The Efficacy and Safety of Cettum for Perennial Allergic Rhinitis

Rhinitis, Allergic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03342105
• Other study ID #: DUIH 2017-0013
• Status: Not yet recruiting
• Phase: N/A
• First received: November 9, 2017
• Last updated: November 9, 2017
• Start date: December 2017
• Est. completion date: December 2018

Study information

• Verified date: November 2017
• Source: DongGuk University
• Contact: Seung Ug Hong, Ph. D.
• Phone: +82-31-961-9085
• Email: heenthsu[@]dumc.or.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

Procedure:
• Cettum
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.
• Acupuncture
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Eun Jung Kim	Dongguk University Ilsan Oriental Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Total serum IgE and eosinophil count levels	Total serum IgE and eosinophil count levels will be measured during visits 2 and 9.	4 weeks
Secondary	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
Secondary	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
Secondary	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