An applicable, effective and accurate clinical application research: effect of Yanghe Dingchuan Ointment on Asthma-COPD Overlap Syndrome

Phase 1

• Conditions: Asthma-COPD Overlap Syndrome

• Registration Number: ITMCTR2000003612
• Lead Sponsor: onghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. FEV1/FVC < 70% after using bronchodilator;
2. Have a history of bronchial asthma diagnosis or FeNO >= 45ppb;
3. The degree of illness belongs to chronic persistent bronchial asthma or stable chronic obstructive pulmonary disease;
4. Smoking history ( >= 10 packs/year), or long-term exposure to polluted air;
5. Meet the TCM syndrome differentiation standard of Yang deficiency with phlegm syndrome;
6. 40 years old <= age <= 75 years old, regardless of gender.
7. Willing to accept standardized treatment with integrated Chinese and Western medicine;
8. Agree to provide informed consent;
9. Able to perform pulmonary ventilation function/bronchodilation test according to ATS (American Thoracic Society) standards.

Exclusion Criteria

1. Some diseases with known causes or specific pathological manifestations and airflow obstruction, such as cystic fibrosis, diffuse panbronchiolitis or bronchiolitis obliterans, and other causes of lung diseases such as tuberculosis, lung cancer, etc.
2. A history of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
3. Clear history of bleeding disorders;
4. Accompanying diseases that seriously endanger the safety of patients or affect the completion of the study (severe arrhythmia, significantly reduced creatinine clearance, severe hypertension, diabetes, etc.);
5. Simultaneously accept any other anti-asthma/chronic obstructive pulmonary treatment outside of this trial protocol;
6. Female patients during pregnancy and lactation;
7. Alcoholism and other bad habits; alcoholism refers to 4 or more drinking behaviors within about 2 hours, 1 drink refers to drinking 5 ounces (150 mL) of wine, 12 ounces (350 mL) of beer, or 1.5 ounces of 80% liquor (50 mL). mL);
8. The patient cannot comply with the trial protocol or cannot understand the nature, scope and consequences of the study;
9. Those who have a history of allergies to the components of this medicine.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FEV1%;

Secondary Outcome Measures

Name	Time	Method
PEF variation rate;FEV1/FVC;FeNO;ACT score;FEV1% duration curve;CAT score;