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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
250
measure autonomic nerve
measure meridian energy
use culture swab to culture nasal discharge
Chang Gung Memorial Hospital
Chiayi City, Taiwan
RECRUITINGWHOQOL-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
Time frame: one month
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
Time frame: 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
Time frame: one month
Autonomic nerve (HRV)
Low frequency (ms2), High frequency (ms2), LF/HF(indicate autonomic function) change from baseline
Time frame: one month
Meridian energy
Yang energy and Yin energy change from baseline
Time frame: 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
Time frame: 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
Time frame: one month
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use nasopharyngoscopy to determine the modified Lund-Kennedy endoscopic scoring system
Chinese herbal medicine (licorice) extract solution with buffered salt packet and water in rinse bottle