Clinical Study of Lung-benefiting Moxibustion Reduce Exacerbations of Asthma

Not Applicable

Not yet recruiting

• Conditions: Asthma
• Interventions: Other: lung-benefiting moxibustion; Drug: The specific drug comes from "GINA (2024)"

• Registration Number: NCT06777472
• Lead Sponsor: Cuiling Feng

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-29
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-10
• Last Update Submitted: 2025-01-10
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Study Start: 2025-07
• Primary Completion: 2026-09
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 384

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
test group	lung-benefiting moxibustion	On the basis of the control group, lung-benefiting moxibustion treatment will be given.Details are as follows： 1. 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. 2. Treatment course: Start 10 days before the "early onset", once every 10 days, intervene 5 times, 1 year as one cycle, 2 consecutive cycles.
test group	The specific drug comes from "GINA (2024)"	On the basis of the control group, lung-benefiting moxibustion treatment will be given.Details are as follows： 1. 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. 2. Treatment course: Start 10 days before the "early onset", once every 10 days, intervene 5 times, 1 year as one cycle, 2 consecutive cycles.
control group	The specific drug comes from "GINA (2024)"	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.

Primary Outcome Measures

Name	Time	Method
Annual number of flare-up of asthma	1year	Frequency

Secondary Outcome Measures

Name	Time	Method
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.
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
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