None listed
Conditions
Interventions
Dietary Supplement : Subjects take test food(1,000 mg/day as KGC-03-PS) or placebo food twice a day, each time 2 tablets within 30 minutes of meal for 12 weeks
Sponsors
Korea Ginseng Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult males and females between the ages of 20 and 70 years old 2) Subject who meet the CAT score criteria of at least 5 and no more than 15 3) FEV1/FVC greater than or equal to 70 % 4) Subject who voluntarily written Informed Consent Form to participate in this clinical trial
Exclusion criteria
Exclusion criteria: 1) Subject who have a history of drug hypersensitivity reactions to medicines, food ingredients, herbal extracts, herbal medicines, dietary supplements etc. 2) Subject who smoked within 3 months prior to the screening test (subjects may participate if they have been smoke-free for 3 months) 3) Subject who diagnosed with COVID-19 within 3 months prior to the screening test 4) Subject who have a history of alpha 1-antitrypsin deficiency or any of the following respiratory system diseases (measured by chest X-ray at screening) - Respiratory disease with underlying lung parenchymal destruction (tuberculous emphysema, bronchiectasis, etc.) - Known or suspected inflammatory lesions of the lung parenchyma, such as pneumonia or tuberculosis - Diagnosed and under treatment for bronchial asthma, COPD, influenza, pneumonia, lung cancer, etc. 5) Subject who diagnosed with and undergoing treatment for a serious illness such as cerebrovascular disease, epilepsy, intellectual disability, neurological disease, endocrine disease, hematologic/malignant tumor, cardiovascular disease, Crohn's disease, etc. 6) Subject who have taken systemic corticosteroids (glucocorticoids, etc.), immunosuppressants, or medications to control expectoration within 4 weeks prior to the screening test 7) Subject who have taken any specialty drugs, over-the-counter drugs, or dietary supplements (red ginseng, gombo cabbage, etc.) within 2 weeks prior to the screening test that may affect the test results 8) Subject with kidney disease or Creatinine exceeding 2.0 mg/dL 9) Subject with ALT, AST exceeds 3 times the upper limit of the normal limit of the site 10) Subject who severe psychiatric illness such as depression, schizophrenia, anxiety disorder or drug or alcohol addiction 11) Subject who body mass index (BMI) of 35 kg/m2 or more 12) Uncontrolled hypertension (blood pressure =180 mmHg/100 mmHg) 13) Uncontrolled glycemia (HbA1c =9.0% or new initiation of medication for diabetes within 3 months prior to screening) 14) Subject who pregnant, nursing mothers, or women of childbearing potential not using adequate contraception 15) Subject who participation in another clinical trial within 3 months prior to the screening test 16) Subjects who, in the opinion of the investigator, are unsuitable for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Saint George's Respiratory Questionnaire(SGRQ) symptom score and total score | — |
Secondary
| Measure | Time frame |
|---|---|
| Chronic obstructive pulmonary disease(COPD) Assessment Test score;IL-6, TNF-a, hs-CRP;SOD, MDA;Pulmonary function test FVC, FEV1, FEV1/FVC | — |
Countries
Korea, Republic of
Contacts
Public ContactMinji Kim
Bundang CHA General Hospital
Outcome results
None listed