Rhinitis, AllergicNCT03342105
The Efficacy and Safety of Cettum for Perennial Allergic Rhinitis
A study testing Cettum and Acupuncture in people with Rhinitis, Allergic, run by Eun Jung Kim.
Trial summary
The purpose of this study is verify the efficacy and safety of Cettum (Electrical moxibustion) for patients with perennial allergic rhinitis. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Rhinitis, Allergic
- What is being tested?
- Cettum and Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2017to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 19 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Rhinitis, Allergic
- Being tested
- Cettum, Acupuncture
- Keywords
- Rhinitis, Allergic, Moxibustion
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CettumProcedure or surgery
Also called Electrical moxibustion
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.
AcupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Cettum (Electrical moxibustion) | Experimental | 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. Receives: Procedure: Cettum |
| Acupuncture | Active comparator | 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. Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (5)
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.
Measured: 4 weeks
Total serum IgE and eosinophil count levels
Total serum IgE and eosinophil count levels will be measured during visits 2 and 9.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study startDec 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, AllergicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eun Jung Kim
- Sponsor type
- University, hospital or other
- Collaborators
- DongGuk University
- Responsible party
- Sponsor-investigator, Eun Jung Kim, DongGuk University
- Investigators
- Seung Ug Hong, Ph. D., Principal investigator, DongGuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342105
- Sponsor's protocol ID
- DUIH 2017-0013
- Status last verified
- Nov 2017
- First submitted
- 9 Nov 2017
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 35470006Jung 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.
PubMed 31324214
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Cettum for Perennial Allergic Rhinitis: a Randomized, Open-label, Assessment-blind, Parallel Designed Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT03342105
- Acronym / sponsor ID
- DUIH 2017-0013
- Conditions
- Rhinitis, Allergic
- Keywords
- Rhinitis, Allergic, Moxibustion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eun Jung KimUniversity, hospital or other
- Collaborators
- DongGuk University
- Study start
- Dec 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cettum (Electrical moxibustion) | Experimental | Procedure: CettumThe 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 comparator | Procedure: AcupunctureThe 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. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 19 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CettumAlso: Electrical moxibustionThe 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. | Procedure or surgery | Cettum (Electrical moxibustion) |
| AcupunctureThe 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. | Procedure or surgery | Acupuncture |
Primary outcome
Total Nasal Symptom Score (TNSS)
Time frame: 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.
5 secondary outcomes
Rhinoconjunctivits Quality of Life Questionnaire (RQLQ)
Time frame: 4 weeks
Total serum IgE and eosinophil count levels
Time frame: 4 weeks
Pre KiFDA AR version 2.0
Time frame: 4 weeks
Pre KiFDA AR version 3.0
Time frame: 4 weeks
Adverse Events
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Derived from this study: PubMed 35470006Jo 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.
- Derived from this study: PubMed 31324214Jung 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung Ug Hong, Ph. D. principal investigator
DongGuk University
Questions about this trial
What is this clinical trial studying?
A study testing Cettum and Acupuncture in people with Rhinitis, Allergic, run by Eun Jung Kim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seung Ug Hong, Ph. D. (+82-31-961-9085, heenthsu@dumc.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Nasal Symptom Score (TNSS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03342105, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.