Status Approved
First Submitted Date
2019/03/05
Registered Date
2019/03/25
Last Updated Date
2021/08/20
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0003665 |
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Unique Protocol ID | DJRM-2017-01 |
Public/Brief Title | Efficacy and safety of GHX02 in the treatment of acute bronchitis and acute exacerbation of chronic bronchitis |
Scientific Title | Efficacy and safety of GHX02 in the treatment of acute bronchitis and acute exacerbation of chronic bronchitis: A phase Ⅱ, randomized, double-blind, placebo-controlled, multicenter trial |
Acronym | GHX02 |
MFDS Regulated Study | Yes |
IND/IDE Protocol | Yes |
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 | DJDSKH-17-DR-22 |
Approval Date | 2019-02-01 |
Institutional Review Board Name | Daejeon University Dunsan Korean Medicine Hospital Institutional Review Board |
Institutional Review Board Address | 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon |
Institutional Review Board Telephone | 042-470-9488 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | YangChun Park |
Title | Ph.D |
Telephone | +82-42-470-9126 |
Affiliation | Dunsan Korean Medicine Hospital of Daejeon University |
Address | 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon |
Contact Person for Public Queries | |
Name | YeeRan Lyu |
Title | KMD |
Telephone | +82-42-470-9663 |
Affiliation | Dunsan Korean Medicine Hospital of Daejeon University |
Address | 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon |
Contact Person for Updating Information | |
Name | YeeRan Lyu |
Title | KMD |
Telephone | +82-42-470-9663 |
Affiliation | Dunsan Korean Medicine Hospital of Daejeon University |
Address | 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon |
4. Status
Study Site | Multi-center Number of center : 3 | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2019-03-16 Actual | |
Target Number of Participant | 117 | |
Primary Completion Date | 2019-12-05 , Actual | |
Study Completion Date | 2019-12-05 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Daejeon Korean Medicine Hospital of Daejeon University | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2019-03-16 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | Kyung Hee University Oriental Medical Center | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2019-06-26 , | |
Recruitment Status by Participating Study Site 3 | ||
Name of Study | Pusan National University Korean Medicine Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2019-06-05 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Korea Institute of Oriental Medicine |
Organization Type | Others |
Project ID | K17510 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Daejeon Korean Medicine Hospital of Daejeon University |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | The objective is to compare the GHX02 and placebo in terms of efficacy and safety, and to determine the appropriate dosage. We planned a phase 2, multicentre, dose-finding, double-blind, randomized placebo-controlled trial of two different doses of GHX02 compared with placebo. A total of 117 patients, aged 19-75 years, with a Bronchitis Severity Score (BSS)≥5 due to acute bronchitis or acute exacerbation of chronic bronchitis starting within 2 weeks of study enrolment will be recruited from three university-affiliated hospitals across Korea. Participants will be stratified into three patterns(wind-heat, wind-cold, others) by pattern identification and randomly assigned to either a high-dose GHX02 group(1,920mg/day), standard-dose GHX02 group(960mg/day), or placebo group according to a 1:1:1 allocation ratio. Patients will take medications three times daily for 7 days, with 2 visiting days. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Phase2 |
Intervention Model | Parallel |
Blinding/Masking | Double |
Blinded Subject | Subject, Investigator, Outcome Accessor |
Allocation | RCT |
Intervention Type | Drug |
Intervention Description | Participants will be randomly assigned to either a high-dose GHX02 group(1,920mg/day), a standard-dose GHX02 group(960mg/day), or a placebo group(control) according to a 1:1:1 allocation ratio using stratification block randomization with pattern identification. Patients will take medications three times daily for 7 days, with 3 visiting days(screening, day0, day7) |
Number of Arms | 3 |
Arm 1 |
Arm Label standard-dose GHX02 |
Target Number of Participant 39 |
|
Arm Type Experimental |
|
Arm Description 2 tablets of the clinical medicine and 2 tablets of the placebo, administered three times daily for 7 days |
|
Arm 2 |
Arm Label high-dose GHX02 |
Target Number of Participant 39 |
|
Arm Type Experimental |
|
Arm Description 4 tablets of the clinical medicine, administered three times daily for 7 days |
|
Arm 3 |
Arm Label placebo |
Target Number of Participant 39 |
|
Arm Type Placebo comparator |
|
Arm Description 4 tablets of the placebo, administered three times daily for 7 days |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (J00-J99)Diseases of the respiratory system (J42)Unspecified chronic bronchitis acute bronchitis or acute exacerbation of chronic bronchitis |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~75Year |
|
Description 1) aged 19–75 years 2) BSS ≥ 5 points at visit 2 due to acute bronchitis starting within 2 weeks before study inclusion or due to acute exacerbation of chronic bronchitis with increased respiratory symptoms for more than 2 days. 3) patients who consent to participate |
|
Exclusion Criteria |
1) pregnant or breast-feeding 2) treatment with antibiotics, bronchodilators, glucocorticoids, immune-depressants, or other clinical trial medicines during the last 4 weeks before study inclusion 3) treatment with antitussives or expectorants during the last 7 days before study inclusion 4) requiring treatment of antibiotics, bronchodilators, glucocorticoids 5) history or presence of confounding respiratory disease that may affect evaluation of the efficacy of clinical medicine (e.g. chronic bronchitis, chronic obstructive pulmonary disease (COPD), bronchiectasis, asthma, pneumonia, cystic fibrosis, lung cancer, or active pulmonary tuberculosis) 6) liver or renal impairment (alanine aminotransferase(ALT), aspartate aminotransferase(AST), alkaline phosphatase(ALP) ≥ 3 times the normal upper limit, or creatinine> 3.0 mg/dL at screening) 7) genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 8) history or presence of clinically relevant cardiovascular, renal, metabolic, haematological, neurological, psychiatric, systemic, infectious disease, or malignant tumour(except where there is no recurrence for more than 5 years after surgery) 9) history of alcoholism or substance abuse 10) smokers of more than 30 years 11) disagree with contraception 12) participation in other clinical drug(medicine) trials during the last 30 days before study inclusion 13) judged by the investigators to be inappropriate for the clinical trial. |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | change in BSS(Bronchitis Severity Score) from visit2 to visit3 |
|
Timepoint | visit2, visit3 |
|
Secondary Outcome(s) 1 | ||
Outcome | Change in Questionnaire of Clinical Symptoms of Cough and Sputum |
|
Timepoint | visit2, visit3 |
|
Secondary Outcome(s) 2 | ||
Outcome | Change in Leicester Cough Questionnaire-acute(LCQ-acute) |
|
Timepoint | visit2, visit3 |
|
Secondary Outcome(s) 3 | ||
Outcome | Change in frequency of coughing fits |
|
Timepoint | visit2, visit3 |
|
Secondary Outcome(s) 4 | ||
Outcome | Integrative Medicine Outcome Scale(IMOS) |
|
Timepoint | visit3 |
|
Secondary Outcome(s) 5 | ||
Outcome | Integrative Medicine Patient Satisfaction Scale(IMPSS) |
|
Timepoint | visit3 |
|
Secondary Outcome(s) 6 | ||
Outcome | adverse effect |
|
Timepoint | visit2, visit3 |
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 | 2020. 3 |
Way of Sharing | To be made available at a later date
(ryr8049@naver.com) |
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