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Allergic RhinitisNCT03673384

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

A study testing infrared-C ray irradiation, eye mask and Xyzal Oral Product in people with Allergic Rhinitis, run by Nanhua University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Allergic Rhinitis
What is being tested?
infrared-C ray irradiation, eye mask and Xyzal Oral Product
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
No sites listed yet
Study dates
2 Mar 2015to 30 Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

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

About this study

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.

Read the 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.

Being tested
infrared-C ray irradiation, eye mask, Xyzal Oral Product, Fluticasone Furoate
Keywords
far-infrared radiation, allergic rhinitis, IgE, eosinophil cationic protein, Taiwanese version of the 20-item Sinonasal Outcome Test, WHOQOL-BREF
Medical subject headings
Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • infrared-C ray irradiationDevice

    Also called infrared-C hot compress

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

  • eye maskDevice

    Also called Long Chi

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

  • Xyzal Oral ProductDrug

    Also called Anti-histamine

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

  • Fluticasone FuroateDrug

    Also called Steroid nasa spray

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

Study groups in NCT03673384
Study groupRoleWhat they receive
experimental groupExperimentalReceived 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.
Receives: Device: infrared-C ray irradiation; Device: eye mask; Drug: Xyzal Oral Product; Drug: Fluticasone Furoate
Control groupPlacebo comparatorreceived only medical treatment, e.g., Xyzal Oral Product and Fluticasone Furoate.
Receives: Drug: Xyzal Oral Product; Drug: Fluticasone Furoate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 3 months

  2. 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.

    Measured: Baseline to 3 months

  3. 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.

    Measured: Baseline to 3 months

  4. 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.

    Measured: Baseline to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2018
  2. Study start2 Mar 2015
  3. Primary completion30 Jul 2017
  4. Study completion30 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03673384
Sponsor's protocol ID
B10304016
Status last verified
Sep 2018
First submitted
16 Aug 2018
Last updated
17 Sep 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Marciniak D, Tomaszewicz-Fryca J, Plusa T, Chcialowski A. [Eosinophil cationic protein in children with allergic diseases of the respiratory tract in exacerbation and remission of symptoms]. Pol Merkur Lekarski. 1998 Feb;4(20):75-7. Polish.

    PubMed 9591438

  • Alvarez Gutierrez FJ, Valenzuela Mateos F, Rodriguez Portal JA, Sanchez Gil R, Tabernero Huguet E, Castillo Gomez J. [Blood levels of eosinophil cationic protein in patients with allergic rhinitis. Evolution after treatment with corticoids]. Arch Bronconeumol. 1997 Jan;33(1):6-11. Spanish.

    PubMed 9072139

  • Ahmadiafshar A, Taghiloo D, Esmailzadeh A, Falakaflaki B. Nasal eosinophilia as a marker for allergic rhinitis: a controlled study of 50 patients. Ear Nose Throat J. 2012 Mar;91(3):122-4. doi: 10.1177/014556131209100309.

    PubMed 22430337

  • Beever R. Far-infrared saunas for treatment of cardiovascular risk factors: summary of published evidence. Can Fam Physician. 2009 Jul;55(7):691-6.

    PubMed 19602651

  • Bentley AM, Jacobson MR, Cumberworth V, Barkans JR, Moqbel R, Schwartz LB, Irani AM, Kay AB, Durham SR. Immunohistology of the nasal mucosa in seasonal allergic rhinitis: increases in activated eosinophils and epithelial mast cells. J Allergy Clin Immunol. 1992 Apr;89(4):877-83. doi: 10.1016/0091-6749(92)90444-7.

    PubMed 1532808

  • Braido F, Arcadipane F, Marugo F, Hayashi M, Pawankar R. Allergic rhinitis: current options and future perspectives. Curr Opin Allergy Clin Immunol. 2014 Apr;14(2):168-76. doi: 10.1097/ACI.0000000000000043.

    PubMed 24535140

  • Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, van Wijk RG, Ohta K, Zuberbier T, Schunemann HJ; Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010 Sep;126(3):466-76. doi: 10.1016/j.jaci.2010.06.047.

    PubMed 20816182

  • Chang Y, Liu YP, Liu CF. The effect on serotonin and MDA levels in depressed patients with insomnia when far-infrared rays are applied to acupoints. Am J Chin Med. 2009;37(5):837-42. doi: 10.1142/S0192415X09007272.

    PubMed 19885944

  • Cheng KJ, Xu YY, Liu HY, Wang SQ. Serum eosinophil cationic protein level in Chinese subjects with nonallergic and local allergic rhinitis and its relation to the severity of disease. Am J Rhinol Allergy. 2013 Jan;27(1):8-12. doi: 10.2500/ajra.2013.27.3845.

    PubMed 23406588

  • Davis WE, Nishioka GJ. Endoscopic partial inferior turbinectomy using a power microcutting instrument. Ear Nose Throat J. 1996 Jan;75(1):49-50.

    PubMed 8608748

  • Everhart RS, Kopel SJ, Esteban CA, McQuaid EL, Klein R, McCue CE, Koinis-Mitchell D. Allergic rhinitis quality of life in urban children with asthma. Ann Allergy Asthma Immunol. 2014 Apr;112(4):365-70.e1. doi: 10.1016/j.anai.2014.02.002. Epub 2014 Feb 28.

    PubMed 24589166

  • Gale GD, Rothbart PJ, Li Y. Infrared therapy for chronic low back pain: a randomized, controlled trial. Pain Res Manag. 2006 Autumn;11(3):193-6. doi: 10.1155/2006/876920.

    PubMed 16960636

  • Groger M, Bernt A, Wolf M, Mack B, Pfrogner E, Becker S, Kramer MF. Eosinophils and mast cells: a comparison of nasal mucosa histology and cytology to markers in nasal discharge in patients with chronic sino-nasal diseases. Eur Arch Otorhinolaryngol. 2013 Sep;270(10):2667-76. doi: 10.1007/s00405-013-2395-2. Epub 2013 Feb 22.

    PubMed 23430080

  • Huang CY, Yang RS, Kuo TS, Hsu KH. Phantom limb pain treated by far infrared ray. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:1589-91. doi: 10.1109/IEMBS.2009.5334124.

    PubMed 19964539

  • Honda K, Inoue S. Sleep-enhancing effects of far-infrared radiation in rats. Int J Biometeorol. 1988 Jun;32(2):92-4. doi: 10.1007/BF01044900. No abstract available.

    PubMed 3410585

Questions about this trial

What is this clinical trial studying?

A study testing infrared-C ray irradiation, eye mask and Xyzal Oral Product in people with Allergic Rhinitis, run by Nanhua University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Score reduce in Taiwan's SNOT-20 nose and sinusitis evaluation form (time frame: Baseline to 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03673384, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.

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