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

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ClinicalTrials.gov Identifier: NCT02637310
Recruitment Status : Completed
First Posted : December 22, 2015
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Acute Bronchitis Drug: N02RS1 1200mg Drug: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acute Bronchitis

Arm Intervention/treatment
Experimental: N02RS1 1200mg
Combination of Broussonetia spp and Lonicera spp
Drug: N02RS1 1200mg
1200mg/day, Three times a day orally, 2 tablets once, 7 days

Placebo Comparator: Placebo
sugar pill
Drug: Placebo
1200mg/day, Three times a day orally, 2 tablets once, 7 days




Primary Outcome Measures :
  1. 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) ]


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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Responsible Party: PharmaKing
ClinicalTrials.gov Identifier: NCT02637310     History of Changes
Other Study ID Numbers: PMK-N02RS1_Phase 2B
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes