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This study is a phase 2, multicentre, dose-finding, double-blind, randomized placebo-controlled trial to evaluate the efficacy and safety of two different doses of GHX02, compared with placebo, for acute bronchitis. One-hundred and fifty patients will be included in this trial and randomly assigned to either a high-dose GHX02 group(1920mg/day), standard-dose GHX02 group(960mg/day), or control group(placebo) in a 1:1:1 allocation ratio. Patients will take one of the medications three times a day for 7 days, with 3 visiting days(screening, day0, day7). On the screening day, the Korean Standard Tool of Pattern Identification of Cough and Sputum, a diagnostic system that determines therapy in Traditional Korean Medicine, will be used to allocate patients into three groups of wind-heat, wind-cold or others.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose GHX02 group(1,920mg/day) | Experimental | 4 tablets of the GHX02, three times daily for 7 days |
|
| Standard-dose GHX02 group(960mg/day) | Experimental | 2 tablets of the GHX02 and 2 tablets of the placebo, three times daily for 7 days |
|
| Placebo control | Placebo Comparator | 4 tablets of the placebo, three times daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GHX02 | Drug | Herbal medicine originating from gualouhengryunhwan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in BSS(Bronchitis Severity Score) | BSS comprises the sum of five major symptom scores for acute bronchitis: cough, sputum, dyspnea, chest pain during coughing, and rales on auscultation. Each symptom is scored on a 4-point-scale (0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe), with a maximum total score of 20 points. The investigator assesses symptom scores on the basis of the patient's subjective symptoms. | Day0, Day7 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Questionnaire of Clinical Symptoms of Cough and Sputum | Questionnaire items are as follows: (1) cough -frequency, intensity, sensitivity; (2) sputum -frequency, volume, difficulty to cough-up, appearance, color; (3) activities of daily living; (4) night-time sleeping. Each item is scored on a 4-point-scale, with a total maximum score of 40 points. | Day0, Day7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YeeRan Lyu | Contact | 82424709663 | yyr900511@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dunsan Korean Medicine Hospital, Daejeon University | Daejeon | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31515828 | Derived | Ji KY, Kim KM, Oh JJ, Kim JW, Lee WJ, Cho H, Lee HK, Lee JY, Chae S. Assessment of the 4-week repeated-dose oral toxicity and genotoxicity of GHX02. J Appl Toxicol. 2020 Feb;40(2):270-284. doi: 10.1002/jat.3902. Epub 2019 Sep 12. | |
| 29764875 | Derived | Lyu YR, Yang WK, Park SJ, Kim SH, Kang WC, Jung IC, Park YC. Efficacy and safety of GHX02 in the treatment of acute bronchitis: protocol of a phase II, double-blind, randomised placebo-controlled trial. BMJ Open. 2018 May 14;8(5):e019897. doi: 10.1136/bmjopen-2017-019897. |
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| ID | Term |
|---|---|
| D001991 | Bronchitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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multicentre, dose-finding,double-blind, randomized placebo-controlled trial
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double-blind
| Placebo | Drug | Placebo tablets |
|
| Change in Leicester Cough Questionnaire-acute(LCQ-acute) | It consists of 19 items divided into three parts, physical, psychological, and social, each scored from 1 to 7. The total score is the sum of the average scores(1-7 points) for each part. The higher the score, the better the quality of life. | Day0, Day7 |
| Change in frequency of coughing fits | participants will be classified into one of the following scales: 0 = 0 time/day, 1 = 1 time/day, 2 = 2-3 times/day, 3 = 4-5 times/day(sometimes), 4 = 6-10 times/day(frequent), 5 = over 15 times/day(consistently). | Day0, Day1, Day2, Day3, Day4, Day5, Day6, Day7 |
| Integrative Medicine Outcome Scale(IMOS) | It's a 5-point-scale for evaluating improvement after treatment (where, 1=complete recovery, 2=major improvement, 3=slight-to-moderate improvement, 4=no change, 5=deterioration), either by the patient or investigator (the investigator in this trial). | Day7 |
| Integrative Medicine Patient Satisfaction Scale(IMPSS) | It's a 5-point-scale for evaluating patient satisfaction with the treatment (where, 1=very satisfied, 2=satisfied, 3=neutral, 4=dissatisfied, 5=very dissatisfied) | Day7 |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |