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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

Tracking Information
First Submitted Date  ICMJE August 5, 2019
First Posted Date  ICMJE August 6, 2019
Last Update Posted Date November 13, 2019
Estimated Study Start Date  ICMJE November 1, 2019
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
WHOQOL-BREF 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
  • 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
  • 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
  • Autonomic nerve (HRV) [ Time Frame: one month ]
    Low frequency (ms2), High frequency (ms2), LF/HF(indicate autonomic function) change from baseline
  • Meridian energy [ Time Frame: one month ]
    Yang energy and Yin energy change from baseline
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2019)
  • 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
  • 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
  • Autonomic nerve (HRV) change [ Time Frame: one month ]
    LF(ms2), HF(ms2), LF/HF, SDNN (ms), RMMSD (ms) change from baseline
  • Meridian energy change [ Time Frame: one month ]
    Yang energy and Yin energy chage from baseline
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigating the Effect of Herbal Medicine Nasal Irrigation on Treatment of Chronic Rhinitis and Sinusitis
Official Title  ICMJE Chia Yi 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Nasal Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Traditional Chinese Medicine(TCM) group
    nasal irrigation with Traditional herbal medicine(licorice) extract-saline isotonic solution
    Interventions:
    • 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
  • Placebo Comparator: Saline control group
    nasal irrigation with saline isotonic solution
    Interventions:
    • Device: Taiwan Scientific" noninvasive blood pressure meter TS-0411
    • Device: Meridian Energy Analysis Device(MEAD)
    • Procedure: bacteria culture
    • Procedure: nasopharyngoscopic examination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 5, 2019)
250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 14, 2022
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pei-Rung Yang +886-5-3621000 ext 2069 pamela750211@hotmail.com
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04046393
Other Study ID Numbers  ICMJE 201801970A3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chang Gung Memorial Hospital
Study Sponsor  ICMJE Chang Gung Memorial Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Pei-Rung Yang Chang Gung Memorial Hospital
PRS Account Chang Gung Memorial Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP