NCT02637310CompletedPhase 2
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
PharmaKing0 sites108 target enrollmentStarted: December 2015Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 108
- Primary Endpoint
- BSS(Bronchitis Severity Score) score variation compared to baseline after 7 days
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
N02RS1 1200mg
Experimental
Combination of Broussonetia spp and Lonicera spp
Intervention: N02RS1 1200mg (Drug)
Placebo
Placebo Comparator
sugar pill
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
No secondary outcomes reported
Investigators
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