Moderate to severe persistent asthma
Conditions
Interventions
Control Group:Basic Western medical treatment + Yanghe DidingOintment placebo (45g per dose, dissolved in hot water, twice daily)
Experimental Group:Basic Western medical treatment + Yanghe Diding (45g per dose, dissolved in hot water, twice daily)
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. According to the "Guidelines for the Prevention and Treatment of Bronchial Asthma (2024 Edition)," the criteria for diagnosing bronchial asthma are met; 2. The asthma condition is in a state of moderate or severe persistence: - Moderate persistence: Symptoms occur daily, affecting activities and sleep, with nighttime asthma symptoms = once per week, FEV1 as a percentage of the predicted value is 60%~79%, or PEF is 60%~79% of the individual's best value, and PEF variability >30%; - Severe persistence: Symptoms occur daily, frequently, with frequent nighttime asthma symptoms, restricted physical activity, FEV1 as a percentage of the predicted value 30%; 3. Meets the diagnostic criteria for the traditional Chinese medicine (TCM) pattern of "Xu Xiao Zheng" (deficient asthma syndrome); 4. Age between 18 and 75 years (inclusive), with no gender restrictions; 5. Understands and adheres to the study procedures, voluntarily participates, and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Body Mass Index (BMI) 1.5 times the upper limit of normal, Serum Creatinine [Scr] > 1.2 times the upper limit of normal). 10. Patients with malignant tumors. 11. History of, as judged by the investigator to be unable to comply with treatment or follow medical advice. 12. Known allergy to any components of the investigational drugs (Western or traditional Chinese medicine). 13. Use of oral traditional Chinese medicine or Chinese patent medicine within 1 week prior to screening. 14. Participation in other drug clinical trials within the past 3 months or in medical device clinical trials within the past month. 15. History of chronic alcohol abuse or substance abuse within 12 months prior to enrollment, or poor compliance during screening, or any factors affecting compliance. 16. Other patients deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients who experienced asthma exacerbation events after the treatment period.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Asthma Control Questionnaire (ACQ-6) Scoring;Pulmonary Function;Asthma medication usage;Asthma Exacerbation;Peak expiratory flow (PEF) variability rate;Asthma symptom-free days;Exhaled nitric oxide;Serum immunoglobulin E;Asthma Quality of Life Questionnaire;TCM Syndrome Score; | — |
Countries
China
Contacts
Public ContactLu Zhenhui
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed