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A Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Umkamin tab. in acute bronchitis patients
Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HL301(Experimental) | Experimental | Total 7 days of treatment and The daily dose is as follows [Morning: HL301 1Tab + Placebo of Umkamin 1Tab] [Noon: Placebo of Umkamin 1Tab] [Evening: HL301 1Tab + Placebo of Umkamin 1Tab] |
|
| Umkamin(Active Comparator) | Active Comparator | Total 7 days of treatment and The daily dose is as follows [Morning: Placebo of HL301 1Tab + Umkamin 1Tab] [Noon: Umkamin 1Tab] [Evening: Placebo of HL301 1Tab + Umkamin 1Tab] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HL301(Experimental) | Drug | Total 7 days of treatment and The daily dose is as follows [Morning: HL301 1Tab + Placebo of Umkamin 1Tab] [Noon: Placebo of Umkamin 1Tab] [Evening: HL301 1Tab + Placebo of Umkamin 1Tab] |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchitis Severity Total Score(BSS) Change | The BSS comprises the following five symptoms typical for Acute Bronchitis: cough, sputum, rales on auscultation, chest pain on coughing, and dyspnoea. These symptoms are each assessed according to a 5-point Likert scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe | Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day) |
| Measure | Description | Time Frame |
|---|---|---|
| The improvement and improvement rate of the tester for the treatment | Improvement and improvement rate are assessed by tester according to a 5 factors: Deterioration, No change, Slight to moderate improvement, Major improvement, Complete recovery | Visit 3 (7 day) |
| The satisfaction of the subject (Questionnaire) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Hospital | Seoul | Dongdaemun-gu | 130-872 | South Korea |
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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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| Umkamin(Active Comparator) | Drug | Total 7 days of treatment and The daily dose is as follows [Morning: Placebo of HL301 1Tab + Umkamin 1Tab] [Noon: Umkamin 1Tab] [Evening: Placebo of HL301 1Tab + Umkamin 1Tab] |
|
|
Satisfaction of the subject (Questionnaire) are assessed by subject according to a 5 factors: Very dissatisfied, Dissatisfied, Neutral, Satisfied, Very satisfied |
| Visit 3 (7 day) |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |