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A Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Placebo in acute bronchitis patients.
Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject, Total usage of Acetaminophen
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment |
|
| Placebo comparator | Placebo Comparator | HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HL301 | Drug | HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchitis Severity Total Score(BSS) Change | Evaluation period: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day) | 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 response (Chi-square test or Fisher's Exact test) | Evaluation period: Visit 3 (7 day) | 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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| HL301(Placebo) |
| Drug |
HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment |
|
Evaluation period: Visit 3 (7 day)
| Visit 3 (7 day) |
| Total usage of Acetaminophen | Evaluation period: Visit 3 (7 day) | Visit 3 (7 day) |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |