Chronic persistent stage of bronchial asthma
Conditions
Interventions
Experimental Group:jiuwei shufeng pingchuan granule
Placebo group:jiuwei shufeng pingchuan granule Simulant
Sponsors
The First Affiliated Hospital of Henan University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for bronchial asthma in Western medicine; (refer to the 2024 edition of the "Guidelines for the Prevention and Treatment of Bronchial Asthma" by the Asthma Group of the Respiratory Disease Branch of the Chinese Medical Association) 2. Meets the diagnostic criteria for the syndrome of Fengxiao in Traditional Chinese Medicine; (refer to "Internal Medicine of Traditional Chinese Medicine," the "Chinese Expert Consensus on Integrated Traditional and Western Medicine Diagnosis and Treatment of Bronchial Asthma (2023)," the "Chinese Expert Consensus on Traditional Chinese Medicine Diagnosis and Treatment of Bronchial Asthma (2012)," and the "Diagnostic Criteria for Bronchial Asthma Syndromes in Traditional Chinese Medicine (2016 Edition)") 3. Patients in the chronic persistent phase with an Asthma Control Test (ACT) questionnaire score <20 points; 4. Patients classified as having mild or moderate asthma in terms of disease severity; 5. Patients who have not used asthma medications for the past 2 weeks or have been using ICS or ICS + LABA/SABA therapy for 4 weeks or more with unchanged drug types and doses; 6. Aged 18 to 65 years (inclusive), with no gender restrictions; 7. Voluntarily participates and signs an informed consent form in writing.
Exclusion criteria
Exclusion criteria: 1. Patients with refractory asthma, critical asthma, occupational asthma, atypical asthma or those with coexisting pulmonary tuberculosis, pulmonary interstitial fibrosis, thoracic deformity, chronic obstructive pulmonary disease, bronchiectasis, cystic pulmonary fibrosis, allergic bronchopulmonary aspergillosis, allergic granulomatous vasculitis or other special types of lung diseases, infectious, restrictive lung diseases and other obstructive pulmonary diseases; 2. Patients who have previously been diagnosed with severe primary diseases of the heart, brain, liver, kidney and hematopoietic system, mental illness, primary immunodeficiency diseases, acquired immunodeficiency syndrome; 3. Patients with allergic constitution or those known to be allergic to the test medication and its components; 4. Patients with glutamic acid transaminase (ALT) and aspartate aminotransferase (AST) greater than 1.5 times the upper limit of normal, and serum creatinine (SCr) greater than the upper limit of normal; 5. Pregnant, lactating or those with a pregnancy plan within the next 3 months; 6. Patients who have had upper and lower respiratory tract infections or pneumonia within 1 month before screening; 7. Patients who have participated in other drug/medical device clinical studies within 1 month before screening; 8. Patients considered not suitable to participate in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Asthma well-controlled rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Asthma well-controlled rate;The change in score from the baseline to the result of the Asthma Control Test (ACT) questionnaire;Classification of asthma control levels (number of people with good control, partial control, and no control);The total effective rate of TCM syndromes, the change value of total scores, the change rate, and the disappearance rate of individual symptoms;Change value of the number of times the reliever medication (sodium cromoglycate inhalation aerosol) was used per week;The score change value of the Mini-AQLQ (Asthma Quality of Life Questionnaire) scale;The frequency and severity of acute asthma attacks;Peak expiratory flow rate (PEF) (morning, bedtime) change values, change rates, variation rates, measurement values / predicted value ratio change values;The change values of FEV1 and FVC before the use of bronchodilators; | — |
Countries
China
Contacts
Public ContactLi Suyun
The First Affiliated Hospital of Henan University of Chinese Medicine
Outcome results
None listed