Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis
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 KALOMIN™ Tab. in patients with acute bronchitis.
The aim of this clinical trial is to demonstrate that KALOMIN™ Tab. is clinically non-inferior to Umckamin syrup, as assessed by BSS(Bronchitis Severity Score), in the treatment of acute bronchitis after 7 days.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
- Total score of BSS(Bronchitis Severity Score) [ Time Frame: 7days ]
- Individual symptom score of BSS [ Time Frame: 7days ]
- reaction rate of treatment [ Time Frame: 7days ]
- IMOS(Integrative Medicine Outcome Scale) [ Time Frame: 7days ]
- IMPSS(Integrative Medicine Patient Satisfaction Scale) [ Time Frame: 7days ]
- Adverse events, clinical laboratory examination, physical examination, etc. [ Time Frame: 7 days ]
|Study Start Date:||August 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: KALOMIN™ Tab.
KALOMIN™ Tab./Placebo to Umckamin syrup
|Drug: KALOMIN™ Tab.|
Active Comparator: Umckamin syrup
Umckamin syrup/Placebo to KALOMIN™ Tab.
|Drug: Umckamin syrup|
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