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NCT Number: NCT06777472

Clinical Study of Lung-benefiting Moxibustion Reduce Exacerbations of Asthma

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

lung-benefiting moxibustion

Other

A kind of external treatment,the treatment theory is to treat winter diseases in summer.

The specific drug comes from "GINA (2024)"

Drug

Refer to "GINA (2024)".

Primary outcomes

  1. Annual number of flare-up of asthma

    Time frame: 1year

    Frequency

Secondary outcomes

  1. ACT and ACQ questionnaires

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

    • ACT asthma control test A score of 25 indicates well-controlled asthma, 20-24 indicates partially controlled asthma, and 20 indicates uncontrolled.
    • 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
  2. AQLQ scale

    Time frame: 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.

  3. 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.

    Ventilation function test ml

  4. FeNO

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

    The fractional concentration of exhaled nitric oxide

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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Cuiling Feng

Other

Collaborators

  • The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
  • Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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