Last updated: April 23, 2023
Sponsor: Henan University of Traditional Chinese Medicine
Overall Status: Active - Not Recruiting
Phase
N/A
Condition
Asthma
Treatment
Huang-long Zhi-xiao Granule placebo
Huang-long Zhi-xiao Granule
Clinical Study ID
NCT05841901
TCM for Asthma
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 todosing or who have been treated with ICS or ICS+LABA for 4 weeks or more prior todosing 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
Exclusion Criteria:
- Patients with special types of refractory asthma, critical asthma, occupationalasthma, seasonal asthma, atypical asthma or tuberculosis, pulmonary interstitialfibrosis, thoracic malformation, chronic obstructive pulmonary disease,bronchiectasis, cystic pulmonary fibrosis, allergic bronchopulmonary aspergillosis,allergic granulomatous vasculitis, infectious, restrictive lung disease and otherairflow obstructive pulmonary diseases
- Patients with severe cardiovascular and cerebrovascular diseases (malignantarrhythmia, unstable angina, acute myocardial infarction, cardiac function grade 3 andabove, stroke, cerebral hemorrhage, etc.)
- Glutamate aminotransferase (ALT), aspartate aminotransferase (AST) > 1.5 times theupper 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 seriousrespiratory 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 toenrollment
Study Design
Total Participants: 224
Treatment Group(s): 2
Primary Treatment: Huang-long Zhi-xiao Granule placebo
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
December 01, 2024