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Comparative Evaluate the Efficacy to Acute and Chronic Bronchitis

P

PharmaKing

Status and phase

Completed
Phase 2

Conditions

Acute Exacerbation of Chronic Bronchitis

Treatments

Drug: Combination of Broussonetia spp and Lonicera spp

Study type

Interventional

Funder types

Industry

Identifiers

NCT01979926
PMK-N02RS1

Details and patient eligibility

About

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.

Enrollment

102 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

102 participants in 3 patient groups, including a placebo group

N02RS1 200mg
Experimental group
Description:
Combination of Broussonetia spp and Lonicera spp
Treatment:
Drug: Combination of Broussonetia spp and Lonicera spp
N02RS1 400mg
Experimental group
Description:
Combination of Broussonetia spp and Lonicera spp
Treatment:
Drug: Combination of Broussonetia spp and Lonicera spp
Placebo
Placebo Comparator group
Description:
Sugar pill
Treatment:
Drug: Combination of Broussonetia spp and Lonicera spp

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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