None listed
Conditions
Interventions
Dietary Supplement : This study was designed as a randomized, double-blind, placebo-controlled clinical trial to evaluate the effects of Sargassum horneri extract on respiratory health. Eligible parti
Sponsors
Jeju National University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 19 to 75 years. 2. Individuals with respiratory symptoms (cough) lasting for more than 8 weeks. 3. Individuals with FEV1/FVC = 70%. 4. Individuals with a COAT questionnaire score = 10. 5. Individuals with an mMRC questionnaire score = 1. 6. Individuals who are capable of normal physical activity and have provided written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Individuals with current or past respiratory diseases, including: - Respiratory diseases accompanied by destruction of the underlying lung parenchyma (e.g., destroyed lung due to tuberculosis, bronchiectasis). - Confirmed or suspected inflammatory lesions in the lung parenchyma, such as pneumonia or tuberculosis. - Individuals diagnosed with and currently undergoing treatment for moderate to severe asthma, COPD, influenza, pneumonia, lung cancer, or other significant respiratory diseases. - Acute or chronic bronchitis, defined as a BCSS score = 9, with persistent cough and sputum symptoms lasting at least 3 months per year for two consecutive years. 2. Current smokers. 3. Individuals with severe cardiovascular or cerebrovascular disease, or malignant tumors within the past 6 months. 4. Individuals with uncontrolled hypertension (blood pressure =160/100 mmHg, measured after 10 minutes of rest). 5. Individuals with poorly controlled diabetes mellitus, defined as fasting blood glucose =160 mg/dL. 6. Individuals with serum creatinine levels =2 times the upper limit of normal (ULN) of the study institution. 7. Individuals with AST (GOT) or ALT (GPT) =2 times the ULN of the study institution. 8. Individuals complaining of severe gastrointestinal symptoms, such as heartburn or dyspepsia. 9. Individuals with alcohol abuse. 10. Individuals currently taking medication for psychiatric disorders (except for intermittent medication for sleep disorders). 11. Individuals who are pregnant, breastfeeding, or planning to become pregnant during the study period. 12. Individuals with allergic reactions to the study product or its components. 13. Individuals who participated in another clinical trial within the past 1 month. 14. Individuals who took health functional foods related to respiratory health improvement within 2 weeks prior to study initiation. 15. Individuals considered unsuitable for participation by the investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in COAT (Cough Assessment Test) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in pulmonary function tests (FVC, FEV1, and FEV1/FVC ratio);Changes in Eosinophil count;Changes in leukocyte count;changes in serum levels of total IgE, IL-1ß, IL-6, and IL-13.;Change in quality of life assessed by EQ-5D.;Change in visual analogue scale;Change in BCSS (Breathless, cough, and sputum scale) score;changes in cough frequency, sputum frequency, and sputum expectoration.;changes in Korean Leicester cough questionnaire (K-LCQ) score;changes in cough symptom scale (CSS) score | — |
Countries
Korea, Republic of
Contacts
Public Contactmiok ko
Jeju National University
Outcome results
None listed