Clinical Study of Lung-benefiting Moxibustion Reduce Exacerbations of Asthma

N/ANot Yet RecruitingNCT06777472

Cuiling Feng384 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

384

Conditions

Asthma

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Annual number of flare-up of asthma

Frequency

Time frame: 1year

Secondary Outcomes

ACT and ACQ questionnaires

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

Time frame: Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, and 104 weeks.

AQLQ scale

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.

Time frame: Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, 104 weeks.

Pulmonary ventilation test and Diastolic test

Ventilation function test ml

Time frame: Pulmonary ventilation test will be performed once before treatment,and at 52, 104 weeks.Diastolic tests will be performed once before treatment.

FeNO

The fractional concentration of exhaled nitric oxide

Time frame: Before treatment,and at 52, 104 weeks.

Eosinophils count,Serum total IgE,and T-Lymphocyte Subsets

EO# x 10\^9/L Ig E IU/mL percent of CD4+ cell、CD8+ cell 、CD4+/CD8+ cell

Time frame: Before treatment,and at 7, 52, 59, 104 weeks.