Acute Bronchitis, Acute Upper Respiratory Tract Infection
Conditions
Brief summary
The purpose of this study is to assess the efficacy and safety of HLIM
Detailed description
A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.
Interventions
DRUGTest
three times a day for five days
three times a day for five days
DRUGActive Comparator Control 2
three times a day for five days
DRUGPlacebo
three times a day for five days
Sponsors
SamA Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 2 and 75 * Weight more than 11.5 kg
Exclusion criteria
* Has a history of hypersensitivity to IP ingredients * Hypertension or Diabetes * Smoking more than 20 pack-years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in BSS(Bronchitis Severity Score)-cough domain of active comparator control 2 versus placebo | 5 days | 0(absent) \ 4(very severe), Total Score: 0\ 20 |
| Changes in BSS(Bronchitis Severity Score) total score of each active comparator control group compared to the test group | 5 days | 0(absent) \ 4(very severe), Total Score: 0\ 20 |
Countries
South Korea
Outcome results
None listed