Allergic asthma
Conditions
Interventions
Experimental Group:+
Control Group:+
Sponsors
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Patients diagnosed with acute exacerbation of allergic asthma, with disease severity classified as mild or moderate (refer to GINA 2025 guidelines); (2) Patients with a traditional Chinese medicine (TCM) diagnosis of wind pathogen invading the lungs and both exterior and interior excess syndrome; (3) Patients aged between 18 and 75 years (inclusive); (4) Patients who voluntarily agree to receive treatment and have signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Subjects with severe lower respiratory tract infections requiring systemic antibiotics; (2) Subjects with severe primary diseases such as cardiovascular, cerebrovascular, respiratory, hepatic, renal, hematopoietic system diseases, or peptic ulcers; (3) Subjects with abnormal liver or kidney function: liver (ALT or AST) exceeding 1.5 times the upper limit of reference values, or kidney function (BUN or CREA) exceeding the upper limit of reference values; (4) Patients with mental illness or those who are unwilling to cooperate with the trial; (5) Subjects with a history of chronic alcohol abuse, drug abuse, or any factors affecting compliance; (6) Subjects currently using herbal decoctions or traditional Chinese medicine with similar components, functions, or mechanisms, or undergoing non-pharmacological therapies such as acupuncture, massage, cupping, ear acupressure, herbal foot baths, or emotional regulation; (7) Pregnant or breastfeeding women, and male or female subjects planning pregnancy within 3 months after the trial or unwilling to take effective contraceptive measures during and after the trial; (8) Subjects with allergies to the drugs used in the trial; (9) Subjects with spleen deficiency and loose stools; (10) Subjects who have participated in other clinical trials within the past month; (11) Other conditions deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Efficacy Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome score;Asthma Control Rate;Asthma Control Test Score;Asthma Daytime and Nighttime Symptom Scores and Symptom Score Halving Rate;Dyspnea, cough, chest tightness Visual Analog Scale score;Asthma Quality of Life Questionnaire Scoring;Usage frequency of relief medication (emergency use medication) and its variation.;Pulmonary function level;Airway inflammatory biomarker exhaled nitric oxide level;Peripheral Blood Eosinophil Count;Serum Total IgE Level;Serum interleukin-13 level;Serum interleukin-10 level;Serum transforming growth factor-beta level;The percentage of peripheral blood CD4+ CD25+ Foxp3+ Treg cells among CD4+ T cells.;Overall Assessment of Treatment Effectiveness;Health Economic Evaluation; | — |
Countries
China
Contacts
Public ContactFan Maorong
China Academy of Traditional Chinese Medicine, Xiyuan Hospital
Outcome results
None listed