The Efficacy and Safety of Cettum for Perennial Allergic Rhinitis

Study Overview
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Brief Summary
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The purpose of this study is verify the efficacy and safety of Cettum (Electrical moxibustion) for patients with perennial allergic rhinitis.

Detailed Description
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The investigators target the patients with perennial allergic rhinitis. After treatment in 2 groups (Cettum treatment and acupuncture treatment) the investigators will compare the effects of relieving symptoms and improving quality of life. So the investigators will confirm the efficacy of Cettum, and further the best treatment method. In addition, the investigators are going to evaluate the safety of abnormal reaction during the treatment.

Official Title
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The Efficacy and Safety of Cettum for Perennial Allergic Rhinitis: a Randomized, Open-label, Assessment-blind, Parallel Designed Pilot Clinical Study

Conditions
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Rhinitis, Allergic

Intervention / Treatment
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* Procedure: Cettum
* Procedure: Acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 19 to 60 years-old Presence of nasal symptoms more than 2 consecutive years Presence of two or more nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) with severity score ≥ 2 (0 = no symptoms, 1 = mild symptom(s), 2 = moderate symptom(s), and 3 = severe symptom(s)) Positive reaction to the one or more perennial allergen in skin prick test Not having a problem with expression of opinion Willingness to participate in this trial and to sign the informed consent agreement Exclusion Criteria: Treatment with nasal/oral corticosteroids within the past month; herbal medication for rhinitis within the past month; nasal cromolyn or tricyclic antidepressants within the past two weeks; nasal/oral decongestants, nasal/oral antihistamines, or antileukotrienes within the past week Presence of rhinosinusitis (paranasal sinus X-ray demonstrating mucosal thickening or opacification of the paranasal sinuses) Presence of neoplasm, severe systemic inflammation, or other systemic disease that affects rhinitis History of anaphylaxis for allergic tests Females who is pregnant or lactating Being difficult to maintain treatment (e.g. paralysis, severe physical or psychiatric disorder, dementia, drug intoxication, severe visual or hearing impairment) Being afraid of moxibustion treatment or expected adverse effects When the investigators determine that it is inappropriate for participation

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cettum (Electrical moxibustion)<br>The patients in this group will receive Cettum (Electrical moxibustion) treatment applied by a certified Korean Medicine Doctor with more than 6 years of traditional Korean medicine college education. | Procedure: Cettum<br>* The treatment will be applied in 8 sessions, 2 times per week for 4 weeks. Moxibustion will be provided at 11 standard acupuncture points: EX-HN3, and both EX-HN8, LI20, LI4, GB2, ST36. A specifically designed device, Cettum (20X28X18mm) manufactured by K-medical Co.(Korea), will be used to treat patients in this group. The expected total time of each treatment session will be 15 min.<br>* Other names: Electrical moxibustion;|
| Active Comparator: Acupuncture<br>The patients in this group will receive acupuncture treatment applied by a certified Korean Medicine Doctor with more than 6 years of traditional Korean medicine college education. | Procedure: Acupuncture<br>* The treatment will be applied in 8 sessions, 2 times per week for 4 weeks. Acupuncture will be provided at same points in the Cettum group. Sterile stainless steel disposable acupuncture needles (0.25X30mm, DongBang Acupuncture Inc, Korea) will be used to treat patients in this group. The needles will be kept in place for 15 min.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Nasal Symptom Score (TNSS) | TNSS evaluates symptoms of rhinorrhea, nasal congestion, nasal itching and sneezing on a 4-point scale. The total score range is from 0 to 12, where 0 = no symptoms, 1 = mild symptom(s), 2 = moderate symptom (s), and 3 = severe symptom(s). TNSS baseline value will be measured prior to the start of the experiment and then again during every visit. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rhinoconjunctivits Quality of Life Questionnaire (RQLQ) | RQLQ is self-report questionnaire used to assess the quality of life in patients with allergic rhinitis. The questionnaire has 7 domains; activity limitations, sleep disturbances, non-hay fever symptoms, practical problems, nasal symptoms, ocular symptoms and emotional problems. Patients will be asked to recall their experiences during the previous week and to rate each question on a ranging from 0 (no impairment) to 6 (severe impairment). RQLQ will be measured during visits 2, 6, 9, and 10. | 4 weeks | 
| Total serum IgE and eosinophil count levels | Total serum IgE and eosinophil count levels will be measured during visits 2 and 9. | 4 weeks | 
| Pre KiFDA AR version 2.0 | The investigator, traditional Korean medicine doctor, will evaluate the nasal endoscopy index during visits 2 and 9. The investigator will check the score following observation of the nasal membrane color, rhinorrhea, and inferior turbinate swelling of the patient via nasal endoscopy. | 4 weeks | 
| Pre KiFDA AR version 3.0 | The investigator, traditional Korean medicine doctor, will select a pattern for each patient from among lung-heat, lung-cold and spleen-qi-deficiency through face-to-face diagnoses, based on body and nasal conditions. | 4 weeks | 
| Adverse Events | Any unpredicted symptoms are checked at every visit and if any, the symptom, time of occurrence, and length of duration are recorded and reported. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhinitis, Allergic, Moxibustion