Investigating the Effect of Herbal Medicine Nasal Irrigation on Treatment of Chronic Rhinitis and Sinusitis
Chia Yi Chang Gung Memorial Hospital
1 other identifier
interventional
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2019
CompletedFirst Posted
Study publicly available on registry
August 6, 2019
CompletedStudy Start
First participant enrolled
December 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2022
CompletedJune 22, 2020
June 1, 2020
8 months
August 5, 2019
June 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
22-item Sino-Nasal Outcome Test score (SNOT-22)
one month
Total symptom score(TSS）
one month
Autonomic nerve (HRV)
one month
Meridian energy
one month
Posttreatment culture negativity
one month
- +1 more secondary outcomes
Study Arms (2)
Traditional Chinese Medicine(TCM) group
EXPERIMENTALnasal irrigation with Traditional herbal medicine(licorice) extract-saline isotonic solution
Saline control group
PLACEBO COMPARATORnasal irrigation with saline isotonic solution
Interventions
measure autonomic nerve
measure meridian energy
use culture swab to culture nasal discharge
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Chiayi City, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Pei-Rung Yang
Chang Gung Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2019
First Posted
August 6, 2019
Study Start
December 31, 2019
Primary Completion
September 1, 2020
Study Completion
February 14, 2022
Last Updated
June 22, 2020
Record last verified: 2020-06