We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparative Evaluate the Efficacy to Acute and Chronic Bronchitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01979926
First Posted: November 8, 2013
Last Update Posted: May 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PharmaKing
October 31, 2013
November 8, 2013
May 30, 2014
November 2013
November 2013   (Final data collection date for primary outcome measure)
Safety [ Time Frame: 12weeks ]
1.Adverse Event: symptom, start day and time, end day and time, injection time, severity, progress, outcome, relation with investigational product.
Same as current
Complete list of historical versions of study NCT01979926 on ClinicalTrials.gov Archive Site
Efficacy [ Time Frame: 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.
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Acute Exacerbation of Chronic Bronchitis
Drug: Combination of Broussonetia spp and Lonicera spp
600 mg/ day or 1200 mg/ day for 7 days
Other Name: N02RS1
  • Experimental: N02RS1 200mg
    Combination of Broussonetia spp and Lonicera spp
    Intervention: Drug: Combination of Broussonetia spp and Lonicera spp
  • Experimental: N02RS1 400mg
    Combination of Broussonetia spp and Lonicera spp
    Intervention: Drug: Combination of Broussonetia spp and Lonicera spp
  • Placebo Comparator: Placebo
    Sugar pill
    Intervention: Drug: Combination of Broussonetia spp and Lonicera spp
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
March 2014
November 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01979926
PMK-N02RS1
Yes
Not Provided
Not Provided
PharmaKing
PharmaKing
Not Provided
Study Director: Wayne B An, Bs Korea Pharmaceutical Manufacturers Association
PharmaKing
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP