Chronic SinusitisBEE-SONICNCT07151313
Efficacy of Bee Venom Phonophoresis in Treating Chronic Sinusitis:
A study testing Bee Venom Phonophoresis in people with Chronic Sinusitis and Acute Sinusitis, run by Sinai University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Sinusitis, Acute Sinusitis, Rhinosinusitis
- What is being tested?
- Bee Venom Phonophoresis
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2026to 25 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of Bee Venom Phonophoresis in Treating Chronic Sinusitis: A Double-Blind Randomized Controlled Trial
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.
Read the detailed description
Chronic sinusitis is a prevalent condition characterized by persistent inflammation of the paranasal sinuses, often resulting in nasal congestion, facial pain, and reduced quality of life. Conventional treatments, including antibiotics, nasal corticosteroids, and decongestants, may provide limited relief and can be associated with adverse effects. Bee venom possesses anti-inflammatory and analgesic properties, while phonophoresis - the use of ultrasound to enhance transdermal drug delivery - can facilitate deeper tissue penetration of therapeutic agents. Combining bee venom with phonophoresis may represent a novel, non-invasive treatment strategy for chronic sinusitis.
This randomized, double-blind, controlled clinical trial (BEE-SONIC) will enroll 30 adult participants aged 18-65 years with clinically diagnosed chronic or acute sinusitis. Participants will be randomly assigned to one of two groups: the intervention group will receive bee venom phonophoresis three times per week for the study duration, and the control group will receive standard care comprising oral decongestants and saline nasal irrigation. Ultrasound parameters for the intervention will be set at a frequency of 1 MHz and low-to-moderate intensity, with each sinus treated for 5-10 minutes per session.
The primary outcome measures are changes in symptom severity assessed by the Sino-Nasal Outcome Test (SNOT-22) and Visual Analog Scale (VAS) for pain, as well as quality of life measured by the SF-33 questionnaire. Secondary outcomes include reductions in facial pain and nasal congestion, and patient satisfaction with the treatment. Data will be collected at baseline, mid-intervention, and post-intervention. Statistical analysis will include descriptive statistics, paired t-tests, and ANOVA, with a significance threshold set at p < 0.05.
Ethics approval has been obtained from Sinai University's Human Research Ethics Committee, and all participants will provide written informed consent prior to study enrollment. Confidentiality will be maintained throughout the trial, and findings will be disseminated through peer-reviewed publications and conference presentations.
- Conditions
- Chronic Sinusitis, Acute Sinusitis, Rhinosinusitis
- Being tested
- Bee Venom Phonophoresis, Standard Care (oral decongestants + saline nasal irrigation)
- Keywords
- Sinusitis, Rhinosinusitis, Chronic, Rhinosinusitis, Acute
- Medical subject headings
- Rhinosinusitis, Sinusitis, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bee Venom PhonophoresisDevice
Ultrasound therapy device
Standard Care (oral decongestants + saline nasal irrigation)Drug
(oral decongestants + saline nasal irrigation)
Bee Venom PhonophoresisBiological
bee venom extract prepared for topical use)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Standard Care (oral decongestants + saline nasal irrigation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).
Secondary outcomes (1)
Change in Quality of Life
Measured using the SF-36 questionnaire, which assesses physical, emotional, and social health domains.
Measured: Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start15 Aug 2026 (estimated)
- Primary completion25 Oct 2027 (estimated)
- Study completion25 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Gomaa Atiaa, Sinai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151313
- Sponsor's protocol ID
- SU.REC.2025(48H)
- Acronym
- BEE-SONIC
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No