A Clinical Trial to Evaluate the Safety and Efficacy of AG1904 in Acute Bronchitis

Study Overview
=================
Brief Summary
-----------------
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

Official Title
-----------------
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

Conditions
-----------------
Acute Bronchitis

Intervention / Treatment
-----------------
* Drug: AGS (Experimental)
* Drug: AGU (Active Comparator)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both gender, 19 years ≤ age ≤ 75 years BSS(Bronchitis Severity Score) ≥ 5point at Visit 2 (Randomized Visit) Patients without fever based on Visit 2(Randomized Visit) Those who can comply with the requirements of clinical trials Written consent voluntarily to participate in this clinical trial Exclusion Criteria: Patients with respiratory and systemic infections requiring systemic antibiotic therapy Patients with bleeding tendency or coagulation disorder Patients who investigators determines to severe respiratory disease that would interfere with study assessment Those who have participated in other clinical trials within 4 weeks before participating in clinical trials In case the investigator judges that it is not suitable for the subject of this clinical trial for other reasons

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AGS (Experimental)<br>AGS + Placebo of AGU | Drug: AGS (Experimental)<br>* tid<br>|
| Active Comparator: AGU (Active Comparator)<br>Placebo of AGS + AGU | Drug: AGU (Active Comparator)<br>* tid<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 7days | 
| Integrative Medicine Patient Satisfaction Scale (IMPSS) |  | 7days |