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
CRIS Registration Number |
KCT0006005 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 2 | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Ministry of Health & Welfare |
Organization Type | Government |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Kyung Hee University |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
* (J00-J99)Diseases of the respiratory system (J45.9)Asthma, unspecified asthma |
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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)
Type of Primary Outcome | Efficacy | |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2024. 5 |
Way of Sharing | Available on Request
(franchisjun@naver.com) |
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