A prospective, randomized, double-blind, placebo-controlled and multicenter trial for Tanreqing capsule in the treatment of patients with AECOPD with upper respiratory tract infectio
- Conditions
- Chronic obstructive pulmonary disease
- Registration Number
- ITMCTR2100005207
- Lead Sponsor
- Shanghai Minhang District Central Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1) Aged 40-85 years;
2) COPD meets the diagnostic criteria for COPD formulated by the Chinese Society of Respiratory Diseases; there has been a report of lung function diagnosis in the past year, that is, FEV1/FVC<70% after inhalation of bronchodilators, and FEV1 accounts for an estimated value of >= 30%;
3) This outpatient visit due to upper respiratory tract infection;
4) At least two of URTI symptoms such as sore throat, nasal congestion, runny nose, sneezing, or flu toxicity symptoms such as fever, headache, and myalgia occurred in the past 3 days;
5) There is no newly added rales in the lungs;
6) There is no new exudation on chest radiograph or lung CT;
7) Imaging examination: In line with chronic bronchitis and emphysema, no new pulmonary exudation was seen. Exclude pulmonary tuberculosis, lung tumors, pulmonary embolism, interstitial lung disease and pulmonary edema. (Secondary mild bronchiectasis is not ruled out);
8) Sign the informed consent form.
1) Patients with bronchiectasis with hemoptysis, or patients with obvious bronchiectasis on imaging;
2) The patient had other active lung diseases before enrollment, such as active tuberculosis, lung cancer, pulmonary embolism, sarcoidosis, interstitial lung disease, primary pulmonary hypertension and bronchial asthma, etc.;
3) Those with severe liver and kidney insufficiency, cardiac insufficiency, etc. who need corresponding medical treatment;
4) Subjects with unstable ischemic heart disease, myocardial infarction and cerebrovascular accident within 6 months before enrollment, acute coronary syndrome within 3 months or underwent percutaneous coronary intervention or paracoronary artery Subjects of road transplantation;
5) Subjects who have mental illness, mental retardation, poor motivation, drug and alcohol abuse, or other restrictions on participating in this study;
6) Participated in other clinical trials within 4 weeks before enrollment;
7) Women who are pregnant or breastfeeding or plan to become pregnant during the study period, or women who are fertile but have not used effective contraceptive methods (women of childbearing age should check urine HCG);
8) Those who are allergic to Tanreqing capsule drugs.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dyspnea, cough and expectoration scale;TCM clinical syndrome index;
- Secondary Outcome Measures
Name Time Method Electrocardigram;ALT;Sputum culture;Pulmonary function;Routine blood test;PCT;CRP;AST;