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Идёт набор NCT07632352

Evaluation of Clinical Effect of Acupuncture on Acute Exacerbation of Bronchial Asthma

Без фазы С лечением Bronchial Asthma

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, Standard Western medicine treatment.
Кому может быть актуально
Состояния в реестре: Bronchial Asthma. Базовые параметры: от 18 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
Китай
Следующий шаг
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Официальное название

Evaluation of Clinical Effect of Acupuncture on Acute Exacerbation of Bronchial Asthma Based on Biological Holography Theory

Обзор

Based on the bioholographic theory, this study preliminarily explores the clinical efficacy of hand acupuncture in treating acute exacerbation of bronchial asthma and evaluates its immediate anti-asthmatic effect, so as to provide a new therapeutic strategy for the clinical management of bronchial asthma.

Подробное описание

This study adopted a randomized controlled trial design, with patients in the acute exacerbation phase of bronchial asthma as the research subjects. A total of 72 patients who met the inclusion criteria were randomly divided into the acupuncture group and the control group in a 1:1 ratio. The control group received standard Western medicine treatment, while the acupuncture group was given acupuncture treatment based on biological holography theory in addition to the standard Western medicine treatment. The acupoints selected were Kechuan point, New Kechuan point, and Yuji point. The treatment was administered once a day for 20 minutes each time, for 5 consecutive days, with a 3-month follow-up. The therapeutic efficacy of manual acupuncture in treating acute exacerbation of bronchial asthma was evaluated with indicators including symptom and sign scores, pulmonary function, ACT , mMRC , Mini-AQLQ scale, serum interleukin-4 (IL-4), serum eotaxin and specific immunoglobulin E (SIgE). In addition, the underlying therapeutic mechanism was preliminarily explored to formulate a technical protocol for rapid anti-asthma acupuncture, laying a foundation for long-term and objective efficacy evaluation of this therapy.

Вмешательства

  • Другое Acupuncture
    The acupoints selected were Kechuan point, New Kechuan point, and Yuji point. The treatment was administered once a day for 20 minutes each time, for 5 consecutive days.
  • Препарат Standard Western medicine treatment
    Evaluate and manage in accordance with the Chinese Expert Consensus on Assessment and Management of Acute Exacerbation of Bronchial Asthma issued by the Asthma Group of the Chinese Thoracic Society, Chinese Medical Association in 2018 and the Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 ).

Первичные конечные точки

  • Peak Expiratory Flow(PEF) [Срок оценки: After treatment on Day 5 and follow-up at 1, 2 and 3 months]
  • Asthma Control Test [Срок оценки: After treatment on Day 5 and follow-up at 1, 2 and 3 months]
Вторичные конечные точки (7)
  • Forced expiratory volume in first second/pred（FEV1%pred） [Срок оценки: After treatment on Day 5 and follow-up at 1, 2 and 3 months]
  • Clinical Symptom and Sign Score [Срок оценки: After treatment on Day 5 and follow-up at 1, 2 and 3 months]
  • Mini Asthma Quality of Life Questionnaire（Mini-AQLQ) [Срок оценки: After treatment on Day 5 and follow-up at 1, 2 and 3 months]
  • modified Medical Research Council (mMRC) [Срок оценки: After treatment on Day 5 and follow-up at 1, 2 and 3 months]
  • Interleukin 4 (IL-4) [Срок оценки: After treatment on Day 5]
  • Eotaxin [Срок оценки: After treatment on Day 5]
  • IgE [Срок оценки: After treatment on Day 5]

Критерии участия

Критерии включения

  • Patients meeting the Western medicine diagnostic criteria for acute exacerbation of bronchial asthma
  • Aged ≥ 18 years old
  • Voluntarily receive treatment and sign the informed consent form

Критерии исключения

  • Those who fail to meet the inclusion criteria
  • Patients suffering from other severe systemic diseases such as diseases of the circulatory system, hematological system and nervous system
  • Pregnant or lactating women
  • Subjects enrolled but not treated per the study protocol
  • Patients who have participated in other clinical trials of medicinal products within 3 months
  • Other circumstances deemed ineligible for enrollment by researchers

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
Лечение

Центры проведения

Китай · 1 центр
  • the First Affiliated Hospital of Henan University of Chinese Medicine — Чжэнчжоу

Идентификаторы

NCT: NCT07632352 · TCM for BA

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗