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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Chia Yi Chang Gung Memorial Hospital

Conditions
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Nasal Disease

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnostic criteria for chronic rhinitis and sinusitis male and female volunteers. Stop using oral and topical steroid and anti-histamine treatments >2 weeks prior to enrollment. >20 years of age. Exclusion Criteria: Allergy to herbal medicine. Presence of a sinus tumor. Significant immune dysfunction. Pregnancy and breast-feeding women. Undergone nasal surgery <1 week prior to enrollment.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rhinitis, sinusitis, nasal irrigation, TCM