Asthma
Conditions
Keywords
asthma out of control, lung-benefiting moxibustion, Treating winter diseases in summer, RCT
Brief summary
For patients with poor asthma control, on the basis of treatment guided by GINA guidelines, lung-benefiting moxibustion treatment will be given, and it will be applied 10 days before early onset, once every 10 days, and the follow-up was 45 weeks, 1 cycle per year, for 2 consecutive cycles (2 years). The annual number of flare-up of asthma patients will be used as the main outcome index to evaluate the clinical effect of lung-benefiting moxibustion on reducing exacerbations of asthma. By observing immunoglobulin, T cell subsets and other indicators, the advantage population and mechanism of moxibustion in treating patients with poor asthma control will be clarified.
Interventions
OTHERlung-benefiting moxibustion
A kind of external treatment，the treatment theory is to treat winter diseases in summer.
DRUGThe specific drug comes from GINA (2024)
Refer to GINA (2024).
Sponsors
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine
Cuiling Feng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who meet the diagnosis of asthma (remission); * Patients with poor clinical control; * Age 18-80 years old; * Voluntarily undergo treatment and sign an informed consent form;
Exclusion criteria
* Patients combined with pulmonary abscess, pulmonary fibrosis, active pulmonary tuberculosis, bronchiectasis or other lung diseases; * Patients with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina pectoris, acute myocardial infarction, cardiac functional classification≥III, stroke, cerebral hemorrhage, etc.)； * Patients with severe liver diseases (liver cirrhosis, portal hypertension, bleeding due to esophageal and gastric varices, etc.) or severe kidney diseases (renal dialysis, kidney transplantation, etc.)； * Patients with confusion, various mental disorders, etc., who are unable to communicate normally; * Pregnant and lactating women; * Patients with heat phlegm pattern through TCM pattern differentiation； * Patients participating in other clinical trials within 1 month prior to enrollment; * Received TCM external treatment such as lung-benefiting moxibustion for 1 year; * Patients allergic to moxibustion drugs, smoke, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annual number of flare-up of asthma | 1year | Frequency |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ACT and ACQ questionnaires | Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, and 104 weeks. | 1. ACT asthma control test A score of 25 indicates well-controlled asthma, 20-24 indicates partially controlled asthma, and 20 indicates uncontrolled. 2. Asthma Control Questionnaire \<0.75 points indicates that asthma is completely controlled: 0.75-1.5 points indicates good control of asthma: \>.15 points indicates that asthma is not well controlled |
| AQLQ scale | Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, 104 weeks. | Asthma Quality of Life Questionnaire When calculating the overall score, the scores of each dimension are averaged to obtain a score between 0 and 7. The higher the score, worse the patient's quality of life. According to the AQLQ scoring criteria, a score above 5 indicates a relatively good quality of life, while a below 3 indicates a poor quality of life. |
| Pulmonary ventilation test and Diastolic test | Pulmonary ventilation test will be performed once before treatment,and at 52, 104 weeks.Diastolic tests will be performed once before treatment. | Ventilation function test ml |
| FeNO | Before treatment,and at 52, 104 weeks. | The fractional concentration of exhaled nitric oxide |
| Eosinophils count,Serum total IgE,and T-Lymphocyte Subsets | Before treatment,and at 7, 52, 59, 104 weeks. | EO# x 10\^9/L Ig E IU/mL percent of CD4+ cell、CD8+ cell 、CD4+/CD8+ cell |
Contacts
Primary ContactC Feng
Outcome results
None listed