asthma
Conditions
Interventions
intervention group:Bu-Shen-Yi-Qi formula add-on to inhaled corticosteroids
control group:Bu-Shen-Yi-Qi formula mimic add-on to inhaled corticosteroids
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Eligible subjects were all genders aged 18 and 70 years, asthma control test (ACT) score lower than 20 and continuous use of ICS (or has an supplement of ICS) for more than 3 months. To be included in this trial, the subjects had to complete the asthma diary records in the introduction stage. Besides, the subjects were required not to have upper or lower respiratory tract infection within two weeks and not oral or intravenous use of glucocorticoid therapy. All subjects agreed to the study protocol and signed a written informed consent.
Exclusion criteria
Exclusion criteria: The main exclusion criteria were subjects with severe duration and acute episodes that need oral use of glucocorticoid. Subjects combined with COPD, pulmonary fibrosis, bronchiectasis, active tuberculosis, pleural effusion, pulmonary embolism and history of pneumonectomy were also excluded. Subjects were excluded if they were pregnant or were planning to become pregnant as well as breast feeding, were malignant tumor or hematopathypatients, participated in other drug trials, heart, liver and kidney damage seriously (cardiac function grade 3 ~ 4, ALT and/or AST above 1.5 times more than normal ceiling, above upper limit of normal). Subjects with conditions that were not proper to be included were also excluded by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| day-time symptom free days;asthma recurrent; | — |
Secondary
| Measure | Time frame |
|---|---|
| IL-17, IL-4, IL-5, IL-13 level in serum;CRHR1, GLCCI1 genotype in Peripheral blood cells;lung function;ACT score; | — |
Countries
China
Contacts
Public ContactWei Ying
Huashan Hospital, Fudan University
Outcome results
None listed