Allergic asthma is a common allergic disease characterized by a protracted disease course and recurrent episodes, which severely impairs patients' physical and mental health. There is a paucity of high-quality clinical evidence in the treatment of allergic asthma with traditional Chinese medicine (TCM). This study will enroll patients who are persistent allergic asthma with spleen deficiency and dampness accumulation syndrome. A multicenter, randomized, double-blind, placebo-controlled trial design is adopted. The experimental group will receive Modified Shenling Baizhu Powder in addition to Budesonide and Formoterol Fumarate Powder for Inhalation, while the control group will receive a placebo in addition to the same inhalation therapy. Both groups will undergo an 8 week of treatment followed by a 12 week of follow-up. The primary outcome is Asthma Control Test scores, and the secondary outcomes include acute exacerbations, Asthma Control Questionnaire scores, Asthma Quality of Life Questionnaire scores, pulmonary function, airway inflammatory markers, clinical symptom scores, serum inflammatory markers, immune markers, and use of controller medications.
Patients who are persistent allergic asthma.
Patients who meet the diagnostic criteria for the spleen deficiency and dampness accumulation syndrome.
Patients who are aged between 18 and 80 years.
Patients who voluntarily accept the treatment and sign the informed consent form.
Patients who have chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, allergic bronchopulmonary aspergillosis, eosinophilic granulomatosis with polyangiitis , active pulmonary tuberculosis, or pulmonary embolism, etc.
Patients who have severe cardiovascular or cerebrovascular diseases.
Patients who have severe liver or kidney diseases.
Patients who have a history of tumor.
Parallel
Modified Shenling Baizhu Powder
DrugModified Shenling Baizhu Powder will be taken twice daily.
Placebo
DrugThe placebo will be taken twice daily.
Budesonide and Formoterol Fumarate Powder for Inhalation
DrugBudesonide and Formoterol Fumarate Powder for Inhalation will be taken twice daily.
Asthma Control Test scores
To be measured by Asthma Control Test.
Acute exacerbation
To be measured by the frequency and severity of acute exacerbation, and the time to first acute exacerbation.
Asthma Control Questionnaire scores
To be measured by Asthma Control Questionnaire.
Asthma Quality of Life Questionnaire scores
To be measured by Asthma Quality of Life Questionnaire.
Pulmonary function
To be measured by pulmonary function test.
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