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

NCT ID: NCT02637310

Last Updated: 2016-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Bronchitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

N02RS1 1200mg

Combination of Broussonetia spp and Lonicera spp

Group Type EXPERIMENTAL

N02RS1 1200mg

Intervention Type DRUG

1200mg/day, Three times a day orally, 2 tablets once, 7 days

Placebo

sugar pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1200mg/day, Three times a day orally, 2 tablets once, 7 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

N02RS1 1200mg

1200mg/day, Three times a day orally, 2 tablets once, 7 days

Intervention Type DRUG

Placebo

1200mg/day, Three times a day orally, 2 tablets once, 7 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

PharmaKing

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PMK-N02RS1_Phase 2B

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.