Nasal DiseasePhase 2/3NCT04046393
Investigating the Effect of Herbal Medicine Nasal Irrigation on Treatment of Chronic Rhinitis and Sinusitis
A Phase 2/3 study testing Taiwan Scientific" noninvasive blood pressure meter TS-0411, Meridian Energy Analysis Device(MEAD) and bacteria culture in people with Nasal Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Disease
- What is being tested?
- Taiwan Scientific" noninvasive blood pressure meter TS-0411, Meridian Energy Analysis Device(MEAD) and bacteria culture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Dec 2019to 14 Feb 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Chiayi City
Pei-Rung Yang, +886-5-3621000 ext. 2069
About this study
Official title: Chia Yi Chang Gung Memorial Hospital
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.
Read the 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.
- Conditions
- Nasal Disease
- Being tested
- Taiwan Scientific" noninvasive blood pressure meter TS-0411, Meridian Energy Analysis Device(MEAD), bacteria culture, nasopharyngoscopic examination, TCM nasal irrigation
- Keywords
- rhinitis, sinusitis, nasal irrigation, TCM
- Medical subject headings
- Nose Diseases, Rhinitis, Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taiwan Scientific" noninvasive blood pressure meter TS-0411Device
measure autonomic nerve
Meridian Energy Analysis Device(MEAD)Device
measure meridian energy
bacteria cultureProcedure or surgery
use culture swab to culture nasal discharge
nasopharyngoscopic examinationProcedure or surgery
use nasopharyngoscopy to determine the modified Lund-Kennedy endoscopic scoring system
TCM nasal irrigationCombination product
Chinese herbal medicine (licorice) extract solution with buffered salt packet and water in rinse bottle
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine(TCM) group | Experimental | nasal irrigation with Traditional herbal medicine(licorice) extract-saline isotonic solution Receives: Device: Taiwan Scientific" noninvasive blood pressure meter TS-0411; Device: Meridian Energy Analysis Device(MEAD); Procedure: bacteria culture; Procedure: nasopharyngoscopic examination; Combination Product: TCM nasal irrigation |
| Saline control group | Placebo comparator | nasal irrigation with saline isotonic solution Receives: Device: Taiwan Scientific" noninvasive blood pressure meter TS-0411; Device: Meridian Energy Analysis Device(MEAD); Procedure: bacteria culture; Procedure: nasopharyngoscopic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one month
Secondary outcomes (6)
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
Measured: 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
Measured: one month
Autonomic nerve (HRV)
Low frequency (ms2), High frequency (ms2), LF/HF(indicate autonomic function) change from baseline
Measured: one month
Meridian energy
Yang energy and Yin energy change from baseline
Measured: 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
Measured: 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
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start31 Dec 2019
- Primary completion1 Sep 2020 (estimated)
- Study completion14 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal DiseaseStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pei-Rung Yang, Study chair, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04046393
- Sponsor's protocol ID
- 201801970A3
- Status last verified
- Jun 2020
- First submitted
- 5 Aug 2019
- Last updated
- 22 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chia Yi Chang Gung Memorial Hospital
- ClinicalTrials.gov ID
- NCT04046393
- Acronym / sponsor ID
- 201801970A3
- Conditions
- Nasal Disease
- Keywords
- rhinitis, sinusitis, nasal irrigation, TCM
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 31 Dec 2019 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 14 Feb 2022 (estimated)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine(TCM) group | Experimental | Device: Taiwan Scientific" noninvasive blood pressure meter TS-0411, Device: Meridian Energy Analysis Device(MEAD), Procedure: bacteria culture, Procedure: nasopharyngoscopic examination, Combination Product: TCM nasal irrigationnasal irrigation with Traditional herbal medicine(licorice) extract-saline isotonic solution |
| Saline control group | Placebo comparator | Device: Taiwan Scientific" noninvasive blood pressure meter TS-0411, Device: Meridian Energy Analysis Device(MEAD), Procedure: bacteria culture, Procedure: nasopharyngoscopic examinationnasal irrigation with saline isotonic solution |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taiwan Scientific" noninvasive blood pressure meter TS-0411measure autonomic nerve | Device | Saline control group, Traditional Chinese Medicine(TCM) group |
| Meridian Energy Analysis Device(MEAD)measure meridian energy | Device | Saline control group, Traditional Chinese Medicine(TCM) group |
| bacteria cultureuse culture swab to culture nasal discharge | Procedure or surgery | Saline control group, Traditional Chinese Medicine(TCM) group |
| nasopharyngoscopic examinationuse nasopharyngoscopy to determine the modified Lund-Kennedy endoscopic scoring system | Procedure or surgery | Saline control group, Traditional Chinese Medicine(TCM) group |
| TCM nasal irrigationChinese herbal medicine (licorice) extract solution with buffered salt packet and water in rinse bottle | Combination product | Traditional Chinese Medicine(TCM) group |
Primary outcome
WHOQOL-brief score (Taiwan version)
Time frame: 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
6 secondary outcomes
22-item Sino-Nasal Outcome Test score (SNOT-22)
Time frame: one month
Total symptom score(TSS）
Time frame: one month
Autonomic nerve (HRV)
Time frame: one month
Meridian energy
Time frame: one month
Posttreatment culture negativity
Time frame: one month
Nasopharyngoscopic examination change
Time frame: one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Rung Yang study chair
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Taiwan Scientific" noninvasive blood pressure meter TS-0411, Meridian Energy Analysis Device(MEAD) and bacteria culture in people with Nasal Disease, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pei-Rung Yang (+886-5-3621000 ext. 2069, pamela750211@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WHOQOL-brief score (Taiwan version) (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.