Evaluate the Efficacy and Safety of N02RS1 in Patient Wit... | NCT02637310

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

NCT02637310

Sponsor

PharmaKing

Status

Completed

Last Update Posted

Mar 30, 2016Estimated

Enrollment

108Actual

Phase

Phase 2

Conditions

Acute Bronchitis

Interventions

N02RS1 1200mg
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Dec 8, 2015

First Submission Date that Met QC Criteria

Dec 17, 2015

First Posted Date

Dec 22, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2016

Last Update Posted Date

Mar 30, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
N02RS1 1200mg	Experimental	Combination of Broussonetia spp and Lonicera spp	Drug: N02RS1 1200mg
Placebo	Placebo Comparator	sugar pill	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
N02RS1 1200mg	Drug	1200mg/day, Three times a day orally, 2 tablets once, 7 days	N02RS1 1200mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BSS(Bronchitis Severity Score) score variation compared to baseline after 7 days		Visit 1(-3days, screening), 2(0day, randomization), 3(3days), 4(8days)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001991	Bronchitis

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided