The Efficacy and Safety of Cettum for Perennial Allergic Rhinitis

Eun Jung Kim

Status: Unknown

Conditions: Rhinitis, Allergic

Treatments: Procedure: Acupuncture; Procedure: Cettum

Study type: Interventional

Funder types: Other

Identifiers

NCT03342105

DUIH 2017-0013

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 19 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Cettum (Electrical moxibustion)

Experimental group

Description:

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.

Treatment:

Procedure: Cettum

Acupuncture

Active Comparator group

Description:

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.

Treatment:

Procedure: Acupuncture