Investigating the Effect of Herbal Medicine Nasal Irrigation on Treatment of Chronic Rhinitis and Sinusitis
Primary Purpose
Nasal Disease
Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
Taiwan Scientific" noninvasive blood pressure meter TS-0411
Meridian Energy Analysis Device(MEAD)
bacteria culture
nasopharyngoscopic examination
TCM nasal irrigation
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Disease focused on measuring rhinitis, sinusitis, nasal irrigation, TCM
Eligibility 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.
Sites / Locations
- Chang Gung Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Traditional Chinese Medicine(TCM) group
Saline control group
Arm Description
nasal irrigation with Traditional herbal medicine(licorice) extract-saline isotonic solution
nasal irrigation with saline isotonic solution
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Autonomic nerve (HRV)
Low frequency (ms2), High frequency (ms2), LF/HF(indicate autonomic function) change from baseline
Meridian energy
Yang energy and Yin energy change from baseline
Posttreatment culture negativity
negative" means if no bacterial pathogen is identified on posttreatment culture but at least one has been present on pretreatment culture
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
Full Information
NCT ID
NCT04046393
First Posted
August 5, 2019
Last Updated
June 18, 2020
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04046393
Brief Title
Investigating the Effect of Herbal Medicine Nasal Irrigation on Treatment of Chronic Rhinitis and Sinusitis
Official Title
Chia Yi Chang Gung Memorial Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 31, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
February 14, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Disease
Keywords
rhinitis, sinusitis, nasal irrigation, TCM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Traditional Chinese Medicine(TCM) group
Arm Type
Experimental
Arm Description
nasal irrigation with Traditional herbal medicine(licorice) extract-saline isotonic solution
Arm Title
Saline control group
Arm Type
Placebo Comparator
Arm Description
nasal irrigation with saline isotonic solution
Intervention Type
Device
Intervention Name(s)
Taiwan Scientific" noninvasive blood pressure meter TS-0411
Intervention Description
measure autonomic nerve
Intervention Type
Device
Intervention Name(s)
Meridian Energy Analysis Device(MEAD)
Intervention Description
measure meridian energy
Intervention Type
Procedure
Intervention Name(s)
bacteria culture
Intervention Description
use culture swab to culture nasal discharge
Intervention Type
Procedure
Intervention Name(s)
nasopharyngoscopic examination
Intervention Description
use nasopharyngoscopy to determine the modified Lund-Kennedy endoscopic scoring system
Intervention Type
Combination Product
Intervention Name(s)
TCM nasal irrigation
Intervention Description
Chinese herbal medicine (licorice) extract solution with buffered salt packet and water in rinse bottle
Primary Outcome Measure Information:
Title
WHOQOL-brief score (Taiwan version)
Description
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
Secondary Outcome Measure Information:
Title
22-item Sino-Nasal Outcome Test score (SNOT-22)
Description
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
Title
Total symptom score(TSS)
Description
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
Title
Autonomic nerve (HRV)
Description
Low frequency (ms2), High frequency (ms2), LF/HF(indicate autonomic function) change from baseline
Time Frame
one month
Title
Meridian energy
Description
Yang energy and Yin energy change from baseline
Time Frame
one month
Title
Posttreatment culture negativity
Description
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
Title
Nasopharyngoscopic examination change
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Rung Yang
Phone
+886-5-3621000
Ext
2069
Email
pamela750211@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Rung Yang
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Chiayi City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pei-Rung Yang
Phone
+886-5-3621000
Ext
2069
12. IPD Sharing Statement
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Investigating the Effect of Herbal Medicine Nasal Irrigation on Treatment of Chronic Rhinitis and Sinusitis
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