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The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), pelargonium sidoides extract 9mL(t.i.d.) or Placebo for 7 days.
The treatments will be assigned randomly to patients (n=116) with acute or chronic bronchitis.
The outcome measures is to evaluate the overall change from baseline to the end of treatment in scores relating to the severity of four symptom of bronchitis: cough, sputum, QOL of daily life, QOL of falling asleep at night.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YHD001 dose level 1 | Experimental | YHD001 dose level 1 |
|
| YHD001 dose level 2 | Experimental | YHD001 dose level 2 |
|
| Pelargonium sidoides extract | Active Comparator | Pelargonium sidoides extract (Syrup) |
|
| Placebo | Placebo Comparator | Placebo for YHD001 & active comparator(syrup) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YHD001 dose level 1 | Drug | three times daily / 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of total symptom score from baseline to the end of treatment | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| safety assessment | comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D7. | 7 days |
| time to response | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young Kyoon Kim, M.D., Ph.D. | Division of Respiratory and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital,College of Medicine, The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea Seoul St. Mary'S Hospital | Seoul | 137-701 | South Korea |
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| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D029481 | Bronchitis, Chronic |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| YHD001 dose level 2 | Drug | three times daily / 7 days |
|
|
| Pelargonium sidoides extract | Drug | 6-9mL three times daily / 7 days |
|
|
| placebo | Drug | three times daily / 7 days |
|
| compliance, defined by drug accountability | 7 days |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |