Status:
COMPLETED
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)
Lead Sponsor:
Hanlim Pharm. Co., Ltd.
Conditions:
Acute Bronchitis
Acute Exacerbations of Chronic Bronchitis
Eligibility:
All Genders
19-80 years
Phase:
PHASE2
Brief Summary
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(Breathlessn...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT02250027
Start Date
March 1 2014
End Date
July 1 2014
Last Update
September 26 2014
Active Locations (1)
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1
Kyung Hee University Hospital
Seoul, South Korea, 130-872