Allergic Asthma
Conditions
Keywords
Allergic asthma, Modified Shenling Baizhu Powder, Spleen Deficiency and Dampness Accumulation Syndrome, Randomized controlled trial
Brief summary
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.
Interventions
DRUGModified Shenling Baizhu Powder
Modified Shenling Baizhu Powder will be taken twice daily.
DRUGPlacebo
The placebo will be taken twice daily.
DRUGBudesonide and Formoterol Fumarate Powder for Inhalation
Budesonide and Formoterol Fumarate Powder for Inhalation will be taken twice daily.
Sponsors
Henan University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Patients who have cognitive impairment or psychiatric disorders. * Patients who are pregnant or breastfeeding. * Patients who are allergic to medication(s) used. * Patients who participated in another clinical trial within one month prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Test scores | At baseline, week 4 and week 8 of treatment, and week 12 of follow-up. | To be measured by Asthma Control Test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute exacerbation | At baseline, week 4 and week 8 of treatment, and week 12 of follow-up. | To be measured by the frequency and severity of acute exacerbation, and the time to first acute exacerbation. |
| Asthma Control Questionnaire scores | At baseline, week 4 and week 8 of treatment, and week 12 of follow-up. | To be measured by Asthma Control Questionnaire. |
| Asthma Quality of Life Questionnaire scores | At baseline, week 4 and week 8 of treatment, and week 12 of follow-up. | To be measured by Asthma Quality of Life Questionnaire. |
| Pulmonary function | At baseline, week 8 of treatment, and week 12 of follow-up. | To be measured by pulmonary function test. |
| Airway inflammatory markers | At baseline, week 8 of treatment, and week 12 of follow-up. | To be measured by fractional exhaled nitric oxide. |
| Clinical symptom scores | At baseline, week 4 and week 8 of treatment, and week 12 of follow-up. | To be measured by clinical symptom questionnaire. |
| Serum inflammatory markers | At baseline, week 4 and week 8 of treatment. | To be measured by blood eosinophil count, total serum IgE, IL-4, IL-5, TNF-α, etc. |
| Immune markers | At baseline, week 4 or week 8 of treatment. | To be measured by CD4+, CD8+, CD4+/CD8+, Th17, and Treg. |
| Use of controller medications | At baseline, week 4 and week 8 of treatment, and week 12 of follow-up. | To be measured by the usage of bronchodilator and glucocorticoid. |
Countries
China
Contacts
CONTACTJiajia Wang, M.D.
Outcome results
None listed