Chronic obstructive pulmonary disease
Conditions
Interventions
Experimental group:Experimental group: Bufei Huoxue capsule 4 capsules (0.35g/ capsule) 3 times a day orally
Treatment course: The treatment period was 24 weeks.
control group:Control group: simulation agent of Bufei Huoxue capsule, 4 capsules (0.35g/ capsule), 3 times a day, orally
Sponsors
Mianyang Central Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1) Age 40-80 years old (including 40 years old and 80 years old) regardless of gender; 2) patients met the diagnosis of chronic obstructive pulmonary disease (COPD) and were in stable phase of COPD at the time of screening (patients with stable or mild symptoms such as cough expectoration and shortness of breath without acute exacerbation in the past 4 weeks); 3) FEV1/ FVC < 70% and 20%= FEV1% predicted < 50% measured 15-25 minutes after inhalation of albuterol sulfate 400µg at screening; 4) symptom level CAT=10 mMRC=2 0-1 moderate acute exacerbation in the past year that did not lead to admission (group B); Or =2 moderate acute exacerbations or 1 acute exacerbation leading to hospital admission in the previous year (group E); 5) Qi deficiency and blood stasis syndrome; 6) voluntarily participated in this clinical trial informed consent and signed informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1) combined with asthma active pulmonary tuberculosis lung cancer diffuse panbronchiolitis pneumonectomy lung volume reduction surgery (within 12 months) severe bronchiectasis primary interstitial lung disease primary pulmonary fibrosis primary pulmonary hypertension respiratory failure or other active lung diseases; 2) combined with severe diseases of the digestive system endocrine system nervous system autoimmune disease or other diseases such as severe hyperthyroidism which will affect the effectiveness safety evaluation or compliance of the subjects after enrollment according to the investigator's judgment; 3) any one of the liver function indexes (ALT AST) exceeded the upper limit of normal reference value and the renal function index Scr exceeded 1.2 times the upper limit of normal reference value; 4) patients with severe liver diseases (such as liver tumors cirrhosis various types of hepatitis etc.) or previous history of drug-induced liver injury and current use or expected use of drugs with potential liver damage (immunosuppressants such as cyclosporine tacrolimus etc. anti-tuberculosis drugs such as rifampicin isoniazid etc.) during the study period; Chemotherapy drugs such as cyclophosphamide methotrexate azathioprine etc. Statins for the treatment of hypercholesterolemia or ischemic cardiovascular and cerebrovascular diseases and traditional Chinese medicine containing polygonum multiflorum Gysanqi tripterygium wilfordii and other liver damage herbs); 5) had a history of alcohol or drug abuse within 1 year before the test; 6) have a history of allergy to the trial drug and its excipients or emergency drugs; 7) have intellectual or mental retardation or cognitive impairment; 8) pregnant or lactating women who plan to become pregnant or are unable to use effective contraception; 9) have participated in any clinical trial within 30 days or 5 half-lives (whichever is longer) before screening; 10) other conditions that absolutely or relatively prohibit the 6-minute walk test such as resting heart rate > 120 beats/min systolic blood pressure > 180mmHg and diastolic blood pressure > 100 MMHG; Or difficulty completing a 6-minute walk test due to limited movement of the lower limbs; 11) requiring hospitalization and/or antibiotic treatment and/or oral or intravenous hormone therapy during screening; Long-term oxygen therapy (> 12 hours per day) was required during the trial; 12) were deemed inappropriate by the investigator to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Changes in 6-minute walking distance at V3 visit compared with baseline between the two groups after treatment;; | — |
Secondary
| Measure | Time frame |
|---|---|
| (6)The occurrence of cold and AECOPD during the study period.;(2) The changes of pulmonary function indexes FVC, FEV1 and FEV1/FVC in the two groups after treatment were compared with the baseline;;(3) The changes of CAT score and mMRC score of V2 and V3 visits after treatment were compared with baseline;;(4) The changes of TCM syndrome scores in V2 and V3 visits after treatment were compared with baseline;;(1) Changes in walking distance of 6 minutes at V2 visit after treatment compared with baseline in both groups;;(5) The changes of PHQ-9 depression screening scale and GAD-7 Generalized Anxiety Disorder Scale scores from baseline were compared between V2 and V3 visits after treatment;; | — |
Countries
China
Contacts
Public ContactWeiguo Xu
Mianyang Central Hospital
Outcome results
None listed