Comparative Evaluate the Efficacy to Acute and Chronic Bronchitis

Double-blind, A Multicenter, Randomized, Placebo-controlled, Parallel, Phase 2 Study to Comparative Evaluate the Efficacy of N02RS1 600mg/Day, 12,00mg/Day in Korean Patients With Acute and Chronic Bronchitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01979926

Enrollment

102

Registered

2013-11-08

Start date

2013-11-30

Completion date

2014-03-31

Last updated

2014-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Exacerbation of Chronic Bronchitis

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.

Interventions

DRUGCombination of Broussonetia spp and Lonicera spp

600 mg/ day or 1200 mg/ day for 7 days

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026