None listed
Conditions
Interventions
Dietary Supplement : 1) Test Food (Atractylodes japonica–Schisandra chinensis Complex Extract, CKD-F497)
· Appearance and form : Reddish-brown hard capsules
· Main ingredients: Atractylodes japonica–S
Sponsors
Chong Kun Dang
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals aged 19 to 75 years, inclusive. 2) Individuals with respiratory symptoms lasting =1 month and <3 months at Visit 1 and a total Breathlessness, Cough, and Sputum Scale score =3 and <9 (sputum =2, cough =1). 3) Individuals with FEV1/FVC =70%. 4) Individuals who voluntarily provide written informed consent to participate in this study prior to study initiation.
Exclusion criteria
Exclusion criteria: 1) Individuals currently receiving treatment for severe cardiovascular, immunological, gastrointestinal, hepatobiliary, renal/urinary, neurological, musculoskeletal, psychiatric, or infectious diseases. 2) Individuals with a history of malignancy within 5 years prior to Visit 1.(However, basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, thyroid cancer, prostate cancer, or malignancies considered completely cured are permitted.) 3) Individuals with clinically significant respiratory disease findings on chest X-ray. 4) Individuals who have been diagnosed with chronic obstructive pulmonary disease (COPD) or asthma and are currently receiving pharmacological treatment. 5) Individuals with chronic bronchitis(defined as persistent cough and sputum production for at least 3 months per year for two consecutive years.) 6) Individuals diagnosed with viral or bacterial respiratory infection within 4 weeks prior to Visit 1. 7) Individuals who have taken systemic corticosteroids or immunosuppressants within 4 weeks prior to Visit 1. 8) Individuals who have taken antihistamines within 1 week prior to Visit 1. {However, individuals who have been receiving antihistamines for conditions other than respiratory diseases (e.g., urticaria) for at least 4 weeks prior to study participation without dose adjustment may continue treatment at the same dose.} 9) Individuals who have taken medications intended to control cough and sputum within 1 week prior to Visit 1, {including asthma or COPD medications (including ICS) and medications for gastroesophageal reflux disease (PPIs), H2RAs, antacids, prokinetic agents, P-CABs).} 10) Current smokers or individuals who quit smoking less than 6 months prior to Visit 1. 11) Individuals who consumed alcohol exceeding an average of 30 g/day (210 g/week) for men or 20 g/day (140 g/week) for women within 4 weeks prior to Visit 1. 12) Individuals with serum creatinine =2 times the upper limit of normal (ULN) at the study site. 13) Individuals with AST (GOT) or ALT (GPT) =3 times the ULN at the study site. 14) Individuals with uncontrolled hypertension, (defined as systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg, measured after at least 5 minutes of rest.) 15) Individuals with uncontrolled diabetes mellitus, (defined as fasting blood glucose =10 mg/dL.) 16) Pregnant or breastfeeding women, or individuals planning to become pregnant during the study period. 17) Individuals who have participated in another interventional clinical trial (including human application studies) and received an investigational product within 3 months prior to Visit 1, or who plan to participate in another interventional clinical trial during the study period. 18) Individuals with known hypersensitivity or allergy to any component of the investigational product (food) used in this study. 19) Individuals deemed ineligible for participation in this study at the investigator’s discretion for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in BCSS (Breathlessness, Cough, and Sputum Scale) score after 8 weeks of intake | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in BCSS (Breathlessness, Cough, and Sputum Scale) score after 4 weeks of intake;Change in COAT (Cough Assessment Test) score after 4 and 8 weeks of intake;Change in LCQ (Leicester Cough Questionnaire) score after 4 and 8 weeks of intake;Change in VAS (Visual Analogue Scale) score after 4 and 8 weeks of intake;PGR (Patient’s Global Rating) rating 4 and 8 weeks of intake;Change in FeNO(Fractional Exhaled Nitric Oxide) level after 4 and 8 weeks of intake | — |
Countries
Korea, Republic of
Contacts
Public ContactYeonseok Choi
Kyung Hee University Hospital
Outcome results
None listed