A study for the efficacy and safety of health foods extracts in promoting respiratory health

Not Applicable

Recruiting

• Conditions: Diseases of th respiratory system

• Registration Number: KCT0003614
• Lead Sponsor: ViroMed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

person with
1) confirmed consent
2) age >= 40 years old
3) persistent respiratory symptoms including cough and sputum
4) following the restriction dietary schedule during study period

Exclusion Criteria

person with
1) respiratory diseases including acute bronchitis, chronic bronchitis (BCSS score >=3 & chronic sputum/cough more than 3 months in subsequent years), pneumonia, tuberculosis, bronchial asthma, COPD, lung cancer
2) Diabetes, cardiovascular diseases except hypertension
3) taking antioxidants or antifilammatory drugs within recent 6weeks
4) serum creatinine = 2 mg/dL or ESRD
5) total bilirubin = 2 mg/dL or AST or ALT = 1.5 x normal value
6) uncontrolled psychologic disease or alcoholics
7) taking heath promoting foods with anti-oxidant activity (RFS score>36)
8) BMI >=35kg/m2
9) history of hypersensitivity for testing substance
10) involving other clinical trials within 1month
11) pregancy or lactating status
12) the investigator's decision

Study & Design

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

Primary Outcome Measures

Name	Time	Method
total antioxidative capacity;respiratory symptom scores including BCSS, VAS, CASA-Q, COAT;inflammatory markers including sRAGE, SP-D, CC-16, CRP, FENO

Secondary Outcome Measures

Name	Time	Method
Quality of life (EuroQoL-5D, EQ-5D), Fatiguee symptom score (FSS)