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

Nasal Disease Clinical Trial

Official title:

Chia Yi Chang Gung Memorial Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04046393
• Other study ID #: 201801970A3
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 31, 2019
• Est. completion date: February 14, 2022

Study information

• Verified date: June 2020
• Source: Chang Gung Memorial Hospital
• Contact: Pei-Rung Yang
• Phone: +886-5-3621000
• Email: pamela750211[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: February 14, 2022
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nasal Disease
• Nose Diseases

Intervention

Device:
• Taiwan Scientific" noninvasive blood pressure meter TS-0411
measure autonomic nerve
• Meridian Energy Analysis Device(MEAD)
measure meridian energy

Procedure:
• bacteria culture
use culture swab to culture nasal discharge
• 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

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Chiayi City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Autonomic nerve (HRV)	Low frequency (ms2), High frequency (ms2), LF/HF(indicate autonomic function) change from baseline	one month
Secondary	Meridian energy	Yang energy and Yin energy change from baseline	one month
Secondary	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
Secondary	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