Clinical Study on Reducing Exacerbations of Asthma by Lung-benefiting Moxibustion Based on "Winter Disease Cured in Summer"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 384
- 主要终点
- Annual number of flare-up of asthma
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
test group
On the basis of the control group, lung-benefiting moxibustion treatment will be given.Details are as follows：
- The procedure of moxibustion includes 13 steps: selecting the body position, choosing the point, disinfecting, applying ginger juice, sprinkling moxibustion powder, covering mulberry paper, laying ginger mud, placing moxa cone, lighting moxa cone, changing moxa cone, removing ginger mud, gently rubbing moxibustion spot and placing blisters; The time of each application of moxibustion is 90 minutes.
- Treatment course: Start 10 days before the "early onset", once every 10 days, intervene 5 times, 1 year as one cycle, 2 consecutive cycles.
干预措施: lung-benefiting moxibustion (Other)
test group
On the basis of the control group, lung-benefiting moxibustion treatment will be given.Details are as follows：
- The procedure of moxibustion includes 13 steps: selecting the body position, choosing the point, disinfecting, applying ginger juice, sprinkling moxibustion powder, covering mulberry paper, laying ginger mud, placing moxa cone, lighting moxa cone, changing moxa cone, removing ginger mud, gently rubbing moxibustion spot and placing blisters; The time of each application of moxibustion is 90 minutes.
- Treatment course: Start 10 days before the "early onset", once every 10 days, intervene 5 times, 1 year as one cycle, 2 consecutive cycles.
干预措施: The specific drug comes from "GINA (2024)" (Drug)
control group
Refer to "GINA (2024)". Regulations on combined medication: When complications occur during treatment, symptomatic treatment can be given according to the clinical situation. At the same time, the name, manufacturer, batch number, usage, dosage, course of treatment, etc. of the drug should be recorded in detail.
干预措施: The specific drug comes from "GINA (2024)" (Drug)
结局指标
主要结局
Annual number of flare-up of asthma
时间窗: 1year
Frequency
次要结局
- ACT and ACQ questionnaires(Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, and 104 weeks.)
- AQLQ scale(Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, 104 weeks.)
- FeNO(Before treatment,and at 52, 104 weeks.)
- Eosinophils count,Serum total IgE,and T-Lymphocyte Subsets(Before treatment,and at 7, 52, 59, 104 weeks.)
- 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.)
研究者
Cuiling Feng
professor
Peking University People's Hospital