Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the efficacy and safety of HLIM
A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLIM | Experimental | HLIM+SA160021 Placebo+SA160022 Placebo |
|
| SA160021 | Active Comparator | HLIM Placebo+SA160021+SA160022 Placebo |
|
| SA160022 | Active Comparator | HLIM Placebo+SA160021 Placebo+SA160022 |
|
| Placebo | Placebo Comparator | HLIM Placebo+SA160021 Placebo+SA160022 Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test | Drug | three times a day for five days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in BSS(Bronchitis Severity Score)-cough domain of active comparator control 2 versus placebo | 0(absent) ~ 4(very severe), Total Score: 0~20 | 5 days |
| Changes in BSS(Bronchitis Severity Score) total score of each active comparator control group compared to the test group | 0(absent) ~ 4(very severe), Total Score: 0~20 | 5 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Recruiting | Seoul | Guro-gu | 08308 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Active Comparator Control 1 | Drug | three times a day for five days |
|
|
| Active Comparator Control 2 | Drug | three times a day for five days |
|
|
| Placebo | Drug | three times a day for five days |
|
|
| D008173 |
| Lung Diseases, Obstructive |
| D008171 | Lung Diseases |