NCT07340411

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2023

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

January 5, 2026

Last Update Submit

January 5, 2026

Conditions

Postoperative CareChronic Rhinosinusitis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Change of the second minimal cross-sectional area of the nasal cavity

    From before operation to 3 months after surgery

  • Change of endoscopic score

    From before operation to 3 months after surgery

  • Change of saccharine transit time

    From before operation to 3 months after surgery

Study Arms (2)

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.

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.

Drug: Salt Powder

Interventions

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.

Saline
Chinese herbal medicine PowderDRUG

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.

Also known as: 2 gram of SHIN YI CHING FEY TANG, 0.5 gram of chrysanthemum, and 0.125 gram of Borneo camphor
Chinese herbal medicine

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Patients with chronic rhinosinusitis who failed medical treatment 2.Patients underwent bilateral primary functional endoscopic sinus surgery.

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

Study Officials

  • Rong-San Jiang, MD, PhD

    Taichung Veterans General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong-San Jiang, MD, PhD

CONTACT

886-4-23592525rsjiang@vghtc.gov.tw

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
visiting doctor

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 14, 2026

Study Start

July 5, 2023

Primary Completion

March 1, 2026

Study Completion

March 31, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Outcome measures

Shared Documents
STUDY PROTOCOL
Time Frame
2 years after the end of the study
Access Criteria
Study Data/Document can be requested from the PI.
More information

Locations

TW(1)