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
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
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
NCT ID
NCT03673384
First Posted
August 16, 2018
Last Updated
September 13, 2018
Sponsor
Nanhua University
Collaborators
Buddhist Tzu Chi General Hospital, Solano Semiconductor Technology., LTD.
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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