Investigating the Effect of Herbal Medicine Nasal Irrigation on Treatment of Chronic Rhinitis and Sinusitis
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- WHOQOL-brief score (Taiwan version) [one month]
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
Secondary Outcome Measures
- 22-item Sino-Nasal Outcome Test score (SNOT-22) [one month]
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
- Total symptom score(TSS） [one month]
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
- Autonomic nerve (HRV) [one month]
Low frequency (ms2), High frequency (ms2), LF/HF(indicate autonomic function) change from baseline
- Meridian energy [one month]
Yang energy and Yin energy change from baseline
- Posttreatment culture negativity [one month]
negative" means if no bacterial pathogen is identified on posttreatment culture but at least one has been present on pretreatment culture
- Nasopharyngoscopic examination change [one month]
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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chang Gung Memorial Hospital | Chiayi City | Taiwan |
Sponsors and Collaborators
- Chang Gung Memorial Hospital
Investigators
- Study Chair: Pei-Rung Yang, Chang Gung Memorial Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 201801970A3