The Clinical Trial to Evaluate the Efficacy and Safety of CKD-497

Phase 2CompletedNCT03726853

Chong Kun Dang Pharmaceutical220 enrolled

Overview

To evaluate the efficacy and safety of CKD-497

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

220

Conditions

Respiratory Infection

Interventions

CKD-497 200mgDRUG

CKD-497 200mg

CKD-497 300mgDRUG

CKD-497 300mg

CKD-497 placeboDRUG

Placebo of CKD-497

Comparator

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 19 ≤ age \< 75 2. Subject with acute upper respiratory infection and acute bronchitis infection 3. Subject who agreeds to participate in this clinical trial voluntarily Exclusion Criteria: 1. Subject who need antibiotics treatment during the clinical trial 2. Subject suffering from severe respiratory diseases such as pneumonia, asthma, chronic closed lung diseases (COPD), tuberculosis, bronchial enlargement, malignant tumors in the lungs, and chronic bronchitis during screening 3. Subject who cannot participate in a clinical trial based on the PI's judgment

Locations (15)

Ulsan University Hospital

Ulsan, Dong-gu, South Korea

KyungHee University Medical Center

Seoul, Dongdaemun-gu, South Korea

Outcomes

Primary Outcomes

BSS(Bronchitis Severity Score)

0(absent) \~ 4(very severe), Total Score: 0\~20

Time frame: 1 week

SUM8(The 8-symptom related questions in the Daily Cough and Phlegm)

0(Never) \~ 4(always), Total Score: 0\~32

Time frame: 1 week

Data from ClinicalTrials.gov

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