The Efficacy and Safety of Cettum for Perennial Allergic Rhinitis
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
The purpose of this study is verify the efficacy and safety of Cettum (Electrical moxibustion) for patients with perennial allergic rhinitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2017
CompletedFirst Posted
Study publicly available on registry
November 14, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedNovember 14, 2017
November 1, 2017
1 year
November 9, 2017
November 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Rhinoconjunctivits Quality of Life Questionnaire (RQLQ)
4 weeks
Total serum IgE and eosinophil count levels
4 weeks
Pre KiFDA AR version 2.0
4 weeks
Pre KiFDA AR version 3.0
4 weeks
Adverse Events
4 weeks
Study Arms (2)
Cettum (Electrical moxibustion)
EXPERIMENTALThe 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
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eun Jung Kimlead
- DongGuk Universitycollaborator
Related Publications (2)
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.
PMID: 35470006DERIVEDJung 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.
PMID: 31324214DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung Ug Hong, Ph. D.
DongGuk University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
November 9, 2017
First Posted
November 14, 2017
Study Start
December 1, 2017
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
November 14, 2017
Record last verified: 2017-11