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| Name | Class |
|---|---|
| Buddhist Tzu Chi General Hospital | OTHER |
| Solano Semiconductor Technology., LTD. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control group | Placebo Comparator | received only medical treatment, e.g., Xyzal Oral Product and Fluticasone Furoate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| infrared-C ray irradiation | Device | Infrared-C irradiation by hot compress with a powered heating compress |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chun-Chih Lin, Professor | Nanhua University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9591438 | Background | 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. | |
| 9072139 | Result | 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. |
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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.
the study period is from 20, Apr 2015 to 30, Jun 2015.
Individual Participant Data (IPD) will not sharing with others people who no included in the study group.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 6, 2018 | Aug 23, 2018 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D006633 | Histamine Antagonists |
| C523187 | fluticasone furoate |
| ID | Term |
|---|---|
| D018494 | Histamine Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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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.
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| eye mask | Device | infrared-C irradiation by hot compress with a powered heating eye mask |
|
|
| Xyzal Oral Product | Drug | used to relieve allergy symptoms, It works by blocking histamine that body secretes during an allergic reaction. |
|
|
| Fluticasone Furoate | Drug | used to treat seasonal and perennial allergic rhinitis. It also helps to reduce the symptoms of seasonal allergic rhinitis. |
|
|
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| 19964539 | Result | 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. |
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| 17968683 | Result | Ishibashi J, Yamashita K, Ishikawa T, Hosokawa H, Sumida K, Nagayama M, Kitamura S. The effects inhibiting the proliferation of cancer cells by far-infrared radiation (FIR) are controlled by the basal expression level of heat shock protein (HSP) 70A. Med Oncol. 2008;25(2):229-37. doi: 10.1007/s12032-007-9020-4. Epub 2007 Oct 30. |
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| 10380774 | Result | Winther L, Moseholm L, Reimert CM, Stahl Skov P, Kaergaard Poulsen L. Basophil histamine release, IgE, eosinophil counts, ECP, and EPX are related to the severity of symptoms in seasonal allergic rhinitis. Allergy. 1999 May;54(5):436-45. doi: 10.1034/j.1398-9995.1999.00910.x. |
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| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |