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Набор скоро начнётся NCT07352488

Modified Shenling Baizhu Powder for Allergic Asthma With Spleen Deficiency and Dampness Accumulation Syndrome

Без фазы С лечением Allergic 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: Modified Shenling Baizhu Powder, Placebo, Budesonide and Formoterol Fumarate Powder for Inhalation.
Кому может быть актуально
Состояния в реестре: Allergic Asthma. 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
Китай
Следующий шаг
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Официальное название

Effect of Modified Shenling Baizhu Powder on Allergic Asthma With Spleen Deficiency and Dampness Accumulation Syndrome: A Multicenter, Randomized Controlled Trial

Обзор

Allergic asthma is a common allergic disease characterized by a protracted disease course and recurrent episodes, which severely impairs patients' physical and mental health. There is a paucity of high-quality clinical evidence in the treatment of allergic asthma with traditional Chinese medicine (TCM). This study will enroll patients who are persistent allergic asthma with spleen deficiency and dampness accumulation syndrome. A multicenter, randomized, double-blind, placebo-controlled trial design is adopted. The experimental group will receive Modified Shenling Baizhu Powder in addition to Budesonide and Formoterol Fumarate Powder for Inhalation, while the control group will receive a placebo in addition to the same inhalation therapy. Both groups will undergo an 8 week of treatment followed by a 12 week of follow-up. The primary outcome is Asthma Control Test scores, and the secondary outcomes include acute exacerbations, Asthma Control Questionnaire scores, Asthma Quality of Life Questionnaire scores, pulmonary function, airway inflammatory markers, clinical symptom scores, serum inflammatory markers, immune markers, and use of controller medications.

Вмешательства

  • Препарат Modified Shenling Baizhu Powder
    Modified Shenling Baizhu Powder will be taken twice daily.
  • Препарат Placebo
    The placebo will be taken twice daily.
  • Препарат Budesonide and Formoterol Fumarate Powder for Inhalation
    Budesonide and Formoterol Fumarate Powder for Inhalation will be taken twice daily.

Первичные конечные точки

  • Asthma Control Test scores [Срок оценки: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.]
Вторичные конечные точки (9)
  • Acute exacerbation [Срок оценки: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.]
  • Asthma Control Questionnaire scores [Срок оценки: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.]
  • Asthma Quality of Life Questionnaire scores [Срок оценки: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.]
  • Pulmonary function [Срок оценки: At baseline, week 8 of treatment, and week 12 of follow-up.]
  • Airway inflammatory markers [Срок оценки: At baseline, week 8 of treatment, and week 12 of follow-up.]
  • Clinical symptom scores [Срок оценки: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.]
  • Serum inflammatory markers [Срок оценки: At baseline, week 4 and week 8 of treatment.]
  • Immune markers [Срок оценки: At baseline, week 4 or week 8 of treatment.]
  • Use of controller medications [Срок оценки: At baseline, week 4 and week 8 of treatment, and week 12 of follow-up.]

Критерии участия

Критерии включения

  • Patients who are persistent allergic asthma.
  • Patients who meet the diagnostic criteria for the spleen deficiency and dampness accumulation syndrome.
  • Patients who are aged between 18 and 80 years.
  • Patients who voluntarily accept the treatment and sign the informed consent form.

Критерии исключения

  • Patients who have chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, allergic bronchopulmonary aspergillosis, eosinophilic granulomatosis with polyangiitis , active pulmonary tuberculosis, or pulmonary embolism, etc.
  • Patients who have severe cardiovascular or cerebrovascular diseases.
  • Patients who have severe liver or kidney diseases.
  • Patients who have a history of tumor.
  • Patients who have cognitive impairment or psychiatric disorders.
  • Patients who are pregnant or breastfeeding.
  • Patients who are allergic to medication(s) used.
  • Patients who participated in another clinical trial within one month prior to enrollment.

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

Китай · 3 центра
  • The First Affiliated Hospital of Henan University of Chinese Medicine — Чжэнчжоу
  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine — Цзинань
  • Hangzhou Third People's Hospital — Ханчжоу

Идентификаторы

NCT: NCT07352488 · 2024YFC3505302

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗