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Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis

Primary Purpose

Acute Bronchitis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

KALOMIN™ Tab.

Umckamin syrup

About this trial

This is an interventional treatment trial for Acute Bronchitis

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients aged 12-75 years old
A total score of BSS ≥ 5
The duration of symptoms had to be less than 14 days and no chronic pulmonary disease
Patients who voluntarily sign a written informed consent to participate in the trial

Exclusion Criteria:

Indication for antibiotic treatment(e.g. severe respiratory infection)
Allergic bronchial asthma
Tendency to bleed
Severe heart, renal, or liver diseases or decline of immune function
Chronic obstructive pulmonary disease
Known or supposed hypersensitivity to investigational medication
Treatment with antibiotics during the past 4 weeks prior to inclusion in the trial
Women during pregnancy or lactation period
Clinically significant abnormal values in the screening test(more than twice the upper limit of normal range for ALT, AST, BUN, and Serum Creatinine)
Participation in any other trial within 30 days prior to inclusion in the trial
Unsuitable patients for enrollment in the opinion of the investigator

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

KALOMIN™ Tab.

Umckamin syrup

Arm Description

KALOMIN™ Tab./Placebo to Umckamin syrup

Umckamin syrup/Placebo to KALOMIN™ Tab.

Outcomes

Primary Outcome Measures

Total score of BSS(Bronchitis Severity Score)

Secondary Outcome Measures

Individual symptom score of BSS

reaction rate of treatment

IMOS(Integrative Medicine Outcome Scale)

IMPSS(Integrative Medicine Patient Satisfaction Scale)

Adverse events, clinical laboratory examination, physical examination, etc.

Full Information

NCT ID

NCT02151734

First Posted

May 28, 2014

Last Updated

May 28, 2014

Sponsor

Korea United Pharm. Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02151734

Brief Title

Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Korea United Pharm. Inc.

4. Oversight

5. Study Description

Brief Summary

This is a multi-center, double-dummy, double-blind, randomized, active-controlled, parallel group phase 3 clinical trial to evaluate the efficacy and safety of KALOMIN™ Tab. in patients with acute bronchitis. The aim of this clinical trial is to demonstrate that KALOMIN™ Tab. is clinically non-inferior to Umckamin syrup, as assessed by BSS(Bronchitis Severity Score), in the treatment of acute bronchitis after 7 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Bronchitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

242 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KALOMIN™ Tab.

Arm Type

Experimental

Arm Description

KALOMIN™ Tab./Placebo to Umckamin syrup

Arm Title

Umckamin syrup

Arm Type

Active Comparator

Arm Description

Umckamin syrup/Placebo to KALOMIN™ Tab.

Intervention Type

Drug

Intervention Name(s)

KALOMIN™ Tab.

Intervention Type

Drug

Intervention Name(s)

Umckamin syrup

Primary Outcome Measure Information:

Title

Total score of BSS(Bronchitis Severity Score)

Time Frame

7days

Secondary Outcome Measure Information:

Title

Individual symptom score of BSS

Time Frame

7days

Title

reaction rate of treatment

Time Frame

7days

Title

IMOS(Integrative Medicine Outcome Scale)

Time Frame

7days

Title

IMPSS(Integrative Medicine Patient Satisfaction Scale)

Time Frame

7days

Title

Adverse events, clinical laboratory examination, physical examination, etc.

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients aged 12-75 years old A total score of BSS ≥ 5 The duration of symptoms had to be less than 14 days and no chronic pulmonary disease Patients who voluntarily sign a written informed consent to participate in the trial Exclusion Criteria: Indication for antibiotic treatment(e.g. severe respiratory infection) Allergic bronchial asthma Tendency to bleed Severe heart, renal, or liver diseases or decline of immune function Chronic obstructive pulmonary disease Known or supposed hypersensitivity to investigational medication Treatment with antibiotics during the past 4 weeks prior to inclusion in the trial Women during pregnancy or lactation period Clinically significant abnormal values in the screening test(more than twice the upper limit of normal range for ALT, AST, BUN, and Serum Creatinine) Participation in any other trial within 30 days prior to inclusion in the trial Unsuitable patients for enrollment in the opinion of the investigator

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis

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