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The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the Efficacy, Safety and Pharmacokinetics of N02RS1 600mg and 1,200mg per day in Patients With acute and acute exacerbation of chronic bronchitis for 7 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N02RS1 200mg | Experimental | Combination of Broussonetia spp and Lonicera spp |
|
| N02RS1 400mg | Experimental | Combination of Broussonetia spp and Lonicera spp |
|
| Placebo | Placebo Comparator | Sugar pill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination of Broussonetia spp and Lonicera spp | Drug | 600 mg/ day or 1200 mg/ day for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | 1.Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product. | 12weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy |
| 12weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wayne B An, Bs | Korea Pharmaceutical Manufacturers Association | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Nat'l University of Boramae Hospital | Seoul | Seoul | South Korea |
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