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Effect of Health Promotion on Allergic Rhinitis by Infrared-C Ray Irradiation

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
infrared-C ray irradiation
eye mask
Xyzal Oral Product
Fluticasone Furoate
Sponsored by
Nanhua University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring far-infrared radiation, allergic rhinitis, IgE, eosinophil cationic protein, Taiwanese version of the 20-item Sinonasal Outcome Test, WHOQOL-BREF

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults that age 20 above and 50 below
  • Clinical diagnosis confirmed as allergic rhinitis
  • Conscious, no mental or cognitive impairment
  • Able to read, write or communicate in Mandarin, Taiwanese or Hakka, and agreed to participate

Exclusion Criteria:

  • Inflammatory skin wounds on the back of the shoulder, neck or lower back
  • Polyposis
  • Acute and chronic sinusitis
  • Vasomotor rhinitis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    experimental group

    Control group

    Arm Description

    Received infrared-C ray irradiation by hot compress with a powered heating compress and an eye mask for 40 minutes/time/day Treated regions: eyes and nose region, back region of head, shoulder neck and low back. Received medical treatment, e.g., Xyzal Oral Product and Fluticasone Furoate.

    received only medical treatment, e.g., Xyzal Oral Product and Fluticasone Furoate.

    Outcomes

    Primary Outcome Measures

    Score reduce in Taiwan's SNOT-20 nose and sinusitis evaluation form
    Measure of outcome in sino-nasal disorders such as sinusitis. Score will reduced after 3 months of the assignment.
    Change in the WHOQOL-BREF questionnaire, Taiwan version
    To measure the following broad domains: physical health, psychological health, social relationships, and environment. Score will increase after 3 months of the assignment.
    The amounts of the immunoglobulin E (IgE) level reduced after the assignment
    An immunoglobulin E (IgE) test measures the level of IgE, higher amounts of IgE antibodies found can be a sign that the body overreacts to allergens. This can lead to an allergic reaction. The level reduced means the assignment is effectively improve the symptoms of allergic rhinitis.
    the Eosinophil Cationic Protein (ECP) level reduced after the assignment
    Measuring Eosinophil Cationic Protein (ECP) levels has been used to evaluate eosinophil-mediated allergic inflammation, asthma, and rhinitis. Levels may reflect current allergen exposure. The level reduced means the assignment is effectively improve the symptoms of allergic rhinitis.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 16, 2018
    Last Updated
    September 13, 2018
    Sponsor
    Nanhua University
    Collaborators
    Buddhist Tzu Chi General Hospital, Solano Semiconductor Technology., LTD.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03673384
    Brief Title
    Effect of Health Promotion on Allergic Rhinitis by Infrared-C Ray Irradiation
    Official Title
    Effect of Health Promotion on Allergic Rhinitis by Infrared-C Ray Irradiation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2, 2015 (Actual)
    Primary Completion Date
    July 30, 2017 (Actual)
    Study Completion Date
    July 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nanhua University
    Collaborators
    Buddhist Tzu Chi General Hospital, Solano Semiconductor Technology., LTD.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Allergic rhinitis is one of the chronic illnesses. At present, the major treatments for allergic rhinitis are avoiding allergens, medical treatment and surgery. However, inadequate effects, and possible side effects of these treatments are still problems to these patients. Therefore, to find an effective non-medical and non-surgical treatment will be of great help in treating patients with allergic rhinitis. Infrared-C (far-infrared) ray irradiation is able to promote normal operation of autonomic nervous system, to improve blood circulation and thereby assumed to relieve discomfort symptoms of patients with vascular, specific or non-specific allergic rhinitis. Consequently, infrared-C ray irradiation is expected to be effective for the treatment of allergic rhinitis. The investigators aimed to probe the adjunct effects of infrared-C ray irradiation in terms of infrared-C hot compress in improving allergy symptoms like sneezing, rhinorrhea, nasal obstruction, nose and conjunctiva itching during a medical treatment for patients with allergic rhinitis. Moreover, the impact of infrared-C irradiation on health and life quality enhancement will also be studied.
    Detailed Description
    This is a quasi-experimental design. The study subjects are recruited from patients visited to a Ear-Nose-Throat Out Patient Department in a regional teaching hospital in south Taiwan. The sampling method is purposive sampling. The inclusion criteria are adults between 20 and 50 year-old with a definite clinical diagnosis of allergic rhinitis. Subjects were randomly divided into experimental and control groups. Thirty persons in the experimental group received both medical and infrared-C ray irradiation by hot compress as intervention. On the other hand, twenty persons in the control group took only medical treatment. Patients in experimental group received anti-histamine, steroid nasal spray and infrared-C ray irradiation for 40 minutes each time, and more than three times per week. The regions for hot compress included head, neck and shoulder, back and lower back, which covered many acupuncture points frequently used by traditional Chinese medicine for the treatment of allergic rhinitis, including point Dazhui (GV14), Dingchuan (EX-B1) , Dazhu (BL11), Fengmen (BL12), Feishu (BL13), Pishu (BL20), and Shenshu (BL23). In addition, patients also received infrared-C hot compress over face, eyes and nose during acute stage of allergic rhinitis. The investigators used a questionnaire as a pre-test to collect basic information of the subjects, and Taiwan's Sino-Nasal Outcome Test-20 (SNOT-20) nose and sinusitis evaluation form as pre-middle and post-test to evaluate the effect of the interventions. World Health Organization Quality of Life Instruments (WHOQOL-BREF) and Taiwan's concise edition of WHOQOL II questionnaire were also used as basic data collection tools for allergic rhinitis. Furthermore, blood tests for patient's serum Immunoglobulin E (IgE) and eosinophil cationic protein levels were determined before and after experiment. Pre-test for the experimental and control group was carried out before the intervention, the first post-test was performed 4 weeks later, and the second post-test was carried out 12 weeks later. Data was analyzed by SPSS 22.0 software.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Rhinitis
    Keywords
    far-infrared radiation, allergic rhinitis, IgE, eosinophil cationic protein, Taiwanese version of the 20-item Sinonasal Outcome Test, WHOQOL-BREF

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The sampling method is purposive sampling. The inclusion criteria are adults between 20 and 50 year-old with a definite clinical diagnosis of allergic rhinitis. Subjects were randomly divided into experimental and control groups. Thirty persons in the experimental group received both medical and infrared-C irradiation as intervention. On the other hand, twenty persons in the control group received only medical treatment. Patients in experimental group received anti-histamine, steroid nasal spray and infrared-C irradiation by hot compress for 40 minutes per time, and more than three times per week. The regions of hot compress included head, neck and shoulder, back and lower back, which covered many acupuncture points frequently used by traditional Chinese medicine for the treatment of allergic rhinitis. In addition, patients also received hot compress over face, eyes and nose during acute stage of allergic rhinitis.
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    Received infrared-C ray irradiation by hot compress with a powered heating compress and an eye mask for 40 minutes/time/day Treated regions: eyes and nose region, back region of head, shoulder neck and low back. Received medical treatment, e.g., Xyzal Oral Product and Fluticasone Furoate.
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    received only medical treatment, e.g., Xyzal Oral Product and Fluticasone Furoate.
    Intervention Type
    Device
    Intervention Name(s)
    infrared-C ray irradiation
    Other Intervention Name(s)
    infrared-C hot compress
    Intervention Description
    Infrared-C irradiation by hot compress with a powered heating compress
    Intervention Type
    Device
    Intervention Name(s)
    eye mask
    Other Intervention Name(s)
    Long Chi
    Intervention Description
    infrared-C irradiation by hot compress with a powered heating eye mask
    Intervention Type
    Drug
    Intervention Name(s)
    Xyzal Oral Product
    Other Intervention Name(s)
    Anti-histamine
    Intervention Description
    used to relieve allergy symptoms, It works by blocking histamine that body secretes during an allergic reaction.
    Intervention Type
    Drug
    Intervention Name(s)
    Fluticasone Furoate
    Other Intervention Name(s)
    Steroid nasa spray
    Intervention Description
    used to treat seasonal and perennial allergic rhinitis. It also helps to reduce the symptoms of seasonal allergic rhinitis.
    Primary Outcome Measure Information:
    Title
    Score reduce in Taiwan's SNOT-20 nose and sinusitis evaluation form
    Description
    Measure of outcome in sino-nasal disorders such as sinusitis. Score will reduced after 3 months of the assignment.
    Time Frame
    Baseline to 3 months
    Title
    Change in the WHOQOL-BREF questionnaire, Taiwan version
    Description
    To measure the following broad domains: physical health, psychological health, social relationships, and environment. Score will increase after 3 months of the assignment.
    Time Frame
    Baseline to 3 months
    Title
    The amounts of the immunoglobulin E (IgE) level reduced after the assignment
    Description
    An immunoglobulin E (IgE) test measures the level of IgE, higher amounts of IgE antibodies found can be a sign that the body overreacts to allergens. This can lead to an allergic reaction. The level reduced means the assignment is effectively improve the symptoms of allergic rhinitis.
    Time Frame
    Baseline to 3 months
    Title
    the Eosinophil Cationic Protein (ECP) level reduced after the assignment
    Description
    Measuring Eosinophil Cationic Protein (ECP) levels has been used to evaluate eosinophil-mediated allergic inflammation, asthma, and rhinitis. Levels may reflect current allergen exposure. The level reduced means the assignment is effectively improve the symptoms of allergic rhinitis.
    Time Frame
    Baseline to 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adults that age 20 above and 50 below Clinical diagnosis confirmed as allergic rhinitis Conscious, no mental or cognitive impairment Able to read, write or communicate in Mandarin, Taiwanese or Hakka, and agreed to participate Exclusion Criteria: Inflammatory skin wounds on the back of the shoulder, neck or lower back Polyposis Acute and chronic sinusitis Vasomotor rhinitis
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chun-Chih Lin, Professor
    Organizational Affiliation
    Nanhua University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Taiwan's SNOT-20 nose and sinusitis evaluation form, WHOQOL-BREF and Taiwan's concise edition of WHOQOL ii questionnaire were used as basic data collection tools for allergic rhinitis. blood tests for patient's serum IgE and eosinophil cationic protein levels will be collected.
    IPD Sharing Time Frame
    the study period is from 20, Apr 2015 to 30, Jun 2015.
    IPD Sharing Access Criteria
    Individual Participant Data (IPD) will not sharing with others people who no included in the study group.
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    Effect of Health Promotion on Allergic Rhinitis by Infrared-C Ray Irradiation

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