Shu Fei Tie: Optimize 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: Shu Fei Tie Placebos are made using substances without active drug ingredients, following the same preparation procedures
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Primary outcome measure(s)
Asthma part：Number of acute attacks per year — Count once a year for three consecutive years 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 — Count once a year for three consecutive years 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 — at weeks 13, 26, 39, and 52, for 3 consecutive cycles (each cycle is 1 year)，Until the first acute exacerbation occurs Record relevant information and evaluate the treatment effect of lung soothing patches on patients.
COPD part:the number of rehospitalizations within a year — Count once a year until the end of the 3-year cycle Record relevant information and evaluate the treatment effect of lung soothing patches on patients.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou
Henan
More Henan University of Traditional Chinese Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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