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

Taichung Veterans General Hospital

Status and phase: Enrolling; Phase 2

Conditions: Chronic Rhinosinusitis; Postoperative Care

Treatments: Drug: Chinese herbal medicine Powder; Drug: Salt Powder

Study type: Interventional

Funder types: Other

Identifiers

NCT07340411

CF23171A

TCVGH-1137302C (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Chinese herbal medicine

Experimental group

Description:

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.

Treatment:

Drug: Chinese herbal medicine Powder

Saline

Placebo Comparator group

Description:

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.

Treatment:

Drug: Salt Powder