Human study to evaluate the efficacy and safety of NS2309 on respiratory health

Not Applicable

Recruiting

• Conditions: Diseases of the respiratory system

• Registration Number: KCT0009044
• Lead Sponsor: Gachon University Gil Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1) Subject who agrees to participate in the study and signs the informed consent form
2) 40–74 years old
3) persistent respiratory symptoms including cough and sputum more than 3 months

Exclusion Criteria

1) abnormal FEV1/FVC
2) respiratory diseases including tuberculous-destroyed lung, bronchiectasis, acute bronchitis, chronic bronchitis, asthma, COPD, lung cancer, pneumonia, tuberculosis, acute upper respiratory infections, diabetes, cardiovascular diseases, GERD
3) taking pills or extracts of quince or deodeok within recent 2 weeks persistently
4) taking antioxidants or anti-inflammatory drugs or dietary supplements within recent 6 weeks
5) serum creatinine = 2 mg/dL or ESRD
6) total bilirubin = 2 mg/dL, AST or ALT = 1.5 x normal value
7) uncontrolled psychologic disease or alcoholics
8) smoker
9) BMI = 35kg/m2
10) history of hypersensitivity for testing substance or severe food allergy
11) involving other clinical trials within 1month
12) pregnant or lactating, or planning to become pregnant
13) the investigator's decision

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
respiratory symptoms;FeNO;spirometry

Secondary Outcome Measures

Name	Time	Method
safety markers