Actively Recruiting
Effect of Chinese Herbal Medicine Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis
Led by Taichung Veterans General Hospital · Updated on 2026-01-14
80
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of Chinese herbal medicine nasal irrigation compared to normal saline nasal irrigation as an additional treatment after functional endoscopic sinus surgery (FESS) in patients with chronic rhinosinusitis. This Phase 2 randomized, double-blind trial aims to assess the safety and effectiveness of these nasal irrigations in improving postoperative care and nasal symptoms. Participants are randomly assigned one month after FESS to receive either Chinese herbal medicine nasal irrigation or normal saline nasal irrigation. Both groups use a NeilMed ae SINUS RINSE trade; Squeeze Bottle to irrigate both nasal cavities twice daily with 240 mL of solution (120 mL per nostril) for two months. The herbal solution includes a mix of SHIN YI CHING FEY TANG, chrysanthemum, and Borneo camphor powder, while the control group uses a saline solution. During the study, patients complete a 22-item Sino-Nasal Outcome Test questionnaire, undergo endoscopic exams, nasal function tests, cytokine measurements, and bacterial cultures before surgery and before and after the irrigation period. Safety is monitored through self-reported adverse events and blood tests. The main outcomes measured are changes in sino-nasal symptoms and adverse events from before surgery to three months after surgery, with additional assessments of nasal cavity area, endoscopic scores, and nasal transit times. The study runs from July 2023 to March 2026.
CONDITIONS
Brief Title
Effect of Chinese Herbal Medicine Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with chronic rhinosinusitis who failed medical treatment
- Patients who underwent bilateral primary functional endoscopic sinus surgery
- Adults aged between 18 and 90 years
You will not qualify if you...
- History of immunodeficiency
- History of sinus surgery
- Antibiotic treatment within one week before functional endoscopic sinus surgery
- Pathological diagnosis of fungal sinusitis
- Pathological diagnosis of sinonasal tumor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 months
Participants perform nasal irrigation of either Chinese herbal medicine or normal saline twice daily for 2 months following functional endoscopic sinus surgery.
Daily nasal irrigation at home
Duration - 1 month
Participants are assessed for safety and efficacy outcomes including symptom questionnaires, endoscopic examinations, nasal function tests, and adverse events monitoring after completing nasal irrigation treatment.
Approximately 2 visits (before and after nasal irrigation treatment)
Trial Site Locations
Total: 1 location
1
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
Research Team
R
Rong-San Jiang, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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