.
• Skin conditions (e.g., eczema, dermatitis, open wounds) over the area of ultrasound application.
• Severe comorbid medical conditions (e.g., uncontrolled asthma, autoimmune disease, malignancy).
• Pregnancy or breastfeeding.
• Use of systemic corticosteroids, antibiotics, or other medications that may significantly alter sinusitis symptoms within 4 weeks prior to enrollment.
• Participation in another clinical trial within the past 30 days.

Sponsors & Collaborators

• Sinai University: lead

Study Sites (1)

Sinai university

Cairo, 44511, Egypt

Location

MeSH Terms

Conditions

Rhinosinusitis; Sinusitis; Bronchiolitis Obliterans Syndrome

Interventions

Standard of Care; Nasal Decongestants

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Vasoconstrictor Agents; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Respiratory System Agents

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Double Blind (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: September 3, 2025
• Study Start: September 15, 2025
• Primary Completion: December 25, 2025
• Study Completion (Estimated): December 25, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-09

Locations

EG (1)