Chronic RhinosinusitisPhase 2Breeze ClearNCT07340411
Effect of Chinese Herbal Medicine Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis
A Phase 2 study testing Chinese herbal medicine Powder and Salt Powder in people with Chronic Rhinosinusitis and Postoperative Care, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
Investigators tried to evaluate the efficacy and safety of Chinese herbal medicine nasal irrigation as an adjuvant therapy after FESS. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Rhinosinusitis, Postoperative Care
- What is being tested?
- Chinese herbal medicine Powder and Salt Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jul 2023to 31 Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients with chronic rhinosinusitis who failed medical treatment 2.Patients underwent bilateral primary functional endoscopic sinus surgery.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
Rong-San Jiang, MD, PhD, +886(4)23592525 ext. 4000, rsjiang@vghtc.gov.tw
Jing-Jie Wang, MD, +886(4)23592525 ext. 5401, nathan07302003@hotmail.com
About this study
Investigators tried to evaluate the efficacy and safety of Chinese herbal medicine nasal irrigation as an adjuvant therapy after FESS.
Read the 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.
- Conditions
- Chronic Rhinosinusitis, Postoperative Care
- Being tested
- Chinese herbal medicine Powder, Salt Powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbal medicine PowderDrug
Also called 2 gram of SHIN YI CHING FEY TANG, 0.5 gram of chrysanthemum, and 0.125 gram of Borneo camphor
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.
Salt PowderDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Chinese herbal medicine | Experimental | 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. Receives: Drug: Chinese herbal medicine Powder |
| Saline | Placebo comparator | 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. Receives: Drug: Salt Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From before operation to 3 months after surgery
Self-reported adverse events
Any adverse events occurring during the 2 months period of nasal irrigation
Measured: From before nasal irrigation to after 2-month nasal irrigation
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From before operation to 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start5 Jul 2023
- Primary completion1 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong-San Jiang, Taichung Veterans General Hospital
- Investigators
- Rong-San Jiang, MD, PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340411
- Sponsor's protocol ID
- CF23171A
- Other IDs
- TCVGH-1137302C
- Acronym
- Breeze Clear
- Status last verified
- Jan 2026
- First submitted
- 5 Jan 2026
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Outcome measures
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chinese Herbal Medicine Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT07340411
- Acronym / sponsor ID
- Breeze Clear / CF23171A
- Conditions
- Chronic Rhinosinusitis, Postoperative Care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators tried to evaluate the efficacy and safety of Chinese herbal medicine nasal irrigation as an adjuvant therapy after FESS.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese herbal medicine | Experimental | Drug: Chinese herbal medicine PowderIn 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. |
| Saline | Placebo comparator | Drug: Salt PowderIn 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patients with chronic rhinosinusitis who failed medical treatment 2.Patients underwent bilateral primary functional endoscopic sinus surgery.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese herbal medicine PowderAlso: 2 gram of SHIN YI CHING FEY TANG, 0.5 gram of chrysanthemum, and 0.125 gram of Borneo camphorThe 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. | Drug | Chinese herbal medicine |
| Salt PowderThe 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. | Drug | Saline |
Primary outcome
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.
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
3 secondary outcomes
Change of the second minimal cross-sectional area of the nasal cavity
Time frame: From before operation to 3 months after surgery
Change of endoscopic score
Time frame: From before operation to 3 months after surgery
Change of saccharine transit time
Time frame: From before operation to 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Yes. Outcome measures
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RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
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RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
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Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
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Enrolling by invitationObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rong-San Jiang, MD, PhD principal investigator
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chinese herbal medicine Powder and Salt Powder in people with Chronic Rhinosinusitis and Postoperative Care, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rong-San Jiang, MD, PhD (886-4-23592525 ext. 82620, rsjiang@vghtc.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Taiwanese version of the 22-item Sino-Nasal Outcome Test (time frame: From before operation to 3 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.