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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | The experimental group will receive Modified Shenling Baizhu Powder in addition to Budesonide and Formoterol Fumarate Powder for Inhalation. |
|
| Control group | Placebo Comparator | The control group will receive a placebo in addition to Budesonide and Formoterol Fumarate Powder for Inhalation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Shenling Baizhu Powder | Drug | Modified Shenling Baizhu Powder will be taken twice daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Test scores | To be measured by Asthma Control Test. | At baseline, week 4 and week 8 of treatment, and week 12 of follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute exacerbation | To be measured by the frequency and severity of acute exacerbation, and the time to first acute exacerbation. | At baseline, week 4 and week 8 of treatment, and week 12 of follow-up. |
| Asthma Control Questionnaire scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiajia Wang, M.D. | Contact | +86-371-66248624 | wangiahn@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Henan University of Chinese Medicine | Zhengzhou | Henan | 450003 | China | ||
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| Placebo | Drug | The placebo will be taken twice daily. |
|
| Budesonide and Formoterol Fumarate Powder for Inhalation | Drug | Budesonide and Formoterol Fumarate Powder for Inhalation will be taken twice daily. |
|
To be measured by Asthma Control Questionnaire.
| 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. | At baseline, week 4 and week 8 of treatment, and week 12 of follow-up. |
| Pulmonary function | To be measured by pulmonary function test. | At baseline, week 8 of treatment, and week 12 of follow-up. |
| Airway inflammatory markers | To be measured by fractional exhaled nitric oxide. | At baseline, week 8 of treatment, and week 12 of follow-up. |
| Clinical symptom scores | To be measured by clinical symptom questionnaire. | 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. | At baseline, week 4 and week 8 of treatment. |
| Immune markers | To be measured by CD4+, CD8+, CD4+/CD8+, Th17, and Treg. | At baseline, week 4 or week 8 of treatment. |
| Use of controller medications | To be measured by the usage of bronchodilator and glucocorticoid. | At baseline, week 4 and week 8 of treatment, and week 12 of follow-up. |
| Affiliated Hospital of Shandong University of Traditional Chinese Medicine |
| Jinan |
| Shandong |
| 250011 |
| China |
| Hangzhou Third People's Hospital | Hangzhou | Zhejiang | 310009 | China |
| ID | Term |
|---|---|
| D019819 | Budesonide |
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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