Clinical Study of Lung-benefiting Moxibustion Reduce Exacerbations of Asthma

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Annual number of flare-up of asthma [Срок оценки: 1year]

Вторичные конечные точки (5)

• ACT and ACQ questionnaires [Срок оценки: Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, and 104 weeks.]
• AQLQ scale [Срок оценки: Before treatment, and at 7, 13, 26, 39, 52, 59, 65, 78, 91, 104 weeks.]
• Pulmonary ventilation test and Diastolic test [Срок оценки: Pulmonary ventilation test will be performed once before treatment,and at 52, 104 weeks.Diastolic tests will be performed once before treatment.]
• FeNO [Срок оценки: Before treatment,and at 52, 104 weeks.]
• Eosinophils count,Serum total IgE,and T-Lymphocyte Subsets [Срок оценки: Before treatment,and at 7, 52, 59, 104 weeks.]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06777472 · 2024PHB342-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗