None listed
Conditions
Interventions
Drug : Oral administration of Ecklonia cava extract complex or placebo for 12 weeks, one capsule twice daily after meals
Sponsors
Daejeon Korean Medicine Hospital of Daejeon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. males and females aged 19–70 years 2. more than two symptoms among cough, sputum, and dyspnea (or chest discomfort) lasting at least one month and a breathlessness, cough and sputum scale (BCSS) score =3 points at visit 1 3. forced expired volume in one second (FEV1)/forced vital capacity (FVC) =70% in pulmonary function test 4. those who agreed to participate in this clinical trial and signed the written informed consent
Exclusion criteria
Exclusion criteria: 1. receiving treatment for severe cardiovascular, immune, gastrointestinal, liver and biliary, renal and urinary, nervous system, musculoskeletal, psychological, or infectious diseases or cancers 2. clinically significant signs of respiratory diseases on chest radiography 3. diagnosis of COPD or asthma 4. chronic bronchitis (BCSS score =9 points and presence of productive cough and sputum for at least three months in one year for more than two years) 5. respiratory symptoms caused by viral or bacterial infections within four weeks at visit 1 (e.g., influenza or COVID-19) (Those whose existing respiratory symptoms deteriorated or had new respiratory symptoms by COVID-19. If those without additional respiratory symptoms by COVID-19, they could participate in this trial more than four weeks after quarantine was released. If those with additional respiratory symptoms, they could participate in this trial more than four weeks after there are no differences compared with before COVID-19 infection.) 6. use of adrenocorticoids, immunosuppressants, or antitussive and expectorant medications within four weeks at visit 1 7. consumption of functional foods related to improvement of respiratory health within two weeks at visit 1 8. current smoking or smoking within the past six months 9. average alcohol consumptions of >30 g (210 g/week) per day for males and >20 g (140 g/week) for females within four weeks at visit 1 10. creatinine levels =2 times the upper normal limit 11. aspartate transaminase (AST) and alkaline phosphatase (ALT) levels =3 times the upper normal limit 12. unregulated hypertension (systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg while relaxing for 10 minutes) 13. unregulated diabetes mellitus (fasting blood sugar level =180 mg/dL) 14. females who were pregnant, lactating, or planned to become pregnancy during the trial 15. sensitivity or allergy to the ingredients in the investigational products 16. participation in other clinical trials within three months of visit 1 or planned participation in other clinical trial once this trial began 17. thyroid diseases 18. those who the investigators determined were ineligible to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Breathlessness, Cough, and Sputum Scale (BCSS) scores between baseline and Week 6, 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in pulmonary function test (forced vital capacity (FVC), forced expired volume in one second (FEV1), FVC/FEV1) between baseline and Week 12;Change in St. George’s Respiratory Questionnaire (SGRQ) score between baseline and Week 6, 12;Change in Visual Analogue Scale (VAS) scores between baseline and Week 6, 12;Change in modified Medical Research Council dyspnea scale (mMRC) between baseline and Week 6, 12 | — |
Countries
Korea, Republic of
Contacts
Public ContactYang Chun Park
Daejeon Korean Medicine Hospital of Daejeon University
Outcome results
None listed