Evaluate the Efficacy and Safety of N02RS1 in Patient With Acute Bronchitis

Phase 2

Completed

• Conditions: Acute Bronchitis
• Interventions: Drug: N02RS1 1200mg; Drug: Placebo

• Registration Number: NCT02637310
• Lead Sponsor: PharmaKing

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 Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-08
• Study First Submitted QC: 2015-12-17
• Study First Posted: 2015-12-22
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N02RS1 1200mg	N02RS1 1200mg	Combination of Broussonetia spp and Lonicera spp
Placebo	Placebo	sugar pill

Primary Outcome Measures

Name	Time	Method
BSS(Bronchitis Severity Score) score variation compared to baseline after 7 days	Visit 1(-3days, screening), 2(0day, randomization), 3(3days), 4(8days)