NCT02151734

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P50-P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
Last Updated

May 30, 2014

Status Verified

May 1, 2014

Enrollment Period

4 months

First QC Date

May 28, 2014

Last Update Submit

May 28, 2014

Conditions

Acute Bronchitis

Outcome Measures

Primary Outcomes (1)

  • Total score of BSS(Bronchitis Severity Score)

    7days

Secondary Outcomes (5)

  • Individual symptom score of BSS

    7days

  • reaction rate of treatment

    7days

  • IMOS(Integrative Medicine Outcome Scale)

    7days

  • IMPSS(Integrative Medicine Patient Satisfaction Scale)

    7days

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

    7 days

Study Arms (2)

KALOMIN™ Tab.

EXPERIMENTAL

KALOMIN™ Tab./Placebo to Umckamin syrup

Drug: KALOMIN™ Tab.

Umckamin syrup

ACTIVE COMPARATOR

Umckamin syrup/Placebo to KALOMIN™ Tab.

Drug: Umckamin syrup

Interventions

KALOMIN™ Tab.DRUG
KALOMIN™ Tab.
Umckamin syrupDRUG
Umckamin syrup

Eligibility Criteria

Age12 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)
  • Unsuitable patients for enrollment in the opinion of the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2014

First Posted

May 30, 2014

Study Start

August 1, 2013

Primary Completion

December 1, 2013

Last Updated

May 30, 2014

Record last verified: 2014-05