Investigating the Effect of Herbal Medicine Nasal Irrigation on Treatment of Chronic Rhinitis and Sinusitis
NCT ID: NCT04046393
Last Updated: 2020-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
250 participants
INTERVENTIONAL
2019-12-31
2022-02-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Traditional Chinese Medicine(TCM) group
nasal irrigation with Traditional herbal medicine(licorice) extract-saline isotonic solution
Taiwan Scientific" noninvasive blood pressure meter TS-0411
measure autonomic nerve
Meridian Energy Analysis Device(MEAD)
measure meridian energy
bacteria culture
use culture swab to culture nasal discharge
nasopharyngoscopic examination
use nasopharyngoscopy to determine the modified Lund-Kennedy endoscopic scoring system
TCM nasal irrigation
Chinese herbal medicine (licorice) extract solution with buffered salt packet and water in rinse bottle
Saline control group
nasal irrigation with saline isotonic solution
Taiwan Scientific" noninvasive blood pressure meter TS-0411
measure autonomic nerve
Meridian Energy Analysis Device(MEAD)
measure meridian energy
bacteria culture
use culture swab to culture nasal discharge
nasopharyngoscopic examination
use nasopharyngoscopy to determine the modified Lund-Kennedy endoscopic scoring system
Interventions
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Taiwan Scientific" noninvasive blood pressure meter TS-0411
measure autonomic nerve
Meridian Energy Analysis Device(MEAD)
measure meridian energy
bacteria culture
use culture swab to culture nasal discharge
nasopharyngoscopic examination
use nasopharyngoscopy to determine the modified Lund-Kennedy endoscopic scoring system
TCM nasal irrigation
Chinese herbal medicine (licorice) extract solution with buffered salt packet and water in rinse bottle
Eligibility Criteria
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Inclusion Criteria
2. Stop using oral and topical steroid and anti-histamine treatments \>2 weeks prior to enrollment.
3. \>20 years of age.
Exclusion Criteria
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.
20 Years
85 Years
ALL
Yes
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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Pei-Rung Yang
Role: STUDY_CHAIR
Chang Gung Memorial Hospital
Locations
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Chang Gung Memorial Hospital
Chiayi City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Pei-Rung Yang
Role: primary
Other Identifiers
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201801970A3
Identifier Type: -
Identifier Source: org_study_id
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