Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis
|ClinicalTrials.gov Identifier: NCT02151734|
Recruitment Status : Completed
First Posted : May 30, 2014
Last Update Posted : May 30, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Bronchitis||Drug: KALOMIN™ Tab. Drug: Umckamin syrup||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||242 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||December 2013|
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|
- 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 ]