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)
NCT ID: NCT02250027
Last Updated: 2014-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
156 participants
INTERVENTIONAL
2014-03-31
2014-07-31
Brief Summary
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\- BSS(Bronchitis Severity Score), BCSS(Breathlessness, Cough, and Sputum Scale), evaluation of symptoms of cough and sputum
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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experimental A (0.6g/day)
HL301 0.6g/day: 2 capsules at once, 3 times a day, for 7 days
HL301 300mg capsule
2 capsules at once, 3 times a day, for 7 days
Placebo
2 capsules at once, 3 times a day, for 7 days
experimental B (1.2g/day)
HL301 1.2g/day: 2 capsules at once, 3 times a day, for 7 days
HL301 300mg capsule
2 capsules at once, 3 times a day, for 7 days
Placebo
2 capsules at once, 3 times a day, for 7 days
experimental C (1.8g/day)
HL301 1.8g/day: 2 capsules at once, 3 times a day, for 7 days
HL301 300mg capsule
2 capsules at once, 3 times a day, for 7 days
Placebo
placebo: 2 capsules at once, 3 times a day, for 7 days
Placebo
2 capsules at once, 3 times a day, for 7 days
Interventions
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HL301 300mg capsule
2 capsules at once, 3 times a day, for 7 days
Placebo
2 capsules at once, 3 times a day, for 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Acute bronchitis or acute exacerbations of chronic bronchitis patients with BSS(Bronchitis Severity Score)\* ≥ 5point at Visit1 and Visit2
3. Written consent voluntarily to participate in this clinical trial
Exclusion Criteria
2. Patients with any of Alanine aminotransferase, Aspartate aminotransferase or serum Blood Urea Nitrogen, Creatinine\> 2 times of the normal upper range
3. Patients who investigators determines to severe respiratory disease that would interfere with study assessment
4. Patients with COPD(Chronic Obstructive Pulmonary Disease) history of stage 3 or more
5. Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to study participation
6. 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
7. Patients who were treated with oral Antitussive, Mucolytic Agents,systemic antimicrobial agent within 3 days prior to study medication dosing
8. Patients with drug or alcohol abuse
9. 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)
10. The aged person with severe medical history which is mental disorder(dementia), cancer, chronic renal failure, chronic liver failure
11. Pregnant or breast-feeding
12. Patients currently participating in or has participated in other clinical study within 30 days prior to study participation
13. Patients who investigators determines not appropriate to take part in this clinical study
19 Years
80 Years
ALL
No
Sponsors
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Hanlim Pharm. Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Kyung Hee University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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HL_HL301_201
Identifier Type: -
Identifier Source: org_study_id
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