A phase 4 study to evaluate efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase)
Double-blind, randomized, placebo controlled, multicenter, phase 4 clinical trial to assess the efficacy and safety of MUCOLASE tablet (streptokinase • streptodornase) in patients with acute upper respiratory infection or acute bronchitis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
346
streptokinase • streptodornase 5mg
Placebo of MUCOLASE tablet
Konkuk University Medical Center
Seoul, South Korea
RECRUITINGChange from baseline in BSS (Bronchitis Severity Score)
BSS (Bronchitis Severity Score) is derived by summing responses to five major symptoms (i. e. cough, sputum, rales/rhonchi, chest pain during coughing, dyspnoea) with higher scores indicating more severe symptomatology, rated from 0 to 4 (0 = absent, 1 = mild, 2=moderate, 3 = severe, 4 = very severe)
Time frame: baseline, 7 days
Change from baseline in each symptom score of BSS (Bronchitis Severity Score)
BSS (Bronchitis Severity Score) is derived by summing responses to five major symptoms (i. e. cough, sputum, rales/rhonchi, chest pain during coughing, dyspnoea) with higher scores indicating more severe symptomatology, rated from 0 to 4 (0 = absent, 1 = mild, 2=moderate, 3 = severe, 4 = very severe)
Time frame: baseline, 7 days
Change from baseline in cough/sputum domain score of BSS (Bronchitis Severity Score)
BSS (Bronchitis Severity Score) is derived by summing responses to five major symptoms (i. e. cough, sputum, rales/rhonchi, chest pain during coughing, dyspnoea) with higher scores indicating more severe symptomatology, rated from 0 to 4 (0 = absent, 1 = mild, 2=moderate, 3 = severe, 4 = very severe)
Time frame: baseline, 7 days
Complete resolution rate of each symptom
Time frame: 7 days
The number of use of relief drugs
Time frame: 7 days
Integrative Medicine Outcomes Scale
Integrative Medicine Outcomes Scale is assessed separately by th subjects and thd investigators at end of study, based on BSS of baseline. (Scoring system: 1 = complete recovery, 2 = major improvement, 3 = slight-to-moderate improvement, 4 = no change, 5 =deterioration)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 7 days
Integrative Medicine Patient Satisfaction Scales
Integrative Medicine Outcomes Scale is assessed by subgects at end of study. (Scoring system: 1 = very satisfied, 2 = satisfied, 3 = neutral, 4 = dissatisfied, 5 =very dissatisfied)
Time frame: 7 days