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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03673384
• Other study ID #: B10304016
• Status: Completed
• Phase: N/A
• Start date: March 2, 2015
• Est. completion date: July 30, 2017

Study information

• Verified date: September 2018
• Source: Nanhua University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 30, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Device:
• infrared-C ray irradiation
Infrared-C irradiation by hot compress with a powered heating compress
• eye mask
infrared-C irradiation by hot compress with a powered heating eye mask

Drug:
• Xyzal Oral Product
used to relieve allergy symptoms, It works by blocking histamine that body secretes during an allergic reaction.
• Fluticasone Furoate
used to treat seasonal and perennial allergic rhinitis. It also helps to reduce the symptoms of seasonal allergic rhinitis.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Nanhua University	Buddhist Tzu Chi General Hospital, Solano Semiconductor Technology., LTD.

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 3 months
Primary	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.	Baseline to 3 months
Primary	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.	Baseline to 3 months
Primary	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.	Baseline to 3 months