The Efficacy and Safety of Cettum for Perennial Allergic Rhinitis

Not Applicable

• Conditions: Rhinitis, Allergic
• Interventions: Procedure: Cettum; Procedure: Acupuncture

• Registration Number: NCT03342105
• Lead Sponsor: Eun Jung Kim

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-09
• Last Update Submitted: 2017-11-09
• Study First Posted: 2017-11-14
• Last Update Posted: 2017-11-14
• Study Start: 2017-12
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. 19 to 60 years-old
2. Presence of nasal symptoms more than 2 consecutive years
3. 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))
4. Positive reaction to the one or more perennial allergen in skin prick test
5. Not having a problem with expression of opinion
6. Willingness to participate in this trial and to sign the informed consent agreement

Exclusion Criteria

1. 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
2. Presence of rhinosinusitis (paranasal sinus X-ray demonstrating mucosal thickening or opacification of the paranasal sinuses)
3. Presence of neoplasm, severe systemic inflammation, or other systemic disease that affects rhinitis
4. History of anaphylaxis for allergic tests
5. Females who is pregnant or lactating
6. Being difficult to maintain treatment (e.g. paralysis, severe physical or psychiatric disorder, dementia, drug intoxication, severe visual or hearing impairment)
7. Being afraid of moxibustion treatment or expected adverse effects
8. When the investigators determine that it is inappropriate for participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cettum (Electrical moxibustion)	Cettum	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.
Acupuncture	Acupuncture	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.

Primary Outcome Measures

Name	Time	Method
Total Nasal Symptom Score (TNSS)	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Pre KiFDA AR version 3.0	4 weeks	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.
Pre KiFDA AR version 2.0	4 weeks	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.
Adverse Events	4 weeks	Any unpredicted symptoms are checked at every visit and if any, the symptom, time of occurrence, and length of duration are recorded and reported.
Rhinoconjunctivits Quality of Life Questionnaire (RQLQ)	4 weeks	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.
Total serum IgE and eosinophil count levels	4 weeks	Total serum IgE and eosinophil count levels will be measured during visits 2 and 9.