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Effect of add-on therapy with montelukast and CSBHT (chungsangboha-tang) in chronic persistent asthma patients: A randomized, placebo-control, parallel, multi-center trial

Status Approved

  • First Submitted Date

    2021/02/18

  • Registered Date

    2021/03/16

  • Last Updated Date

    2021/03/10

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0006005
    Unique Protocol ID KOMCIRB 2020-09-005-004
    Public/Brief Title Effect of add-on therapy with montelukast and CSBHT (chungsangboha-tang) in chronic persist ent asthma patients: A randomized, placebo-control, parallel, multi-center trial
    Scientific Title Effect of add-on therapy with montelukast and CSBHT (chungsangboha-tang) in chronic persistent asthma patients: A randomized, placebo-control, parallel, multi-center trial
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number KOMCIRB 2020-09-005-004
    Approval Date 2021-01-29
    Institutional Review Board Name KYUNG HEE UNIVERSITY KOREAN MEDICINE HOSPITAL IRB
    Institutional Review Board Address 23, Kyungheedae-ro, Dongdaemun-gu, Seoul
    Institutional Review Board Telephone 02-958-9105
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Beom-Joon Lee
    Title associate professor
    Telephone +82-2-958-9146
    Affiliation Kyung Hee University Hospital
    Address dongdaemoon-gu, kyungheedaero 23, seoul
    Contact Person for Public Queries
    Name Beom-Joon Lee
    Title associate professor
    Telephone +82-2-958-9146
    Affiliation Kyung Hee University Hospital
    Address dongdaemoon-gu, kyungheedaero 23, seoul
    Contact Person for Updating Information
    Name Beom-Joon Lee
    Title associate professor
    Telephone +82-2-958-9146
    Affiliation Kyung Hee University Hospital
    Address dongdaemoon-gu, kyungheedaero 23, seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 2
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-05-01 Anticipated
    Target Number of Participant 210
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Inha University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-05-01 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Kyung Hee University Oriental Medical Center
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-05-01 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Health & Welfare
    Organization Type Government
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Kyung Hee University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Asthma is a common chronic inflammatory disease of the airways, leading to airway obstruction, airway hyperresponsiveness, and even remodeling of the airway. There's currently no cure for asthma, but treatment can help control the symptoms.
    In recent guidelines, inhaled corticosteroids and beta 2-adrenoceptor agonists are the main treatments, and montelukast was frequently used as adjuvant treatment. However, current agents could not completely control the asthma symptoms and future risks, and some people may have exacerbations of asthma. Moreover, there is still a number of people using asthma medications having side effects; especially, easy bruising, an increase beyond the usual age-related risk of osteoporosis, cataracts and glaucoma, and adrenal suppression due to high dose and/or long-term inhaled corticosteroids use. 
    Chungsangboha-tang (CSBHT) is an herbal prescription that has been widely used to treat chronic respiratory diseases in traditional Korean medicine. CSBHT has been shown to be effective and safe alternatives or complements to standard therapy for asthma. In this study, we investigate the add-on effect and safety of CSBHT for asthma patients receiving conventional treatments.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Phase3
    Intervention Model Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator
    Allocation RCT
    Intervention Type Drug  
    Intervention Description
    intervention(CSBHT) and control (placebo), 1 pack 3 times a day for 8 weeks, 1 hr after meal
    Number of Arms 2
    Arm 1

    Arm Label

    CSBHT

    Target Number of Participant

    105

    Arm Type

    Experimental

    Arm Description

    CSBHT, 1 pack 3 times a day for 8 weeks, 1 hr after meal
    Arm 2

    Arm Label

    placebo

    Target Number of Participant

    105

    Arm Type

    Placebo comparator

    Arm Description

    placebo
    1 pack 3 times a day for 8 weeks, 1 hr after meal
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (J00-J99)Diseases of the respiratory system 
       (J45.9)Asthma, unspecified 

    asthma
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~85Year

    Description

    1) male and female aged 19-85
    2) patients who have been diagnosed with asthma and treated for more than 4 weeks
    3) patients who are administered ICS/LABA and montelukast or ICS and montelukast
    4) patients who voluntarily decide to participate in this clinical trial and signs a consent form
    Exclusion Criteria
    1) Patients with serious abnormalities such as pneumonia, interstitial lung disease, and active pulmonary tuberculosis on chest X-ray examination
     2) Patients who have been using maintenance therapy with oral steroids since 4 weeks ago, are receiving anti-IgE antibodies, or taking herbal medicines for asthma treatment.
     3) more than AST/ALT twice the normal value or Cr 1.5 mg/dL. 
     4) chronic heart failure of class III or IV (New York Heart Association)
     5) Patients with alcohol or other substance abuse/dependency or history
     6) Patients with malignant tumors or a history of malignant tumors (however, if they have not recurred for more than 5 years, participation is possible)
     7) Patients with a history of hypersensitivity reactions or allergies to research-related drugs
     8) Patients who are unable to read and write or have cognitive impairment
     9) Pregnant or lactating women
     10) patients who participated in other clinical trials within recent 30 days prior to this clinical trial (based on the date of written consent)
     11) If the researcher determines that it is inappropriate for participation in clinical research due to other reasons
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    change of FEV1(forced expiratory volume in one second)
    Timepoint
    base line and after 8 weeks
    Secondary Outcome(s) 1
    Outcome
    change of peak expiratory flow rate (PEFR)
    Timepoint
    base line and after 8 weeks
    Secondary Outcome(s) 2
    Outcome
    change of bronchoprovocation test and Fractional Exhaled Nitric Oxide (FeNO)
    Timepoint
    base line and after 8 weeks
    Secondary Outcome(s) 3
    Outcome
    change of St. George’s Respiratory Questionnaire (SGQR) and Asthma Control Test (ACT)
    Timepoint
    base line and after 8 weeks
    Secondary Outcome(s) 4
    Outcome
    frequency of rescue medicine
    Timepoint
    after 8 weeks
    Secondary Outcome(s) 5
    Outcome
    questionnaire of asthma symptoms of korean medicine
    Timepoint
    base line and after 8 weeks
    Secondary Outcome(s) 6
    Outcome
    Serum IgE, eosinophil count, CRP
    Timepoint
    base line and after 8 weeks
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2024. 5
    Way of Sharing Available on Request
    (franchisjun@naver.com)
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