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Набор скоро начнётся NCT06869525

Study on Acupuncture Treatment of Chronic Airway Diseases(Asthma and Chronic Obstructive Pulmonary Disease)

Без фазы С лечением COPD Exacerbation Acute Asthma Acute

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Acupuncture, Sham Acupuncture.
Кому может быть актуально
Состояния в реестре: COPD Exacerbation Acute, Asthma Acute. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Study on the Efficacy and Mechanism of Acupuncture in the Acute Stage of Chronic Airway Diseases (Asthma and Chronic Obstructive Pulmonary Disease)

Обзор

For patients in the acute phase of chronic airway diseases, on the basis of guideline-directed treatment, the experimental group was given acupuncture treatment, while the control group was given sham acupuncture treatment. The treatment lasted for one week, followed by a 13-week follow-up. For asthma and COPD, PEF and CAT were respectively used as the primary outcome measures to evaluate the clinical efficacy and safety of acupuncture. Based on the improvement of the primary outcome measures, the advantageous population was identified. The mechanism by which acupuncture reduces airway mucus hypersecretion was preliminarily explained.

Подробное описание

This study was a multicenter, randomized, double-blind, controlled trial. A total of 336 patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) and 240 patients with acute attack of asthma were included. On the basis of guideline-directed treatment, the experimental group received acupuncture treatment, while the control group was given sham acupuncture treatment. For patients with AECOPD, the acupoints selected were Zhongfu, Dingchuan, Tiantu, Fenglong, and Feishu. For patients with acute attack of asthma, the acupoints selected were Dingchuan, Zhongfu, Tiantu, Feishu, and Kongzui. The acupoints were connected to electroacupuncture and treated for 30 minutes. The control group received sham acupuncture treatment. The acupoints were located 5 to 10 mm away from the actual acupoints, and the needles were inserted superficially through the skin. The acupoints were connected to electroacupuncture but without electricity. The treatment lasted for 30 minutes, once a day, for one week. Follow-up was conducted for 13 weeks. For COPD, the COPD Assessment Test (CAT) was the primary outcome measure, and the secondary outcome measures included the mMRC scale, assessment of airway mucus hypersecretion, CT assessment of airway mucus, basic vital signs, clinical symptom scores, use of control medications and antibiotics, acute exacerbation status, hospitalization time, tracheal intubation rate, and arterial blood gas. For asthma, the peak expiratory flow (PEF) was the primary outcome measure, and the secondary outcome measures included the Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), Asthma Quality of Life Questionnaire (AQLQ), assessment of airway mucus hypersecretion, CT assessment of airway mucus, basic vital signs, clinical symptom scores, use of control medications and antibiotics, acute attack status, hospitalization time, and fractional exhaled nitric oxide (FeNO). The clinical efficacy and safety of acupuncture were evaluated. The population with advantages was identified based on the improvement of the primary outcome measures. The mechanism of acupuncture in reducing airway mucus hypersecretion was preliminarily explained.

Вмешательства

  • Поведенческое Acupuncture
    Dingchuan, Shanzhong, Tiantu, Feishu, Kongji, after obtaining qi, connect the electric needle (continuous wave, The frequency was 2Hz, the current intensity was 1\~5mA, and the current intensity was gradually increased according to patient tolerance), and the treatment was 30min.
  • Поведенческое Sham Acupuncture
    Dingchuan, Shanzhong, Tiantu, Feishu, hole the most points open 5\~10mm, shallow piercing through the skin, connected with the electric needle but no electricity, treatment 30min.

Первичные конечные точки

  • Astham part: PEF [Срок оценки: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up]
  • COPD part:CTA [Срок оценки: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up]
Вторичные конечные точки (12)
  • Astham part: the Asthma Control Test (ACT) [Срок оценки: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up]
  • Asthma part:Asthma Control Questionnaire(ACQ) [Срок оценки: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up]
  • Asthma part:Asthma Quality of Life Questionnaire(AQLQ) [Срок оценки: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up]
  • Asthma part:The cough and expectoration assessment questionnaire (CASA-Q) [Срок оценки: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up]
  • Asthma part:Evaluation of Airway Mucus Hypersecretion [Срок оценки: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up]
  • Asthma part:Evaluation of Airway Mucus by CT Imaging [Срок оценки: Before treatment, and day 7]
  • Asthma part:Clinical symptom score [Срок оценки: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up]
  • Asthma part:Acute attack status [Срок оценки: Follow-up at the 4th and 13th weeks]
  • Asthma part:Hospitalization time [Срок оценки: At 4 weeks of follow-up]
  • Asthma part:Fractional exhaled nitric oxide (FeNO) [Срок оценки: Before treatment, and day 7]
  • COPD part:clinical symptoms and signs questionnaire [Срок оценки: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up]
  • COPD part:mMRC [Срок оценки: Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up]

Критерии участия

Критерии включения

  • Meets the diagnostic criteria for acute attack of asthma/AECOPD;
  • Age range from18 years to 80 years(asthma) and 40 yesrs to 80 years(COPD);
  • The investigators agreed to participate in this clinical study by voluntarily signing an informed consent form.

Критерии исключения

  • Patients with combined pulmonary abscess, pulmonary interstitial fibrosis, active pulmonary tuberculosis, bronchiectasis and other pulmonary diseases;
  • Patients with severe cardiovascular and cerebrovascular diseases (such as malignant arrhythmia, unstable angina pectoris, acute myocardial infarction, grade 3 or above cardiac function, stroke, cerebral hemorrhage, etc.);
  • Patients with severe liver diseases (such as liver cirrhosis, portal hypertension and bleeding caused by esophageal and gastric fundus varices) and severe kidney diseases (such as dialysis, kidney transplantation, etc.);
  • Patients with impaired consciousness or various mental disorders who are unable to communicate normally;
  • Pregnant and lactating women;
  • Those who are currently participating in other clinical trials within 1 month before enrollment;
  • Patients with contraindications to acupuncture (such as severe allergic or infectious skin diseases);

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Zhu S, Yang Q, Zhang P, Xu J, Li S, Xie Y. Efficacy of electroacupuncture in the treatment of Acute Exacerbation of Chronic Obstructive Pulmonary disease: study protocol for a multicenter, randomized, sham-controlled trial. Front Med (Lausanne). 2026 Jul 13;13:1879332. doi: 10.3389/fmed.2026.1879332. eCollection 2026. PMID 42517050

Идентификаторы

NCT: NCT06869525 · TCM for Chronic Airway Disease

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗