Bronchial Asthma
Conditions
Interventions
Therapy group:Bailing Capsules 0.2g/granules, 3 times a day, 2 capsules each time, oral
Placebo group:Bailing Capsule Placebo 0.2g/granule, 3 times a day, 2 capsules each time, oral
Sponsors
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years old, male or female, community or outpatient cases; 2. Patient with chronic persistent mild (needing GINA step 2 treatment) or moderate (needing GINA step 3 treatment) asthma. TCM syndrome differentiation is deficiency syndrome; 3. Able to communicate in language or written, signed written consent or witnessed oral consent in the case of illiteracy before undertaking any trial related activity, and able to complete the examinations.
Exclusion criteria
Exclusion criteria: 1. Patients with acute exacerbation bronchial asthma; 2. Serious diseases other than bronchial asthma. Serious illnesses are defined as: according to the investigator's judgment, patients participating in the trial can be dangerous, affect the test result or affect patients' ability to participate the test, such as severe heart, brain, liver, kidney, blood system disease or malignancy. 3. Significant abnormalities in laboratory tests, including: Blood routine (white blood cell count = 12 × 10^9/L, neutrophil ratio =80%; hemoglobin = 60g/L); liver and kidney function (ALT AST more than 1.5 times the upper limit of normal; serum creatininemore than 1.2 times the upper limit of normal or creatinine clearance rate is = 50 ml/min); 4. Clinical diagnosis of lung cancer, bronchiectasis, pneumoconiosis or other simple restrictive ventilatory dysfunction; 5. Patients with chronic obstructive pulmonary disease (FEV1/FVC <70% after inhalation of bronchodilator); 6. Suffering from active tuberculosis; 8. Patients with life-threatening diseases such as pulmonary embolism, a1-antitrypsin deficiency, or cystic fibrosis; 9. Patients who have undergone a pneumonectomy; 10. Hospitalization and/or antibiotic and/or oral or intravenous glucocorticoid are required during the enrollment period; 11. A patient who has used a test drug 30 days before the first visit (V0) or during the six-half-life period (whichever is longer); 12. Long-term use of oxygen therapy, unstable (dose stabilization time less than 6 weeks) oral or intravenous glucocorticoid, exceed oral or intravenous glucocorticoid which doses are more than equivalent to prednisone 10 mg/d, or long-term use of antibiotics; 13. Pregnant or breast feeding; 14. Patients scheduled to be hospitalized or donate blood during the trial; 15. Patients with a history of allergies or intolerance of the test drug; 16. Have a history of chronic alcohol abuse, drug abuse, or any factors that affect compliance; 17. The patient is participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Asthma down stepped (combined medication) treatment;Asthma control level; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary function;FeNO;IgE;ECP;Tumor Necrosis Factor-a;Interleukin-5;Asthma Control Test;Asthma quality life questionnaire;Asthma Control Questionnaire; | — |
Countries
China
Contacts
Public ContactFeng Jihong
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed