chronic obstructive pulmonary disease
Conditions
Interventions
Group 1:Bufei Huoxue Capsule
Group 2:Placebo
Sponsors
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged 40-70 years old, male or female, community or outpatient cases; (2) GOLD II-III grade COPD: 20 minutes after inhalation of salbutamol 400 µg, FEV1/FVC <70% and 30% = FEV1 < 80% predicted value; (3) Patients with qi deficiency and blood stasis syndrome who meet the diagnostic criteria for common syndrome of traditional Chinese medicine; (4) The patient is in a stable phase of chronic obstructive pulmonary disease; (5) Ability to conduct language or text communication, agree to participate in the study and sign an informed consent form, and be able to complete the test-related examination.
Exclusion criteria
Exclusion criteria: (1) Major diseases other than COPD. Major illnesses are defined as: according to the investigator's judgment, because participating in the trial can put the patient at risk or affect a test result or a patient's ability to participate in the test, such as severe heart, brain, liver, kidney, blood system Disease or malignancy; (2) Significant abnormalities in laboratory tests, including: Blood routine (white blood cell count = 12 × 10^9/L, neutrophil ratio = 80%; hemoglobin = 60g/L); liver and kidney function (ALT AST exceeds the upper limit of normal value by 1.5 times; serum creatinine exceeds the upper limit of normal value by 1.2 times or creatinine clearance rate is = 50 ml/min); (3) Clinical diagnosis of lung cancer, bronchiectasis, pneumoconiosis or other simple restrictive ventilatory dysfunction; (4) Patients with a history of asthma, a history of allergic rhinitis, or a blood eosinophil count of =600/mm3 (0.6×10^9/L) within 4 weeks; (5) Now has active tuberculosis; (6) Patients with life-threatening pulmonary embolism, or a1-antitrypsin deficiency, or cystic fibrosis; (7) Patients who have undergone a pneumonectomy; (8) Acute exacerbation of COPD within 4 weeks prior to the first visit (V0), or hospitalization and/or antibiotic treatment and/or oral or venous hormone therapy during enrollment; (9) Patients who used a test drug 30 days prior to the first visit (V0); (10) Long-term use of oxygen therapy, systemic (oral or intravenous) hormone doses are unstable (ie, dose stabilization time is less than 6 weeks) or hormone doses exceed 10 mg/d equivalent to prednisone, or long-term use of antibiotics; (11) Women who are pregnant, breastfeeding, or have a pregnancy; (12) Patients scheduled to be admitted during the trial, or patients scheduled to donate blood; (13) A patient who has a history of allergies or intolerance to the test drug; (14) Have a history of chronic alcohol abuse, drug abuse, or any factors that affect compliance; (15) The patient is currently participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and degree of cold or acute exacerbations;First acute exacerbation time after medication;Acute exacerbation interval;Acute exacerbation duration;The time and total amount of emergency medicine used.;Pulmonary function; | — |
Secondary
| Measure | Time frame |
|---|---|
| CAT score;CCQ score;mMRC dyspnea score;Exercise endurance;TCM syndrome points;Arterial blood gas analysis;Blood rheology;Fibrinogen;D-dimer;Immune and inflammatory indicators;Echocardiography;BNP;FeNO; | — |
Countries
China
Contacts
Public ContactFeng JiHong
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed