REspiratory diSEAse cohoRt Studies of CHinese Medicine for Asthma (RESEARCH- 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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Bronchial 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The purpose of this study is to define the standard use of TCM treatment regimen as the TCM cohort group and the non-TCM cohort group of those who use conventional Western medicine treatment without the standard TCM treatment regimen through a multi-center, large-sample prospective cohort study design. To evaluate the clinical efficacy and safety of TCM treatment regimens in the treatment of bronchial asthma, and to provide high-quality evidence for the promotion and application of TCM syndrome differentiation treatment in bronchial asthma.
Подробное описание
Bronchial asthma is characterized by chronic inflammation of the airways, which is often recurrent, long-lasting and difficult to cure. Clinical studies have confirmed that the clinical symptoms and quality of life of asthma patients have been significantly improved after TCM intervention. However, most of the current clinical research methods on asthma are small-sample and RCT studies, resulting in insufficient demonstration of efficacy, and there is an urgent need to carry out multi-center, large-sample, high-quality real-world studies in order to obtain higher quality evidence-based medical evidence.
This is a multi-center, large-sample prospective cohort study, which will evaluate the clinical efficacy and safety of TCM treatment regimens in the treatment of bronchial asthma, and provide high-quality evidence for the promotion and application of TCM syndrome differentiation therapy in bronchial asthma. The cohort study will enroll 1508 patients, and the standard use of TCM treatment regimen will be set as the TCM cohort group, and those who will use the conventional treatment of Western medicine but not the standard TCM treatment regimen will be the non-TCM cohort group. The asthma control rate was the main outcome index, and the asthma control questionnaire (ACQ), asthma quality of life score (AQLQ), clinical symptom and sign score, lung function, exhaled nitric oxide, induced sputum inflammation phenotype, glucocorticoid dose, and fast-acting β2 agonist dose were the secondary outcome indicators. Follow-up was conducted every 3 months for 1 year.
Первичные конечные точки
- Asthma control rate [Срок оценки: The follow-up period was followed up every 3 months for 1 year.]
Вторичные конечные точки (12)
- Number of exacerbations [Срок оценки: The follow-up period was followed up every 3 months for 1 year.]
- Asthma exacerbation severity [Срок оценки: The follow-up period was followed up every 3 months for 1 year.]
- Change in severity of chronic persistent disease [Срок оценки: The follow-up period was followed up every 3 months for 1 year.]
- The dose used by glucocorticoids [Срок оценки: The follow-up period was followed up every 3 months for 1 year.]
- Rapid-acting beta2 agonists use drugs and doses [Срок оценки: The follow-up period was followed up every 3 months for 1 year.]
- Asthma Control Test (ACT) score [Срок оценки: The follow-up period was followed up every 3 months for 1 year.]
- Asthma Control Questionnaire (ACQ) [Срок оценки: The follow-up period was followed up every 3 months for 1 year.]
- Asthma Quality of Life Score (AQLQ) [Срок оценки: The follow-up period was followed up every 3 months for 1 year.]
- Anxiety Self-Assessment Form (SAS) [Срок оценки: The follow-up period was followed up every 3 months for 1 year.]
- Depression Self-Rating Scale (SDS) [Срок оценки: The follow-up period was followed up every 3 months for 1 year.]
- Pulmonary function [Срок оценки: The follow-up period was followed up every 3 months for 1 year.]
- Exhaled nitric oxide (FeNO) [Срок оценки: The follow-up period was followed up every 3 months for 1 year.]
Критерии участия
Критерии включения
- Patients who meet the diagnosis of bronchial asthma;
- Age 18\~80 years old;
- Have not participated in other clinical studies within 1 month before enrollment;
- Voluntarily participate in the study and sign the informed consent form.
Критерии исключения
- Patients with respiratory failure and mechanical ventilation during acute asthma exacerbation;
- Delirium, impaired consciousness, dementia, and various mental illnesses;
- Patients with other lung diseases such as COPD, lung abscess, cystic fibrosis, bronchiectasis, etc., and severe liver and kidney diseases;
- Patients with neuromuscular diseases that affect respiratory motor function and are unable to complete the six-minute walk test;
- Pregnant and lactating patients;
- Those who are participating in other clinical trials.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine — Чжэнчжоу
Идентификаторы
NCT: NCT06373692 · TCM for Asthma Cohort