Comparative Evaluate the Efficacy to Acute and Chronic Bronchitis

Phase 2

Completed

• Conditions: Acute Exacerbation of Chronic Bronchitis
• Interventions: Drug: Combination of Broussonetia spp and Lonicera spp

• Registration Number: NCT01979926
• Lead Sponsor: PharmaKing

Brief Summary

The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the Efficacy, Safety and Pharmacokinetics of N02RS1 600mg and 1,200mg per day in Patients With acute and acute exacerbation of chronic bronchitis for 7 days.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-31
• Study Start: 2013-11
• Primary Completion: 2013-11
• Study First Submitted QC: 2013-11-04
• Study First Posted: 2013-11-08
• Study Completion: 2014-03
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-29
• Last Update Posted: 2014-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Patients over 18, under 75 years of age
• Patients Acute and Chronic Bronchitis

Exclusion Criteria

• Patients who have gotten a glucocorticoids treatment within 4 weeks.
• Patients who need treatments of antibiotic and acute bronchitis infection.
• Patients who have gotten teatments of antibiotic,bronchodilator,painkiller and secretagog within 7 days.
• Bronchial asthma patient.
• Patients who have an indication of bleeding.
• Patients who have a serious heart and renal disease or liver ailment or immunosuppressive response.
• Patients who have history of over 3 phage of Chronic obstructiv lung disease
• Bronchiectasis patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
N02RS1 200mg	Combination of Broussonetia spp and Lonicera spp	Combination of Broussonetia spp and Lonicera spp
N02RS1 400mg	Combination of Broussonetia spp and Lonicera spp	Combination of Broussonetia spp and Lonicera spp
Placebo	Combination of Broussonetia spp and Lonicera spp	Sugar pill

Primary Outcome Measures

Name	Time	Method
Safety	12weeks	1.Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product.

Secondary Outcome Measures

Name	Time	Method
Efficacy	12weeks	1. Before and after physical examination; 2. Before and after bital Sign: blood pressure, pulse rate, temperature.; 3. Before and after Lanza Score at the duodenum and stomach; 4. Lab: hematologic examination, blood coagulation examination,urine examination; 5. Cumulative incidence rate of an endoscopic peptic ulcer.

Trial Locations

Locations (1)

Seoul Nat'l University of Boramae Hospital; 🇰🇷 Seoul, Korea, Republic of