Jianpi Shufei Granule for Early-stage Chronic Obstructive Pulmonary Disease: a Multicenter, Randomized, Placebo-controlled Trial
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- ITMCTR2100005359
- Lead Sponsor
- Guangdong Provincial Hospital of Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
?Patients who are aged 40–85 years; ?Patients who meet the diagnostic criteria of COPD, stage I-II, with stable stage; ?Patients who meet the Chinese medicine syndrome classification of Qi deficiency and phlegm obstruction; ?Patients who sign the written informed consent form.
?Patients with asthma,bronchiectasis,obstructive sleep apnea syndrome,lung malignant tumors or active pulmonary tuberculosis;?Chinese medicine syndrome based on Yin deficiency;?Patients with acute exacerbation of COPD within 4 weeks before enrollment;?Patients with history of allergies or hypersensitivity for any research drug component, or the researcher believes that it is known to have a disease that should not be participated in research;?Those who cannot complete the lung function test; ?Long-term of traditional Chinese medicine diet (astragalus, ginseng) and other Chinese medicinal materials);?Patients with severe cardiovascular, cerebrovascular, liver and kidney disease;?Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or serum creatinine (Scr) exceed 1.5 times the upper limit of normal value;?Poor compliance;?Patients who have received any experimental drug treatment within 1 month;?Patients who Participated in or plan to participate in other clinical trials.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CAT;
- Secondary Outcome Measures
Name Time Method Acute exacerbation per year;Safety;BODE;Time to first exacerbation;mMRC;CCQ;6MWT;CASA;lung function;