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To evaluate the efficacy and safety of CKD-497
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD-497 200mg | Experimental | CKD-497 200mg |
|
| CKD-497 300mg | Experimental | CKD-497 300mg |
|
| Active Comparator | Active Comparator | compartor |
|
| Placebo | Placebo Comparator | CKD-497 placebo and comparator placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-497 200mg | Drug | CKD-497 200mg |
| |
| CKD-497 300mg |
| Measure | Description | Time Frame |
|---|---|---|
| BSS(Bronchitis Severity Score) | 0(absent) ~ 4(very severe), Total Score: 0~20 | 1 week |
| SUM8(The 8-symptom related questions in the Daily Cough and Phlegm) | 0(Never) ~ 4(always), Total Score: 0~32 | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulsan University Hospital | Ulsan | Dong-gu | South Korea | |||
| KyungHee University Medical Center |
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| Drug |
CKD-497 300mg |
|
| CKD-497 placebo | Drug | Placebo of CKD-497 |
|
| Comparator | Drug | Comparator |
|
| Comparator placebo | Drug | Comparator placebo |
|
| Seoul |
| Dongdaemun-gu |
| South Korea |
| Seoul Metropolitan Government Seoul National University Boramae Medical Center | Seoul | Dongjak-gu | South Korea |
| Hallym University Chuncheon Sacred Heart Hospital | Chuncheon | Gangwon-do | South Korea |
| Wonju Severance Christian Hospital | Wŏnju | Gangwon-do | South Korea |
| Konkuk University Medical Center | Seoul | Gwangjin-gu | South Korea |
| Hanyang University Guri Hospital | Guri-si | Gyenggi-do | South Korea |
| Hallym University Sacred Heart Hospital | Anyang-si | Gyeonggi-do | South Korea |
| Kangbuk Samsung Hospital | Seoul | Jongno-gu | South Korea |
| Kangdong Sacred Heart Hospital | Seoul | Kangdong-gu | South Korea |
| Gachon University Gil Medical Center | Incheon | Namdong-gu | South Korea |
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | Seocho-gu | South Korea |
| Korea University Anam hospital | Seoul | Seongbuk-gu | South Korea |
| EWHA Womans University Mokdong Hospital | Seoul | Yangcheon-gu | South Korea |
| The Catholic University of Korea, Yeouido ST. Mary's Hospital | Seoul | Yeongdeungpo-gu | South Korea |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D001991 | Bronchitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C000715822 | CKD-497 |
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