Chinese herbal nasal rinses after sinus surgery
Effect of Chinese Herbal Medicine Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis
This test sees if daily Chinese herbal nasal rinses for two months help people recovering from FESS for chronic rhinosinusitis compared with normal saline.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Taichung Veterans General Hospital Academic / other |
| Locations | 1 site (Taichung) |
| Trial ID | NCT07340411 on ClinicalTrials.gov |
What this trial studies
In this randomized Phase 2 trial, adults who had bilateral primary functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis were assigned one month after surgery to receive either 240 mL daily Chinese herbal medicine nasal irrigation or 240 mL normal saline for two months. Symptoms were measured with the 22-item Sino-Nasal Outcome Test (SNOT-22) and patients underwent nasal endoscopy, nasal function tests, cytokine analysis of the irrigant, and bacterial cultures from the middle meatus before surgery and before and after the irrigation period. Safety monitoring included self-reported adverse events and blood tests. The trial compares symptom and objective findings between the herbal and saline groups as an adjunct to routine postoperative care.
Who should consider this trial
Good fit: Adults with chronic rhinosinusitis who failed medical therapy and underwent bilateral primary FESS, without immunodeficiency, prior sinus surgery, recent antibiotics, fungal sinusitis, or sinonasal tumor.
Not a fit: Patients with immunodeficiency, prior sinus surgery, fungal sinusitis, sinonasal tumors, or those unable to perform daily nasal irrigation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could reduce postoperative sinus symptoms and improve healing after FESS, possibly lowering the need for additional treatments.
How similar studies have performed: There is limited and mixed evidence from small trials on herbal or alternative nasal irrigations, so this approach remains relatively unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Patients with chronic rhinosinusitis who failed medical treatment 2.Patients underwent bilateral primary functional endoscopic sinus surgery. Exclusion Criteria: * 1\. Patients with a history of immunodeficiency 2.Patients with a history of sinus surgery 3.Patients who receiving antibiotic treatment within a week before functional endoscopic sinus surgery 4.Patients with a pathological diagnosis of fungal sinusitis 5.Patients with a pathological diagnosis of sinonasal tumor
Where this trial is running
Taichung
- Taichung Veterans General Hospital — Taichung, Taiwan (Recruiting)
Study contacts
- Principal investigator: Rong-San Jiang, MD, PhD — Taichung Veterans General Hospital
- Study coordinator: Rong-San Jiang, MD, PhD
- Email: rsjiang@vghtc.gov.tw
- Phone: 886-4-23592525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.