Respiratory Infection Clinical Trial
Official title:
A Phase 2, Randomized, Double-blind, Multi-center, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-497
Verified date | November 2018 |
Source | Chong Kun Dang Pharmaceutical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the efficacy and safety of CKD-497
Status | Completed |
Enrollment | 220 |
Est. completion date | March 21, 2019 |
Est. primary completion date | March 21, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Hallym University Sacred Heart Hospital | Anyang | Gyeonggi-do |
Korea, Republic of | Hallym University Chuncheon Sacred Heart Hospital | Chuncheon | Gangwon-do |
Korea, Republic of | Hanyang University Guri Hospital | Guri | Gyenggi-do |
Korea, Republic of | Gachon University Gil Medical Center | Incheon | Namdong-gu |
Korea, Republic of | EWHA Womans University Mokdong Hospital | Seoul | Yangcheon-gu |
Korea, Republic of | Kangbuk Samsung Hospital | Seoul | Jongno-gu |
Korea, Republic of | Kangdong Sacred Heart Hospital | Seoul | Kangdong-gu |
Korea, Republic of | Konkuk University Medical Center | Seoul | Gwangjin-gu |
Korea, Republic of | Korea University Anam hospital | Seoul | Seongbuk-gu |
Korea, Republic of | KyungHee University Medical Center | Seoul | Dongdaemun-gu |
Korea, Republic of | Seoul Metropolitan Government Seoul National University Boramae Medical Center | Seoul | Dongjak-gu |
Korea, Republic of | The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | Seocho-gu |
Korea, Republic of | The Catholic University of Korea, Yeouido ST. Mary's Hospital | Seoul | Yeongdeungpo-gu |
Korea, Republic of | Ulsan University Hospital | Ulsan | Dong-gu |
Korea, Republic of | Wonju Severance Christian Hospital | Wonju | Gangwon-do |
Lead Sponsor | Collaborator |
---|---|
Chong Kun Dang Pharmaceutical |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | BSS(Bronchitis Severity Score) | 0(absent) ~ 4(very severe), Total Score: 0~20 | 1 week | |
Primary | SUM8(The 8-symptom related questions in the Daily Cough and Phlegm) | 0(Never) ~ 4(always), Total Score: 0~32 | 1 week |
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