An interventional study of Modified Shenling Baizhu Powder and Placebo in Allergic Asthma, sponsored by Henan University of Traditional Chinese Medicine. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Henan University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
The experimental group will receive Modified Shenling Baizhu Powder in addition to Budesonide and Formoterol Fumarate Powder for Inhalation.
Drug: Modified Shenling Baizhu Powder · Drug: Budesonide and Formoterol Fumarate Powder for Inhalation
The control group will receive a placebo in addition to Budesonide and Formoterol Fumarate Powder for Inhalation.
Drug: Placebo · Drug: Budesonide and Formoterol Fumarate Powder for Inhalation
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.
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.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Henan University of Traditional Chinese Medicine