Conduct a multi-center, large-sample, randomized controlled clinical study of "winter disease being cared in summer" with Shu Fei Tie prevent recurrence of Asthma and COPD, scientifically evaluate the clinical efficacy and safety of Shu Fei Tie in reducing the recurrence of chronic airway diseases, identify target population, clarify the mechanism of efficacy, and establish a prevention and treatment technology plan for Shu Fei Tie to reduce the recurrence of chronic airway diseases.
Meets the diagnostic criteria for asthma/COPD(Group E in the GOLD classification); ② Age range from18 years to 80 years(asthma) and 40 yesrs to 80 years(COPD);
The investigators agreed to participate in this clinical study by voluntarily signing an informed consent form.
Patients with other pulmonary diseases (lung abscess, pulmonary interstitial fibrosis, active pulmonary tuberculosis, bronchiectasis，etc);
Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina, acute myocardial infarction, heart grade 3 or above, stroke, cerebral hemorrhage, etc.);
Patients with severe liver diseases (liver cirrhosis, portal hypertension, and caused by esophageal and gastric varices) and severe kidney diseases (dialysis, kidney transplantation, etc.);
Patients with impaired consciousness or various illnesses who cannot communicate normally; ⑤Pregnant and lactating women; ⑥Patients who are participating in other clinical trials within one month prior to enrollment; ⑦Patients who have received acupuncture or other traditional Chinese medicine external treatments within the past year; ⑧ Patients who are allergic to external patches
Parallel
Shu Fei Tie
DrugOptimize the extraction process and matrix formulation, and combine the use of traditional Chinese medicine volatile oil and chemical transdermal enhancers to develop adermal patch（Shu Fei Tie）
Shu Fei Tie placebo
DrugShu Fei Tie Placebos are made using substances without active drug ingredients, following the same preparation procedures
Asthma part：Number of acute attacks per year
Record the number of acute attacks per year for each patient, and evaluate the effect of the lung-clearing patch on reducing the number of acute attacks
COPD part：The number of acute exacerbations per year
Record the number of acute exacerbations in patients per year to evaluate the treatment effect of Shu Fei Tie on patients.
COPD part：the interval between successive acute exacerbations
Record relevant information and evaluate the treatment effect of lung soothing patches on patients.
COPD part:the number of rehospitalizations within a year
Record relevant information and evaluate the treatment effect of lung soothing patches on patients.
Asthma part：Asthma Control Test
ACT includes five questions. Every question will be assessed using a 5-point scale with scores ranging from 5 to 25. The higher the score, the better the symptom control.25 is considered complete control level, 20 \~ 24 is considered good control level, and \<20 is considered non-control level.
Asthma part：Asthma Control Questionnaire
The content of ACQ involves the following aspects: asthma-related, symptoms, the use of first-aid drugs, the impact on daily life and lung function test results.The higher the score, the worse the state.
Asthma part：Asthma Quality of Life Questionnaire
The asthma quality of life scale (5-point scale-RRB- consists of 35 items, including activity limitation (1-12) , asthma symptoms (13-20) , psychological status (22-26) , response to stimuli (27-31) , concern for one's own health (32-35) . On a 5-point scale, 1 is the worst and 5 is the best.
Asthma part：Frequency of anti-inflammatory and analgesic use
Detailed record of the use of treatment drugs, evaluation of treatment effect
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Henan University of Traditional Chinese Medicine
Lead sponsor
Qingdao Municipal Hospital of Traditional Chinese Medicine
Collaborator
Henan Lingrui Pharmaceutical Co., Ltd
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
