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

NCT ID: NCT03673384

Last Updated: 2018-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-02

Study Completion Date

2017-07-30

Brief Summary

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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

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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.

Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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experimental group

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.

Group Type EXPERIMENTAL

infrared-C ray irradiation

Intervention Type DEVICE

Infrared-C irradiation by hot compress with a powered heating compress

eye mask

Intervention Type DEVICE

infrared-C irradiation by hot compress with a powered heating eye mask

Xyzal Oral Product

Intervention Type DRUG

used to relieve allergy symptoms, It works by blocking histamine that body secretes during an allergic reaction.

Fluticasone Furoate

Intervention Type DRUG

used to treat seasonal and perennial allergic rhinitis. It also helps to reduce the symptoms of seasonal allergic rhinitis.

Control group

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

Group Type PLACEBO_COMPARATOR

Xyzal Oral Product

Intervention Type DRUG

used to relieve allergy symptoms, It works by blocking histamine that body secretes during an allergic reaction.

Fluticasone Furoate

Intervention Type DRUG

used to treat seasonal and perennial allergic rhinitis. It also helps to reduce the symptoms of seasonal allergic rhinitis.

Interventions

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infrared-C ray irradiation

Infrared-C irradiation by hot compress with a powered heating compress

Intervention Type DEVICE

eye mask

infrared-C irradiation by hot compress with a powered heating eye mask

Intervention Type DEVICE

Xyzal Oral Product

used to relieve allergy symptoms, It works by blocking histamine that body secretes during an allergic reaction.

Intervention Type DRUG

Fluticasone Furoate

used to treat seasonal and perennial allergic rhinitis. It also helps to reduce the symptoms of seasonal allergic rhinitis.

Intervention Type DRUG

Other Intervention Names

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infrared-C hot compress Long Chi Anti-histamine Steroid nasa spray

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Buddhist Tzu Chi General Hospital

OTHER

Sponsor Role collaborator

Solano Semiconductor Technology., LTD.

UNKNOWN

Sponsor Role collaborator

Nanhua University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chun-Chih Lin, Professor

Role: STUDY_DIRECTOR

Nanhua University

References

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Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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B10304016

Identifier Type: -

Identifier Source: org_study_id

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