A Multicenter, Randomized, Double-blind, Parallel Group Study to Determine the Optimal Dose of HL301 After 7 Days Oral Administration in Acute Bronchitis or Acute Exacerbations of Chronic Bronchitis Patients (HL301: Mixed Extract of Rehmannia Glutinosa, Schisandra and so on)

Study Overview
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Brief Summary
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The purpose of this study is to determine the optimal dose of HL301 in patients with acute bronchitis or acute exacerbations of chronic bronchitis. - BSS(Bronchitis Severity Score), BCSS(Breathlessness, Cough, and Sputum Scale), evaluation of symptoms of cough and sputum

Conditions
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Acute Bronchitis, Acute Exacerbations of Chronic Bronchitis

Intervention / Treatment
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* Drug: HL301 300mg capsule
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both gender, 19 years ≤ age ≤ 80 years Acute bronchitis or acute exacerbations of chronic bronchitis patients with BSS(Bronchitis Severity Score)* ≥ 5point at Visit1 and Visit2 Written consent voluntarily to participate in this clinical trial Exclusion Criteria: Patients who were increased the bleeding tendency Patients with any of Alanine aminotransferase, Aspartate aminotransferase or serum Blood Urea Nitrogen, Creatinine> 2 times of the normal upper range Patients who investigators determines to severe respiratory disease that would interfere with study assessment Patients with COPD(Chronic Obstructive Pulmonary Disease) history of stage 3 or more Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to study participation Patients who were treated with oral β2-agonist, anticholinergic, Methylxanthine, antibiotics, antihistamines, sympathomimetic agent or oriental medicine/health functional food for antitussive and mucolytic Effect within 1 weeks prior to study participation Patients who were treated with oral Antitussive, Mucolytic Agents,systemic antimicrobial agent within 3 days prior to study medication dosing Patients with drug or alcohol abuse Patients with clinically significant active liver, renal, cardiovascular, respiratory, endocrine, central nervous system disease or history of malignant tumor or mental illness(except no relapse for 5 years after surgery) The aged person with severe medical history which is mental disorder(dementia), cancer, chronic renal failure, chronic liver failure Pregnant or breast-feeding Patients currently participating in or has participated in other clinical study within 30 days prior to study participation Patients who investigators determines not appropriate to take part in this clinical study

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental A (0.6g/day)<br>HL301 0.6g/day: 2 capsules at once, 3 times a day, for 7 days | Drug: HL301 300mg capsule<br>* 2 capsules at once, 3 times a day, for 7 days<br>* Other names: experimental C (1.8g/day) : HL301 300mg 6 capsule;Drug: Placebo<br>* 2 capsules at once, 3 times a day, for 7 days<br>* Other names: Microcrystalline Cellulose;|
| Experimental: experimental B (1.2g/day)<br>HL301 1.2g/day: 2 capsules at once, 3 times a day, for 7 days | Drug: HL301 300mg capsule<br>* 2 capsules at once, 3 times a day, for 7 days<br>* Other names: experimental C (1.8g/day) : HL301 300mg 6 capsule;Drug: Placebo<br>* 2 capsules at once, 3 times a day, for 7 days<br>* Other names: Microcrystalline Cellulose;|
| Experimental: experimental C (1.8g/day)<br>HL301 1.8g/day: 2 capsules at once, 3 times a day, for 7 days | Drug: HL301 300mg capsule<br>* 2 capsules at once, 3 times a day, for 7 days<br>* Other names: experimental C (1.8g/day) : HL301 300mg 6 capsule;|
| Placebo Comparator: Placebo<br>placebo: 2 capsules at once, 3 times a day, for 7 days | Drug: Placebo<br>* 2 capsules at once, 3 times a day, for 7 days<br>* Other names: Microcrystalline Cellulose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bronchitis Severity Score | Bronchitis Severity Score | baseline(day 0) and day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breathlessness, Cough, and Sputum Scale | Breathlessness, Cough, and Sputum Scale | baseline(day 0) and day 7 | 
| evaluation of symptoms of cough and sputum |  | baseline(day 0) and day 7 | 
| Total usage of acetaminophen |  | baseline(day 0) and day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute bronchitis, acute exacerbations of chronic bronchitis