Investigating the Effect of Herbal Medicine Nasal Irrigation on Treatment of Chronic Rhinitis and Sinusitis

Chia Yi Chang Gung Memorial Hospital

This study investigate the nasal irrigation with Traditional herbal medicine extract-saline isotonic solution in the treatment of chronic rhinitis and sinusitis. Half of participants will receive Traditional herbal medicine extract-saline isotonic solution nasal irrigation, while the other half will receive saline alone nasal irrigation.

Study Overview

• Status: Unknown
• Conditions: Nasal Disease
• Intervention / Treatment: Device: Taiwan Scientific" noninvasive blood pressure meter TS-0411; Device: Meridian Energy Analysis Device(MEAD); Procedure: bacteria culture; Procedure: nasopharyngoscopic examination; Combination product: TCM nasal irrigation

Detailed Description

In the program, the investigators plan to investigate a clinical triad to research the outcomes of nasal irrigation with Traditional herbal medicine extract-saline isotonic solution for treatment of chronic rhinitis and sinusitis. The aims of this study are listed below:

Aim 1: evaluating the outcomes and quality of life of nasal irrigation with Traditional herbal medicine extract-saline isotonic solution to treat enrolled patients with chronic rhinitis or sinusitis. The investigators use modern devices to evaluate the autonomic nerve, meridian energy and pulse. The questionnaires of quality of life and symptoms will be recorded. Nasal irrigation with saline alone will be conducted during the clinical triad to compare the effectiveness and quality of life with Traditional herbal medicine extract.

Aim 2: analyzing the changes of bacteria culture in nasal discharge collected during the clinical triad before and after nasal irrigation for investigating the microenvironment of Traditional herbal medicine extract-saline isotonic solution.

According to the research, the investigators will realize the improvement of using Traditional herbal medicine extract-saline isotonic solution for nasal irrigation to treat sino-nasal diseases, by investigating the changes of quality of life and microenvironment of nasal cavity. The nasopharyngoscopic examination, autonomic nerve, meridian energy and pulse were record to compare the effectiveness of Traditional herbal medicine extract-saline isotonic solution with nasal irrigation with saline alone.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Chiayi City, Taiwan
    • Recruiting
    • Chang Gung Memorial Hospital
    • Contact: Pei-Rung Yang; Phone Number: 2069 +886-5-3621000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Diagnostic criteria for chronic rhinitis and sinusitis male and female volunteers.
2. Stop using oral and topical steroid and anti-histamine treatments >2 weeks prior to enrollment.
3. >20 years of age.

Exclusion Criteria:

1. Allergy to herbal medicine.
2. Presence of a sinus tumor.
3. Significant immune dysfunction.
4. Pregnancy and breast-feeding women.
5. Undergone nasal surgery <1 week prior to enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traditional Chinese Medicine(TCM) group; nasal irrigation with Traditional herbal medicine(licorice) extract-saline isotonic solution	Device: Taiwan Scientific" noninvasive blood pressure meter TS-0411; measure autonomic nerve; Device: Meridian Energy Analysis Device(MEAD); measure meridian energy; Procedure: bacteria culture; use culture swab to culture nasal discharge; Procedure: nasopharyngoscopic examination; use nasopharyngoscopy to determine the modified Lund-Kennedy endoscopic scoring system; Combination product: TCM nasal irrigation; Chinese herbal medicine (licorice) extract solution with buffered salt packet and water in rinse bottle
Placebo Comparator: Saline control group; nasal irrigation with saline isotonic solution	Device: Taiwan Scientific" noninvasive blood pressure meter TS-0411; measure autonomic nerve; Device: Meridian Energy Analysis Device(MEAD); measure meridian energy; Procedure: bacteria culture; use culture swab to culture nasal discharge; Procedure: nasopharyngoscopic examination; use nasopharyngoscopy to determine the modified Lund-Kennedy endoscopic scoring system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WHOQOL-brief score (Taiwan version)	consisting of 28 items, each scored from 1 to 5; total score recorded as the sum of all items change from baseline: the questionnaires of quality of life	one month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
22-item Sino-Nasal Outcome Test score (SNOT-22)	consisting of 22 items, each scored from 0 to 5; total score recorded as the sum of all items, 0 to 110 change from baseline: the questionnaires of chronic sinusitis severity	one month
Total symptom score(TSS）	consisting of 4 items, each scored from 0 to 3; total score recorded as the sum of all items, 0 to 12 change from baseline: the questionnaires of chronic rhinitis severity	one month
Autonomic nerve (HRV)	Low frequency (ms2), High frequency (ms2), LF/HF(indicate autonomic function) change from baseline	one month
Meridian energy	Yang energy and Yin energy change from baseline	one month
Posttreatment culture negativity	negative" means if no bacterial pathogen is identified on posttreatment culture but at least one has been present on pretreatment culture	one month
Nasopharyngoscopic examination change	consisting of 3 items, each scored from 0 to 2; total score recorded as the sum of both side all items, 0 to 12 change from baseline	one month

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Chair: Pei-Rung Yang, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2019
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): February 14, 2022

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): June 22, 2020
• Last Update Submitted That Met QC Criteria: June 18, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: rhinitis, sinusitis, nasal irrigation, TCM
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases
• Other Study ID Numbers: 201801970A3

Drug and device information, study documents

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