Evaluation of the Efficacy and Mechanism of Action of Huang-long Zhi-xiao Granule to Improve the Control Rate of Chronic Persistent of Asthma

TCM for Asthma

The goal of this observational study is to test the Evaluation of the efficacy and mechanism of action about Huang-long Zhi-xiao Granule to improve the control rate of Asthma chronic duration. The main questions it aims to answer are: * \[Relying on the top-level experimental design, scientifically evaluated the efficacy and safety of Huang-long Zhi-xiao Granule in patients with chronic asthma (hot asthma), and provided evidence support for the clinical application of Classical Prescriptions.\] * \[Through the retained sample to test Asthma-related inflammatory indicators, immunoglobulins, T cell subsets, etc. To investigate the mechanism of action of Huang-long Zhi-xiao Granule in patients with chronic duration of asthma (hot asthma).\]

2023-06-01

2024-02-01

2024-12-01

Not yet recruiting

224

Inclusion Criteria: * Patients who meet the diagnostic criteria for chronic persistent bronchial asthma * It meets the TCM differentiation standards for wheezing and hot wheezing * Asthma Control Test (ACT) questionnaire score\<20 score * The severity of disease is graded from mild to moderately persistent * Patients who have not been treated with anti-asthmatic drugs for 2 weeks prior to dosing or who have been treated with ICS or ICS+LABA for 4 weeks or more prior to dosing and who have the same type and dose of the drug * Age form 18-80 years old * Have not participated in other clinical studies within 1 month prior to enrollment * Voluntarily participate in the study and sign an informed consent form Exclusion Criteria: * Patients with special types of refractory asthma, critical asthma, occupational asthma, seasonal asthma, atypical asthma or tuberculosis, pulmonary interstitial fibrosis, thoracic malformation, chronic obstructive pulmonary disease, bronchiectasis, cystic pulmonary fibrosis, allergic bronchopulmonary aspergillosis, allergic granulomatous vasculitis, infectious, restrictive lung disease and other airflow obstructive pulmonary diseases * Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina, acute myocardial infarction, cardiac function grade 3 and above, stroke, cerebral hemorrhage, etc.) * Glutamate aminotransferase (ALT), aspartate aminotransferase (AST) \> 1.5 times the upper limit of normal value， blood creatinine (Cr) \> upper limit of normal value * Those who are allergic and allergic to the components of drugs in known test drugs * Patients with bronchiectasis, tuberculosis, pulmonary embolism, or other serious respiratory conditions * Combined with severe cognitive and psychiatric abnormalities * Participants who are pregnant, lactating, and planning to become pregnant * Those who are participating in other clinical trials within 1 month prior to enrollment

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 224, 'type': 'ESTIMATED'}}

2023-05-03