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A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of AGS Compared to AGU for Acute Bronchitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGS (Experimental) | Experimental | AGS + Placebo of AGU |
|
| AGU (Active Comparator) | Active Comparator | Placebo of AGS + AGU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGS (Experimental) | Drug | tid |
| |
| AGU (Active Comparator) |
| Measure | Description | Time Frame |
|---|---|---|
| Bronchitis Severity Total Score(BSS) change of Visit 3 compared to Visit 2 | The BSS comprises the following five symptoms typical for Acute Bronchitis: cough, sputum, rales/rhonchi on auscultation, chest pain during coughing, and dyspnea. These symptoms are each assessed according to a 5-point 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 |
|---|---|---|
| Individual symptom score of Bronchitis Severity Score(BSS) of Visit 3 compared to Visit 2 | 7days | |
| Treatment response rate at Visit 3 | 7days | |
| Integrative Medicine Outcome Scale (IMOS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Konkuk University Medical Center | Seoul | 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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| ID | Term |
|---|---|
| D001227 | Aspartylglucosylaminase |
| ID | Term |
|---|---|
| D000581 | Amidohydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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| Drug |
tid |
|
| 7days |
| Integrative Medicine Patient Satisfaction Scale (IMPSS) | 7days |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |