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)
NCT02250027 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156
Last updated 2014-09-26
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(Breathlessness, Cough, and Sputum Scale), evaluation of symptoms of cough and sputum
Conditions
- Acute Bronchitis
- Acute Exacerbations of Chronic Bronchitis
Interventions
- DRUG
-
HL301 300mg capsule
2 capsules at once, 3 times a day, for 7 days
- DRUG
-
2 capsules at once, 3 times a day, for 7 days
Sponsors & Collaborators
-
Hanlim Pharm. Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-03-31
- Primary Completion
- 2014-07-31
- Completion
- 2014-07-31
Countries
- South Korea
Study Locations
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