An observational study of herbal medicine treatment in obstructive airways diseases(asthma or chronic obstructive pulmonary disease) patients
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0004919
- Lead Sponsor
- Dunsan Korean Medicine Hospital of Daejeon University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
1. aged = 19 years
2. A person diagnosed with chronic obstructive pulmonary disease (COPD) in the GOLD standard or asthma in the GINA standard(including those who submitted documents diagnosed with asthma or chronic obstructive pulmonary disease at other hospitals)
3. patients who voluntarily agreed to a clinical research agreement
1. presence of severe respiratory disease other than asthma or COPD(ex. cystic fibrosis, pneumonia, interstitial lung disease, lung cancer, etc.)
2. history of abuse or dependence on alcohol or other substances
3. history or presence of clinically relevant cardiovascular, renal, metabolic, haematological, neurological, psychiatric, systemic, infectious disease, or malignant tumour(except where there is no recurrence for more than 5 years after surgery)
4. have a disease that can affect drug absorption or have digestive disorders after surgery related to it
5. history of hypersensitivity and allergies to research-related drugs
6. pregnant or breast-feeding
7. judged by the investigators to be inappropriate for the clinical study
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pulmonary function Test(FEV1, FVC, FEV1/FVC)
- Secondary Outcome Measures
Name Time Method mCAMSOM-V(modified Clinical Asthma Measurement Scale in Oriental Medicine-V);PEFR(Peak expiratory flow rate);6-minute walk test;modified Borg Scale;mMRC(modified medical research council);SGRQ(St. George's Respiratory Questionnaire);CAT(COPD assessment test)(for COPD patients only);ACT(Asthma control test)(for asthma patients only);Biomarker (CRP, Fibrinogen, neutrophil, TNF-a, IL-4, IL-5, IL-6, IL-13, IgE, eosinophil);BMI(body mass index);IMPSS(Integrative Medicine Patient Satisfaction Scale);Number of using rescue drugs