Study of Chinese Herbal Medicine Nasal Irrigation Versus Saline for Post-Surgery Care in Adults with Chronic Rhinosinusitis

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 NeilMedae SINUS RINSEtrade 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.

Effect of Chinese Herbal Medicine Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis