An interventional study of infrared-C ray irradiation and eye mask in Allergic Rhinitis, sponsored by Nanhua University. Completed. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-17.
Sponsored by Nanhua University · Not applicable, Interventional, and Treatment
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.
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.
1,042 studies on the registry are indexed under Rhinitis, Allergic; 91 are open to participants now.
This study's enrollment of 50 is below the median of 90 across 858 interventional studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →Nanhua University is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
received only medical treatment, e.g., Xyzal Oral Product and Fluticasone Furoate.
Drug: Xyzal Oral Product · Drug: Fluticasone Furoate
Infrared-C irradiation by hot compress with a powered heating compress
Also known as: infrared-C hot compress
infrared-C irradiation by hot compress with a powered heating eye mask
Also known as: Long Chi
used to relieve allergy symptoms, It works by blocking histamine that body secretes during an allergic reaction.
Also known as: Anti-histamine
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 3 months
No study locations are listed for this record.
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
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.
Ran from Mar 2015 to primary completion in Jul 2017, 28 months.
Of 74 non-industry interventional studies with no phase under Rhinitis, Allergic, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 30. This study's 28 months is above that.
Counting every sponsor, half of 94 studies reached it within 12 months; a quarter within 4 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nanhua University