Clinical trial NCT06777472: Clinical Study of Lung-benefiting Moxibustion Reduce Exacerbations of Asthma
Official title: Clinical Study on Reducing Exacerbations of Asthma by Lung-benefiting Moxibustion Based on "Winter Disease Cured in Summer"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asthma
Keywords: asthma out of control
lung-benefiting moxibustion
Treating winter diseases in summer
RCT
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine
First posted: 2025-01-15
Enrollment: 384
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Annual number of flare-up of asthma
timeFrame: 1year
Secondary outcomes:
measure: ACT and ACQ questionnaires
timeFrame: Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, and 104 weeks.
measure: AQLQ scale
timeFrame: Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, 104 weeks.
measure: Pulmonary ventilation test and Diastolic test
timeFrame: Pulmonary ventilation test will be performed once before treatment,and at 52, 104 weeks.Diastolic tests will be performed once before treatment.
measure: FeNO
timeFrame: Before treatment,and at 52, 104 weeks.
measure: Eosinophils count,Serum total IgE,and T-Lymphocyte Subsets
timeFrame: Before treatment,and at 7, 52, 59, 104 weeks.
Other outcomes:
Locations:
Study officials:
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