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The Efficacy and Safety of Cettum for Perennial Allergic Rhinitis

Primary Purpose

Rhinitis, Allergic

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cettum
Acupuncture
Sponsored by
Eun Jung Kim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis, Allergic focused on measuring Rhinitis, Allergic, Moxibustion

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Cettum (Electrical moxibustion)

    Acupuncture

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    Total serum IgE and eosinophil count levels
    Total serum IgE and eosinophil count levels will be measured during visits 2 and 9.
    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.
    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.
    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.

    Full Information

    First Posted
    November 9, 2017
    Last Updated
    November 9, 2017
    Sponsor
    Eun Jung Kim
    Collaborators
    DongGuk University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03342105
    Brief Title
    The Efficacy and Safety of Cettum for Perennial Allergic Rhinitis
    Official Title
    The Efficacy and Safety of Cettum for Perennial Allergic Rhinitis: a Randomized, Open-label, Assessment-blind, Parallel Designed Pilot Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2017 (Anticipated)
    Primary Completion Date
    December 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Eun Jung Kim
    Collaborators
    DongGuk University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rhinitis, Allergic
    Keywords
    Rhinitis, Allergic, Moxibustion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cettum (Electrical moxibustion)
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Acupuncture
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Cettum
    Other Intervention Name(s)
    Electrical moxibustion
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Acupuncture
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Total Nasal Symptom Score (TNSS)
    Description
    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.
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Rhinoconjunctivits Quality of Life Questionnaire (RQLQ)
    Description
    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.
    Time Frame
    4 weeks
    Title
    Total serum IgE and eosinophil count levels
    Description
    Total serum IgE and eosinophil count levels will be measured during visits 2 and 9.
    Time Frame
    4 weeks
    Title
    Pre KiFDA AR version 2.0
    Description
    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.
    Time Frame
    4 weeks
    Title
    Pre KiFDA AR version 3.0
    Description
    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.
    Time Frame
    4 weeks
    Title
    Adverse Events
    Description
    Any unpredicted symptoms are checked at every visit and if any, the symptom, time of occurrence, and length of duration are recorded and reported.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Seung Ug Hong, Ph. D.
    Phone
    +82-31-961-9085
    Email
    heenthsu@dumc.or.kr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Seung Ug Hong, Ph. D.
    Organizational Affiliation
    DongGuk University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    35470006
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    31324214
    Citation
    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.
    Results Reference
    derived

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    The Efficacy and Safety of Cettum for Perennial Allergic Rhinitis

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