Back to resultsEvaluate the Efficacy and Safety of N02RS1 in Patient With Acute Bronchitis
Primary Purpose
Acute Bronchitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
N02RS1 1200mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Bronchitis
Eligibility Criteria
Inclusion Criteria:
- Patients over 19, under 75 of age
- Patients acute bronchitis, sputum symptoms, BSS over 7 points.
- Patients acute bronchitis within 7days.
- Non-pregnant, patients who agree to contraception.
- Patients who can write diary and available to communicate.
- Patients voluntarily agreed
Exclusion Criteria:
- Patients with hypersensitivity to the drug.
- Patients who have gotten systemic steroid treatment within 4 weeks.
- Patients who have gotten treatment of antibiotics, bronchodilators, painkiller and secretagog within 7 days.
- Patients who have gotten treatment of mucus solvents or antitussives within 3 days.
- Patients who serious respiratory infections requiring antibiotic treatment, allergic bronchial asthma, bronchiectasis and chronic obstructive pulmonary disease.
- Patients heart disease, severe kidney, liver disease.
- The bleeding tendency or immunosuppressed patients.
- Patients with clinically significant abnormal values.
- Pregnant women or nursing mothers.
- Patients alcoholics or drug abuse.
- Patients taking other clinical trail's medicines within 30 days.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
N02RS1 1200mg
Placebo
Arm Description
Combination of Broussonetia spp and Lonicera spp
sugar pill
Outcomes
Primary Outcome Measures
BSS(Bronchitis Severity Score) score variation compared to baseline after 7 days
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02637310
Brief Title
Evaluate the Efficacy and Safety of N02RS1 in Patient With Acute Bronchitis
Official Title
A Multi Center, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 2b Clinical Trial to Evaluate the Efficacy and Safety of N02RS1 in Patients With Acute Bronchitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PharmaKing
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A multi center, randomized, double-blind, placebo-controlled, parallel, phase 2b clinical trial to evaluate the efficacy and safety of N02RS1 in patients with acute bronchitis
Detailed Description
Suitable subjects randomized to the experimental or control group. The subjects eat IP during 7days. Visit 3(3 days) evaluate BSS through phone call and visit 4(8 days) evaluate efficacy and safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bronchitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N02RS1 1200mg
Arm Type
Experimental
Arm Description
Combination of Broussonetia spp and Lonicera spp
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
sugar pill
Intervention Type
Drug
Intervention Name(s)
N02RS1 1200mg
Intervention Description
1200mg/day, Three times a day orally, 2 tablets once, 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1200mg/day, Three times a day orally, 2 tablets once, 7 days
Primary Outcome Measure Information:
Title
BSS(Bronchitis Severity Score) score variation compared to baseline after 7 days
Time Frame
Visit 1(-3days, screening), 2(0day, randomization), 3(3days), 4(8days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over 19, under 75 of age
Patients acute bronchitis, sputum symptoms, BSS over 7 points.
Patients acute bronchitis within 7days.
Non-pregnant, patients who agree to contraception.
Patients who can write diary and available to communicate.
Patients voluntarily agreed
Exclusion Criteria:
Patients with hypersensitivity to the drug.
Patients who have gotten systemic steroid treatment within 4 weeks.
Patients who have gotten treatment of antibiotics, bronchodilators, painkiller and secretagog within 7 days.
Patients who have gotten treatment of mucus solvents or antitussives within 3 days.
Patients who serious respiratory infections requiring antibiotic treatment, allergic bronchial asthma, bronchiectasis and chronic obstructive pulmonary disease.
Patients heart disease, severe kidney, liver disease.
The bleeding tendency or immunosuppressed patients.
Patients with clinically significant abnormal values.
Pregnant women or nursing mothers.
Patients alcoholics or drug abuse.
Patients taking other clinical trail's medicines within 30 days.
12. IPD Sharing Statement
Learn more about this trial
Evaluate the Efficacy and Safety of N02RS1 in Patient With Acute Bronchitis
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