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Not yet recruiting NCT06777472

Clinical Study of Lung-benefiting Moxibustion Reduce Exacerbations of Asthma

No phase Interventional Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: lung-benefiting moxibustion, The specific drug comes from "GINA (2024)".
Who it may be relevant to
Registry conditions: Asthma. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Study on Reducing Exacerbations of Asthma by Lung-benefiting Moxibustion Based on "Winter Disease Cured in Summer"

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.

Interventions

  • Other lung-benefiting moxibustion
    A kind of external treatment，the treatment theory is to treat winter diseases in summer.
  • Drug The specific drug comes from "GINA (2024)"
    Refer to "GINA (2024)".

Primary outcome measures

  • Annual number of flare-up of asthma [Time frame: 1year]
Secondary outcome measures (5)
  • ACT and ACQ questionnaires [Time frame: Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, and 104 weeks.]
  • AQLQ scale [Time frame: Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, 104 weeks.]
  • Pulmonary ventilation test and Diastolic test [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 [Time frame: Before treatment,and at 52, 104 weeks.]
  • Eosinophils count,Serum total IgE,and T-Lymphocyte Subsets [Time frame: Before treatment,and at 7, 52, 59, 104 weeks.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06777472 · 2024PHB342-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗