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Investigating the Effect of Herbal Medicine Nasal Irrigation on Treatment of Chronic Rhinitis and Sinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04046393
Recruitment Status : Not yet recruiting
First Posted : August 6, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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
Nasal Disease 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chia Yi Chang Gung Memorial Hospital
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : February 14, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 22-item Sino-Nasal Outcome Test score (SNOT-22) [ Time Frame: 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

  2. Total symptom score(TSS) [ Time Frame: 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

  3. Autonomic nerve (HRV) [ Time Frame: one month ]
    Low frequency (ms2), High frequency (ms2), LF/HF(indicate autonomic function) change from baseline

  4. Meridian energy [ Time Frame: one month ]
    Yang energy and Yin energy change from baseline

  5. Posttreatment culture negativity [ Time Frame: one month ]
    negative" means if no bacterial pathogen is identified on posttreatment culture but at least one has been present on pretreatment culture

  6. Nasopharyngoscopic examination change [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Diagnostic criteria for chronic rhinitis and sinusitis male and female volunteers.
  2. Stop using oral and topical steroid and anti-histamine treatments >2 weeks prior to enrollment.
  3. >20 years of age.

Exclusion Criteria:

  1. Allergy to herbal medicine.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04046393


Contacts
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Contact: Pei-Rung Yang +886-5-3621000 ext 2069 pamela750211@hotmail.com

Locations
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Taiwan
Chang Gung Memorial Hospital
Chiayi City, Taiwan
Contact: Pei-Rung Yang    +886-5-3621000 ext 2069      
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Chair: Pei-Rung Yang Chang Gung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT04046393    
Other Study ID Numbers: 201801970A3
First Posted: August 6, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
rhinitis, sinusitis, nasal irrigation, TCM
Additional relevant MeSH terms:
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Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases