The Efficacy and Safety of Cettum for Perennial Allergic Rhinitis

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

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

Study Overview

• Status: Unknown
• Conditions: Rhinitis, Allergic
• Intervention / Treatment: Procedure: Cettum; Procedure: Acupuncture

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Seung Ug Hong, Ph. D.; Phone Number: +82-31-961-9085; Email: heenthsu@dumc.or.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cettum (Electrical moxibustion); 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; 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.; Other Names: Electrical moxibustion
Active Comparator: 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.	Procedure: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eun Jung Kim
• Collaborators: DongGuk University
• Investigators: Principal Investigator: Seung Ug Hong, Ph. D., DongGuk University

Publications and helpful links

General Publications

• Jo HR, Sung WS, Jung CY, Lim CY, Lee SD, Hong SU, Kim KH, Kim EJ. Effectiveness and safety of electric heating moxibustion for perennial allergic rhinitis: A pilot, randomized, assessor-blind trial. Complement Ther Med. 2022 Sep;68:102835. doi: 10.1016/j.ctim.2022.102835. Epub 2022 Apr 22.
• Jung CY, Cho MJ, Kang HR, Hong SU, Sung WS, Kim EJ. Efficacy and safety of electric heating moxibustion for perennial allergic rhinitis: protocol for a randomized controlled trial. Trials. 2019 Jul 19;20(1):445. doi: 10.1186/s13063-019-3550-x.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2017
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: November 9, 2017
• First Submitted That Met QC Criteria: November 9, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 9, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Moxibustion; Rhinitis, Allergic
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
• Other Study ID Numbers: DUIH 2017-0013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No