An interventional study of Bee Venom Phonophoresis and Standard Care (oral decongestants + saline nasal irrigation) in Chronic Sinusitis, Acute Sinusitis and Rhinosinusitis, sponsored by Sinai University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Sinai University · Not applicable, Interventional, and Treatment
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.
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.
251 studies on the registry are indexed under Rhinosinusitis; 69 are open to participants now.
This study's planned enrollment of 30 is below the median of 74 across 177 interventional studies indexed under Rhinosinusitis.
Browse Rhinosinusitis studies →Sinai University is the lead sponsor of 24 studies on the registry; 11 are open to participants now.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
Ultrasound therapy device
(oral decongestants + saline nasal irrigation)
bee venom extract prepared for topical use)
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).
Time frame: 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).
Time frame: Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).
Change in Quality of Life
Measured using the SF-36 questionnaire, which assesses physical, emotional, and social health domains.
Time frame: Baseline (day 0), mid-intervention (week 2), and end of intervention (week 4).
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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