Chronic Obstructive Pulmonary Disease
Conditions
Interventions
experimental group:On the basis of conventional Western medicine treatment,they received oral Chinese herbal medicine treatment (using the Qingfei Qiangxin Formula during the acute exacerbation period
control group:On the basis of conventional Western medicine treatment, they received the corresponding oral placebo (the placebo of the Qingfei Qiangxin Formula during the acute exacerbation period an
Sponsors
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for chronic obstructive pulmonary disease and left heart failure, and is in the acute exacerbation stage; (2) Age 40 to 85 years old; (3) Hospitalized patients with moderate to severe severity of the disease; (4) Patients with cardiac function grades I to IV; (5) Treated with the syndrome differentiation of "phlegm-heat blocking the lung" in traditional Chinese medicine; (6) Signed the informed consent form.
Exclusion criteria
Exclusion criteria: Those who meet any of the following conditions shall not be included in this trial: (1) Have concurrent malignant lung tumors, active pulmonary tuberculosis or other respiratory system diseases; (2) Have undergone lung resection surgery in the past, or have received lung volume reduction surgery within 12 months before screening; (3) Have other severe cardiovascular, liver, kidney diseases, mental disorders or cancers; (4) Are known to be allergic to the components of the study drug; (5) Have participated in other drug clinical trials within 3 months before the screening examination; (6) Are lactating women, pregnant women, or women of childbearing age who plan to get pregnant within 6 months after the screening examination, or have a fertility or sperm donation plan; (7) Have immunodeficiency or positive human immunodeficiency virus (HIV) antibody (such as organ or bone marrow transplant recipients, AIDS patients, or those who took immunosuppressive drugs within 3 months before the screening examination); (8) Other situations that the researcher deems unsuitable for participating in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 90-day readmission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of acute exacerbations/hospitalizations (chronic obstructive pulmonary disease and/or heart failure);Interval between acute exacerbation/hospitalization (chronic obstructive pulmonary disease and/or heart failure);Pulmonary function parameters (such as Forced Expiratory Volume in One Second, Forced Vital Capacity, Forced Expired Volume in One Second to Forced Vital Capacity Ratio, etc.);N-terminal pro-B-type natriuretic peptide;Cough and Sputum Assessment Questionnaire;ultrasonic cardiogram;COPD Assessment Test;6-minute walk test; St. George's Respiratory Questionnaire;Minnesota Living with Heart Failure Questionnaire;Kansas City cardiomyopathy questionnaire; Chest X-ray/Chest CT ;Health economics indicators;weight;New York Heart Association Functional Classification; | — |
Countries
China
Contacts
Public ContactGUO Sijia
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed