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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
400
Modified Shenling Baizhu Powder will be taken twice daily.
The placebo will be taken twice daily.
Budesonide and Formoterol Fumarate Powder for Inhalation will be taken twice daily.
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, China
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, China
Asthma Control Test scores
To be measured by Asthma Control Test.
Time frame: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
Acute exacerbation
To be measured by the frequency and severity of acute exacerbation, and the time to first acute exacerbation.
Time frame: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
Asthma Control Questionnaire scores
To be measured by Asthma Control Questionnaire.
Time frame: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
Asthma Quality of Life Questionnaire scores
To be measured by Asthma Quality of Life Questionnaire.
Time frame: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
Pulmonary function
To be measured by pulmonary function test.
Time frame: At baseline, week 8 of treatment, and week 12 of follow-up.
Airway inflammatory markers
To be measured by fractional exhaled nitric oxide.
Time frame: At baseline, week 8 of treatment, and week 12 of follow-up.
Clinical symptom scores
To be measured by clinical symptom questionnaire.
Time frame: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
Serum inflammatory markers
To be measured by blood eosinophil count, total serum IgE, IL-4, IL-5, TNF-α, etc.
Time frame: At baseline, week 4 and week 8 of treatment.
Immune markers
To be measured by CD4+, CD8+, CD4+/CD8+, Th17, and Treg.
Time frame: At baseline, week 4 or week 8 of treatment.
Use of controller medications
To be measured by the usage of bronchodilator and glucocorticoid.
Time frame: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.