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Effects of mucolytic agents on postoperative outcomes and the nasal mucociliary clearance system in patients with chronic sinusitis and bilateral nasal polyps after endoscopic sinus surgery

Effects of mucolytic agents on postoperative outcomes and the nasal mucociliary clearance system in patients with chronic sinusitis and bilateral nasal polyps after endoscopic sinus surgery: A randomized, controlled, multi-center studyery

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055224
Enrollment
Unknown
Registered
2022-01-03
Start date
2022-01-03
Completion date
Unknown
Last updated
2023-01-16

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

Conditions

Chronic rhinosinusitis with polyposis

Interventions

Experimental group:Mometasone Furoate Nasal Spray + Nasal Rinse + Eucalyptus, Lime and Pinene Enteric Capsules
Control group:Mometasone Furoate Nasal Spray + Nasal Rinse

Sponsors

Beijing Tongren Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years (including critical value), gender is not limited; 2. According to the ''Chinese Chronic Rhinosinusitis Diagnosis and Treatment Guidelines 2018 Edition'', the diagnosis of patients with sinusitis and nasal polyps (sinus CT Lund-Mackay score >=10 points, at the same time, endoscopic nasal polyps Lund-Kennedy score >= 2 points) patients who are planning to undergo functional rhinoscopic surgery; 3. The patient signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who are allergic to experimental drugs or have drug intolerance (with gastrointestinal complications such as gallstones, kidney stones, cholecystitis, gastroenteritis or a history of severe diarrhea after taking the drug) are excluded; 2. Patients with contraindications to surgery were excluded; 3. Patients who have used oral hormones, antibiotics, nasal sprays containing traditional Chinese medicine, and nasal decongestants (including ephedrine and oxymetazoline) 4 weeks before surgery were excluded; 4. Patients with refractory rhinosinusitis (patients with recurrent chronic rhinosinusitis with secondary functional nasal endoscopy) or fungal rhinosinusitis, drug-induced rhinitis, acute rhinitis, and benign and malignant tumors of the nasal cavity and sinus are excluded; 5. Those with severe respiratory diseases as judged by the investigator: severe asthma, chronic obstructive pulmonary disease (COPD), emphysema and bronchitis, and those with acute upper respiratory tract infection within 2 weeks before screening were excluded; 6. Patients with ciliary dysfunction are excluded; 7. Patients with respiratory epithelial hamartoma or other conditions that are not eligible for inclusion in postoperative pathology, or patients who need oral glucocorticoids in the judgment of postoperative investigators are excluded; 8. Pregnancy and lactation; 9. Those with a clear history of neurological or mental disorders, such as epilepsy, dementia, and poor compliance; 10. Participate in other clinical trials within 4 weeks or the investigator thinks it is not suitable to participate in this research.

Design outcomes

Primary

MeasureTime frame
Mucociliary transport time;Nasal endoscopy Lund-Kennedy score;SNOT-22 rating;Visual Analog Scale (VAS) score for overall condition;Patient symptom score (MSS score);Disease control rate;

Secondary

MeasureTime frame
Lund-Mackay score;Nasal secretion immune factors, cytokines;Nasal pH;Pathological tissue samples;Cell activity;Ciliary beat frequency;Mucins MUC5AC and MUC5B expression and secretion;Ciliated cells differentiate;Goblet cell differentiation;Mucin expression and secretion;LPS-induced secretion of inflammatory cytokines;

Countries

China

Contacts

Public ContactZhang Luo

Beijing Tongren Hospital Affiliated to Capital Medical University

dr.luozhang@139.com+86 10 58265709

Outcome results

None listed

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