Effect of Chinese Herbal Medicine Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis (Breeze Clear)

Investigators tried to evaluate the efficacy and safety of Chinese herbal medicine nasal irrigation as an adjuvant therapy after FESS.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Care; Chronic Rhinosinusitis
• Intervention / Treatment: Drug: Chinese herbal medicine Powder; Drug: Salt Powder

Detailed Description

In this study, patients with chronic rhinosinusitis who received FESS were recruited and randomly assigned to 2 groups at one month post-surgery. Patients in the xylitol group received 240ml of Chinese herbal medicine nasal irrigation daily for 2 months, and those in the normal saline (NS) group received 240ml of NS nasal irrigation daily for 2 months. Before FESS as well as before and after nasal irrigation, sino-nasal symptoms were assessed by a 22-item Sino-Nasal Outcome Test questionnaire and patients received endoscopic examination, nasal function tests, cytokine measurement of nasal irrigant, and bacterial culture from the middle meatus. The safety of nasal irrigation was assessed by self-reported adverse events, and blood test. This study tried to evaluate the efficacy and safety of Chinese herbal medicine nasal irrigation as an adjuvant therapy after FESS.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rong-San Jiang, MD, PhD; Phone Number: 82620 886-4-23592525; Email: rsjiang@vghtc.gov.tw

Study Locations

• Taiwan
  • Taichung, Taiwan, 40705
    • Recruiting
    • Taichung Veterans General Hospital
    • Contact: Rong-San Jiang, MD, PhD; Phone Number: 4000 +886(4)23592525; Email: rsjiang@vghtc.gov.tw
    • Contact: Jing-Jie Wang, MD; Phone Number: 5401 +886(4)23592525; Email: nathan07302003@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chinese herbal medicine; In the Chinese herbal medicine group, Chinese herbal medicine nasal irrigant was first prepared by mixing a pack of 2 gram of SHIN YI CHING FEY TANG, 0.5 gram of chrysanthemum, and 0.125 gram of Borneo camphor powder with 240mL of sterile water in the container of the irrigator. Nasal irrigation was performed by using a NeilMed® SINUS RINSE™ Squeeze Bottle (NeilMed Pharmaceuticals, Inc., Santa Rosa, CA ). When irrigating the nose, patients irrigated both of their nasal cavities each with 120 mL of solutions twice a day. Patients performed nasal irrigations for 2 months.	Drug: Chinese herbal medicine Powder; The bilateral nasal cavity was irrigated by using a NeilMed® SINUS RINSE™ Squeeze Bottle containing 240ml of Chinese herbal medicine solution twice a day for 2 months.; Other Names: 2 gram of SHIN YI CHING FEY TANG, 0.5 gram of chrysanthemum, and 0.125 gram of Borneo camphor
Placebo Comparator: Saline; In the saline group, the normal saline solution was prepared by mixing 1 pack of 2.16 gram salt powder with 240mL of sterile water in the container of the irrigator. Nasal irrigation was performed by using a NeilMed® SINUS RINSE™ Squeeze Bottle (NeilMed Pharmaceuticals, Inc., Santa Rosa, CA ). When irrigating the nose, patients irrigated both of their nasal cavities each with 120 mL of solutions twice a day. Patients performed nasal irrigations for 2 months.	Drug: Salt Powder; The bilateral nasal cavity was irrigated by using a NeilMed® SINUS RINSE™ Squeeze Bottle containing 240ml of of normal saline twice a day for 2 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Taiwanese version of the 22-item Sino-Nasal Outcome Test	The Taiwanese version of the 22-item Sino-Nasal Outcome Test contains 22 items of symptoms and social/emotional consequences from nasal disorder. Patients are asked to rate their problems based on how they have been over the past two weeks. Each item is graded from 0 (no problem) to 5 (as bad as it can be) according to its severity and frequency.	From before operation to 3 months after surgery
Self-reported adverse events	Any adverse events occurring during the 2 months period of nasal irrigation	From before nasal irrigation to after 2-month nasal irrigation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the second minimal cross-sectional area of the nasal cavity	The second minimal cross-sectional area of the nasal cavity was measured by acoustic rhinometry.	From before operation to 3 months after surgery
Change of endoscopic score	The endoscopic appearances were categorized into polyps (0: no polyps; 1: polyps present within the middle meatus; 2: polyps beyond the middle meatus); nasal secretion (0: no secretion; 1: clear, thin secretion; 2: thick, purulent secretion); mucosal edema; scarring; crusting; (0: absent; 1: mild; 2: severe). The score ranged from 0 to 20 for both nostrils together.	From before operation to 3 months after surgery
Change of saccharine transit time	The saccharine transit test involved placing saccharine granules under the head of the inferior turbinate in the more severely affected nostril. The time interval (minute) between placement of saccharine granules and sensation of sweetness in the throat was recorded.	From before operation to 3 months after surgery

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Investigators: Principal Investigator: Rong-San Jiang, MD, PhD, Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: January 5, 2026
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CF23171A; TCVGH-1137302C (Other Grant/Funding Number: Taichung Veterans General Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Outcome measures
• IPD Sharing Time Frame: 2 years after the end of the study
• IPD Sharing Access Criteria: Study Data/Document can be requested from the PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No