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Trial record 64 of 66 for:    Levocetirizine

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

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ClinicalTrials.gov Identifier: NCT03673384
Recruitment Status : Completed
First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Collaborators:
Buddhist Tzu Chi General Hospital
Solano Semiconductor Technology., LTD.
Information provided by (Responsible Party):
Nanhua University

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.


Condition or disease Intervention/treatment Phase
Allergic Rhinitis Device: infrared-C ray irradiation Device: eye mask Drug: Xyzal Oral Product Drug: Fluticasone Furoate Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Health Promotion on Allergic Rhinitis by Infrared-C Ray Irradiation
Actual Study Start Date : March 2, 2015
Actual Primary Completion Date : July 30, 2017
Actual Study Completion Date : July 30, 2017

Arm Intervention/treatment
Experimental: 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.

Device: infrared-C ray irradiation
Infrared-C irradiation by hot compress with a powered heating compress
Other Name: infrared-C hot compress

Device: eye mask
infrared-C irradiation by hot compress with a powered heating eye mask
Other Name: Long Chi

Drug: Xyzal Oral Product
used to relieve allergy symptoms, It works by blocking histamine that body secretes during an allergic reaction.
Other Name: Anti-histamine

Drug: Fluticasone Furoate
used to treat seasonal and perennial allergic rhinitis. It also helps to reduce the symptoms of seasonal allergic rhinitis.
Other Name: Steroid nasa spray

Placebo Comparator: Control group
received only medical treatment, e.g., Xyzal Oral Product and Fluticasone Furoate.
Drug: Xyzal Oral Product
used to relieve allergy symptoms, It works by blocking histamine that body secretes during an allergic reaction.
Other Name: Anti-histamine

Drug: Fluticasone Furoate
used to treat seasonal and perennial allergic rhinitis. It also helps to reduce the symptoms of seasonal allergic rhinitis.
Other Name: Steroid nasa spray




Primary Outcome Measures :
  1. Score reduce in Taiwan's SNOT-20 nose and sinusitis evaluation form [ Time Frame: Baseline to 3 months ]
    Measure of outcome in sino-nasal disorders such as sinusitis. Score will reduced after 3 months of the assignment.

  2. Change in the WHOQOL-BREF questionnaire, Taiwan version [ Time Frame: Baseline to 3 months ]
    To measure the following broad domains: physical health, psychological health, social relationships, and environment. Score will increase after 3 months of the assignment.

  3. The amounts of the immunoglobulin E (IgE) level reduced after the assignment [ Time Frame: Baseline to 3 months ]
    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.

  4. the Eosinophil Cationic Protein (ECP) level reduced after the assignment [ Time Frame: Baseline to 3 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673384


Sponsors and Collaborators
Nanhua University
Buddhist Tzu Chi General Hospital
Solano Semiconductor Technology., LTD.
Investigators
Study Director: Chun-Chih Lin, Professor Nanhua University
  Study Documents (Full-Text)

Documents provided by Nanhua University:
Study Protocol  [PDF] August 6, 2018


Publications of Results:

Other Publications:
Responsible Party: Nanhua University
ClinicalTrials.gov Identifier: NCT03673384     History of Changes
Other Study ID Numbers: B10304016
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nanhua University:
far-infrared radiation
allergic rhinitis
IgE
eosinophil cationic protein
Taiwanese version of the 20-item Sinonasal Outcome Test
WHOQOL-BREF

Additional relevant MeSH terms:
Levocetirizine
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Cetirizine
Histamine
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists