A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Placebo in Acute Bronchitis Patients
NCT ID: NCT03309800
Last Updated: 2017-10-16
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
168 participants
INTERVENTIONAL
2017-03-29
2017-08-28
Brief Summary
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Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject, Total usage of Acetaminophen
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental
HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment
HL301
HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment
Placebo comparator
HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment
HL301(Placebo)
HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment
Interventions
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HL301
HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment
HL301(Placebo)
HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment
Eligibility Criteria
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Inclusion Criteria
2. (Bronchitis Severity Score)\* ≥ 5point at Visit 2 (Randomized Visit)
3. Acute bronchitis within 48hr based on Visit 2 (Randomized Visit)
4. Those who can comply with the requirements of clinical trials
5. Written consent voluntarily to participate in this clinical trial
Exclusion Criteria
2. Patients with bleeding tendency
3. Patients who investigators determines to severe respiratory disease that would interfere with study assessment
4. Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to Visit 2
5. Patients who were treated with oral antihistamines, ACE suppressive. or systemic/inhalative glucocorticosteroid within 2 weeks prior to Visit 2
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, Dongdaemun-gu, South Korea
Countries
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Other Identifiers
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HL_HL301_202
Identifier Type: -
Identifier Source: org_study_id