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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02151734

Enrollment

242

Registered

2014-05-30

Start date

2013-08-31

Completion date

Unknown

Last updated

2014-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Bronchitis

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.

Interventions

DRUGKALOMIN™ Tab.

DRUGUmckamin syrup

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Total score of BSS(Bronchitis Severity Score)	7days

Secondary

Measure	Time frame
IMOS(Integrative Medicine Outcome Scale)	7days
IMPSS(Integrative Medicine Patient Satisfaction Scale)	7days
Adverse events, clinical laboratory examination, physical examination, etc.	7 days
Individual symptom score of BSS	7days
reaction rate of treatment	7days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026