asthma
Conditions
Interventions
control:budesonide/formoterol powder inhalation 320µg/9µg, batch number: H20140458 (AstraZeneca AB), one inhalation three times daily.
Treat: budesonide/formoterol powder inhalation 320µg/9µg, batch number: H20140458 (AstraZeneca AB), one inhalation three times daily.zhijing decoction(Centipede 3g, Scorpion 3g, Sichuan New Green Phar
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Conforms to the diagnosis of severe asthma in the Chinese Guidelines for the prevention and treatment of Bronchial Asthma 2020; 2. The stage of the disease belongs to the chronic persistent stage 3. In line with the key points of syndrome differentiation of lung obstruction syndrome of wheezing 4. Age between 18 and 80 years old, regardless of gender. 5. Patients gave informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Patients whose disease stage belongs to acute attack or clinical control stage; 2. Chronic cough and wheezing caused by chronic obstructive pulmonary disease, bronchiectasis, bronchial tumor, tuberculosis, fungi, irritating gas or allergy; 3. Patients with invasive lesions, space-occupying lesions, diffuse interstitial lesions, extensive emphysema, pulmonary bullae, pneumothorax, pleural effusion, cavity, multiple nodules, mediastinal and/or hilar lymphadenopathy on chest imaging; Patients with previous lobectomy or segmentectomy; 4. Patients with severe cardiovascular disease or liver and kidney dysfunction; 5. Patients with a history of allergic or adverse reactions to any test drug or other animal Chinese medicine; 6. Pregnant or lactating women; 7. Persons with legal disabilities (blind, deaf, dumb, intellectual disability, mental disorder, etc.); 8. Suspected history of alcohol or drug abuse, or other medical history that, according to the investigator's judgment, may reduce or complicate the possibility of enrollment, such as frequent changes in work environment and loss to follow-up; 9. Patients enrolled in clinical trials of other drugs within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fractional exhaled nitric oxide;Forced expiratory volume in one second;Forced expiratory volume in one second as a percentage of predicted value;The ratio of forced expiratory volume in one second to the forced vital capacity;maximal mid-expiratory flow curve;forced expiratory flow at 25% of FVC exhaled;forced expiratory flow at 50% of FVC exhaled;forced expiratory flow at 75% of FVC exhaled;Airway wall thickness;Outer airway diameter;Airway wall area;Total airway area;Ratio of airway wall thickness to airway outer diameter;Ratio of airway wall area to total airway area; | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of acute asthma exacerbations;Asthma control test;TCM syndrome score;matrix metalloprotein-9;tissue inhibitor of metal protease 1;glutathione;Oxidized glutathione;Transferrin Receptor 1;Ferric ion;Neutrophil count;eosinophil count; | — |
Countries
china
Contacts
Public Contactzhang yada
Shanghai Municipal Hospital of Traditional Chinese Medicine
Outcome results
None listed