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Does carrageenan nasal spray improve quality of life in patients with chronic rhinosinusitis?

Effects of carrageenan nasal spray as additive therapy on quality of life and clinical outcome in patients diagnosed with chronic rhinosinusitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15435307
Enrollment
220
Registered
2017-06-30
Start date
2017-09-01
Completion date
Unknown
Last updated
2017-07-24

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

Conditions

Chronic Rhinosinusitis Ear, Nose and Throat Chronic Rhinosinusitis

Interventions

Patients diagnosed with chronic rhinosinusitis who did not receive any treatment in the past three months or patients diagnosed with chronic rhinosinusitis presenting for functional endoscopic sinus s

Sponsors

Medical University of Vienna
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with Chronic Rhinosinusitis who did not yet receive treatment and patients treated by functional endoscopic sinus surgery for the first time and have signed an informed consent form will be included in this study. If no medical treatment was applied in the last three months, patients are classified as treatment naive. 2. Chronic rhinosinusitis is diagnosed according to the clinical practice guidelines of the American Academy of Otolaryngology, Head and Neck Surgery. Patients meet the criteria when the following conditions are found: 2.1. Twelve weeks or longer of two or more of the following signs and symptoms: 2.1.1. Mucopurulent drainage (anterior, posterior, or both) 2.1.2. Nasal obstruction (congestion) 2.1.3. Facial pain-pressure-fullness or decreased sense of smell 2.2. Inflammation is documented by one or more of the following findings: 2.2.1. Purulent (not clear) mucus or edema in the middle meatus or anterior ethmoid region, 2.2.2. Polyps in nasal cavity or the middle meatus, and/or 2.2.3. Radiographic imaging showing inflammation of the paranasal sinuses 3. Ability to sign informed consent form 4. Signed informed consent form 5. Age over 18 years 6. Computed tomography scan showing signs of inflammation in the paranasal sinuses

Exclusion criteria

Exclusion criteria: 1. Patients diagnoses with medical conditions like allergic rhinitis, cystic fibrosis, immunocompromised state, ciliary dyskinesia, acetylsalicylic acid intolerance or severe anatomic variations 2. Pregnant women and minors 3. Patients who received nasal corticosteroid therapy for Chronic Rhinosinusitis in the prior three months and not presenting for surgery will not be included 4. Patients intending to use other nasal sprays during the study period, patients not able to use a nasal spray every day 5. Patients who had an adverse reaction to seaweed products will not be included

Design outcomes

Primary

MeasureTime frame
Quality of life is measured using SNOT-20 GAV questionnaire at baseline, after 60 days of treatment and 30 days after completion of treatment.

Secondary

MeasureTime frame
1. Necessity of surgery in the treatment naive group will be evaluated 90 days after enrollment 2. Onset of improved quality of life will be evaluated after 60 days of treatment

Countries

Austria

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026