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The aim of this clinical trial is to evaluate the antitussive effect of "Theobromine capsule 300mg" in patients with acute bronchitis.
This study is double blinded, randomized, parallel designed, phase III clinical trial to evaluate the efficacy and safety of "Theobromine capsule 300mg" versus "Levodropropizine syrup" in patients with acute bronchitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theobromine | Experimental | Theobromine capsule 300mg |
|
| levodropropizine | Active Comparator | levodropropizine syrup |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Theobromine 300mg | Drug | Capsule, b.i.d. |
| |
| Levodropropizine 10mg |
| Measure | Description | Time Frame |
|---|---|---|
| cough remission rate | cough remission : no cough or 1 short cough in day time | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| cough recovery rate | 1 day, 2 days, within 3days | |
| difference of DCS score between screening and closing visit. | 3 days | |
| required time for cough remission |
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Inclusion Criteria:
patient who will continue to cough more than 1 week.(by physician's judgment)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ki-Suck Jung, M.D. | Hallym University Medical Center | Principal Investigator |
| Soo-Taek Uh, M.D. | Soonchunhyang University Hospital | Principal Investigator |
| Jae Yeol Kim, M.D. | Chung-Ang University Medical Center | Principal Investigator |
| Young Kyoon Kim, M.D. | The Catholic University of Korea-St. Mary's Hospital | Principal Investigator |
| Sung Soon Lee, M.D. | Inje University Ilsan Paik Hospital | Principal Investigator |
| Yong Bum Park, M.D. | Kangdong Sacred Heart Hospital | Principal Investigator |
| Kwan Ho Lee, M.D. | Yeungnam University Hospital | Principal Investigator |
| Jung Hyun chang, M.D. | Ewha Womans University Mokdong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Medical Center | Anyang-si | Gyeonggi-do | 431-070 | South Korea |
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| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D003371 | Cough |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D013805 | Theobromine |
| C035916 | dipropizine |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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| Drug |
Syrup, t.i.d. |
|
| 3 days |
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |