Clinical trial NCT05841901: Huang-long Zhi-xiao Granule Improves the Control Rate of Chronic Persistent of Asthma
Official title: Evaluation of the Efficacy and Mechanism of Action of Huang-long Zhi-xiao Granule to Improve the Control Rate of Chronic Persistent of Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma Chronic
Keywords: Huang-long Zhi-xiao Granule
Chronic persistent of asthma
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
First posted: 2023-05-03
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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:

* \[Relying on the top-level experimental design, scientifically evaluated the efficacy and safety of Huang-long Zhi-xiao Granule in patients with chronic asthma (hot asthma), and provided evidence support for the clinical application of Classical Prescriptions.\]
* \[Through the retained sample to test Asthma-related inflammatory indicators, immunoglobulins, T cell subsets, etc. To investigate the mechanism of action of Huang-long Zhi-xiao Granule in patients with chronic duration of asthma (hot asthma).\]

Detailed description: Bronchial asthma attacks are erratic and difficult to heal, which seriously affects the quality of life of patients, and their physical and mental health is also seriously affected by asthma.

This study will conduct clinical observations in patients with chronic persistence (hot wheezing) of bronchial asthma, scientifically evaluate the efficacy and safety of Huanglong Anti-Wheezing in patients with asthma chronic duration (hot wheezing), and provide evidence support for the clinical application of Huanglong Anti-Wheezing Formula.

Eligibility criteria: 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

Primary outcomes:
measure: Asthma control tests（CAT）
timeFrame: Change from baseline CAT scores at week 4, 8, 21, 34，47 and 52.
measure: Frequencies of acute attacks
timeFrame: Up to week 52.
Secondary outcomes:
measure: Asthma exacerbation severity and hospitalization rate
timeFrame: Week0(before treatment),week4、week8、week21、week34、week47and week52.
measure: Change in severity of chronic persistent disease
timeFrame: Week0(before treatment),week4、week8、week21、week34、week47and week52.
measure: The dose used by glucocorticoids
timeFrame: Week0(before treatment),week4、week8、week21、week34、week47 and week52.
measure: Rapid-acting beta2 agonists use drugs and doses
timeFrame: Week0(before treatment),week8 and after follow-up（week52）
measure: Score for clinical signs and symptoms
timeFrame: Week0(before treatment),week8 and after follow-up（week52）
measure: Pulmonary function
timeFrame: Week0(before treatment),week4、week8、week21、week34、week47and week52.
measure: Exhaled nitric oxide
timeFrame: Week0(before treatment),week4、week8、week21、week34、week47and week52.
measure: Asthma Control Questionnaire (ACQ)
timeFrame: Week0(before treatment),week8 and after follow-up（week52）
measure: Asthma Quality of Life Score (AQLQ) score
timeFrame: Week0(before treatment),week8 and after follow-up（week52）
measure: Sputum detection indicators
timeFrame: Week0(before treatment), week 8，after follow-up（week52）
Other outcomes:
Locations:
Study officials:
affiliation: Henan University of Traditonal Chinese Medicine
name: Minghang Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: