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This is a multi-center, double-dummy, double-blind, randomized, active-controlled, parallel group phase 3 clinical trial to evaluate the efficacy and safety of KALOMINâ„¢ Tab. in patients with acute bronchitis.
The aim of this clinical trial is to demonstrate that KALOMINâ„¢ Tab. is clinically non-inferior to Umckamin syrup, as assessed by BSS(Bronchitis Severity Score), in the treatment of acute bronchitis after 7 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KALOMINâ„¢ Tab. | Experimental | KALOMINâ„¢ Tab./Placebo to Umckamin syrup |
|
| Umckamin syrup | Active Comparator | Umckamin syrup/Placebo to KALOMINâ„¢ Tab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KALOMINâ„¢ Tab. | Drug |
| ||
| Umckamin syrup |
| Measure | Description | Time Frame |
|---|---|---|
| Total score of BSS(Bronchitis Severity Score) | 7days |
| Measure | Description | Time Frame |
|---|---|---|
| Individual symptom score of BSS | 7days | |
| reaction rate of treatment | 7days | |
| IMOS(Integrative Medicine Outcome Scale) |
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Inclusion Criteria:
Exclusion Criteria:
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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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|
| 7days |
| IMPSS(Integrative Medicine Patient Satisfaction Scale) | 7days |
| Adverse events, clinical laboratory examination, physical examination, etc. | 7 days |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |