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

NCT03673384 | Completed DMC

• 1 other identifier: B10304016
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allergic Rhinitis

Keywords

far-infrared radiation; allergic rhinitis; IgE; eosinophil cationic protein; Taiwanese version of the 20-item Sinonasal Outcome Test; WHOQOL-BREF

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

experimental group

EXPERIMENTAL

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.

Device: infrared-C ray irradiation; Device: eye mask; Drug: Xyzal Oral Product; Drug: Fluticasone Furoate

Control group

PLACEBO COMPARATOR

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

Drug: Xyzal Oral Product; Drug: Fluticasone Furoate

Interventions

infrared-C ray irradiation DEVICE

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

Also known as: infrared-C hot compress

experimental group

eye mask DEVICE

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

Also known as: Long Chi

experimental group

Xyzal Oral Product DRUG

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

Also known as: Anti-histamine

Control group; experimental group

Fluticasone Furoate DRUG

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

Also known as: Steroid nasa spray

Control group; experimental group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nanhua University: lead
• Buddhist Tzu Chi General Hospital: collaborator
• Solano Semiconductor Technology., LTD.: collaborator

Related Publications (29)

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MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Histamine Antagonists; fluticasone furoate

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• Chun-Chih Lin, Professor

  Nanhua University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: September 17, 2018
• Study Start: March 2, 2015
• Primary Completion: July 30, 2017
• Study Completion: July 30, 2017
• Last Updated: September 17, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: the study period is from 20, Apr 2015 to 30, Jun 2015.
• Access Criteria: Individual Participant Data (IPD) will not sharing with others people who no included in the study group.