Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07340411

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Rhinosinusitis Postoperative Care

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chinese herbal medicine Powder

Drug

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

Salt Powder

Drug

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.

Primary outcomes

  1. Taiwanese version of the 22-item Sino-Nasal Outcome Test

    Time frame: From before operation to 3 months after surgery

    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.

  2. Self-reported adverse events

    Time frame: From before nasal irrigation to after 2-month nasal irrigation

    Any adverse events occurring during the 2 months period of nasal irrigation

Secondary outcomes

  1. Change of the second minimal cross-sectional area of the nasal cavity

    Time frame: From before operation to 3 months after surgery

    The second minimal cross-sectional area of the nasal cavity was measured by acoustic rhinometry.

  2. Change of endoscopic score

    Time frame: From before operation to 3 months after surgery

    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.

  3. Change of saccharine transit time

    Time frame: From before operation to 3 months after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rong-San Jiang, MD, PhD

CONTACT

[email protected]

886-4-23592525 ext. 82620

Sponsors and collaborators

Lead sponsor

Taichung Veterans General Hospital

Other

Registry information

Acronym: Breeze Clear

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.