Bronchial asthma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients who meet the Western medical diagnosis of bronchial asthma; (2) Patients who meet the cold croup syndrome of traditional Chinese medicine; (3) Patients with chronic duration and Asthma Control Test (ACT) questionnaire score < 20; (4) Age 18-65 years old (including 18 and 65 years old); (5) Sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) previous fatal asthma attacks; (2) Occupational asthma; (3) Seasonal asthma; (4) Combined with structural lung diseases such as thoracic malformation, chronic obstructive pulmonary disease, bronchiectasis, cystic pulmonary fibrosis, etc.; (5) Patients with serious primary diseases of the heart, brain, liver, kidney and hematopoietic system and mental illness; (6) Patients with primary immunodeficiency disease or acquired immunodeficiency syndrome; (7) Allergic to the drug ingredients in the known experimental drug; (8) Glutamic aminotransferase (ALT) and aspartate aminotransferase (AST) were more than 1.5 times the upper limit of normal value, and serum creatinine (Scr) was greater than the upper limit of normal value; (9) Pregnant, lactating and pregnant women; (10) Participate in other clinical studies within 1 month prior to screening; (11) Participants considered unsuitable for this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Good asthma control rate, week 4 assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Asthma control level (total control, partial control, proportion of uncontrolled people), week 4 evaluation;The change value and change rate of TCM syndrome score were evaluated at week 2 and week 4;The change in the number of press-weekly use of palliative drugs (salbutamol aerosol) was evaluated at week 2 and week 4;Changes in Asthma Quality of Life Questionnaire (Mini-AQLQ) scores were evaluated at week 2 and week 4;Changes in Asthma Quality of Life Questionnaire (Mini-AQLQ) scores were evaluated at week 2 and week 4;Peak expiratory flow velocity (PEF) measurements and changes were evaluated at week 2 and week 4;FEV1, FVC, FEV1/FVC measurements and changes before and after bronchodilator were evaluated at week 4; | — |
Countries
China
Contacts
China-japan Friendship Hospital