None listed
Conditions
Interventions
Dietary Supplement : Test Product: capsule that contains the CKDB-315(L. plantarum KC3/Leonurus japonicus Houtt. Extracts combination)
Comparator Product: matching placebo
Sponsors
Chong Kun Dang Bio
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Voluntarily decides to participate in this clinical study and signs the informed consent 2) Men and women aged 19 to 75 years inclusive at the time of signing the informed consent 3) Have persistent respiratory discomfort symptoms (cough, phlegm or dyspnea) for more than 12 weeks prior to screening 4) Non-smokers (including those who have quit smoking for more than 6 months before screening)
Exclusion criteria
Exclusion criteria: 1) Have radiological findings suggesting other respiratory diseases contributing to current respiratory symptoms 2) Clinically significant respiratory diseases (e.g., chronic obstructive pulmonary disease, asthma, active pulmonary infection, clinically significant bronchiectasis, pulmonary fibrosis, interstitial lung disease, sarcoidosis, obesity-related hypoventilation syndrome, lung cancer, alpha1 antitrypsin deficiency, primary ciliary dyskinesia) 3) Active significant infections within 12 weeks prior to screening 4) Active autoimmune diseases or those who require immunosuppressive therapy for autoimmune diseases 5) Diagnosed with a malignant tumor within 5 years before screening or those whose malignant tumor has recurred 6) Have a history of alcohol abuse* or drug abuse or have a current medical condition 7) Clinically significant cardiovascular disorders, gastrointestinal disorders, liver disorders, kidney disorders, nervous system disorders, musculoskeletal disorders, infectious disorders, endocrine disorders, metabolic disorders, blood disorders, immune system disorders, mental disorders, or major physical damage
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in SGRQ total score and CAT total score | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in SGRQ subscores (Symptoms Score, Activity Score, Impacts Score);Changes in CAT total score;Proprotion of subjects who reached MCID(Minimal Clinically Important Difference) of SGRQ total score ;Proprotion of subjects who reached MCID(Minimal Clinically Important Difference) of CAT total score | — |
Countries
Korea, Republic of
Contacts
Public ContactJong Chen Joo
Wonkwang University Oriental Medical Hospital, Jeonju
Outcome results
None listed