None listed
Conditions
Interventions
Dietary Supplement : Take test food (ETB-F01) or placebo with water once a day, one capsule at a time
Sponsors
Kyung Hee University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) adults aged 19 or above and 70 or below 2) cough, sputum and breathless(or chest pain) for more than 1 month and less than 3 months based on visit 1 A person who has two or more symptoms and has a BCSS score of 3 or more to 9 or less 3) A Person with a rate of 70% or more per second (FEV1/FVC) 4) A person who agrees to participate in the human body application test and prepares a written consent form prior to the commencement of the human body application tes
Exclusion criteria
Exclusion criteria: 1) Those currently being treated for severe cardiovascular, immune, gastrointestinal/hepatic and biliary systems, kidney and urology, nervous, musculoskeletal, mental, infectious diseases, and malignant tumors (cancer cure) In the case of a child, subjects who have been cured for 5 years can participate.) 2) Those who have clinically significant respiratory diseases as a result of chest X-ray 3) Persons diagnosed with chronic obstructive pulmonary disease (COPD) or asthma and currently on medication 4) A person who has chronic bronchitis (with symptoms of persistent cough and phlegm for at least three months a year for two consecutive years or more, above 9 BCSS) 5) A person who has not passed 4 weeks since the diagnosis of respiratory infections caused by viruses or bacteria 6) A person who has taken systemic adrenal cortical hormones and immunosuppressants within 4 weeks of visiting 1 7) A person who has taken medication (including asthma and COPD treatment (ICS), gastric acid secretion inhibitor (PPI preparation), etc.) for the purpose of controlling Jinhae girdle within one week of visitation 1 8) A smoker or a person who has not passed six months after smoking cessation 9) A person who drinks alcohol equivalent to an average of at least 30 g per day (210 g/week) for men and at least 20 g per day (140 g/week) for women within 4 weeks of visit 10) Those whose creatine is more than twice the normal upper limit of the implementing agency 11) A person whose AST (GOT) or ALT (GPT) is more than three times the upper limit of the institution 12) Patients with uncontrolled hypertension (measured after 10 minutes of stabilization of systolic blood pressure above 160 mmHg or diastolic blood pressure above 100 mmHg) 13) Uncontrolled diabetes patients (over 180 mg/dL of fasting blood sugar) 14) A person who has administered antibiotics or intestinal drugs within two weeks of visiting 15) A person who has been administered or ingested probiotics, prebiotics, and lactobacillus products continuously (more than four times a week) within two weeks of visiting 16) A person who is pregnant, lactating, or plans to conceive during this human body application test 17) A person who is sensitive or allergic to food ingredients for this human body application test 18) A person who has participated in another interventional clinical trial (including human application test) within three months of visit, or plans to participate in another interventional clinical trial (including human application test) after the start of this human application test 19) A person who judges that the tester is inappropriate for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BCSS(Breathlessness, Cough, and Sputum Scale) | — |
Secondary
| Measure | Time frame |
|---|---|
| Lung function test (?FEV1?FVC?FEV1/FVC);SGRQ (St George’s Respiratory Questionnaire);mMRC(modified Medical Research Council dyspnea scale);VAS(Visual Analogue Scale);The degree of improvement in respiratory symptoms through the symptom log;a fecal germ gun;FeNO(Fractional exhaled nitric oxide) | — |
Countries
Korea, Republic of
Contacts
Public ContactHYE SOOK CHOI
KyungHee University Medical Center
Outcome results
None listed